Executive Summary - Australian Government … · Web viewGroup 9 products represent the largest financial impost on the scheme overall and make-up 24% of the SAS’s cost in 2012-13,

A literature review and background analysis to support the review of accessory products listed under Group 9 of the Stoma Appliance Scheme

Schedule

Prepared for the Australian Government Department of Health

by the Centre for Health Services Research, University of Tasmania

May 2014

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A C K N O W L E D G E M E N T S

This project is funded by the Australian Government Department of Health. The information and opinions contained in it do not necessarily reflect the views or policy of the Australian Government or the Department of Health.

Disclosures: Dr Kelly Shaw and Dr Paul Woodhouse are senior consultants with KP Health.

C I T A T I O N

Roberts A, Shaw K, Woodhouse P. A literature review and background analysis to support the review of accessory products listed under Group 9 of the Stoma Appliance Scheme Schedule: a report prepared for the Australian Government by the Centre for Health Services Research, University of Tasmania. May 2014.

Centre for Health Services ResearchSchool of MedicineUniversity of TasmaniaLevel 1, Medical Science 117 Liverpool StreetHobart TAS AustraliaT +61 3 6226 4757F +61 3 6226 4816W http://www.utas.edu.au/medicine/medicine/research/chsr

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TABLE OF CONTENTS

Executive Summary.................................................................................................................5

Key findings..........................................................................................................................5

Conclusions..........................................................................................................................7

Introduction..............................................................................................................................8

This project...........................................................................................................................8

This report..........................................................................................................................11

The context for stoma accessory use....................................................................................11

Use of accessories in stoma management.........................................................................13

Project methods.....................................................................................................................17

Project results........................................................................................................................18

The effectiveness of Group 9 accessories.........................................................................18

The cost-effectiveness of Group 9 accessories..................................................................21

Discussion..............................................................................................................................36

Appendix 1 - A systematic review of the peer-reviewed and 'grey' literature.........................45

Criteria for considering publications for inclusion...............................................................45

Databases searched...........................................................................................................45

Criteria for inclusion and exclusion of studies....................................................................48

Critical appraisal and data extraction.................................................................................49

Assimilation and interpretation of the body of evidence.....................................................50

Evidence statements for peer-reviewed studies.................................................................50

Part A: Results from the peer-reviewed literature..................................................................51

Level of evidence of included references...........................................................................53

Systematic reviews identified in the peer-reviewed literature.............................................53

Other publications identified in the peer-reviewed literature..............................................55

1. Skin care and protection accessories................................................................................56

2. Stoma support garments....................................................................................................62

3. Cleansers and adhesive removal accessories...................................................................65

4. Deodorisers and gas suppressants....................................................................................68

5. Skin fillers and adhesive products......................................................................................71

Summary of the main results from the peer-reviewed literature.........................................75

Overall completeness and applicability of the evidence.....................................................75

Quality of the evidence.......................................................................................................75

Potential biases in the systematic review process.............................................................76

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Conclusions........................................................................................................................76

Part B - Results from the 'grey' literature...............................................................................77

'Grey' literature database searches....................................................................................77

Position papers...................................................................................................................78

Guidelines and best practice manuals................................................................................78

International stoma schemes..............................................................................................82

Conclusions........................................................................................................................89

Attachment 1 (Appendix 1): Characteristics of excluded publications................................90

Attachment 2 (Appendix 1): Included 'grey' literature.........................................................93

Attachment 3 (Appendix 1): References from peer-reviewed literature review..................96

Appendix 2 - Analysis of available financial information regarding Group 9 products.........102

Introduction.......................................................................................................................102

Sub-group price comparison............................................................................................103

Financial studies identified in searches of peer-reviewed literature.................................126

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Executive SummaryThe Stoma Appliance Scheme (SAS) is an Australian Government program that assists eligible people with stomas to better manage their condition by providing subsidised access to a range of different stoma-related products.

The Department engaged the Centre for Health Services Research, University of Tasmania, to perform a literature review and background analysis to support the SAS Schedule Group 9 - Accessories Review. Group 9 of the Schedule is a collection of miscellaneous products used to support the clinical management of both paediatric and adult patients with a stoma.

Evidence about Group 9 SAS products was compiled from all identifiable information sources in order to describe the clinical appropriateness and relevance of these products for any described outcome in patients with a stoma. The project methods comprised:

A systematic review of the peer-reviewed literature;

A systematic review of the 'grey' literature; and

An analysis of available financial information regarding Group 9 products.

Key findings

We identified a small, methodologically limited body of evidence regarding the effectiveness of stoma accessories. As a result, firm conclusions about the effectiveness and cost-effectiveness of Group 9 products cannot be drawn from the available literature.

Our comprehensive search of the peer-reviewed literature identified 13 references. Accessories for which outcomes information was available included skin care and protection accessories (five studies), stoma support garments (one study), cleansers and adhesive removal accessories (three studies), deodorisers (one study) and skin fillers and adhesive products (five studies). Some publications provided information regarding more than one class of accessory. The effectiveness of all sub-groups of accessories within Group 9 of the Schedule was unable to be determined from the available studies.

The level of evidence of included studies was generally low and the quality of included studies was poor. One study was a systematic review that included randomised controlled trials (RCTs); however this study did not identify RCTs that were relevant to Group 9 accessories in spite of searching for relevant RCTs. In addition, we identified one RCT, one nested diagnostic study conducted within a cohort study and one case series. All other studies were not able to be rated against the National Health and Medical Research Council's levels of evidence.

Our search of the 'grey' literature identified 27 materials of broad relevance to stoma accessories. Of these, 11 publications were documentation from international stoma schemes, nine publications related to accessory product pricing, three publications were guidelines / best practice manuals, two publications were consensus statements and two publications were position papers. These materials provided information regarding stoma schemes in other countries including product costs, limits in quantities of Group 9 accessory

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products supplied to consumers in other countries and guidelines that are in place in other countries to inform use of Group 9 accessories.

Guideline developers internationally confirm the results of our systematic review and have also noted a paucity of published studies of the effectiveness of stoma accessories. Published guidelines are based largely on the opinions of clinicians in the stoma field rather than on empirical evidence. Further, industry sponsorship of panel members involved in developing guidelines is common and introduces a significant risk of bias in the guideline development process.

In the absence of data regarding the effectiveness of accessories, cost-effectiveness of these products is unable to be assessed. We therefore conducted a comparative analysis of SAS accessory costs compared with other domestic and international product schemes. Our analysis demonstrates that sub-groups of accessories on the SAS Schedule split neatly into two categories in terms of the overall cost of the sub-group and the growth in costs over the past five years. The first category are the sub-groups with a high total cost, high growth and dynamic changes in market share of products within the sub-group (adhesive barriers (a), adhesive removers / cleansers and adhesive removal (d), hernia belts (h), protective films (k) and seals (l)). The second category comprises the sub-groups with lower total cost, low annual growth and stable product mixes.

We identified that new products are more commonly introduced in the high cost, high growth sub-groups and quickly achieve a significant share of the product market. This was in spite of an absence of published studies in the public domain that demonstrate the effectiveness of the new product. Further, there were no studies of comparative effectiveness that indicate substitution of an established product with a newer product is justified by published evidence of improved effectiveness of the newer product.

We found that the SAS price of some high cost products exceeds international comparator product costs. There are five products from sub-group seals (l), three in adhesive barriers (a), one in adhesive removers / cleansers and adhesive removal (d), one in hernia belts. The international comparator cost for these products is $1.9 million less in total than the SAS cost in 2012-13 dollars and suggest that cost savings may be achieved through achieving a purchase price for these products that is equivalent to the product price in comparator schemes.

Limits to the quantity of Group 9 accessories provided to consumers are specified in the SAS Schedule. Some international stoma guideline documents also specify limits to the quantity of stoma products that are provided to consumers. Overall, limits to product quantities specified in the SAS Schedule are consistent with limits in international schemes. No studies were identified that indicated product limits were inappropriate or had any adverse impact on patient outcomes.

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Conclusions

We formulated the following conclusions regarding the effectiveness and cost-effectiveness of Group 9 accessories on the SAS Schedule and how these may be determined into the future.

Conclusion 1

A requirement for level 2 evidence or higher for the listing of new accessory products on the Group 9 SAS Schedule would enable a more detailed assessment of the effectiveness and cost-effectiveness of Group 9 accessories to be performed into the future.

Conclusion 2

A review of current purchasing arrangements for high cost products with a comparator price that is lower than the current SAS price would confirm that the purchasing arrangements for these products are efficient.

Conclusion 3

Limits to product quantities specified in the SAS are consistent with limits in international schemes.

Conclusion 4

There is an absence of evidence that Group 9 accessory products are either effective or ineffective, and therefore insufficient information to suggest changes to the range of accessory product types on Group 9 of the SAS based on this review alone.

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IntroductionThe Stoma Appliance Scheme (SAS) is an Australian Government program that assists eligible people with stomas to better manage their condition by providing subsidised access to a range of different stoma-related products.

The SAS commenced operation in 1975 and is legislated under Section 9A of the National Health Act (1953).

The Australian Government Department of Health ('the Department') and the Department of Human Services administer the SAS on behalf of the Australian Government. The Department has overall policy responsibility for the Scheme and manages the SAS Schedule and the product application and assessment process. It also provides secretariat support for the Stoma Product Assessment Panel (SPAP), the Department’s independent technical advice panel.

Subsidised stoma-related products are distributed via 22 regional stoma associations in Australia.

This project

The Department engaged the Centre for Health Services Research, University of Tasmania, to perform a literature review and background analysis to support the SAS Schedule Group 9 - Accessories Review. The objective of the SAS Group 9 Review is to examine the accessories listed under Group 9 of the SAS Schedule to assess their clinical appropriateness, cost effectiveness and relevance to the SAS.

Group 9 of the Schedule is a collection of miscellaneous products used to support the clinical management of both paediatric and adult patients with a stoma. The group can be broadly categorised into the following product types (Table 1):

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Table 1: Products in Group 9 of the ScheduleCategory Indication Product type9a and 9f and 9k Skin care and protection Protective sheets

Elastic tapeStrips to picture frame skin barriersBarrier creamsConditioning creamProtective pastesEmollient creamsProtective barrier wipesProtective barrier sprayProtective barrier film

9b and 9h Stoma support garments Stoma support belts / briefsHernia support garmentsStoma and hernia support garmentsAbdominal support garments / belts

9c Clamps & clips ClampsClips

9d Cleanser & adhesive removal WipesSprayLotionsLiquids

9e Convexity inserts Convex seal inserts9g Deodorisers and gas suppressants Deodoriser drops

Deodoriser liquidsLubricating deodorantsGas suppressant tabletsGas suppressant liquids

9i Night drainage Taps

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Category Indication Product typeDrainage outletsDrainage bags

9j Skin fillers and adhesive products Stomadhesive pasteStomadhesive powderSkin filling pasteMoisture-absorbing powderProtective stoma paste

9l Seals Stoma sealsStoma ringsStoma collarsCushioning and sealing dressingsBarrier ringsBarrier seals

9m Miscellaneous Carbon filtersAbsorbent powderVelcro bandsThickening agentsAdhesive aerosol spray

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This report

Evidence about Group 9 SAS products was compiled from all identifiable information sources in order to describe the effectiveness and cost-effectiveness of these products for any described outcome in patients with a stoma. The evidence was identified and critically appraised through:

A systematic review of the peer-reviewed literature;

A systematic review of the 'grey' literature; and

An analysis of available financial information regarding Group 9 products.

This is the report of the review.

The context for stoma accessory useA stoma, also known as an ostomy, is a surgically created opening onto the abdominal wall to allow the exit of faeces and / or urine. There are three main types of stomas1:

A colostomy is formed from the colon (large bowel/intestine). The colostomy is often formed in the left iliac fossa. The output is often formed stool and flatus.

An ileostomy is made from the ileum (small bowel). The ileostomy is generally formed in the right iliac fossa. The faeces will be more liquefied than a colostomy output, which is often described as a porridge consistency—flatus will also be passed.

A urostomy (or ileal conduit) is frequently formed in the right iliac fossa. The urostomy is usually formed from the ileum, but is used to pass urine and not faeces.

A stoma can be temporary or permanent. Stomas are required for paediatric or adult patients due to diseases (including cancer and inflammatory bowel disease), injury, birth defects or other causes2.

People who have a stoma require stoma appliances and accessories for the ongoing care and maintenance of their stoma. In Australia these are largely accessed through a funded national program: the SAS. In 2008-09 there were approximately 37,000 ostomates (people with a stoma) in Australia who received products under the SAS3.

To be eligible for SAS products, an ostomate must become a member of a stoma association. The volunteer stoma associations purchase stoma related products from suppliers and distribute to their members as required. Total Australian Government

1 Burch J, Sica J. Common peristomal skin problems and potential treatment options. British Journal of Nursing 2008;17(17):S4, S6, S8 passim. Epub 2008/10/25.2 Burch J, Sica J. Common peristomal skin problems and potential treatment options. British Journal of Nursing 2008;17(17):S4, S6, S8 passim. Epub 2008/10/25.3 Deloitte Access Economics. Deloitte report on the economic impact of incontinence in Australia. 2011.

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Australian Government expenditure on the SAS was $67 million in 2008-09 and $72. million in 2009–104.

The stomal care needs of ostomates change over time. In the immediate post-operative period, patients usually wear a clear bag, so that the stoma can be seen. This enables staff and the patient to check for complications that may occur, including necrosis of the bowel used to form the stoma. In the post-operative period the appliance used for a colostomy or ileostomy often does not have a filter. No filter in the appliance allows the nurse and ostomate to see when flatus is passed5.

Once discharged, the patient enters a maintenance phase in the care of their stoma. Some ostomates continue to use a clear appliance once they are discharged home into the community. Alternatively the ostomate may choose an opaque or patterned appliance. This is supplemented with the use of accessories to facilitate achieving positive outcomes for patients. Stoma accessories are used in conjunction with stomal appliances to maintain peristomal skin integrity and promote pouch reliability, thereby increasing patients' confidence in their stoma management. There are a multitude of stoma accessories that are used in conjunction with stoma appliances, the types of which are described below.

The ideal outcome for patients with a stoma is that they reach the optimal level of rehabilitation and return to their normal day-to-day activities, while being able to manage their stoma without disruption and reliance on excessive routine.

The equipment needs of ostomates vary between patients and according to stoma type. Indicative average use of stoma supplies by an ostomate are provided at Table 2.

Table 2: Average use of stoma supplies6

One piece appliance Two piece applianceColostomy 2 bags a day 2-3 flanges a week

2 bags a dayIleostomy 1 bag a day 2-3 flanges a week

1 bag a dayUrostomy 1 bag a day 2-3 flanges a week

1 bag a day1 night bag a week

Night bag 1 bag a weekAccessories (if needed):Adhesive remover

2-3 a month

4 AIHW. Incontinence in Australia: prevalence, experience and cost. 2012.5 Burch J. An update on available stoma appliances in the community. British Journal of Community Nursing. 2009;14(4):146.6 Black P. Stoma care nursing management: cost implications in community care. British Journal of Community Nursing. 2009;14(8):350.

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One piece appliance Two piece applianceSkin protector 2-3 a month

Use of accessories in stoma management

A stoma accessory is defined as 'any product used in addition to a stomal appliance'7.

Ostomates may manage independently without needing to use the wide array of accessories available on the market. However, there are a subgroup of patients for whom accessories enable greater independence and improved management of their stoma - an estimated one in three patients has a problematic stoma that requires the use of one or more accessories to keep them clean and dry for a period of 24 hours8 and between 39% and 55% of people with a stoma will experience problems at some time that necessitate the use of stoma accessories9.

Clinical decisions regarding the use of accessories are guided by the ability of the individual patient to use them, and also take into account10:

the condition of peristomal skin;

the likelihood of increased skin sensitivity and with it an increased probability of further problems;

the type of stoma/fistula and the nature of its output; and

the patient’s ability to use the products.

Indications for the use of accessories vary according to stoma care nurses and patients (Table 3)11:

Table 3: Indications for the use of accessories, according to stoma care nurses and patients

Stoma care nurses Patients

Sore skin

Peristomal moats and dips

Damage to skin

Leakage around the stoma

Sore skin

Damage to skin

Enhancing pouch security

Pain on removal of appliance

7 Rudoni C, Dennis H (2009) Accessories or necessities? Exploring consensus on usage of stoma accessories. Br J Nurs 18(18): 1106–1128 Cottam J, Richards K (2006) National audit of stoma complications within 3 weeks of surgery. Gastrointestinal Nursing 4(8): 34–9.9 Lyon CC, Beck MH (2001) Irritant reactions and allergy. In: Lyon CC, Smith AJ, eds. Abdominal Stomas and their Skin Disorders. Martin Dunitz, London. 10 Borwell B, Breckman B (2005) Practical management of bowel stomas. In: Breckman B, ed. Stoma Care and Rehabilitation. Churchill Livingstone, Edinburgh.11 Rudoni C, Dennis H. Accessories or necessities? Exploring consensus on usage of stoma accessories. British Journal of Nursing. 2009;18(18):1106.

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Stoma care nurses Patients

Pain on removal of appliance Odour

Ideally, patients using stoma accessories are assessed intermittently with regard to their ongoing need for accessories because of the financial constraints faced by the health service and the resultant costs associated with the use of accessories on health system budgets12.

Different categories of stoma accessories have different functions. Broadly, these can be described as products for13:

leakage prevention;

adhesive removal;

skin protection;

adhesion assistance;

support and protection; and

odour elimination.

Leakage prevention and management14: Seals (also termed washers), filler paste (available in tubes or strips) and belts may be used by providers to prevent and / or manage a leaking appliance. Seals and filler paste may be used to ‘fill’ skin dips or creases and are used under the flange. A seal is circular in shape and may be used directly around the stoma or broken into pieces to fill creases. Filler paste may be used in the same way. A belt may be used to more securely hold the appliance to the abdomen.

Adhesive removal15: Adhesive removers are available in wipes and sprays and may be used to help remove appliances. For ostomates with fragile or damaged skin, an adhesive remover may be used to reduce trauma or pain associated with appliance removal. Adhesive removers may also be used to remove the adhesive left on the abdomen by the appliance. This may collect the fluff from clothes and leave an unsightly ring on the abdomen. Alternatively, patients may use a damp cloth to assist in appliance removal. Instead of an adhesive remover, a small amount of soap may be used to remove residual adhesive but this may dry the skin.

Skin protection16: Accessories may be used to protect the peristomal skin. These are available as protective films, wipes, creams, sprays and protective powders. 12 Boyles A. Keeping up to date with stoma care accessories: Enabling informed choice. Gastrointestinal Nursing. 2010;8(6).13 Boyles A. Keeping up to date with stoma care accessories: Enabling informed choice. Gastrointestinal Nursing. 2010;8(6).14 Burch J. Resuming a normal life: holistic care of the person with an ostomy. British Journal of Community Nursing. 2011b;16(8):366-73. Epub 2011/08/16.15 Ibid16 Ibid

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Peristomal skin may be treated with a protective film if it is at risk of damage due to appliance leakage. Broken peristomal skin may be managed using protective powder to help to ‘dry’ and protect the skin prior to an appliance being adhered to the abdomen. Barrier creams may be used on the peristomal skin to add protection and provide moisture to dry skin that is potentially at risk of cracking or breaking down. Barrier creams may also be used on perianal skin following reversal of a stoma, to protect the skin around the anus.

If the stomal output comes into contact with the skin, skin breakdown may occur. This is particularly evident in ileostomies or urostomies because urine and loose faeces are more corrosive on the skin than the more formed stool passed from the colostomy. To protect the peristomal skin, barrier wipes or sprays may be used. These are applied after the peristomal skin is cleaned and dried. Barrier sprays or wipes either protect skin that is red but intact, or protect healthy peristomal skin that is at risk of becoming damaged (i.e. if the patient has a known high output from his/her stoma).

Protective powder may be used to protect wet, weeping peristomal skin.

Adhesion assistance17: If an appliance is not adhering adequately to the skin this might lead to appliance leakage or seepage of the stoma effluent under the flange. Both may result in sore skin, discomfort and possibly embarrassment if the appliance leaks. There are a number of stoma accessories that may be used to aid adhesion.

Stoma filler paste may be used to improve adhesion or to ‘level’ skin for the flange to adhere more securely. The paste comes in two forms; either in a tube, which may be ‘squeezed’ into the appropriate area, or in strips that may be ‘ripped’ into the correct size and placed in the area of leakage (i.e. a skin crease).

Seals are generally used directly around the stoma to protect the skin by giving greater adhesive properties or to level the skin in that area to improve adhesion. Seals also allow the stoma flange to remain in place for longer periods of time before skin damage occurs, extending the length of time the appliance may be worn and reducing the number of appliance changes required. Some ostomates have a ‘moat’ or ‘dip’ below the stoma, and in this case a seal cut in half may be used in the dip to level the skin.

Specialist adhesives are also available for appliance flanges that do not adhere with adequate strength to the abdomen. These are used directly on the back of the flange to increase the adhesive properties.

Some stomas are large in diameter and thus the aperture in the flange also needs to be large. Although there is always a few centimetres of flange left outside the cutting area, for some ostomates there may be concerns about the flange securely adhering to the abdomen. Other ostomates may have stomas near abdominal creases and the outer edge of the flange might not adhere well. In these situations the use of a flange extension may be used.

17 Burch J. Resuming a normal life: holistic care of the person with an ostomy. British Journal of Community Nursing. 2011b;16(8):366-73. Epub 2011/08/16.

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Many of the flanges, particularly the convex appliances, have two small ‘hooks’ on the edge of the appliance. These are used, if necessary, to clip a thin elastic belt to. These thin belts are used to secure a stoma shield to the abdomen.

Support and protection18: Support belts may be used for ostomates with a parastomal hernia. Both small and large hernias may cause a ‘dragging’ sensation of the abdomen. Supporting the hernia may make it less obtrusive, more comfortable and more discreet. Support belts need to be specifically measured for the ostomate by the stoma specialist nurse

Ostomates may use a stoma shield to prevent inadvertent damage to their stoma. The shield is applied on top of the stoma appliance and held in position with a thin elastic belt. Some ostomates also use a stoma shield to prevent stoma prolapse.

Odour elimination19: Ostomates may be concerned about odour from their stoma. Although often the faeces do not smell worse than faeces passed by people anally, the smell may be more evident due to the position of the stoma. Stoma odour-eliminating sprays are designed to eliminate rather than mask odours.

18 Burch J. Resuming a normal life: holistic care of the person with an ostomy. British Journal of Community Nursing. 2011b;16(8):366-73. Epub 2011/08/16.19 Ibid

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Project methodsWe conducted a systematic literature review and background analysis to answer the question: What is the effectiveness and cost effectiveness of accessory products on the Group 9 SAS Schedule?

The project methods are described in detail at Appendix 1 (a systematic review of the peer-reviewed and ‘grey’ literature) and Appendix 2 (analysis of financial information).

In summary, we considered for inclusion any publication that reported on the use of a Group 9 class of product for the management of any patient with a stoma regardless of publication type. We sought publications in children and adults of any age, gender or socio-demographic characteristics with a stoma and that reported any patient relevant outcome (including morbidity, mortality, quality of life, patient satisfaction, cost or any economic metric related to cost). We sought relevant literature only from countries with comparable health systems, including Australasia, Europe and North America.

The databases that were used to obtain relevant publications were MEDLINE via Pubmed; EMBASE; CINAHL via Ebsco and the Cochrane Library. The findings of the above search strategy were supplemented with a systematic search of the 'grey' literature using Google; Google Scholar; OpenSIGLE; and Bing to identify position papers; other literature reviews; information on international stoma schemes; suppliers’ websites and domestic and international guidelines and best practice manuals. The search terms used and findings from these searches are reported at Appendix 1.

We also examined national and international stoma schemes and product prices of relevance to the review and analysed financial information provided by the Department. The findings from these searches are reported at Appendix 2 - an analysis of available financial information regarding Group 9 products.

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Project results

The effectiveness of Group 9 accessories

The findings from the systematic review of peer-reviewed and ‘grey’ literature are reported in full at Appendix 1.

Findings from the peer-reviewed literature

We identified a small, methodologically limited body of evidence. Firm conclusions about the effectiveness and cost-effectiveness of Group 9 products cannot be drawn from the studies that were identified.

Our comprehensive search of the peer-reviewed literature regarding stoma accessories identified 2,548 records. Of these 465 were excluded as they were duplicate records, 2,009 were excluded at the abstract stage and 61 full text articles were excluded.

Reasons for excluding abstracts were:

not a human study (11 abstracts);

participants did not have a stoma (1,649 abstracts);

publication not relevant to any patient outcome (morbidity, mortality, quality of life, patient satisfaction, cost or any economic metric related to cost) (312 abstracts); and

publication not from a country with a comparable health system i.e. not Australasia, Europe or North America (37 abstracts).

Reasons for exclusion of full text records were:

no patient relevant outcomes were reported (35 articles);

the article was not relevant to a Group 9 product (21 articles);

the article referred to previously published (and included) data (three articles);

participants did not have a stoma (one article); and

the article was a narrative discussion about unpublished data (one article).

This resulted in a total of 13 references that were identified by the above search strategy and were included in the systematic review of the literature. The types of Group 9 products that were the subject of included studies were skin care and protection accessories (five studies), stoma support garments (one study), cleansers and adhesive removal accessories (three studies), deodorisers (one study) and skin fillers and adhesive products (five studies).

Five studies reported information about Group 9 skin care and protection accessories. One study reported seven proven allergic reactions to skin wipes and skin gel in 149 patients with unexplained peristomal dermatitis. A product evaluation in over 3,000 patients reported reduced accessory product use with the SenSura

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ostomy appliance. Another product evaluation involving 172 patients and 49 nurses showed high product performance with SurFit Natura mouldable skin barrier protection. A case series of four patients reported reduced peristomal skin problems with the Hollister brand of appliance products. A survey of nurses showed high awareness of nurses of alcohol- and silicone-based skin products and a nurse preference to prescribe silicone products.

One publication described relevant outcomes for stoma support garments. This survey of 322 people with a parastomal hernia reported that 45% of people with stoma support garments used them regularly and 27% thought that these garments were the best way to manage their hernia.

Three publications described outcomes for cleansers and adhesive removal accessories. One cohort study showed three of 149 patients experienced allergic reactions to adhesive removers. A product evaluation of a silicone-based adhesive remover in 54 patients showed silicone-based products improve ease of removal of the stoma bag and improve skin condition. A survey of 363 nurses reported nurses preferred prescribing silicone-based removers to patients who find it painful and / or difficult to remove their pouch.

One publication described relevant outcomes for deodoriser. Patch testing in 149 patients with unexplained dermatitis showed three positive reactions to deodorisers. Two of these patients were using the deodoriser product inappropriately.

Five studies reported patient outcomes associated with skin filler and adhesive products. A survey of 363 nurses showed high nurse awareness of adhesive tape and hydrocolloid products. The majority of nurses recommended hydrocolloid instead of adhesive tape products for patients who require extra adhesion or security. A product evaluation in over 3,000 patients reported reduced skin filler and adhesive use with the SenSura ostomy appliance. One case study reported a positive skin reaction to Gantrez 425 and a second case study reported a positive skin reaction to Dansac 1 soft paste, an ingredient of stomadhesive paste. A final study reported the results of a RCT in 81 patients. Findings from this study demonstrated improved peristomal skin in patients treated with hydrocolloid power versus water cleansing before application of the ostomy appliance.

We identified no studies for clamps, convexity inserts, gas suppressants, night drainage, seals or miscellaneous products not already addressed in the other product groupings.

The level of evidence of included studies was generally low and the quality of included studies was generally poor. One study was a systematic review that included RCTs; however this study did not identify RCTs that were relevant to Group 9 accessories in spite of searching for relevant RCTs (Recalla 2013). This review therefore did not contribute empirical evidence to our systematic review. In addition to this systematic review, we identified one RCT (Park 2011), one nested diagnostic study conducted within a cohort study (Al Niami 2012) and one case series (Thompson 2011). All other studies were not able to be rated using the NHMRC’s levels of evidence.

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Findings from the ‘grey’ literature

We identified 27 publications of broad relevance to Group 9 accessories from the 'grey' literature. These materials provided information regarding stoma schemes in other countries, recommended limits in quantities of Group 9 accessory products supplied to consumers in other countries and guidelines that are in place in other countries to inform use of Group 9 accessories.

Two guidelines informing the use of Group 9 accessory products were identified. The guidelines are based on consensus due to a paucity of published studies. Guidelines identified are limited to the role of accessory products in moisture associated skin disease (MASD). Guidelines by Colwell20 and Gray21 recognise the role of accessory products in improving the seal between the stoma appliance skin barrier and the skin. Guidelines also recognise the need for appropriate use of accessory products and that inappropriate use can result in skin related problems and increased or variant accessory use. However, published guidelines are based largely on the opinion of clinicians in the stoma field rather than empirical evidence. Further, industry sponsorship of panel members involved in developing guidelines introduces a significant risk of bias in the guideline development process.

Three prescribing guidelines for stoma appliances were identified that included Group 9 accessories. All three prescribing guidelines were developed by committees within English NHS Trusts. Consensus guidelines for prescribing have been developed in response to the high and growing cost of stoma accessories with the aim of facilitating more judicious prescribing and use of the products. The prescribing guidelines identified were brief, generally describing products at the category level rather than the product level. In comparing the recommended quantities with those listed on the Australian SAS, where comparators were available, they were broadly consistent.

In comparing the Australian Stoma Appliance Scheme Schedule with schedule information available from other international stoma schemes, similarities exist between the SAS Scheme and NHS Scotland and NHS England and Wales schemes. The three schemes provide an extensive list of stoma care products that are available free of charge (or very low cost) to resident ostomates. Choice of product is supported by Stoma Care Nurses. The Australian SAS Schedule varies from the NHS Price lists as it includes maximum quantity and other product restriction information. Comparative price information is provided in the cost effectiveness of group 9 accessories section of this report.

When comparing the stoma schemes of NHS Scotland and NHS England and Wales with the Australian SAS, the schemes are most divergent in product order and

20 Colwell, JC. MASD Part 3: Peristomal Moisture-Associated Dermatitis and Periwound Moisture-Associated Dermatitis: A consensus. Journal of Wound Ostomy and Continence Nursing. 2011;38(5):541-53.

21 Gray, M. Peristomal Moisture Associated Skin Damage in Adults with Fecal Ostomies: A Comprehensive Review and Consensus. Journal of Wound Ostomy and Continence Nursing. 2013;40(4):389-99.

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distribution methodology. Both NHS schemes require stoma care items to be prescribed by a GP. NHS Scotland also allows items to be prescribed by Specialist Stoma Care Nurses with demonstrated prescribing competency. Prescriptions are dispensed through a Community Pharmacy Contractor, Dispensing GP or Appliance Contractor. Dispense and delivery fees are paid for prescriptions and customisation fees are also payable for eligible products. The NHS dispense and delivery fees are higher than the Australian SAS handling fees paid to stoma associations. The comparison identifies that the SAS has lower order and distribution costs for Government compared with NHS Scotland and NHS England and Wales.

Information pertaining to the evaluation and selection process for stoma care items listed on the NHS Scotland Stoma Appliance Price List and the NHS England and Wales Drug Tariff was not identified in the grey literature search and as such a comparison of product listing process cannot be considered.

The cost-effectiveness of Group 9 accessoriesIn order to assess cost-effectiveness, the cost of a product in monetary terms is assessed against the expected health gain associated with the use of the product. We were unable to establish the effectiveness of Group 9 products. As a result, the cost-effectiveness of these products cannot be determined.

In the absence of sufficient data to assess cost-effectiveness we have compared the SAS Scheme with other stoma appliance schemes and direct purchasing options in countries with similar health systems.

We found that NHS Scotland and NHS England / Wales were sufficiently detailed to enable price comparisons with the Australian Scheme to be performed. We have also reviewed direct pricing in US, Canadian and domestic markets with available (albeit limited) information.

The findings from the analysis of financial information are reported in full at Appendix 2.

Stoma Appliance Scheme – All group comparison

The Department of Health provided five year trend data on the cost impacts of the SAS Group 9 products at the group level and at the cost of individual products which has informed this analysis.

The SAS is divided into 11 product groups, with Group 9 (Accessories) being the subject of this review. Table 4 describes the change in costs for the period 2007-08 to 2012-13.

Group 9 products represent the largest financial impost on the scheme overall and make-up 24% of the SAS’s cost in 2012-13, up from 19% in 2007-08. This change in the relative impact of Group 9 products is reflected in the average annual growth rate of 11.7% since 2007-08, compared with the overall rate of growth of the SAS of 6.3%. With the exception of the Group 11 (Fistula) products which contribute just over 1% of the costs of the scheme, the rate of increase for Group 9 products has been more than 50% higher than any of the other nine groups.

21

This is represented graphically in Figure 1, which shows the relative contributions each Group of products makes to the overall cost of the SAS. It clearly demonstrates the progressive increase in Group 9 costs compared with the other groups.

Table 4: Change in SAS Group costs 2007/08 to 2012/13 (AUD)

Year 2007/08 2008/09 2009/10 2010/11 2011/12 2012/13 Annual growth rate

Group 01 $11,401,09

7

$12,135,02

1

$12,381,18

1

$12,971,697 $14,842,97

0

$16,191,91

3

7.3%

Group 02 $11,087,84

6

$12,469,98

6

$13,319,18

8

$14,440,770 $13,891,58

7

$13,559,06

6

4.1%

Group 03 $3,544,760 $3,985,410 $4,371,743 $4,812,129 $4,564,467 $4,271,633 3.8%

Group 04 $8,832,263 $9,813,590 $10,185,49

2

$10,693,668 $10,997,43

0

$11,009,46

0

4.5%

Group 05 $5,127,611 $5,630,828 $5,834,220 $6,089,981 $5,909,208 $5,631,498 1.9%

Group 06 $5,156,007 $5,754,269 $5,829,166 $6,216,335 $6,302,235 $6,126,315 3.5%

Group 07 $1,867,503 $2,047,498 $1,999,969 $2,046,758 $2,268,865 $2,485,377 5.9%

Group 08 $609,235 $667,333 $696,771 $749,828 $803,547 $856,954 7.1%

Group 09 $11,272,01

8

$13,000,16

7

$14,368,32

2

$15,950,913 $17,499,42

5

$19,560,43

7

11.7%

Group 10 $193,471 $215,111 $215,560 $229,053 $233,061 $248,912 5.2%

Group 11 $510,394 $699,401 $735,732 $700,564 $998,516 $953,418 13.3%

Total $59,602,20

6

$66,418,61

3

$69,937,34

3

$74,901,698 $78,311,31

1

$80,894,98

2

6.3%

22

Figure 1: SAS group expenditure as percentage of total SAS expenditure, 2007/08-2012/13

Group 0

1 - O

ne-P

iece C

losed

Group 0

2 - O

ne-P

iece D

rainab

le

Group 0

3 - O

ne-P

iece U

rosto

my

Group 0

4 - Tw

o-Piec

e Bas

eplate

Group 0

5 - Tw

o-Piec

e Clos

ed

Group 0

6 - Tw

o-Piec

e Dra

inable

Group 0

7 - Tw

o-Piec

e Uro

stomy

Group 0

8 - A

ltern

ative

Sys

tems

Group 0

9 - A

cces

sorie

s

Group 1

0 - P

aediat

ric

Group 1

1 - Fi

stula

0%

5%

10%

15%

20%

25%

30%

2007-08 2008-09 2009-10 2010-112011-12 2012-13 Annual growth rate

Per

cent

age

of to

tal S

AS

exp

endi

ture

Group 9 (Accessories) sub-group analysis

Group 9 is made up of 13 sub-groups, with costs in 2012/13 ranging from a low of $2,657 for ‘Clamps and Clips’ to more than $7.7 million for ‘Seals’ (Table 5). As there is such a divergent impact upon overall Group 9 costs, there is value in assessing the relative effects of each of the sub-groups.

Five of the subgroups: ‘Seals (l), Cleansers and Adhesive Removal (d), Skin Care and Protection (k), Adhesive Barriers (a) and Stoma Support Garments (h) generate costs in excess of $1 million each, with an average exceeding $3.5 million. By comparison the other eight sub-groups have average costs of $252,180.

23

Table 5: Group 9 sub-group change in costs 2007/08 to 2012/13 (AUD)

Financial year 2007/08 2008/09 2009/10 2010/11 2011/12 2012/13(a) Adhesive barrier $987,903 $1,252,209 $1,565,969 $1,860,024 $2,066,363 $2,458,283

Year on year change - 26.8% 25.1% 18.8% 11.1% 19.0%

(b) Stoma support

garments (belts)

$73,116 $101,878 $82,987 $90,346 $93,124 $95,632

Year on year change - 39.3% -18.5% 8.9% 3.1% 2.7%

(c) Clamps & clips $2,991 $3,059 $2,443 $3,194 $2,752 $2,657

Year on year change - 2.3% -20.1% 30.7% -13.8% -3.4%

(d) Cleanser & adhesive

removal

$1,747,760 $2,022,004 $2,173,107 $2,451,586 $2,764,343 $3,135,468


(e) Convexity inserts $19,282 $16,187 $14,909 $12,754 $11,070 $11,598

Year on year change - -16.1% -7.9% -14.5% -13.2% 4.8%

(f) Skin care &

protection

$152,250 $142,265 $131,787 $137,657 $130,751 $132,141

Year on year change - -6.6% -7.4% 4.5% -5.0% 1.1%

(g) Deodorisers & gas

suppressants

$575,048 $472,971 $465,595 $534,081 $501,986 $498,985

Year on year change - -17.8% -1.6% 14.7% -6.0% -0.6%

(h) Stoma support

garments (hernia belts)

$800,719 $1,016,540 $1,114,367 $1,045,551 $1,120,668 $1,205,900

Year on year change - 27.0% 9.6% -6.2% 7.2% 7.6%

(i) Night drainage $203,793 $231,764 $259,652 $268,848 $297,136 $311,639


(j) Skin fillers &

adhesive products

$733,095 $713,937 $685,800 $697,459 $706,050 $741,751

Year on year change - -2.6% -3.9% 1.7% 1.2% 5.1%

(k) Skin care &

protection (films)

$1,991,598 $2,284,000 $2,419,542 $2,631,735 $2,819,304 $3,017,659


(l) Seals $3,880,517 $4,636,817 $5,324,310 $6,033,143 $6,782,096 $7,725,689


(m) Miscellaneous $103,946 $106,536 $127,852 $184,535 $203,782 $223,035


SAS Group 9 $11,272,018 $13,000,167 $14,368,322 $15,950,913 $17,499,425 $19,560,437


Source: Department of Health, 2014

Table 6 sets out the effect of the change in sub-group costs over the period under review. The five high cost sub-groups represent 90% of the total Group 9 costs. The percentage increase in this set of sub-groups, increased by 86% over the five years, compared with just 8% for other eight sub-groups. Of the $8.3 million increase in Group 9 costs, $8.1 million, or 98% can be attributed to the high cost sub-groups.

24

Table 6: Cost impact of high- and low-cost sub-groups

Group 9 sub-groups % of Group 9 costs % increase 2007/08-2012/13

% of increased costs 2007/08-2012/13

Five high cost sub-groups 90% 86% 98%

Eight lower cost sub-groups 10% 8% 2%

Figure 2 demonstrates the consistent increase year to year for the high cost sub-groups.

Figure 2: Group 9 high cost sub-group annual costs, 2007/08-2012/13

(l) Seals (d) Cleansers & Solvents

(k) Protective Films

(a) Adhesive barrier

(h) Hernia Support Belts

$0

$1,000,000

$2,000,000

$3,000,000

$4,000,000

$5,000,000

$6,000,000

$7,000,000

$8,000,000

$9,000,000

2007/08 2008/09 2009/10 2010/11 2011/12 2012/13

Ann

ual s

ub-g

roup

cos

ts

The average annual increase for each of these sub-groups was therefore: Adhesive Barriers – 20.0%; Seals – 14.8%; Cleaners and Adhesive Removal – 12.4%; Protective Films – 8.7% and Hernia Belts and Garments – 8.5%.

Sub-group analysis

The analysis of each sub-group will provide information about products that have been prescribed in 2012/13, including the SAS specified Pack Price, a comparator rate, which will usually be the NHS England and Wales (E&W)22,23 except where that was not available, in which case one of the following will be used:

an Australian private consumer rate (APri) - the price to an Australian consumer purchasing from a national on-line wholesaler website24

22 NHS Electronic Drug Tariff England and Wales (Mar. 29, 2014).

23 Conversion rate1 Great British Pound = 1.84 Australian Dollar (Mar. 13, 2014).24 CH2 Online Intouch (Feb. 28, 2014).

25

http://direct.ch2.net.au/index.php?mode=intouch

https://www.google.com.au/search?q=converting+great+british+pound+to+australian+dollar

http://www.ppa.org.uk/edt/March_2014/mindex.htm

an Australian online rate (AOnl) - the price displayed on the company’s Australian website or electronic brochure.

the NHS Scotland rate (Scot)25;

a US online rate (US)26;

a Canadian online rate27 (Can)

In general terms the NHS England and Wales costs are very similar to the NHS Scotland rates, with some slightly higher and others lower. Similarly with the US online rates, there is no uniform finding, with some product prices higher than the NHS prices and others lower. The price to the Australian private consumer is typically substantially higher than the SAS Pack Price.

The conversion rate used for the United Kingdom prices was $1AUD = 0.5435 pence (i.e. x1.84)28, for the United States $1AUD=90.1US cents (i.e. x1.11)29 and Canada $1AUD=98 Canada30 cents.

The annual SAS cost in 2012/13 for each product is presented, with a brief description of the trend in costs since 2007/08. An estimate of the potential cost differential with the comparator is also made, where the comparison rate is lower than the SAS price.

Further pricing detail including data references and findings from the analysis of financial information are reported in full at Appendix 2.

Analysis of sub-group (a) – Adhesive Barrier price and costs

The Department of Health identified costs were incurred for ten products in the Adhesive Barrier sub-group out of 13 listed.

In 2007/08 there were just six of the current products prescribed at a total cost to the SAS of $987,903. Of those Omnigon Welland Hydroframe represented 76% of the market, with Coloplast Protective Sheet having 13% and Convatec Skin Barrier 8% of the total, with the other three products having a negligible impact.

During 2008/09 Ainscorp Salts Secu Plast Hydro was listed as a product and quickly secured a 12% share in that year, with a peak in costs being achieved in 2011/12 at $759,127, which was 37% of total sub-group costs. Omnigon Welland Hydroframe also achieved peak costs in 2011/12 of $1,015,307 and 49% of the market.

25 NHS Scotland. Stoma Appliances Price List Scotland March 2014. (Mar. 12, 2014). 26 Cos Medical Supplies Online (Apr. 7, 2014).

27 Online Ostomy Supplies (Apr.7, 2014).

28 Conversion rate1 Great British Pound = 1.84 Australian Dollar (Mar. 13, 2014).

29 Conversion rate $1US=$1.11 Australian (Mar. 21, 2014).30 Conversion rate $1 Australian = $0.98 Canadian. (Apr. 7, 2014).

26

https://www.google.com.au/#q=convert+canadian+dollar+to+australian+dollar

https://www.google.com.au/search?q=converting+us+dollar+to+australian+dollar


http://www.myOSTOMY.com.ca/

http://www.continentostomymystore.org/

http://www.isdscotland.org/Health-Topics/Prescribing-and-Medicines/Stoma-Supplies

A second Ainscorp product Salts SecuPlast Hydro Aloe was introduced in 2011/12 year and by 2012/13 had achieved a 16% share, with the other Ainscorp product achieving 25% in the same year. In 2012/13 another new product, Coloplast Elastic Tape was listed and it too rapidly established a market share.

Overall the costs for this sub-group are volatile, with new products on the list quickly establishing a presence in the market, so much so that three dominant products in 2007/08 which collectively represented 97% of the costs, had been reduced to a share of 48% in 2012/13, with the three new products making up almost all the rest.

The SAS pack price for the three new products was found to be in excess of available comparator prices, with the NHS England and Wales price for the two Ainscorp products being 45-50% less than the SAS price.

Brand Name

SAS Pack Price (AUD)

Comparator (AUD)

2012/13 costs (AUD)

% of total sub-group costs 2012/13

Estimated cost using lower price comparator (AUD)

Ainscorp Salts Secu Plast Hydro $43.74$21.96 (E&W)

$44.53 (Can)$608,423 25% $305,464

Ainscorp Salts SecuPlast Hydro Aloe $43.74$23.79 (E&W)

$48.70 (Can)$388,577 16% $211,346

Coloplast Brava Elastic Tape $29.16 $23.39 (E&W) $259,611 11% $208,241

Coloplast Brava Protective Sheet $72.90 $96.66 (E&W) $137,112 6% n/a

Coloplast Protective Sheet Dispenser $47.14 $201.70 (APri) $13,812 1% n/a

Convatec Skin Barrier $14.38 $21.91 (E&W) $52,087 2% n/a

Hollister Flextend $14.38 $14.38 (E&W) $4,990 0% n/a

Hollister Hollihesive $14.38 $22.15 (E&W) $3,466 0% n/a

Omnigon Welland Hydroframe $28.56 $42.74 (US) $985,877 40% n/a

Omnigon Welland Hydroframe Mini $42.84 $18.29 (E&W) $4,327 0% $1,847

Analysis of sub-group (b) – Stoma Support Garments prices and costs

The Department identified costs for nine products listed in sub-group B, with some products having a number of sizes. In 2007/08 six of these products had costs attributed to them. There has been a relatively modest 6% annual growth rate for this sub-group, with little change in relative market share, with the notable exception of the Coloplast Brava Belt which was introduced in 2012/13, and which appears to have substantially displaced the other Coloplast product.

None of the identified price comparators were less than the SAS pack price.

Brand Name


Comparator (AUD)

2012/13 costs (AUD)


Estimated cost using lower price comparator

Ainscorp Salts Adjust. Ostomy Belt $5.98 $13.56 (Scot) $3,654 4% n/a

27

Coloplast Belt $5.98 n/a $3,211 3% n/a

Coloplast Brava Belt $5.98 $12.16 (E&W) $22,234 23% n/a

ConvaTec Belt $5.98 $6.33 (E&W) $8,593 9% n/a

Dansac Beige Ostomy Belt $5.98 13.41 (Scot) $11,799 12% n/a

Hollister Adapt $5.98 $14.30 (E&W) $32,872 34% n/a

Omnigon Adjustable Belt $5.98 n/a $9,329 10% n/a

Omnigon Braun Stomacare Belt $5.98 13.89 (Scot) $1,429 1% n/a

Omnigon Flair Belt Pack* $5.98 $13.41 (E&W) $2,512 3% n/a

*This product is listed as one belt and one ring on the SAS and listed as one belt and five rings on the E&W drug

tariff. The E&W price has been divided by five to allow for comparison. Further detail about NHS E&W pricing for

this product is provided at Appendix 2, Table 2.3.

Analysis of sub-group (c) – Clamps and Clips prices and costs

The Clamps and Clips sub-group represent just 0.01% of the total cost of the SAS, which is reduction in absolute and relative terms compared with 2007/08 when it constituted 0.03%. Costs have fallen by 10% over that period as well.

No new products have been introduced to the list in the five years of analysis and the share of the costs for each product appears fairly stable from year to year.

Comparator costs were less than the SAS pack price for the Hollister Clamps and Coloplast Alterna Slimline.

28

Brand Name SAS Pack Price (AUD)

Comparator (AUD)

2012/13 costs (AUD)



Hollister Clamps $46.10 $38.90 (E&W) $1,346 51% $1,136

ConvaTec Clips $23.05 $44.20 (APri) $373 14% n/a

Coloplast Alterna Slimline $46.10 $39.43 (E&W) $537 20% $459

Hollister ModermaFlex $2.30 $2.30 (AOnl) $243 9% n/a

Dansac Nova Drainable Clamp $2.30 n/a $156 6% n/a

Analysis of sub-group (d) – Cleansers and Adhesive Removal prices and costs

The Cleansers and Adhesive Removal sub-group represent the second largest cost of the Group 9 sub-groups which in 2012/13 was 16% up from 15.5% of the total cost in 2007/08. The sub-group costs increased at an annual rate of 12%.

In 2007/08 there were six products to which costs were attributed with ConvaTec Convacare and Dansac Skin Wipes contributing almost three quarters of the sub-group costs. Five new products have been added to the list since 2007/08 though none have established a significant share.

The major shift has been the increase in the Omnigon Welland share from just 2% in 2007/08 to 36% in the latest year and Dansac Skin Lotion increasing from less than 1% to 14% over the same period.

In terms of comparative costs all accessed costs were higher than the SAS pack prices.


Comparator (AUD)

2012/13 costs (AUD)



Ainscorp Salts Wipe Away $14.34 $16.54 (E&W) $77,386.10 2% n/a

Coloplast Brava No Sting Adhesive

Remover Wipes

$11.94 $26.97 (E&W) $37,214.96 1% n/a

Coloplast Brava No Sting Adhesive

Remover Spray

$10.23 $16.27 (E&W) $49,144.92 2% n/a

Coloplast Comfeel (2 products) $8.35 $32.16 (E&W) $135,458.58 4% n/a

ConvaTec ConvaCare $32.00 $33.10 (E&W) $541,587.52 17% n/a

Dansac Skin Lotion $8.35 $32.22 (E&W) $403,586.82 13% n/a

Dansac Skin Lotion Wipes $23.90 $27.60 (E&W) $454,412.61 14% n/a

Hollister Cleanser $8.35 $8.35 (AOnl) $8,792.55 0% n/a

Hollister Universal $16.00 $24.95 (E&W) $145,500.80 5% n/a

Omnigon Eakin Release Wipes $11.94 n/a $12,895.20 0% n/a

Omnigon Welland $23.90 $43.09 (US) $1,122,607.39 36% n/a

Omnigon Welland Adhesive

Remover Spray

$10.23 n/a $9,176.31 0% n/a

29

Smith & Nephew Remove $16.00 $44.00 (APri) $137,136.00 4% n/a

Smith & Nephew SECURA $8.35 n/a $567.80 0% n/a

Analysis of sub-group (e) – Convexity Inserts prices and costs

The Convexity Inserts sub-group cost was the second smallest cost of the Group 9 sub-groups. In 2012/13 it had declined from 0.17% of the total group 9 costs to 0.06%, which represents a 9% per annum reduction in costs.

There is one brand on the SAS list, with various size options available. No comparator price was identified.


Comparator 2012/13 costs (AUD)



ConvaTec Sur-Fit Plus $9.46 n/a $11,598 100% n/a

Analysis of sub-group (f) – Skin care and protection (creams and ointments) prices and costs

The products in 2012/13 were unchanged from the 2007/08 list, which reflects the very stable nature of the products, their share and cost profiles.

Overall there was a 2.8% annual decrease in the sub-group costs, which led to the sub-groups proportion of total costs falling from 1.4% in 2007/08 to 0.7% in 2012/13.

Within the sub-group Coloplast Comfeel had reduced share from 22% to 8% whilst Sudocream increased from 5% to 19%.



Comparator (AUD)

2012/13 costs (AUD)



3M Cavilon Durable $5.75 $7.32 (E&W) $2,105 2% n/a

Calmoseptine Oint 20g $4.71 $5.20 (APri) $871 1% n/a

Calmoseptine Oint 75g $7.68 $11.30 (APri) $8,387 6% n/a

Coloplast Comfeel $7.92 $8.85 (E&W) $10,288 8% n/a

Coloplast Conveen Critic $7.85 $19.60 (APri) $3,721 3% n/a

ConvaTec Orabase $8.74 $15.90 (APri) $34,444 26% n/a

Dansac Ostomy $8.74 n/a $15,888 12% n/a

Hollister Skin Conditioning

Cream

$7.92 $7.92 (AOnl) $21,859 17% n/a

Smith & Nephew Uni Derm $7.92 n/a $10,058 8% n/a

Sudocrem Healing Cream $5.54 $8.90 (APri) $24,520 19% n/a

30

Analysis of sub-group (g) – Deodorisers & Gas Suppressants prices and costs

Deodorisers & Gas Suppressants is another sub-group with a very stable product and cost profile, with an average annual reduction in costs of 2.8%. This led to the overall sub-group costs falling as a percentage of total Group costs from 5.1% to 2.6%.

All products except for the Ainscorp product were available in 2007/08, with the three leading brands Hollister Adapt, Dansac Windless and Dansac Nodor maintaining dominance throughout the period.



Comparator (AUD) 2012/13 costs (AUD)



Ainscorp Salts No-Roma $8.13 $5.15 (E&W) $4,740 1% n/a

Dansac Nodor "S" $4.05 $8.02 (E&W) $73,698 15% n/a

Dansac Windless $11.31 n/a $133,718 27% n/a

Hollister Adapt $9.91 $17.13 (E&W) $209,226 42% n/a

Hollister M9 Drop $8.13 $8.13 (AOnl) $13,301 3% n/a

Hos-Toma Lube $9.91 n/a $10,406 2% n/a

Hos-Toma No Smell $4.05 n/a $25,879 5% n/a

Hos-Toma No-Gas $11.31 n/a $12,565 3% n/a

Laza Odorgon $4.05 n/a $16 0% n/a

Smith & Nephew Banish $3.97 n/a $7,142 1% n/a

Wooltec Wooltec $4.05 n/a $8,294 2% n/a

Analysis of sub-group (h) – Stoma support garments prices and costs

The Stoma Support Garments of sub-group (h) has the fifth highest costs of all the sub-groups. Costs have increased by an annual rate of 8.5% since 2007/08, however even in that context the sub-groups share of group costs has fallen from 7.1% to 6.2%

The product range has been quite dynamic, with just four products representing nearly all costs in 2007/08. In 2012/13 the share for those products had declined to just 32%.

Unfortunately this sub-group proved the most difficult to establish comparative prices. Where they were available they were generally lower than the SAS pack price.

31


Comparator (AUD)

2012/13 costs (AUD)



Ainscorp Salts Simplicity

Abdominal support$60.00 $22.93 (E&W) $371,400 31% $141,937

Omnigon Diamond Plus $60.00 n/a $256,373 21% n/a

Omnigon Kool-Knit $45.15 n/a $140,146 12% n/a

Omnigon Mens support Boxers.

Hernia support garment,$60.00 $31.28 (E&W) $1,380 0% n/a

Omnigon Stoma Support Belt $71.01 $83.57 (Scot) $106,160 9% n/a

Omnigon Support Briefs for Her $60.00 $31.28 (E&W) $42,120 3% $21,959

Omnigon Support Pants for Him $60.00 $31.28 (E&W) $99,360 8% $51,800

Omnigon Total Control $71.01 n/a $63,270 5% n/a

Statina Healthcare Corsinel

Abdominal support$120.02 $155.00 (Aonl) $125,421 10% n/a

Sutherland Medical Abdominal

Binder$45.15 n/a $271 0% n/a

Analysis of sub-group (i) – Night Drainage prices and costs

The Night Drainage sub-group costs increased by a significant 8.9% each year, with it contributing 1.6% of total group costs in 2012/13 compared with 1.8% in 2007/08.

There has been a marked shift in the availability of products, where previously the two Unomedical products were the only ones available, now there are eight. Again the entry of new products has significantly shifted the cost mix between products.

These appear to be fairly standard products with the SAS pack price below the comparators.


Comparator (AUD)

2012/13 costs (AUD)



Ainscorp Salts Night Drainage Bag $2.19 n/a $6,301 2% n/a

Coloplast S3 extended term -urostomy

night drainage bag

$2.19 $2.50 (APri) $39,845 13% n/a

Coloplast Simpla S4 - urostomy night

drainage bag

$2.19 $6.40 (APri) $73,361 25% n/a

Hollister T-Tap Night Drainage Collector $65.70 $65.70 (AOnl) $28 0% n/a

Hollister Night Drainage Collector - $2.19 $2.19 (AOnl) $122,672 41% n/a

Omnigon Braun Urimed Bag 2L $21.90 n/a $1,229 0% n/a

Unomedical A4 Drainage Bag $2.19 n/a $45,291 15% n/a

Unomedical Night Drainage Bag $2.19 n/a $9,813 3% n/a

32

Analysis of sub-group (j) – Skin Filler and Adhesive Product prices and costs

The Skin Filler and Adhesive Products subgroup has the sixth highest costs in the group. In the five year period there was an annual average increase in sub-group costs of just 0.24%, with its proportion of overall group costs falling from 6.5% to 3.8%.

The product range has been very stable with the introduction of just one new product since 2007/08, the Ainscorp Paste, which is responsible for just 1% of the sub-group costs. Otherwise the shares of the dominant products have been largely maintained.

The NHS England and Wales comparator prices for some products remain significantly lower.


Comparator (AUD)

2012/13 costs (AUD)



Ainscorp Salts Stoma Paste $11.28 $12.80 (E&W) $8,448 1% n/a

Coloplast Brava Strip Paste $11.28 $14.35 (E&W) $21,781 3% n/a

Coloplast Paste Tube $11.28 $11.59 (E&W) $21,307 3% n/a

ConvaTec Paste $11.28 $13.73 (E&W) $325,112 44% n/a

ConvaTec Powder $8.70 $18.10 (APri) $201,805 27% n/a

Dansac Soft Paste $11.28 $6.62 (E&W) $38,216 5% $22,428

Hollister Adapt Paste $11.28 $7.10 (E&W) $72,214 10% $45,454

Hollister Karaya Paste $11.28 $15.51 (E&W) $6,023 1% n/a

Hollister Premium Powder $8.70 $4.73 (E&W) $46,840 6% $25,466

Analysis of sub-group (k) – Skin Care and Protection (films) prices and costs

The Skin Care and Protection sub-group (k) has the third highest costs in the group. It has had increases in annual costs of 8.7% over the period. In 2007/08 there were seven products to which costs were attributed of which two shared 88% of the total. The 3M Cavilon product was introduced in 2009/10 and has quickly achieved a 45% share. Whilst the Omnigon WBF Barrier Film has dropped from 51% to a 37% sub-group share, given the dynamics involved the total costs incurred for this product has still increased by 50%.

With respect to price comparison, some low volume products have SAS prices in excess of the comparators, whereas the high volume products are typically lower.

33


Comparator (AUD)

2012/13 costs (AUD)

% of total sub-group

costs 2012/13

Estimated cost using

lower price

comparator (AUD)

3M Cavilon $31.95 $36.97 (Scot) $1,351,712 45% n/a

3M No Sting $15.31 $12.24 (E&W) $22,812 1% $18,238

Ainscorp Salts Peri-Prep Sensitive $31.95 $28.47 (E&W) $53,484 2% $47,893

Coloplast Brava No Sting Skin

Barrier Spray

$26.25 $21.12 (E&W) $11,970 0% $9,631

Coloplast Brava No Sting Skin

Barrier Wipes

$31.95 $40.11 (E&W) $48,760 2% n/a

ConvaTec ConvaCare $29.00 $33.10 (E&W) $323,249 11% n/a

Hollister Skin Gel $14.50 $25.54 (E&W) $40,426 1% n/a

Omnigon WBF Barrier Film $31.95 $49.50 (AOnl) $1,113,319 37% n/a

Smith & Nephew SECURA No-Sting

Barrier Film

$52.10 $41.78 (E&W) $470 0% $377

Smith & Nephew Skin Prep $14.50 n/a $49,957 2% n/a

Smith & Nephew Skin Prep Aerosol $8.45 $18.64 (US) $1,470 0% n/a

Smith and Nephew Skin Prep Spray $15.31 $10.25 (E&W) $31 0% $21

Analysis of sub-group (l) – Seals prices and costs

The Seals subgroup costs represent by far the greatest cost in the overall Group 9 costs, which in 2012/13 was 39.5%, compared with 34.4% in 2007/08. Annual growth in costs has been 14.8% over the period.

In 2007/08 five products incurred SAS costs, with four representing almost a 100% share. These products represented an 82% share in 2012/13, with five new products causing some displacement of these products.

However with the near doubling in Seal sub-group costs all products incurred increased costs.

The NHS England and Wales comparator costs are often significantly lower than the SAS price.

34


Comparator (AUD)

2012/13 costs (AUD)



Ainscorp Salts

Dermacol

$135.96 $100.22 (E&W) $438,471 6% $323,210

Ainscorp Salts

Secuplast mouldable

$45.31 $41.44 (E&W) $583,595 8% $533,749

AMSL Medicina Ace $104.19 n/a $37,925 0% n/a

Coloplast Brava

Mouldable Ring

$135.93 $104.24 (E&W) $176,392 2% $135,729

Dansac GX-TRA $135.96 $77.94 (E&W) $1,050,291 14% $602,087

Dansac NovaLife $135.96 $122.14 $166,242 2% $149,344

Hollister Adapt barrier

seals

$45.31 $32.27 (E&W) $1,438,103 19% $1,024,224

Hollister Oval Convex

Barrier Rings

$45.31 $34.22 (E&W) $38,649 1% $29,189

Omnigon Cohesive Seal $135.96 $204.66 (US) $1,859,587 24% n/a

Omnigon Cohesive

Slims

$135.96 $171.45 (US) $1,936,433 25% n/a

Analysis of sub-group (m) – Miscellaneous prices and costs

There has been a rapid increase in the Miscellaneous sub-group costs of 16.9% per annum, which can be attributed almost solely to the introduction of the Omnigon Eakin Perform product in 2008/09. Indeed alone it contributed to 93% of the increased expenditure in the sub-group between 2008/09 and 2012/13.


Comparator (AUD)

2012/13 costs (AUD)



Coloplast Cathstrap $4.78 $13.38 (APri) $7,184 3% n/a

Coloplast Filtrodor $17.95 $42.03 (E&W) $8,616 4% n/a

Ebos Group Vernagel $74.70 $137.20 (APri) $22,299 10% n/a

Hollister Silicone Adhesive Spray $35.65 $30.73 (E&W) $8,271 4% $7,130

Omnigon Eakin Perform $49.80 n/a $176,666 76% n/a

35

Discussion

The SAS is an Australian Government program legislated under Section 9A of the National Health Act (1953) that assists eligible people with stomas to better manage their condition by providing subsidised access to a range of different stoma-related products. The Stoma Product Assessment Panel (SPAP) is an independent technical advice panel appointed by the Department to review applications from suppliers requesting inclusion of a stoma-related product on the SAS Schedule.

The SAS Application and Assessment Guidelines (September 2012) state that SPAP "refers to the National Health and Medical Research Council (NHMRC)’s Hierarchy of Evidence when assessing the quality of evidence presented in applications". The NHMRC specifies levels of evidence for the effectiveness of interventions. Level 1 evidence (the 'gold standard' for interventions in health care) is a systematic review of randomised controlled clinical trials (RCTs); level 2 evidence is a single RCT of an intervention.

While reference may be made, according to the Guidelines there is no minimum level of evidence required for the listing of new products on the SAS. However, SPAP considers the following questions to determine the relevance and propriety of the evidence submitted:

Has an appropriate approach been used to select studies for presentation in the application (i.e. is there any risk that there is selection bias in the presentation of studies)?

What is the quality of the studies (i.e. what is the likelihood that the results of the studies have been affected by bias during their conduct)?

Are the results of the studies presented consistent and are they consistent with the results of studies that may have been excluded from presentation in the application?

Is there any reason why results of the studies may not be generalised to the Australian setting?

We sought evidence for the effectiveness and cost-effectiveness of the thirteen product sub-groups in the Group 9 accessories. We found that these sub-groups split neatly into two categories in terms of the overall cost of the sub-group and the growth in costs over the past five years. The first category are the sub-groups with a high total cost, high growth and dynamic changes in market share of products within the sub-group (adhesive barriers (a), adhesive removers / cleansers and adhesive removal (d), hernia belts (h), protective films (k) and seals (l)). The second category comprises the sub-groups with lower total cost, low annual growth and stable product mixes.

We found insufficient evidence for the effectiveness of any product type within any sub-group of the Group 9 accessories schedule. We identified that new products are more commonly introduced in the high cost, high growth sub-groups and quickly achieve a significant share of the product market. There were no studies of comparative effectiveness that indicate substitution of an established product with a newer product is justified by published evidence of improved effectiveness of the newer product.

36

It is possible that robust studies have been conducted but have not been published in the public domain due to commercial in-confidence reasons. We approached manufacturers to request unpublished studies but did not receive any information in addition to materials identified in the public domain. Our conclusions are therefore based on the information described in this report and accompanying appendices.

Our systematic review of the peer-reviewed literature identified the potential for adverse events associated with some accessories, as demonstrated in case reports and case series, and low patient compliance with some Group 9 garments. Intervention studies are required to establish with greater certainty the comparative safety, adverse event profile, patient satisfaction and quality of life impacts of different product types within Group 9 sub-groups.

Guideline developers internationally confirm the results of our systematic review and have also noted a paucity of published studies of the effectiveness of stoma accessories. The NHMRC Guidelines for Guideline Developers31 determine the appropriate level of evidence for an intervention is level 2 evidence or higher. Well-conducted RCTs that compare products listed on the Group 9 SAS schedule with either no intervention or an active comparison intervention are feasible. RCTs would provide much-needed evidence to inform development of clinical practice guidelines and protocols for the effective and cost-effective use of Group 9 accessories.

Conclusion 1

A requirement for level 2 evidence or higher for the listing of new accessory products on the Group 9 SAS Schedule would enable a more detailed assessment of the effectiveness and cost-effectiveness of Group 9 accessories to be performed into the future.

Where comparison prices could be identified, 19 of 48 (40%) products in high cost, high growth sub-groups had SAS prices exceeding international comparators, compared with just 4 of 40 (10%) for the low cost, low growth sub-groups

Table 7 provides an overview of the individual Group 9 accessory products which incurred the highest cost in 2012/13. Of the top 29 highest cost products, 25 were in the high cost sub-groups.

31 NHMRC (2009). NHMRC Levels of Evidence and Grades for Recommendations for Developers of Guidelines. Canberra: National Health and Medical Research Council.

37

Table 7: Analysis of highest cost products, 2012/13

Brand Name Sub-group 2012/13 (AUD) Annual growth rate Data range SAS Pack Price (AUD) Comparator (AUD)Omnigon Cohesive Slims

9l seals $1,936,433 24% 07/08-12/13 $135.96 $171.45 (US)$248.95 (AOnl)

Omnigon Cohesive Seal

9l seals $1,859,587 3% 07/08-12/13 $135.96 $204.46 (US)$213.30 (AOnl)

Hollister Adapt barrier seals

9l seals $1,438,103 16% 07/08-12/13 $45.31 $31.10 (Scot)$32.27 (E&W)$45.31 (AOnl)$76.19 (US)

3M Cavilon 9k films, skin care $1,351,712 14% 09/10-12/13 $31.95 $36.97 (Scot)$42.87 (E&W)

Omnigon Welland 9d adhesive removal $1,122,607 99% 07/08-12/13 $23.90 $43.09 (US)Omnigon WBF Barrier Film

9k films, skin care $1,113,319 18% 07/08-12/13 $31.95 $49.50 (AOnl)

Dansac GX-TRA 9l seals $1,050,291 2% 07/08-12/13 $135.96 $77.94 (E&W)

Omnigon Welland Hydroframe

9a adhesive barrier $985,877 6% 07/08-12/13 $28.56 $42.74 (US)

Ainscorp Salts Secu Plast Hydro

9a adhesive barrier $608,423 41% 08/09-12/13 $43.74 $21.16 (Scot)$21.96 (E&W)

Ainscorp Salts Secuplast seal

9l seals $583,595 247% 08/09-12/13 $45.31 $39.56 (Scot)$41.44 (E&W)

ConvaTec ConvaCare 9d adhesive removal $541,588 -5% 07/08-12/13 $32.00 $31.61 (Scot)$33.10 (E&W)$59.70 (APri)

Dansac Skin Lotion Wipes

9d adhesive removal $454,413 -4% 07/08-12/13 $23.90 $27.60 (E&W)

Ainscorp Salts 9l seals $438,471 31% 09/10-12/13 $135.96 $99.36 (Scot)

38

Brand Name Sub-group 2012/13 (AUD) Annual growth rate Data range SAS Pack Price (AUD) Comparator (AUD)Dermacol $100.22 (E&W)Dansac Skin Lotion 9d adhesive removal $403,587 165% 07/08-12/13 $8.35 $32.22 (E&W)Ainscorp Salts SecuPlast Hydro Aloe


Ainscorp Salts Simplicity underwear

9h support garments belts $371,400 341% 07/08-12/13 $60.00 $22.28 (Scot)$22.93 (E&W)

ConvaTec Paste 9j skin filler and adhesive $325,112 -4% 07/08-12/13 $11.28 $13.73 (E&W)$15.93 (US)$21.20 (APri)

ConvaTec ConvaCare 9k skin care $323,249 -2% 07/08-12/13 $29.00 $31.61 (Scot)$60.20 (APri)

Coloplast Brava Elastic Tape

9a adhesive barrier $259,611 n/a 12/13 only $29.16 $23.09 (Scot)

Omnigon Diamond Plus

9 hernia support $256,373 33% 10/11-12/13 $60.00 n/a

Hollister Adapt 9g deodorisers $209,226 0% 07/08-12/13 $9.91 $9.91 (AOnl)$16.50 (Scot)

ConvaTec Powder 9j skin filler, paste and powder $201,805 5% 07/08-12/13 $8.70 $13.25 (US)$18.10 (APri)

Omnigon Eakin Perform

9m miscellaneous $176,666 137% 08/09-12/13 $49.80 n/a

Coloplast Brava Mouldable Ring

9l seals $176,392 n/a 12/13 only $135.93 $99.25 (Scot)$104.24 (E&W)

Dansac NovaLife 9l seals $166,242 363% 11/12-12/13 $135.96 $122.14 (Scot)Hollister Universal 9d adhesive removal $145,501 2% 07/08-12/13 $16.00 $16.00 (AOnl)

$24.03 (Scot)

39

Brand Name Sub-group 2012/13 (AUD) Annual growth rate Data range SAS Pack Price (AUD) Comparator (AUD)Omnigon Kool-Knit 9 hernia support $140,146 77% 08/09-12/13 $45.15 n/a

Smith & Nephew Remove

9d adhesive removal $137,136 4% 07/08-12/13 $16.00 $40.00 (APri)

Coloplast Brava Protective Sheet


40

Table 8, identifies the high cost products where the SAS price exceeds international comparators. There are five products from sub-group seals (l), three in adhesive barriers (a), one in adhesive removers / cleansers and adhesive removal (d), one hernia belt in stoma support garments (h).

Table 8: Highest cost products with comparator prices lower than SAS price

Brand Name

Sub-group 2012/13 (AUD)

Annual growth rate

Data range


Comparator (AUD)

Low comp /SAS

Hollister Adapt barrier seals

9l seals $1,438,103 16% 07/08-12/13

$45.31 $31.10 (Scot)$32.27 (E&W)$45.31 (AOnl)$76.19 (US)

69%

Dansac GX-TRA

9l seals $1,050,291 2% 07/08-12/13

$135.96 $77.94 (E&W) 57%

Ainscorp Salts Secu Plast Hydro

9a adhesive barrier

$608,423 41% 08/09-12/13

$43.74 $21.16 (Scot)$21.96 (E&W)

48%

Ainscorp Salts Secuplast seal

9l seals $583,595 247% 08/09-12/13

$45.31 $39.56 (Scot)$41.44 (E&W)

87%

ConvaTec ConvaCare

9d adhesive removal

$541,588 -5% 07/08-12/13

$32.00 $31.61 (Scot)$33.10 (E&W)$59.70 (APri)

99%

Ainscorp Salts Dermacol

9l seals $438,471 31% 09/10-12/13

$135.96 $99.36 (Scot)$100.22 (E&W)

73%

Ainscorp Salts SecuPlast Hydro Aloe

9a adhesive barrier

$388,577 117% 11/12-12/13

$43.74 $22.72 (Scot)$23.79 (E&W)

52%

Ainscorp Salts Simplicity underwear

9h support garments belts

$371,400 341% 07/08-12/13

$60.00 $22.28 (Scot)$22.93 (E&W)

37%

Coloplast Brava Elastic Tape

9a adhesive barrier

$259,611 n/a 12/13 only

$29.16 $23.09 (Scot) 79%

Coloplast Brava Mouldable Ring

9l seals $176,392 n/a 12/13 only

$135.93 $99.25 (Scot)$104.24 (E&W)

73%

Total 2012/13 costs for these products

$5,856,451 Estimated cost at low comparator

$3,920,320 Estimated saving: $1,936,130

The international comparator cost for these products is $1.9 million less in total than the SAS cost. These data suggest that cost savings may be achieved through achieving a purchase price for products in Table 8 that is equivalent to the product price in comparator schemes.

Conclusion 2

A review of current purchasing arrangements for high cost products with a comparator price that is lower than the current SAS price would confirm that the purchasing arrangements for these products are efficient.

41

Limits to the quantity of Group 9 accessories provided to consumers are specified in the Schedule. Some international stoma guideline documents also specify limits to the quantity of stoma products that are provided to consumers. We found one publication that described the equipment needs of ostomates in the UK but no publications that described accessory use in detail (Table 9). According to Black (2009), night bag, adhesive remover and skin protector use varies according to the type of appliance the ostomate uses32.

Table 9: Estimated accessory product use

One piece appliance Two piece applianceUrostomy 1 night bag a weekNight bag 1 bag a weekAdhesive remover 2-3 a monthSkin protector 2-3 a month

We identified consensus based prescribing guidelines for stoma appliances and accessories published by NHS Trusts in England. The SAS specifies limits at the product level whereas the NHS Trust guidelines generally specify these limits at the category level.

In comparing the recommended quantities with those listed on the Australian SAS where comparators were available they were broadly consistent (Table 10).

Overall, limits to product quantities specified in the SAS are consistent with limits in international schemes. No studies were identified that indicated product limits had an adverse impact on patient outcomes.

32 Black P. Stoma care nursing management: cost implications in community care. British Journal of Community Nursing. 2009;14(8):350.

42

Table 10: Summary of recommended product quantities from published guidelines

Item type SAS Max Qty33

Coventry and Warwickshire Av. Qty / month34

Northamptonshire Qty / month35

Leicestershire Qty / Month36

Ostomy Belts 4 / year 3 / year 3 / year 2-3 / yearNight Drainage Bags

5 bags 4 bags 4 bags 4 bags

Adhesive Remover Spray

2 / month 1-3 cans 1-3 cans 2-3 bottles

Deodorants 1-2 / month (depending on bottle size)

1 bottle n/a n/a

Lubricating deodorant gel

1 bottle / month

2 bottles n/a n/a

Powder 2 / month n/a n/a 1 containerBarrier Wipes 30 / month n/a n/a 10-15 wipes (one

wipe / flange)Barrier Spray 1 / month n/a n/a 1-9 bottles (1

bottle / 10 pouches)

Protective Rings 30 / month n/a n/a 10-15 (one / flange)

Adhesive remover wipes

100 / month n/a n/a 15-90 wipes (one / pouch change)

Pastes 3 tubes / month

n/a n/a 1 tube

Hernia Belts, Girdles and Garments

3 belts / year, 6 garments / year (restricted access)

n/a n/a 3-6 / year

Retention strips 60 / month n/a n/a 30-90 (1-3 / pouch)

Clips 10 / year n/a n/a 10 every 6 months

*n/a = not available

Conclusion 3

33 Department of Health, Stoma Appliance Scheme Schedule (Mar. 30, 2014).34 Coventry and Warwickshire Area Prescribing Committee, Arden Cluster Prescribing Guidelines for Stoma Appliances, (Mar. 4, 2014).35 National Health Service Northamptonshire, Prescribing Guidelines for Stoma Appliances, (Mar. 3, 2014).36 Leicestershire Medicines Strategy Group, A Guideline to Prescribing Stoma Care Appliances and Stoma Nurse Referral November 2011, (Mar. 4, 2014).

43

http://www.lmsg.nhs.uk/LMSGDocs%5CGuidelines%5CStomaGuidelines2014_LMSG.pdf


http://www.neneccg.nhs.uk/resources/uploads/stomaguidelines.pdf

http://www.coventrywarksapc.nhs.uk/


http://www.health.gov.au/internet/main/publishing.nsf/Content/health-stoma-schedule

Limits to product quantities specified in the SAS are consistent with limits in international schemes.

Consumers are able to request additional quantities of products from the Department if required. An important limitation to this analysis is that we did not review data regarding applications for additional quantities. The Department may wish to review this additional information to establish the extent to which consumer demand for additional product quantities.

The accessory product range available on Group 9 of the SAS Schedule is comprehensive and is of similar range to the NHS Scotland and NHS England / Wales. We found no empirical evidence to suggest that any accessory product on the Schedule is ineffective per se. Further, we found no statements within consensus guidelines that explicitly discourage the use of any accessory product type in the Schedule.

In the absence of evidence to the contrary we could find no justification for removal of any product type from the SAS.

Conclusion 4

There is an absence of evidence that Group 9 accessory products are either effective or ineffective, and therefore insufficient information to suggest changes to the range of accessory product types on Group 9 of the SAS based on this review alone.

Finally, evidence-based guidelines identified in the peer-reviewed literature demonstrate that increased accessory use is associated with poor support of patients, a lack of access to specialist stomal therapist nurses and inappropriate use of accessory products. Although outside the direct scope of this project, it is important to ensure other elements of the quality of the stomal service system is maximised in order to ensure judicious use of accessories on Group 9 of the SAS Schedule.

44

Appendix 1 - A systematic review of the peer-reviewed and 'grey' literatureWe conducted a systematic literature review to answer the question:

What is the effectiveness and cost effectiveness of accessory products on the Group 9 SAS Schedule?

Criteria for considering publications for inclusion

In this systematic review we considered for inclusion any publication that reported on the use of a Group 9 class of product for the management of any patient with a stoma. The following PICO criteria informed the methods of the literature review:

Population: children and adults of any age, gender or socio-demographic characteristics with a stoma;

Intervention: any Group 9 product listed in the Group 9 SAS;

Comparison: no intervention, inactive (i.e. 'sham') intervention or active intervention comparison; and

Outcome: any patient relevant outcome as reported in each information source [(including morbidity, mortality, quality of life), patient satisfaction, cost (any cost or economic metric related to cost)]. These outcomes included but were not limited to the following stoma-relevant patient outcomes: security, support, amount of leakage, skin integrity, smell, wound healing rates, erosion, tissue overgrowth and infection.

Databases searched

The following databases were used to obtain relevant peer-reviewed publications:

Electronic searches

MEDLINE via Pubmed;

EMBASE;

CINAHL via Ebsco;

Cochrane Library.

The following search strategies were used to identify peer-reviewed publications.

Cochrane library

#1 MeSH descriptor: [Surgical Stomas] explode all trees

#2 stoma:ti,ab,kw OR ostomy:ti,ab,kw OR urostomy:ti,ab,kw

#3 #1 OR #2

45

46

MEDLINE via Pubmed

#1 "Surgical Stomas"[Mesh] OR stoma[TIAB] OR stoma[all fields] OR ostomy[all fields] OR urostomy[all fields]

#2 Accessor*[all fields] OR product*[all fields] OR equip*[all fields] OR care[all fields] OR skin[all fields] OR paste*[all fields] OR cream*[all fields] OR adhesive*[all fields] OR wipe*[all fields] OR cleans*[all fields] OR spray*[all fields] OR powder*[all fields] OR remov*[all fields] OR filler*[all fields] OR collar*[all fields] OR protective[all fields] OR garment[all fields] OR belt*[all fields] OR underwear[all fields] OR support*[all fields] OR clamp*[all fields] OR clip*[all fields] OR tape*[all fields] OR deodoris*[all fields] OR gas[all fields] OR seal*[all fields] OR hernia[all fields] OR ‘peristomal hernia’[all fields]

#3 #1 AND #2

#4 #3 AND ("2004/01/01"[PDAT] : "current"[PDAT])

EMBASE

#1 ‘Surgical stoma'/exp OR stoma:ab,ti OR stoma* OR ostom* OR urostom*

#2 Accessor* OR product* OR equip* OR care OR skin OR paste* OR cream* OR adhesive* OR wipe* OR cleans* OR spray* OR powder* OR remov* OR filler* OR collar* OR protective OR garment OR belt* OR underwear OR support* OR clamp* OR clip* OR tape* OR deodoris* OR gas OR seal* OR hernia* OR ‘peristomal hernia’

#3 #1AND #2

#4 #3 AND (2004:py OR 2005:py OR 2006:py OR 2007:py OR 2008:py OR 2009:py OR 2010:py OR 2011:py OR 2012:py OR 2013:py OR 2014:py)

CINAHL via Ebsco

#1 exp stoma/

#2 stoma.ti,ab.

#3 Stoma* OR ostom* OR urostom*

#4 1 or 2 or 3

#5 Accessor* OR product* OR equip* OR care OR skin OR paste* OR cream* OR adhesive* OR wipe* OR cleans* OR spray* OR powder* OR remov* OR filler* OR collar* OR protective OR garment OR belt* OR underwear OR support* OR clamp* OR clip* OR tape* OR deodoris* OR gas OR seal* OR hernia* OR ‘peristomal hernia’

#6 #4 AND #5

#7 limit 6 to yr="2004 -Current"

47

The findings of the above search strategy were supplemented with a systematic search of the 'grey' literature (Google; Google Scholar; OpenSIGLE; and Bing) to identify:

position papers;

other literature reviews;

information on international stoma schemes;

suppliers’ websites; and

domestic and international guidelines and best practice manuals.

The following search strategies were used to identify 'grey' literature publications.

Google Scholar

#1 (stoma OR surgical stoma) AND (Accessor* OR product* OR equip* OR care OR skin OR paste* OR cream* OR adhesive* OR wipe* OR cleans* OR spray* OR powder* OR remov* OR filler* OR collar* OR protective OR garment OR belt* OR underwear OR support* OR clamp*)

#2 01/01/2004 to 28/02/2014

#1 "stoma guidelines" OR "stoma manual" OR "stoma scheme" OR "stoma literature review"

#2 01/01/2004 to 04/03/2014

Google (chrome)


#2 01/01/2004 to 28/02/2014

Open SIGLE

#1 ‘stoma'

#2 01/01/2004 to 28/02/2014

Bing


#2 01/01/2004 to 04/03/2014

In addition to the systematic searches above, direct Google searches were performed of publicly available information from companies that supply products on the SAS Schedule and from national supply warehouses:

Hollister;

Statina Healthcare Australia;

48

Smith and Nephew;

Convatec;

Coloplast;

Ainscorp;

Dansac;

Future Environmental Services;

Omnigon;

3M;

Clifford Hallam Health Care; and

Ebos.

We also examined national and international stoma schemes and product prices of relevance to the review. The findings from these searches are reported at Appendix 2 - an analysis of available financial information regarding Group 9 products. Searches were performed using combinations of the search terms specified above in order to identify international schemes and schedule pricing.

Criteria for inclusion and exclusion of studies

We appraised all materials identified using the following criteria in order to identify materials of broad relevance to the review (Table 1).

Table 1: Criteria for inclusion and exclusion of studies

1. Is the publication relevant to children and adults of any age, gender or socio-demographic characteristics with a stoma?

Yes

No - exclude

2. Is the publication relevant to any Group 9 product listed in the Group 9 SAS?

Yes

No - exclude

3. Does the publication report results on any patient relevant outcome (including morbidity, mortality, quality of life), patient satisfaction, cost (any cost or economic metric related to cost), a specific stoma-relevant patient outcome: security, support, amount of leakage, skin integrity, smell, wound healing rates, erosion, tissue overgrowth or infection.

Yes

No - exclude

Types of studies

Publications relating to the use of Group 9 products in humans with stomas for any clinical indication were considered for inclusion. Only materials published since 2004 were considered for inclusion. We included studies with any empirical study design.

49

Types of participants

We included human studies with participants of any age or gender. We considered studies of Group 9 products for any clinical indication or health problem as long as the participants had a stoma. We included studies of Group 9 products with participants in any setting (hospital, other healthcare, non-healthcare).

We sought relevant literature from the following countries / geographical areas:

Australasia;

Europe;

North America; and

other countries with comparable health systems.

Types of interventions

We considered studies of Group 9 products as a:

single intervention for a single condition and / or setting;

single intervention for multiple conditions and / or settings; or

component of a multiple intervention (i.e. in conjunction with one or more other therapies) for a single condition and / or setting (e.g. stoma paste plus insert plus urostomy bag versus urostomy bag alone).

We did not exclude any studies on the basis of being combination therapies.

Types of comparators

We considered studies comparing Group 9 products with a placebo/no treatment comparison or with active therapeutic comparison.

Types of outcome measures

We considered the impact of Group 9 products on patient relevant outcomes, both beneficial and harmful, as reported by the authors of the individual study. We also considered materials describing costs of Group 9 products.

In reporting outcomes we described the highest level of evidence identified and associated with any relevant outcomes.

Critical appraisal and data extraction

Two reviewers independently screened and reviewed full articles to determine if they met the inclusion criteria. Any disagreement between reviewers regarding study inclusion was resolved by achieving consensus between the reviewers.

We extracted all relevant information from included studies. Evidence was grouped into appropriate categories according to the effectiveness, safety, quality and cost categories to which the evidence related.

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Assimilation and interpretation of the body of evidence

We developed a narrative account of the literature based on the findings from included studies.

We summarised the benefits of products in each product sub-group of Group 9 for their clinical effectiveness and cost.

Evidence statements for peer-reviewed studies

We have prepared an evidence statement for each product type from available evidence. The evidence statements consist of three components, i) the clinical question addressed, ii) a summary of the effects of the intervention and an assessment of the quality of the evidence, and iii) a conclusion.

Conclusions were formed by considering the quality of available evidence about that product type. We considered four factors that may lead to rating down the quality of the evidence, namely, applicability of the evidence to all products listed in the relevant section of the Group 9 schedule, level of evidence of the studies that were identified and consistency of the findings of included studies (the proportion of studies that found positive outcomes associated with the product’s use). Based on the quality of the evidence, the following conclusions were drawn (Table 2):

Table 2: Conclusions based on quality of the evidence

Quality of the evidence

Conclusion (evidence statement)

Very low The effects of the product type on outcomes are uncertain

Low There is weak evidence for the product type on outcomes

Moderate There is moderate evidence for the product type on outcomes

High There is strong evidence for the product type on outcomes

In order to achieve a high quality rating, the available evidence had to be applicable to all products listed in the relevant section of the Group 9 schedule, have level 1 evidence for relevant outcomes and have consistent findings across all studies that were identified.

In order to achieve a moderate quality rating, the available evidence had to be applicable to the majority of products listed in the relevant section of the Group 9 schedule, have level 2 evidence or higher for relevant outcomes and have the majority of effect estimates from included studies in favour of the relevant products.

In order to achieve a low quality rating, the available evidence had to be applicable to at least some products listed in the relevant section of the Group 9 schedule, have level 3 evidence or higher for relevant outcomes and have the majority of effect estimates from included studies in favour of the relevant products.

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The quality of the evidence was rated by one reviewer and checked by a second reviewer. Any disagreements in quality ratings were addressed through discussion in order to achieve consensus.

Part A: Results from the peer-reviewed literatureThe initial electronic search identified a large number of potential articles (over 25,000 results in Medline via PubMed alone). To restrict this to the most relevant references, the following additional inclusion and exclusion filters were applied:

the filter ‘research’ was applied in EMBASE and CINAHL; and

the filter ‘human’ was specifically applied in MEDLINE via Pubmed, EMBASE and CINAHL.

Figure A.1 shows the PRISMA chart outlining the selection process and number of references at each stage (Moher et al., 2009).

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Of 2,548 records identified through database searches, 465 were excluded as they were duplicate records, 2,009 were excluded at the abstract stage and 61 full text articles were excluded (described at Attachment 1). In summary, the reasons for exclusion of full text articles were as follows:

1 was not related to participants with a stoma;

21 were not relevant to a Group 9 class of product;

35 did not report patient relevant outcomes from empirical data;

3 were publications that referred to previously published (and included) data; and

1 was a narrative discussion about unpublished data.

This resulted in a total of 13 references that were identified by the above search strategy and were included in the systematic review of the literature.

We have set out the results of the publications according to the type of Group 9 product used by the included participants and have presented these in the following sections (Table A.1).

Table A.1: References containing information relevant to Group 9 product types

Product type ReferencesSkin care and protection accessories Al Niami 2012

Berry 2007

Erwin 2012

Hoeflok 2009

Thompson 2011

Stoma support garments Cowin 2012

Clamps & clips No references

Cleansers and adhesive removal accessories

Al Niami 2012

Berry 2007

Rudoni 2008

Convexity inserts No references

Deodorisers and gas suppressants Al Niami 2012

Night drainage No references

Skin fillers and adhesive products Berry 2007

Erwin 2012

Field 2010

Martin 2005

Park 2011

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Product type ReferencesSeals No references

Miscellaneous No references

Level of evidence of included references

The level of evidence of included references was generally low.

One systematic review reported results from included studies, including a single RCT (Recalla 2013 (level 1 evidence);

One RCT compared peristomal skin care techniques in ostomy patients (Park 2011) (level 2 evidence);

One nested diagnostic study conducted within a cohort study of ostomates assessed patch testing in peristomal dermatitis (Al Niami 2012) (level 3 evidence); and

One case series described skin barriers for different skin types (Thompson 2011) (level 4 evidence).

In addition to the above there were also two open-label studies (Erwin 2012, Hoeflok 2009), two case reports (Field 2010, Martin 2005) and three surveys of providers and / or patients (Berry 2007, Cowin 2012, Rudoni 2008).

Finally, two studies reported the results of financial analyses relating to the cost of stomal accessory products (Martins 2012, Meisner 2012). These publications are described in Part C of the report and are not considered further in this section of the report.

Systematic reviews identified in the peer-reviewed literatureA single systematic review was identified in the peer reviewed literature that was of broad relevance to this project. However, the review authors did not identify and report the results of any studies that are relevant to Group 9 accessories.

Recalla 2013 conducted a systematic review of the literature to inform the development of a best practice guideline in Canada (Registered Nurses’ Association of Ontario) for the assessment and management of persons with colostomies, ileostomies and urostomies.

The questions that guided the systematic review were:

1. What physical and psychosocial needs require nurse-led interventions to prepare the neonate, paediatric, or adult populations for ostomy surgery?

2. What nurse-led interventions are effective in improving ostomy care and peristomal skin care (e.g. reducing degree / frequency of complications, shortening healing time) in neonatal, paediatric, or adult populations?

3. What nurse-led interventions are effective in promoting patient self-care of ostomy and peristomal skin in paediatric or adult populations?

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4. What nurse-led interventions are effective in managing complications in ostomies and peristomal skin in neonatal, paediatric, or adult populations?

5. What are the special considerations in caring for individuals with ostomies who have special needs, including blindness?

6. What are the educational needs of nurses looking after individuals with ostomies?

7. What patient-focused educational interventions are effective in improving physical and psychosocial status of individuals with ostomies?

8. What resources used by nurses in ostomy care are most effective in managing ostomies (e.g. promoting healing, reducing complications)?

9. What resources used by patients in self-managed ostomy and peristomal care are most effective in managing ostomies (e.g. promoting healing, reducing complications)?

A literature search was conducted in February 2008 in MEDLINE, CINAHL, PsycINFO, and EMBASE and was updated in 2011. Broad search terms included stoma, ostomy, enterostomy, cecostomy, colostomy, continent ileostomy, duodenostomy, ileostomy, jejunostomy, ureterostomy, urinary diversion, fecal diversion, ostomy care, peristomal skin care, complications, education, quality of life, enterostomal therapy and nursing. English-language systematic reviews and primary studies were included if they were within the scope of the clinical questions and published between 1998 and 2011. There was no preference on the basis of research design; both qualitative and quantitative primary studies of various designs were included.

The initial search identified 929 abstracts. An additional 193 abstracts were added in the 2011 update. These were independently screened by two reviewers and 95 articles were included in the final review. Of these, 69 were quantitative, 11 were qualitative and eight were systematic reviews. The nature of the remaining seven studies was not reported.

Questions 2, 3, 4, 8 and 9 are of direct relevance to this project. For each of these questions the authors searched for but did not identify studies about stoma accessory products.

2. What nurse-led interventions are effective in improving ostomy care and peristomal skin care (e.g. reducing degree / frequency of complications, shortening healing time) in neonatal, paediatric, or adult populations?

Fourteen descriptive quantitative studies provided information about the common types of complications and three studies that described tools to assist nurses with diagnosing and choosing treatment of ostomy complications. One systematic review discussed the role that stoma irrigation played in managing complications of the ostomy. This review reported that the literature was not extensive but what had been published identified irrigation as a safe means of caring for one's ostomy and decreasing complications. No studies of Group 9 accessories were reported.

3. What nurse-led interventions are effective in promoting patient self-care of ostomy and peristomal skin in paediatric or adult populations?

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Three studies described and evaluated different appliances and interventions that promoted patient self-care of ostomy and peristomal skin in the adult population. Two evaluated types of ostomy appliances, including impacts on appliance changes, stool seepage, overfilling, patient mobility, odour management, pouch flexibility, adhesiveness and erosion. One study evaluated nurse-led interventions such as the practice of colostomy irrigation. No studies of Group 9 accessories were reported.

4. What nurse-led interventions are effective in managing complications in ostomies and peristomal skin in neonatal, paediatric, or adult populations?

Twelve studies provided information to address this question. Five studies describe factors that contribute to ostomy-related complications (gender, obesity, siting of the stoma, involvement of a stomal therapist in ongoing care). Three studies reported that pre-operative marking reduces ostomy complications and peristomal skin complications. One study reported the importance of patient education in reducing complications. The topic of the remaining three studies was not described in detail. No studies of Group 9 accessories were reported.

8. What resources used by nurses in ostomy care are most effective in managing ostomies (e.g. promoting healing, reducing complications)?

A single study (a randomized controlled trial) was reported that addressed this question. The study compared the costs and effectiveness of enterostomal education using a multimedia learning education program (MLEP) and a conventional education service program (CESP). No studies of Group 9 accessories were reported.

9. What resources used by patients in self-managed ostomy and peristomal care are most effective in managing ostomies (e.g. promoting healing, reducing complications)?

No studies were found that addressed this research question.

Methodological quality of the systematic review

The methodological quality of this systematic review was assessed using AMSTAR criteria. This systematic review met 4 of 11 AMSTAR criteria (there was an a priori design, duplicate study selection and data extraction, a comprehensive literature search and status of publication did not influence inclusion), suggesting this is a poor quality systematic review37.

Other publications identified in the peer-reviewed literatureWe have set out below the results of the other publications identified in the peer-reviewed literature according to the type of Group 9 products described in Table A.1.

37 Shea B, Grimshaw JM, Wells GA, Boers M, Andersson N, Hamel C, et al. Development of AMSTAR: a measurement tool to assess the methodological quality of systematic reviews. BMC Medical Research Methodology 2007;7(10):1-7.

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1. Skin care and protection accessoriesWe identified five publications that described relevant outcomes for skin care and protection (Al Niami 2012, Berry 2007, Erwin 2012, Hoeflok 2009, Thompson 2011).

Al Niami 2012 reported the results of patch testing for peristomal dermatitis in 149 (18%) patients with unexplained dermatitis identified from a cohort study of 850 participants with a stoma. Of the 149 patients there were 53 (36%) who had positive reactions on patch testing. Of these, seven (13%) had reactions of proven relevance to their stoma products (five patients to skin wipes, three to deodoriser and two to skin gel – some patients reacted to more than one product), 26 (49%) had reactions of some relevance to their stoma treatment (three to epoxy resins, two to ‘tackifiers’, one to adhesive, one to foam applicator and all others to acrylates) and 20 (38%) were considered not relevant as they were not related to any stoma product used by the patient. In all cases the dermatitis resolved once use of the allergen was ceased.

Berry 2007 conducted an industry-funded survey of 648 stoma care nurses (363 responses received; 56% response rate). The study authors reported high levels of awareness of stomal care nurses of skin products used to manage peristomal skin problems. Nurses mainly used silicone-based skin preparations to treat excoriated peristomal skin, wounds, fistulae or skin at risk of excoriation (96% of respondents).

Erwin 2012 conducted an industry-funded non-controlled multicentre intervention study with 3,017 patients across 18 countries to assess patient outcomes associated with the SenSura ostomy appliance. There were 52.5% of patients with a colostomy and 47.1% with an ileostomy. Participants reported that the accessories they most commonly used were ‘pastes or similar’ and ‘protective film’. At baseline 87% of participants used accessories. At 6 to 8 weeks follow-up (after commencement of use of the SenSura product and regular visits with the wound and ostomy clinic nurse) 66% of participants used accessories (baseline to follow-up test for statistical significance p<0.0001).

Hoeflok 2009 conducted a multicentre product evaluation study with a convenience sample of 49 enterostomal therapy nurses from acute care facilities and 172 patients with a stoma in Canada. The study evaluated patient outcomes with the SUR-FIT Natura Moldable Skin Barrier (ConvaTec). At baseline 36% of patients had a colostomy and 59% had an ileostomy; 51% had intact skin without redness. Skin barrier performance was rated as ‘excellent’ or ‘very good’ by 84% with colostomies, 85% with ileostomies and 93% with urostomies. Average skin protection effectiveness (rated out of 5 by participant) was greatest for patients with a colostomy and did not vary substantially between patients with intact skin, minor redness or extensive redness. The most common problems reported by participants were adhesion or attachment problems, issues with the flange, seal or filter, or with wear time or skin condition. Reasons for discontinuation of the product were participants preferred another product, (9%), difficulty with attachment or adhesive (6%) and leakage (6%).

Thompson 2011 reported narratively a case series of four patients with peristomal skin problems whose skin conditions were subsequently managed with the Hollister range of products. The cases demonstrated the specialist nursing approach to patient assessment, including identification of the patient’s skin type, patient’s expectation in relation to wear time

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and stoma output. The case reports showed an association between reduced skin irritation and a well-fitting skin barrier where leakages do not occur on a regular basis.

Costs

No financial data were reported in these publications.

Levels of evidence of primary references

The publication by Al Niami 2012 was the highest level of evidence (level 3) identified.

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Table A.2 References with outcomes relating to skin care and protection for people with a stoma

Reference ID Study description

Methods Outcome description

Effects for selected outcomes Study quality issues

Al Niami 2012

Level III evidence

Cohort study Study of 149 patients with peristomal dermatitis conducted within a cohort study of 850 ostomates.

Participants were assessed with a general medical history and examination, testing for infection, observation of changing their appliance then patch testing using an extended Manchester standard battery, the patient’s own products and the researcher’s stoma series.

Skin reaction to patch testing

53 out of 149 patients had positive reactions on patch testing.

Seven had reactions of proven relevance to their stoma products (including five patients to skin wipes and two to skin gel – some patients reacted to more than one product)

26 had reactions of some relevance to their stoma treatment (three to epoxy resins, two to tackifiers, one to adhesive, one to foam applicator and all others to acrylates)

20 were considered not relevant as they were not related to any stoma product used by the patient.

Details of cohort study not provided. Cohort appears to be patients of a stomal therapy clinic. As a result, risk of selection bias unable to be assessed.

Berry 2007

Level of evidence not applicable

Postal survey A survey was conducted of 648 stomal care nurses in the United Kingdom. A structured questionnaire was distributed by post with space for qualitative comments. Four weeks was given for return of the survey.

Questions assessed nurses’ views on: Skin preparations, adhesive removers and flange

security products The types of products recommended in specific clinical

situations The benefits of certain types of products to stoma

patients with particular medical needs Whether the outcomes of the survey should be brought

to the attention of the DH by stomal care nurses.

Nurses attitudes and practices in using skin products

363 of 648 surveys were returned (response rate of 56%).

Three-hundred and sixty three (100%) were aware of alcohol-based skin products and 362 (99.9%) were aware of silicone-based products. Skin preparations used on excoriated peristomal skin, wounds, fistulae or skin at risk of excoriation were silicone (348 of 363 respondents).

Survey commissioned by four companies in the United Kingdom who manufacture silicone and hydrocolloid products used in stoma care to inform reimbursement decisions of the Department of Health.

Erwin 2012


Multicentre product evaluation

Open label non-comparative multicentre study. This paper reported the results of analysis of a sub-group of participants of the Dialogue study. The Dialogue study is a non-controlled clinical study that collected information about patient experience relating to Coloplast’s SenSura ostomy appliance. Dialogue collected data on 3,017 participants with an ostomy and included 500 wound and ostomy care nurses across 18 countries worldwide. There were 36 participants from Australia.

This paper reports results of assessment of peristomal skin and health-related quality of life by WOC nurses at

Skin condition

Quality of life

Frequency of output under the adhesive and leakage decreased between baseline and study follow-up with the SenSura product.

52.5% had a colostomy and 47.1% had an ileostomy.

This study reports decreased accessory use, improved skin condition and significant improvement in quality of life with the SenSura product and regular

Uncontrolled clinical trial. No comparison group for assessing outcomes.

Study funded by Coloplast, a manufacturer of stomal products.

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baseline and after 6 to 8 weeks following the use of the SenSura double-layer adhesive ostomy pouching system the 743 patients in North America.

contact with a Wound and Ostomy Clinic nurse.

The most widely used accessories were ‘pastes or similar’ and ‘protective film’. At baseline 87% of participants used accessories. At 6 to 8 weeks follow-up 66% of participants used accessories (baseline to follow-up test for statistical significance p<0.0001).

Hoeflok 2009



Convenience sample of 60 enterostomal therapy nurses from acute care facilities and 172 patients with a stoma in Canada. Purpose of study was to evaluate patient outcomes with use of SUR-FIT Natura Moldable Skin Barrier (ConvaTec).

Evaluation sponsor provided nurses with training on product use, product samples and written information on product use. Nurses identified a convenience sample of their patients to participate in the study.

The patient or the nurse decided how long to trial the product and when to complete the evaluation forms – no minimum or maximum time frames for use were established.

Skin barrier performance and protection effectiveness

Problems with product

Discontinuation of product

49 of 60 invited nurses participated in the study and completed 195 evaluation forms for 172 people with a stoma. The 172 patients completed 367 evaluation forms. At baseline 36% of patients had a colostomy and 59% had an ileostomy; 51% had intact skin without redness.

Skin barrier performance was rated as ‘excellent’ or ‘very good’ by 84% with colostomies, 85% with ileostomies and 93% with urostomies.

Average skin protection effectiveness (rated out of 5 by participant) varied depending on skin condition:- For patients with intact skin was 3.5 for colostomy, 3.3 for ileostomy and 3 for urostomy.- For people with some redness ratings were 2.9 and 3.1 for colostomy and ileostomy respectively (no patients with urostomy in this skin category).- For extensive redness, scores were 2.5 and 3.5 for ileostomy and urostomy (no patients with colostomy in this skin category).

Problems reported by > 5% of participants included adhesion or attachment problems, issues with the flange, seal or filter, or with wear time or skin condition.

Reasons for discontinuation reported by > 5% of patients were participant


Study conducted by ConvaTec, a manufacturer of stomal products.

Study authors received financial benefits from company.

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preferred another product, (9%), difficulty with attachment or adhesive (6%) and leakage (6%).

Thompson 2011

Level IV evidence

Case series Narrative description of case series (four patients) with peristomal skin problems whose skin conditions are subsequently managed with the Hollister range of products.

Patient satisfaction

Leakage

Maintenance of seal

This article describes the specialist nursing assessment and management of four stoma patients, highlighting matching of patient skin type with a Hollister skin barrier product.

Different skin barrier products were chosen for patients depending on skin type (oily, normal, sensitive / fragile or dry), stoma appearance (retracted, normal, herniated), patient build (underweight, normal, excess body weight) and patient preferences.

One co-author is staff member of Hollister, a manufacturer of stomal therapy products.

Another co-author is a ‘Dansac Senior Lecturer in Gastrointestinal Nursing’ at an academic institution. It is assumed that the company that produces Dansac sponsors this position.

Article only refers to the use of the Hollister product range in managing peristomal skin problems.

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Evidence statements

Are Group 9 skin care and protection accessories effective for improving outcomes in people with a stoma?

Body of evidenceOutcome domain Results Quality of

evidencePatient health- Allergy- Skin condition

Two studies reported on patient health outcomes.One cohort study (n=149 patients) reported 7 allergic reactions of proven relevance to a patient’s stoma product (5 to skin wipes, 2 to skin gel) and 26 reactions of some relevance (3 to epoxy resins, 2 to tackifiers, 1 to adhesive, 1 to foam applicator and all others to acrylates).One product evaluation study (n=3,017 patients) reported a 21% decrease in accessory use (87% used at baseline) and improved skin condition (quantitative outcomes not reported) associated with SenSura ostomy appliance.

Very low

Quality of life One product evaluation study (n=3,017 patients) reported a 21% decrease in accessory use and improved quality of life (quantitative outcomes not reported) associated with SenSura ostomy appliance.

Very low

Patient satisfaction One case series (n=4 patients with peristomal skin problems) who were managed with the Hollister range of products reported high patient satisfaction associated with the product. Quantitative outcome measures were not reported.

Very low

Product performance- Leakage- Maintenance of seal- Skin barrier performance and protection effectiveness- Problems with product- Product discontinuation

Two studies reported product performance outcomes.One product evaluation study (n=172 patients and 49 nurses) of SUR-FIT Natura Moldable Skin Barrier Skin found skin protection effectiveness was greatest for patients with intact skin and lowest for patients with extensive redness. The most common problems reported was adhesion or attachment problems and the most common reason for discontinuation was participant preferred another product.One case series (n=4 patients with peristomal skin problems) who were managed with the Hollister range of products reported reduced leakage associated with the product. Quantitative outcome measures were not reported. Products used at baseline were not reported.

Very low

Nursing attitudes and practices

One survey (n=363 stoma care nurses) reported 100% of nurses were aware of alcohol-based skin products and 99.9% were aware of silicone-based products.The preferred skin preparations used on excoriated peristomal skin, wounds, fistulae or skin at risk of excoriation was silicone-based (96% of respondents).

Very low

Evidence statement

The effectiveness of Group 9 skin care and protection accessories for improving outcomes in people with a stoma are uncertain.

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2. Stoma support garmentsWe identified one publication that described relevant outcomes for stoma support garments (Cowin 2012).

Cowin 2012 analysed results of a survey completed by 322 people with a parastomal hernia who were clients of a home-delivery stoma care products service in the UK. The survey response rate was 28% and the publication was authored by employees of the home-delivery company.

Among respondents, 55% had a colostomy, 33% an ileostomy and 10% a urostomy. Stoma problems reported by participants included leakage under the adhesive onto the skin (66%), ‘sensations’ (56%), discomfort (40%) and odour (30%). Leakage was most severe for patients with an ileostomy (60%) compared with urostomy (52%) or colostomy (41%).

Although all participants were registered on the home-delivery company’s database as having received a stoma support garment, 45% of participants reported that they used their stoma belts or girdles regularly and 27% thought that wearing a support belt or pants was the best way to manage their hernia.

Costs

No financial data were reported in this publication.


Not applicable as no studies were identified where level of evidence could be rated.

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Table A.3 References with outcomes relating to stoma support garments for people with a stoma




Cowin 2012


Survey Study of experiences of patients with parastomal hernias.

The survey was mailed to 1,876 people who had placed an order for a support garment on a UK home-delivery service providing stoma care products (Salts Medilink).

Use of stoma support garments to manage parastomal hernia

The response rate was 28%. A total of 322 people stated they had been diagnosed with a parastomal hernia; 55% had a colostomy, 33% an ileostomy and 10% a urostomy.

40% reported discomfort, 30% reported odour, 56% reported ‘sensations’, 66% reported leakage under the adhesive onto the skin. Leakage was described as very or fairly bad by 60% with ileostomy, 52% with urostomy and 41% with colostomy.

59% never or rarely sought help with their hernia management; 45% of patients regularly used their support belt or girdle; 27% stated wearing a support belt or pants was the best way to manage a parastomal hernia.

Paper authors employed by Salts Healthcare, a UK home-delivery stoma care product service

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Evidence statements

Are Group 9 stoma support garments effective for improving outcomes in people with a stoma?

Body of evidenceOutcome domain Results Quality of evidence

Patient health- Use of stoma support garments to manage parastomal hernia

One survey (n=322 patients with a parastomal hernia) reported 45% of participants used their stoma belts or girdles regularly and 27% thought that wearing a support belt or pants was the best way to manage their hernia.

Very low

Evidence statement The effectiveness of Group 9 stoma support garments for improving outcomes in people with a stoma are uncertain.

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3. Cleansers and adhesive removal accessoriesWe identified three publications that described relevant outcomes for cleansers and adhesive removal accessories (Al Niami 2012, Berry 2007, Rudoni 2008).

Al Niami 2012 reported the results of patch testing for peristomal dermatitis in 149 (18%) patients with unexplained dermatitis identified from a cohort study of 850 participants with a stoma. Of the 149 patients there were 53 (36%) who had positive reactions on patch testing. Of these, three patients (6%) had reactions to adhesive removal products. Three patients had positive reactions to components of cleansing wipes that are intended to remove the adhesive debris that is left when removing a bag. These included propylene glycol (two cases) and isopropyl alcohol (propan-2-ol; one case). All three patients reported a definite improvement in the peristomal dermatitis following discontinuation and substitution of the wipes with ones which did not contain either allergen.

Berry 2007 conducted an industry-funded survey of 648 stoma care nurses (363 responses received; 56% response rate). The study authors reported high levels of awareness of stomal care nurses of alcohol-based adhesive removers (99.4%) and silicone-based removers (99.9%). The type of adhesive remover that nurses recommended to patients who find it painful and/or difficult to remove their pouches was silicone-based removers (354 of 363 respondents).

Rudoni 2008 evaluated a silicone-based adhesive remover with a convenience sample of people with a stoma who attended a stoma care open day at a single UK hospital. Of the 60 volunteers who were provided with samples of the adhesive remover 54 returned a questionnaire reporting their experience of using the product. According to the self-reported results, the use of the product was associated with greater ease of removal of the stoma bag (91% of participants) and a difference with their skin (81%; the nature of the difference in the participant’s skin was not described).

Costs



The publication by Al Niami 2012 was the highest level of evidence (level 3) identified.

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Table A.4 References with outcomes relating to cleansers and adhesive removal accessories for people with a stoma




Al Niami 2012

Level III evidence





Three patients (6%) had reactions to adhesive removal products - propylene glycol (two cases) and isopropyl alcohol (propan-2-ol; one case).

Peristomal dermatitis improved following discontinuation of the product.


Berry 2007



Questions assessed nurses’ views on: Skin preparations, adhesive removers and

flange security products The types of products recommended in

specific clinical situations The benefits of certain types of products to

stoma patients with particular medical needs

Whether the outcomes of the survey should be brought to the attention of the DH by stomal care nurses.

Nurses attitudes and practices in using adhesive removal accessories


Three-hundred and sixty-one (99.4%) were aware of alcohol-based adhesive removers and 362 (99.9%) were aware of silicone-based removers. The type recommended to patients who find it painful and/or difficult to remove their pouches was silicone (354 of 363 respondents).


Rudoni 2008


Product evaluation using a questionnaire

A convenience sample of 60 participants was provided with samples of a silicone-based adhesive remover (Lift Plus).

Participants were volunteers who attended a stoma care open day at a single UK hospital.

Participants were provided with a questionnaire to return after using the product.

Effectiveness of silicone-based adhesive remover

54 of 60 patients returned the survey (response rate of 90%); 46% had ileostomies, 39% had colostomies and 15% had urostomies.

91% reported the stoma bag was easier to remove, 93% found the spray easy to use, 81% noticed a difference with their skin when the spray was used, 96% indicated they would continue to use the adhesive remover and 93% felt adhesive remover should be offered to all patients.

Selection bias of participants – those who attended an open day at a single hospital and volunteered to participate.

Non-controlled study of the product; no comparison group to compare results with.

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Evidence statements

Are Group 9 cleansers and adhesive removal accessories effective for improving outcomes in people with a stoma?


Patient health- Allergy- Skin condition

Two studies reported on patient health outcomes.One cohort study (n=149 patients) reported 3 allergic reactions to adhesive removal products.One product evaluation study (n=54 patients) reported 81% of patients found ‘a difference with their skin’ with silicone-based removers

Very low

Product performance- Ease of stoma bag removal

One product evaluation study (n=54 patients) reported 91% of patients found greater ease of removal of the stoma bag with silicone-based removers.

Very low

Nursing attitudes and practices One survey (n=363 stoma care nurses) reported 99.4% of nurses were aware of alcohol-based adhesive removers and 99.9% were aware of silicone-based removers. 97.5% of nurses recommended silicone-based removers to patients who found it painful / difficult to remove their pouches.

Evidence statement The effectiveness of Group 9 cleansers and adhesive removal accessories for improving outcomes in people with a stoma are uncertain.

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4. Deodorisers and gas suppressantsWe identified one publication that described relevant outcomes for deodorisers and gas suppressants (Al Niami 2012).

Al Niami 2012 reported the results of patch testing for peristomal dermatitis in 149 (18%) patients with unexplained dermatitis identified from a cohort study of 850 participants with a stoma. Of the 149 patients there were 53 (36%) who had positive reactions on patch testing. Of these, three (6%) had reactions to deodorisers of proven relevance to their stoma products.

One patient was sensitive to oak moss absolute (Evernia prunastri) and the deodorising product he was using that contained it. The other patient who was sensitive to a fragranced deodorizer specifically reacted to cinnamal. Both patients were using their deodorising preparation inappropriately, allowing significant skin contact instead of placing a few drops in the bag itself as per the package instructions. A third patient was sensitive to formaldehyde and the formaldehyde-releasing biocide bronopol (2-bromo-2-nitropropane-1,3-diol) which was a declared ingredient of a deodorising spray she used intermittently. In all cases the dermatitis resolved once use of the allergen was ceased.

Costs

No financial data were reported in this publication.


The sole publication by Al Niami 2012 was the highest level of evidence (level 3) identified.

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Table A.5 References with outcomes relating to deodorisers and gas suppressants for people with a stoma

Reference ID

Study description



Al Niami 2012

Level III evidence





Three patients (6%) had allergic reaction to deodorisers - oak moss (Evernia prunastri) (1 patient), cinnamal (1 patient) and formaldehyde and the formaldehyde-releasing biocide bronopol (2-bromo-2-nitropropane-1,3-diol) (1 patient).

The patients allergic to oak moss and cinnamal were using their deodorising preparation inappropriately.

In all cases the dermatitis resolved once use of the allergen was ceased.


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Evidence statements

Are Group 9 deodorisers and gas suppressants effective for improving outcomes in people with a stoma?


Patient health- Allergy

One cohort study (n=149 patients) reported 3 allergic reactions to deodorisers that were of proven relevance to their stoma product.

Very low

Evidence statement The effectiveness of Group 9 deodorisers and gas suppressants for improving outcomes in people with a stoma are uncertain.

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5. Skin fillers and adhesive productsWe identified five publications that described relevant outcomes associated with the use of skin fillers and adhesive products (Berry 2007, Erwin 2012, Field 2010, Martin 2005, Park 2011).

Berry 2007 conducted an industry-funded survey of 648 stoma care nurses (363 responses received; 56% response rate). Three hundred and fifty-nine (98.9%) were aware of adhesive tape for picture framing and 363 (100%) were aware of hydrocolloid flange extenders. Of these, 360 of 363 recommended hydrocolloid and 25 recommended adhesive tape for patients who require extra adhesion or security.

Erwin 2012 conducted an industry-funded non-controlled multicentre intervention study with 3,017 patients across 18 countries to assess patient outcomes associated with the SenSura ostomy appliance. There were 52.5% of patients with a colostomy and 47.1% with an ileostomy. Participants reported that the accessories they most commonly used were ‘pastes or similar’ and ‘protective film’. At baseline 87% of participants used accessories. At 6 to 8 weeks follow-up (after commencement of use of the SenSura product and regular visits with the wound and ostomy clinic nurse) 66% of participants used accessories (baseline to follow-up test for statistical significance p<0.0001).

Field 2010 reports a case of allergic contact dermatitis due to Gantrez 425 in a patient with an ileostomy with peristomal erythema, pruritus and scale around the stoma. The patient was patch tested and had a positive reaction to Gantrez 425 but not Gantrez 335. The case demonstrates a lack of cross reactivity between different Gantrez entities despite similar chemical structure.

Martin 2005 reports a case of allergic contact dermatitis due to Dansac1 soft paste in a patient with a colostomy who experienced a severe disabling blistering peristomal dermatitis. Patch testing to the patient’s own products gave a positive reaction to Dansac1 soft paste and Stomahesive1 paste. Further patch testing to the components of Dansac1 soft paste showed a positive reaction at D2 and D4 to ester of polymethyl vinyl/maleic acid copolymer.

Park 2011 conducted a randomised controlled trial to compare the effects of standardised peristomal skin care (SPSC) and crusting technique (CT) on the peristomal skin of ostomates. SPSC consisted of water cleansing and direct application of ostomy appliances. CT involved crusting hydrocolloid powder and patting with water sponge or protective barrier liquid film. A total of 81 ostomates recruited from a tertiary hospital completed the baseline, 1-month, 2-month, and 3-month follow-up (SPSC group, n=45; CT group, n=36). Significant between-group differences in favour of SPSC were observed for erosion and tissue overgrowth but not discolouration.

Costs



The publication by Park 2011 was the highest level of evidence (level 2) identified.

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Table A.6 References with outcomes relating to skin fillers and adhesive products for people with a stoma

Reference ID

Study description



Berry 2007



Questions assessed nurses’ views on: Skin preparations, adhesive removers and flange

security products The types of products recommended in specific

clinical situations The benefits of certain types of products to stoma

patients with particular medical needs Whether the outcomes of the survey should be

brought to the attention of the DH by stomal care nurses.

Nurses attitudes and practices in using skin products


Three hundred and fifty-nine (98.9%) were aware of adhesive tape for picture framing and 363 (100%) were aware of hydrocolloid flange extenders. 360 of 363 recommended hydrocolloid and 25 recommended adhesive tape.


Erwin 2012



Open label non-comparative multicentre study. This paper reported the results of analysis of a sub-group of participants of the Dialogue study. The Dialogue study is a non-controlled clinical study that collected information about patient experience relating to Coloplast’s SenSura ostomy appliance. Dialogue collected data on 3,017 participants with an ostomy and included 500 wound and ostomy care nurses across 18 countries worldwide. There were 36 participants from Australia.

This paper reports results of assessment of peristomal skin and health-related quality of life by WOC nurses at baseline and after 6 to 8 weeks following the use of the SenSura double-layer adhesive ostomy pouching system the 743 patients in North America.

Skin condition

Quality of life

Frequency of output under the adhesive and leakage decreased between baseline and study follow-up with the SenSura product.

52.5% had a colostomy and 47.1% had an ileostomy.

This study reports decreased accessory use, improved skin condition and significant improvement in quality of life with the SenSura product and regular contact with a Wound and Ostomy Clinic nurse.

The most widely used accessories were ‘pastes or similar’ and ‘protective film’. At baseline 87% of participants used accessories. At 6 to 8 weeks follow-up 66% of participants used accessories (baseline to follow-up test for statistical significance p<0.0001).


Study funded by Coloplast, a manufacturer of stomal products.

Field 2010


Case report Report of the case of a 71-year old patient with an ileostomy who developed peristomal erytherma, pruritus and scale around the stoma.

Peristomal dermatitis

While awaiting patch testing, the patient changed his stoma adhesive. His rash relapsed when using Stomahesive (ConvaTec Ltd.), Adapt (Hollister Ltd.), Dansac soft paste (Dansac Ltd.) but did not relapse when using Karaya paste (HollisterLtd.).

Patch testing was performed using a Finn chambers and Scanpor series. Reactions were

Conflicts of interest not reported

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Reference ID

Study description



graded using International Contact Dermatitis Research group criteria. There was a 2+ reaction toGantrez 425 at 100% concentration only and negative to all concentrations of Gantrez 335 at D4. Ten controls were negative to both Gantrez 425 and Gantrez® 335.

Martin 2005


Case report Report of the case of a colostomy patient with a severe disabling blistering peristomal dermatitis.

Peristomal dermatitis

Patch testing to a British Contact Dermatitis Society standard series, medicaments and plastics and glues series was negative. Patch testing to the patient’s own products gave a positive reaction (+) at D2 and D4 to Dansac1 soft paste and Stomahesive1 paste. Further patch testing to the components of Dansac1 soft paste showed a positive (+) reaction at D2 and D4 to ester of polymethyl vinyl/maleic acid copolymer (Gantrez1-ES) only.

Conflicts of interest not reported

Park 2011

Level II evidence

Randomised controlled trial

A randomized controlled pilot trial with 2 parallel arms was conducted to compare the effects of standardised peristomal skin care (SPSC) and crusting technique (CT) on the peristomal skin of ostomates.

81 ostomates recruited from a tertiary hospital completed the baseline, 1-month, 2-month, and 3-month follow-up (SPSC group, n=45; CT group, n=36). SPSC consisted of water cleansing and direct application of ostomy appliances. CT involved crusting hydrocolloid powder and patting with water sponge or protective barrier liquid film.

Skin discolouration, erosion and tissue enlargement

In both SPSC and CT groups, the likelihood of occurrence of discolouration (OR, 1.99; 95% CI, 1.61-2.46), erosion (OR, 1.87; 95% CI, 1.55-2.25) and tissue enlargement (OR, 1.94; 95% CI, 1.36-2.77) increased with time.

There was no significant difference in discolouration between the groups, whereas the probability of erosion (OR, 0.38; 95% CI, 0.16-0.89) and tissue overgrowth (OR, 0.09; 95% CI, 0.02-0.55) was lower in the SPSC group than in CT group.

Rating of risk of bias using Cochrane Risk of Bias Tool.

Met 3/7 risk of bias criteria (random sequence generation, reporting of outcome data, free from selective reporting).

Trial at high risk of bias.

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Evidence statements

Are Group 9 skin fillers and adhesive products effective for improving outcomes in people with a stoma?


Patient health- Peristomal dermatitis- Skin condition- Skin problems (discolouration, erosion and tissue enlargement)

Four studies reported patient health outcomes.One RCT (n=81 patients) reported reduced erosion and tissue overgrowth but not discolouration of the skin with crusting hydrocolloid powder +/- protective barrier liquid film compared with water alone.Two case studies (n=2) reported peristomal dermatitis associated with the use of products containing Gantrez 425 and Dansac1 soft paste / stomadhesive paste respectively.One product evaluation study (n=3,017 patients) reported a 21% decrease in accessory use (including ‘pastes or similar’) associated with SenSura ostomy appliance.

Very low

Quality of life One product evaluation study (n=3,017 patients) reported a 21% decrease in accessory use (including ‘pastes or similar’) and improved quality of life (quantitative outcomes not reported) associated with SenSura ostomy appliance.

Very low

Nursing attitudes and practices One survey (n=363 stoma care nurses) reported 98.9% were aware of adhesive tape for picture framing and 100% were aware of hydrocolloid flange extenders. 99% recommended hydrocolloid and 7% recommended adhesive tape.

Very low

Evidence statement The effectiveness of Group 9 skin fillers and adhesive products for improving outcomes in people with a stoma are uncertain.

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Summary of the main results from the peer-reviewed literature

We conducted a systematic review of peer-reviewed studies investigating outcomes associated with the use of Group 9 accessory products. Thirteen studies were identified. One study was a systematic review that included RCTs (Recalla 2013), one was a RCT (Park 2011), one was a nested diagnostic study conducted within a cohort study (Al Niami 2012) and one was a case series (Thompson 2011). All other studies were not able to be rated using the NHMRC’s levels of evidence. Although we identified one relevant systematic review, this study searched for but did not identify RCTs of Group 9 accessory products. This review therefore did not contribute empirical evidence to our systematic review.

The types of Group 9 products that were the subject of included studies were skin care and protection accessories (5 studies), stoma support garments (1 study), cleansers and adhesive removal accessories (3 studies), deodorisers (1 study) and skin fillers and adhesive products (5 studies). We identified no studies for clamps & clips, convexity inserts, gas suppressants, night drainage, seals or miscellaneous products not already addressed in the other product groupings.

We were unable to draw firm conclusions about the association between outcomes and any type of Group 9 product due to a lack of high quality primary studies.

Overall completeness and applicability of the evidence

We sought publications of any Group 9 product listed in the Group 9 SAS that was used in children and adults of any age, gender or socio-demographic characteristics with a stoma. We included any publication regardless of patient-relevant outcomes that were reported in each information source [(including morbidity, mortality, quality of life), patient satisfaction, cost (any cost or economic metric related to cost)].

We found important gaps in the research evidence regarding Group 9 accessory products and the evidence presented in Part A has important limitations. The systematic review included 13 studies in total. This is a relatively small body of research from which conclusions can be drawn. Further, conclusions about the impact of Group 9 accessories on patient outcomes are limited largely to adult patients.

Quality of the evidence

The overall quality of the evidence was poor. The majority of studies were unable to be rated using the NHMRC’s levels of evidence. The single RCT that was identified included a small patient sample, relatively short follow-up of patients and a lack of quantitative reporting of outcomes.

Primary outcomes were self-reported or reported by nursing proxy across included publications, making them susceptible to reporting bias.

Significant conflicts of interest were identified for the majority of included studies. Industry funding of the studies themselves, and / or the authors reporting the results of studies increases the risk of bias of included studies.

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Potential biases in the systematic review process

We are aware that there are risks of introducing bias at all stages of a systematic review. We took steps to reduce bias by specifying an ‘a priori design and performing a comprehensive search of the literature. Duplicate study selection and data extraction was performed. We searched for publications regardless of publication type and provided a list of included and excluded studies. The characteristics of included studies were provided and their scientific quality were assessed and documented. We used the scientific quality of included studies in formulating our conclusions. We were unable to assess for the likelihood of publication bias due to a lack of availability of primary studies from which graphical and statistical tests of publication bias could be performed.

We modified our search strategy after conducting our initial searches as the initial number of abstracts that were identified was too large to enable a systematic review to be conducted. To identify the most relevant references, the following additional inclusion and exclusion filters were applied: the filter ‘research’ was applied in EMBASE and CINAHL; and the filter ‘human’ was specifically applied in MEDLINE via Pubmed, EMBASE and CINAHL.

We developed quality criteria to assist in the preparation of an evidence statement for each product type. These criteria were specified after the original review protocol was developed and after the included studies were identified.

Based on the findings of the systematic review by Recalla 2013, that searched for but did not identify RCTs of Group 9 accessory products, we do not believe these amendments to the review methods substantially affect the conclusions we have drawn from the available evidence.

Conclusions

There is little evidence available in the literature on the use and efficacy of Group 9 accessories, and decisions on accessories and how to use them are often based on shared experience and information among clinical nurse specialists rather than empirical studies demonstrating impacts on outcomes.

There is a need for high quality randomised controlled trials to evaluate the association between Group 9 accessories and patient outcomes. Well-designed studies with adequate power and length of follow-up are required to allow definite conclusions to be drawn.

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Part B - Results from the 'grey' literature'Grey' literature database searches

The combined systematic searches of the 'grey' literature yielded 1,360 potential publications. Of these, 1,304 publications were excluded and 56 publications were retained for full text review (Table B.1).

Table B.1 Results of ‘grey’ literature review

Database Results Publications identified for reviewGoogle Scholar #1

963 results, review ceased at 80 items due to lack of relevance, 45 publications identified

40 peer reviewed journal articles and 1 systematic review– for inclusion in the systematic literature review

3 practice manuals

1 conference presentation.

Google Scholar #2

9 results, 1 publication identified

1 practice manual

Google (chrome)

302 results, ceased search at item 100 due to lack of relevance.1 guideline selected

1 guideline

Open SIGLE

7 results Nil

Bing 79 results, 9 publications selected

1 summary document

4 guidelines

1 stoma appliance scheme outline

1 consultation document

1 summary document for consultation responses

1 practice manual

Following review of the retained publications:

40 peer review journal articles and one systematic literature review were included in the literature review at abstract review stage;

two duplicate practice manuals were removed;

two duplicate guidelines were removed;

two practice manuals were excluded as they do not include data about any patient relevant outcomes and provide a nursing opinion;

one practice manual was, on review, a consensus guideline and included in the grey literature review as a guideline;

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one conference presentation was excluded as it did not include data about group 9 products; and

one consensus guideline was included from the systematic review search of peer reviewed publications.

In addition to the structured ‘grey’ literature review a targeted search relating to stoma appliance accessory manufacturers, distributors and stoma schemes was performed. Further information is provided at attachment 2.

Overall, the following 27 materials of broad relevance were identified:

Position Papers (two publications);

Documentation from international stoma schemes (11 publications);

Guidelines and best practice manuals (three publications);

Consensus Guidelines (two publications);

Product pricing (nine publications).

A list of excluded publications with reasons for exclusion is provided at Attachment 1. Publications identified from industry sources are provided at Attachment 2.

Key findings from included 'grey' literature are now described.

Position papers

Two position papers were identified. The position papers provide information to consumers regarding stoma schemes and are discussed in the international stoma scheme section of this report.

Guidelines and best practice manuals

Prescribing guidelines for stoma appliances and accessories

Three prescribing guidelines for stoma appliances were identified that included Group 9 accessories. All three prescribing guidelines were developed by committees within English NHS Trusts.

The aim of the prescribing guidelines is to provide prescribers with information regarding appropriate quantities and use of appliances and accessories. As the NHS England and Wales Drug Tariff does not include maximum or recommended quantity information for products listed, Trusts have developed this information independently.

A summary of recommended quantities for each guideline together with the actual or averaged Australian SAS maximum quantity is provided at Table B.2.

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Table B.2: Summary of recommended product quantities from published guidelines

Item type SAS Max Qty38

Coventry and Warwickshire Av. Qty / month39

Northamptonshire Qty / month40

Leicestershire Qty / Month41

Ostomy Belts 4 / year 3 / year 3 / year 2-3 / yearNight Drainage Bags

5 bags 4 bags 4 bags 4 bags

Adhesive Remover Spray

2 / month 1-3 cans 1-3 cans 2-3 bottles

Deodorants 1-2 / month (depending on bottle size)

1 bottle N/A N/A

Lubricating deodorant gel

1 bottle / month

2 bottles N/A N/A

Powder 2 / month N/A N/A 1 containerBarrier Wipes 30 / month N/A N/A 10-15 wipes (one

wipe / flange)Barrier Spray 1 / month N/A N/A 1-9 bottles (1

bottle / 10 pouches)Protective Rings 30 / month N/A N/A 10-15 (one / flange)Adhesive remover wipes

100 / month N/A N/A 15-90 wipes (one / pouch change)

Pastes 3 tubes / month

N/A N/A 1 tube

Hernia Belts, Girdles and Garments

3 belts / year, 6 garments / year (restricted access)

N/A N/A 3-6 / year

Retention strips 60 / month N/A N/A 30-90 (1-3 / pouch)Clips 10 / year N/A N/A 10 every 6 months

*N/A = not applicable

Of the three identified NHS guidelines, the Leicestershire guideline provides guidance for the greatest range of product types by category. In general the small number of product categories with recommended quantities in the NHS guidelines is similar to maximum quantities set in the Australian SAS Schedule. The Australian SAS Schedule provides a comprehensive list of maximum quantities for each product listed. SAS maximum quantities listed by category in the table immediately above may include the average or most regularly applied quantity across a category type where quantities vary within a category.

Consensus Guidelines

38 Department of Health, Stoma Appliance Scheme Schedule (Mar. 30, 2014)39 Coventry and Warwickshire Area Prescribing Committee, Arden Cluster Prescribing Guidelines for Stoma Appliances (Mar. 4, 2014)40 National Health Service Northamptonshire, Prescribing Guidelines for Stoma Appliances , (Mar. 3, 2014)41 Leicestershire Medicines Strategy Group, A Guideline to Prescribing Stoma Care Appliances and Stoma Nurse Referral November 2011, (Mar. 4, 2014)

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http://www.neneccg.nhs.uk/resources/uploads/stomaguidelines.pdf




Two consensus guidelines containing information pertaining to stoma accessories were identified.

Peristomal Moisture Associated Skin Damage in Adults with Faecal Ostomies (Gray 2013)

The publication by Gray42 provides a summary of the outcomes a systematic literature review to identify studies that evaluated assessment, treatment or prevention of peristomal moisture associated skin damage (MASD). Peristomal MASD is defined in the publication as ‘inflammation and denudation of the skin adjacent to a stoma associated with exposure to effluent such as urine or stool’.

In addition to the results of the systematic literature review the publication also includes 10 consensus statements developed by a panel of expert Wound Ostomy Continence Nurses and Enterostomal Therapy Nurses from the United States of America and Canada.

The literature for the systematic review was searched using MEDLINE and CINAHL, key terms used included “ostomy,” “stoma” “peristomal,” “peristomal skin,” “complications,” dermatitis” and “moisture associated skin damage”.

Publication type criteria for inclusion were; original research reports, integrative and systematic reviews, best practice guidelines, individual case studies and multiple case studies. Publications in languages other than English were excluded as were those published before 1990. Boolean functions were used to narrow the search.

The search identified 331 articles, 96 were eliminated as they were either duplicates or written in a language other than English. Of the 239 remaining articles 35 were original research reports, 204 were integrative and systematic reviews, best practice guidelines, individual case studies or multiple case studies.

The systematic review did not identify any studies that specifically evaluated treatment or prevention of MASD. Given the paucity of evidence the expert panel drafted statements outlining current best practice for the assessment, treatment and prevention of MASD. Statements required agreement by more than 80% of panel members to be included.

Of the 10 consensus statements developed by the panel, four statements included information pertaining to accessory products. The four statements identified are provided below:

Statement Two – Conduct a focused history relating to pouching method and management.

o The panellists agreed that determining pouching method and management including use of accessory products used to cleanse and protect peristomal skin is essential when assessing an individual with MASD. Changes in the use of accessory products may indicate impaired efficiency of the seal of the pouching system and its solid skin barrier.

42 Gray, M. Peristomal Moisture Associated Skin Damage in Adults with Fecal Ostomies: A Comprehensive Review and Consensus. Journal of Wound Ostomy and Continence Nursing. 2013;40(4):389-99.

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Statement Seven - Teach the patient about the correct use of accessory products on peristomal skin.

Statement eight - Teach the patient to limit or avoid behaviours that may interfere with the seal between the pouch and peristomal skin.

o Panellists agreed that misuse of accessory products or use of untested products may interfere with the seal between skin and the pouching system. Examples provided included emollient and oil based products reducing adhesion and inappropriate product use resulting in drying of the peristomal skin.

Statement Ten - Treatment is directed at alleviating skin damage while maintaining an effective seal between solid skin and peristomal skin

o Identified methods for prolonging an effective seal included:

Correct sizing of the skin barrier aperture;

Appropriate skin barrier characteristics based on stoma and abdominal contours (i.e. flat vs convex, extended wear vs standard);

Appropriate use of accessory products;

Maintenance of an optimal pouch wear time; and

Appropriate pouch changing technique.

o The panel did not reach a consensus regarding the frequency of use of accessory products.

Panel activities were supported by an unrestricted grant from Hollister Inc.

Peristomal Associated Moisture Associated Dermatitis and Periwound Moisture Associated Dermatitis (Colwell 2011)

The publication by Colwell43 is the third of a series providing opinion from a panel of nursing experts on various forms of MASD. In this publication peristomal MASD and periwound MASD is discussed. Only peristomal MASD is considered in this review as only peristomal MASD is specifically relevant to individuals with a stoma. Peristomal MASD is defined as inflammation and erosion of the skin related to moisture that begins at the stoma/skin junction and can extend outwards in a four inch radius.

The expert panel make the following consensus statements regarding stoma accessory products and peristomal MASD:

It is a priority when managing peristomal MASD to determine the source of the irritant and modification of the pouching system or the use of accessory products in order to prevent further damage.

43 Colwell, JC. MASD Part 3: Peristomal Moisture-Associated Dermatitis and Periwound Moisture-Associated Dermatitis: A consensus. Journal of Wound Ostomy and Continence Nursing. 2011;38(5):541-53.

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Patients should be queried about activities including product use.

In some cases accessory products can be considered to enhance the seal: skin barrier paste, skin barrier strips or rings, skin barrier powder, liquid skin protectants and belts. Custom made convex barriers are also an option for difficult cases.

Healing irritated skin can be done using several techniques, topical therapies are limited to products that will allow the adhesive seal to be secured. Skin barrier powder can be dusted over the moist skin to facilitate a seal of the solid skin barrier to the skin. Some experts suggest the use of polymer acrylate liquid skin protectant over the powder as a sealant. An astringent may be applied prior to pouch placement to dry the peristomal skin.

International stoma schemes

Information was identified for stoma schemes in England and Wales, Scotland, Canada, New Zealand and Australia.

Schemes were found to be managed at the national level (England and Wales, Scotland and Australia) or managed at the provincial or district level (Canada and New Zealand).

Nationally managed stoma schemes

NHS Scotland

Stoma care items can be prescribed by General Practitioners and Specialist Stoma Care Nurses with prescribing training. Prescriptions are dispensed by community pharmacy contractors and appliance contractors (collectively known as stoma services contractors). Specialist stoma care nurses are employed directly by NHS Boards44.

National reimbursement prices for a wide range of stoma care items are listed on the NHS Scotland Stoma Appliances Price List45. The list includes products that may be ordered by authorised prescribers, as listed on Health Board authorised prescriber lists. The list outlines product specifications and reimbursement prices that apply to stoma services contractors. It is updated monthly. Applications for addition, amendment or deletion of items on the list must be made in writing and forwarded to National Procurement. All Scottish residents are eligible to receive free NHS Scotland prescriptions.

Stoma services contractors are paid service fees according to the Stoma Supply Fee schedule issued quarterly46. The fee rate for 1 January 2014 to 31 March 2014 is;

Dispensing fee £7.18 ($13.21 AUD)47

Customisation fee £5.77 ($10.62 AUD)

44 Scottish Government Primary Care Division, Provision of appliances for Stoma Care, Scottish Government Conclusions Following Meetings of Stoma National Review Group 2006-2009, (Mar. 4, 2014).45 NHS Scotland, Stoma Appliances Price List March 2014 , (Mar. 14, 2014).46 NHS Scotland, Stoma Supply Fees , (Apr. 4, 2014).47 Conversion rate1 Scottish Pound = 1.84 Australian Dollar, (Mar. 13, 2014).

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http://www.google.com.au/search?q=converting+great+british+pound+to+australian+dollar

https://isdscotland.scot.nhs.uk/Health-Topics/Prescribing-and-Medicines/Stoma-Supplies/Docs/2014-01-Stoma_fees.pdf


http://www.scotland.gov.uk/Publications/2009/11/20142737/3


Delivery fee £4.49 ($8.26 AUD)

Fees are paid annually by global sum and adjusted as required to ensure no significant under spend or overspend compared with the fee per occasion rate. Service fees have been gradually reducing over the past three price revisions (Table B.3).

Table B.3: NHS Scotland Service fee changes with price revisions, 2012 to 2014

Fee TypeJan-Mar 2014 (£)

Oct-Dec 2013 (£)

Oct-Sep 2012 (£)

Jul-Sep 2012 (£)

Apr-Jun 2012 (£)

Dispensing Fee 7.18 7.39 7.7 8.27 8.24

Customisation Fee 5.77 5.94 6.19 6.65 6.62

Delivery Fee 4.49 4.63 4.82 5.18 5.15

Stoma services contractors are required to adhere to the NHS Service Standards Relating to the Supply and Provision of Stoma Care Appliances to Patients in the Community48 (the Standards). The Standards aim to ensure a high quality and cost effective service which meets patients’ needs and equity of provision of care.

The Standards set the following minimum requirements:

suppliers work within the nationally established contract terms;

supplier to liaise with the prescriber if clarification required on prescription or if supply difficulties are anticipated;

requests should be dealt with by personnel trained in the use of stoma products, who can provide advice and support in a confidential and private atmosphere; ensure confidentiality of patient information; respond to a request to dispense a prescription, immediately on receipt by notifying patients of expected delivery date and informing the patient if any delay is anticipated in filling the order;

delivery should be within two working days if so requested by the patient;

supplier to provide provision for supply tailored to suit the needs of the individual patient, ensuring flexibility of options;

provide a customer modification service of stoma appliance as required, e.g. flange cutting and customisation on request;

supply of disposal bags and wipes are to be automatic with each delivery;

manufacturers are to make available on prescription or purchase order sample packs of appropriate products to allow patient/stoma nurse to select the most appropriate solution to the individual’s needs;

48 NHS Scotland, Service Standards Relating to the Supply and Provision of Stoma Care Appliances to Patients in the Community 2005, (Mar. 4, 2014).

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http://www.sehd.scot.nhs.uk/appliance_contractors/documents/service_standards_14_11_05.pdf

supply and delivery of product to patient in accordance with patient’s needs e.g. delivery times volumes, discretion of carrier;

home delivery within two working days if requested by the patient;

procedures in place for referral to the appropriate healthcare professionals to address patient concerns, queries and problems;

monitor supply of stoma products to patients and notify prescriber in the event of any unusual requests or change in ordering patterns;

supplier to provide data to allow audit of service provision; and

Provide a confidential and private patient support service e.g. via phone help line or face-to-face.

The Standards also outline the level of training staff providing stoma services should attain and maintain. It is the responsibility of each NHS Board to audit compliance with the Standards.

The NHS Scotland stoma care scheme was significantly restructured in 2006. The restructure was in response to concerns by the Scottish Executive Health Department that prior arrangements were:

not of uniform quality;

were unduly influenced by industry through industry sponsorship of Specialist Stoma Care Nurses; and

did not represent value for money.

Value for money concerns were primarily due to an inequitable two-tiered funding arrangement that created perverse incentives for contractors to establish agency arrangements and cross boarder arrangements to increase reimbursement49.

After a period of stakeholder consultation documented in 200450 and a trial of new arrangements in 2005, the reforms were introduced on 1 April 2006. Reforms included:

Introduction of service standards for all contractors.

A single tier funding regime for all contractors

A formal procurement process to establish specific Scottish reimbursement prices to replace the direct link with English Tariff prices.

Establishment of specific Scottish procedure before new items are added to the list of the products which may be prescribed.

49 Scottish Executive Health Department, Appliance Contractors Consultation Document 18 June

2003, (Mar. 4, 2014).50 Scottish Executive Health Department, Appliance Contractors Consultation Summary Report May 2004 . (Mar. 4, 2014).

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http://www.sehd.scot.nhs.uk/publications/ApplianceContractorsSummaryReport.pdf



Abolition of practice of company employment or company sponsoring of specialist stoma nurses operating within NHS Scotland and their transfer into direct NHS employment.

Discontinued ad hoc provision of samples and replaced this with the introduction of formal procurement arrangements for purchasing samples in the secondary sector.

Patient choice of appliance as selection of prescribed item to remain at the clinical discretion of the Clinical Nurse Specialist (CNS).

It was the expectation of the Scottish Executive Health Department that the reforms would be cost neutral as increased employment costs of Specialist Stoma Care Nurses (due to the abolition of industry sponsorship of these positions) would be offset by improved product purchasing terms established through national tendering.

The Scottish Government Primary Care Division released the findings of a review of the new arrangements in 200951. The review found that the new arrangements had been implemented and did not require further review with the exception of; development of local and national audit arrangements against the National Service Standard and further investigation of the value for money aspects of the arrangements.

The reduced prices for products gained through national tendering had not been sufficient to cover the increased costs associated with transferring sponsored Specialist Stoma Care Nurses to direct NHS employment and stoma product prescription growth occurring at a greater rate than forecasted52. The review recommended that further steps be taken to secure best value for money contract pricing.

NHS England and Wales

Stoma care items are prescribed by General Practitioners. Prescriptions can be dispensed by community pharmacy contractors, dispensing appliance contractors (DAC’s) and Dispensing General Practices.

Community Pharmacy Contractors and Dispensing General Practices may supply two types of service;

Essential service; includes provision of complimentary wipes, disposal bags, delivery service and advice. All pharmacies and dispensing general practices provide at least this level of service53.

Advanced Services; also includes customisation and appliance use review services54.

51 Provision of Appliances for Stoma Care:Scottish Government Conclusions Following Meetings of Stoma National Review Group 2006-2009 52 Ibid53 Colostomy Association, Obtaining Prescription Supplies March 2013 , (Apr. 4, 2014).54 NHS England and Wales, Electronic Drug Tariff Part VIC Advanced Services , (Apr. 4, 2014).

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http://www.ppa.org.uk/edt/April_2014/mindex.htm

http://www.colostomyassociation.org.uk/



DAC’s are often integrated with stoma product manufacturers and supply companies.

Specialist stoma care nurses are employed by NHS Boards, nursing positions may be sponsored by private companies, some reports estimate up to 75% of stoma nurse positions are sponsored55.

National reimbursement prices for a wide range of stoma care items are listed in part IXC of the Drug Tariff56. The list includes products that may be ordered by prescribers. The list outlines product specifications and reimbursement prices that apply. It is updated monthly. In addition to the listed price a delivery fee of £3.40 is payable for each item listed.

Contractors providing advanced services are also eligible for additional service fees as outlined in parts VIC and VID of the Drug Tariff.

Advanced service fees include:

Customisation Fee of £4.32 ($7.95AUD)57 per customised item (for those items flagged as able to be customised on the Drug Tariff)

Appliance Review Fee of £28 ($51.52 AUD) per review conducted at premises managed by the pharmacy or appliance contractor and £54 ($99.36 AUD) per review conducted at the user's home. Limit of one review per qualifying item per annum.

All Welsh residents are eligible to receive free prescriptions. In England ostomates with a permanent stoma are eligible to receive free prescriptions via a medical exemption certificate. Ostomates with a temporary stoma do not receive free prescriptions although prescription costs can be capped at £2 per week through purchase of prescription prepayment certificates58.

Australia

The Stoma Appliance Scheme, established and subsidised by the Australian Government, is accessible free of charge (following payment of an Association membership fee) to all Australian residents and eligible overseas residents with a permanent or temporary ostomy59.

The wide range of products available is listed on the Stoma Appliance Scheme (SAS) Schedule (the Schedule). Products on the Schedule have been recommended for listing by the Stoma Product Assessment Panel (SAP), as being appropriate for use by a person with a stoma. The SPAP is an independent technical advice panel appointed by the Department of Health60. The Schedule lists products by group, SAS code, company code, product brand

55 Basil, N. Stoma Care: The Market in Products Lets Patients Down. British Medical Journal. 2013;347:f6129. Epub17/10/13.56 NHS England and Wales, Electronic Drug Tariff, (Apr. 4, 2014).57 Converting Great British pound to Australian dollar

58 NHS England, Help With NHS Costs , (Apr. 4, 2014).59 Department of Health, Stoma Appliance Scheme , (Apr. 5, 2014).

87

http://www.health.gov.au/internet/main/publishing.nsf/Content/Stoma+Appliance+Scheme-3

http://www.nhs.uk/NHSEngland/Healthcosts/Pages/Prescriptioncosts.aspx

http://www.google.com.au/search?q=converting+great+british+pound+to+australian+dollar

http://www.ppa.org.uk/edt/April_2014/mindex.htm

name, description, pack size, maximum quantity, pack price and where applicable pack price premiums and restrictions61.

Choice of products is guided by Stomal Therapy Nurses. Products are ordered and distributed through 22 regional stoma associations across Australia. Stoma associations are paid a 2.75% handling fee on all eligible orders. In addition stoma associations charge ostomates a mandatory service fee or membership fee inclusive of a service fee component62.

Ostomates apply to access the Stoma Appliance Scheme using an SAS Application Form. The form must be signed by a Stomal Therapy Nurse or Medical Practitioner and supplied to the local stoma association. All participating stoma associations must be members of the Australian Council of Stoma Associations.

Stoma association membership is paid by the Ostomate to their local association; the current annual fee is $45 per annum for full members and $35 per annum for concessional members. Once approved, ostomates can order SAS Schedule products through the stoma association. Ostomates are charged postage and handling costs associated with their orders63.

Additional quantities of product above the listed maximum quantities may be obtained by application for additional stoma supplies through the Department of Human Services, or the Department of Health if the request is for more than 4 times the maximum listed amount. The application must be authorised by a Stomal Therapy Nurse or Medical Practitioner64.

Locally managed stoma schemes

Canada

Canada has a publically funded health insurance scheme called PharmaCare. The public reimbursement of stoma care products is dependent on the PharmaCare plan type of each individual and the product eligibility determined by the Ministry of Health for each Province.

Information published by The Ministry of Health for the Province of British Columbia (BC) provides a list of PharmaCare Ostomy Benefits for the BC Province65. The one page list includes product categories by product identification number, category title i.e. ‘adhesive removers’ and then one or more example products. The list is indicative rather than exhaustive.

Ostomates need to contact Pharmacare to confirm product eligibility and level of subsidy with their specific insurance plan. Unlike the other international stoma schemes discussed

60 Ibid61 Dept. of Health Stoma Scheme Schedule62 Department of Health, Information for Stoma Associations , (Apr. 5, 2014)63 Ostomy New South Wales Limited, Ostomy NSW , (Apr. 5, 2014).64 Dept. of Health Stoma Operational Guidelines65 Ministry of Health, PharmaCare Ostomy Benefits October 2012 , (Mar. 30, 2013).

88

http://www.health.gov.bc.ca/pharmacare/pins/pdf/Ostomy.pdf

http://www.health.gov.au/internet/main/publishing.nsf/Content/health-stoma-op_guidelines.htm

http://www.ostomynsw.org.au/



earlier, the BC list of ostomy supplies does not include ostomy support belts, pouch deodorants, lubricants, support garments, cleansers and most tapes.

New Zealand

New Zealand Ostomy Services are provided through a contractual service specification, via local District Health Boards (DHB)66. Ostomy Clinical Nurse Specialists are employed by the DHB to provide education support and product supplies to Ostomates in the Community.

Ostomy supplies as assessed by the Clinical Nurse Specialist are provided free of charge to Ostomates. Supplies are delivered from the DHB nominated Supply Company by courier67.

Conclusions

We identified 27 publications of broad relevance to Group 9 accessories from the 'grey' literature. These materials provided information regarding stoma schemes in other countries, limits in quantities of Group 9 accessory products supplied to consumers in other countries and guidelines that are in place in other countries to inform use of Group 9 accessories.

Consensus guidelines by Colwell and Gray recognise the role of accessory products in improving the seal between the stoma appliance skin barrier and the skin. Guidelines also recognise the need for appropriate use of accessory products and that inappropriate use can result in skin related problems and increased accessory use. However, published guidelines are based largely on the opinion of clinicians in the stoma field rather than empirical evidence. Further, industry sponsorship of panel members involved in developing guidelines introduces a significant risk of bias in the guideline development process.

In comparing the Australian Stoma Appliance Scheme with information available from other international stoma schemes, similarities exist between the SAS Scheme and NHS Scotland and NHS England and Wales schemes. The three schemes provide an extensive list of stoma care products that are available free of charge (or very low cost) to resident ostomates. Choice of product is supported by Stoma Care Nurses. The Australian SAS Schedule varies from the NHS Price lists as it includes maximum quantity and other product restriction information.

The schemes vary most in product order and distribution methods. Both NHS schemes require stoma care items to be prescribed by a GP. NHS Scotland also allows items to be prescribed by Specialist Stoma Care Nurses with demonstrated prescribing competency. Prescriptions are dispensed through a Community Pharmacy Contractor, Dispensing GP or Appliance Contractor. Dispense and delivery fees are paid for prescriptions and customisation fees are also payable for eligible products.

The NHS Scotland dispense and delivery fee for one item is equivalent to $21.47 AUD. In comparison the SAS scheme requires orders for eligible SAS members to be made by Stoma Associations on behalf of ostomates. Stoma associations receive a 2.75% handling fee (i.e. $2.75 per order value of $100). Ostomates are responsible for stoma association

66 NZ Continence Association, Continence Services in New Zealand , (Mar. 30, 2014).67 Waitemata District Health Board, Ostomy Service , (Apr. 5, 2014).

89

http://www.healthpoint.co.nz/specialists/older-peoples-health/waitemata-dhb-ostomy-service

http://www.continence.org.nz/user_files/Continence_Services_in_New_Zealand_FINAL_Oct_2009.pdf

membership and postage and handling fees. The SAS has lower order and distribution costs for Government compared with NHS Scotland (and NHS England and Wales).

Information pertaining to the evaluation and selection process for stoma care items listed on the NHS Scotland Stoma Appliance Price List and the NHS England and Wales Drug Tariff was not identified in the grey literature search and as such a comparison of product listing process cannot be considered.

90

Attachment 1 (Appendix 1): Characteristics of excluded publications

Excluded peer-reviewed references

Study Reason for Exclusion

Bafford 2012 Does not report data for any patient relevant outcomes. Narrative review. Not systematic review.

Basil 2013 Does not report data for any patient relevant outcomes. Editorial comment.

Black 2007 Does not report data for any patient relevant outcomes. Narrative review.

Black 2009 Does not report data for any patient relevant outcomes. Clinical review article. Not systematic review.

Black 2011 Does not report data for any patient relevant outcomes. Editorial comment.

Black 2013 Does not report data for any patient relevant outcomes. Editorial comment.

Bolton 2008 Publication not relevant to participants with a stoma. Participants had wounds not stomas.

Boyd 2004 Does not report data for any patient relevant outcomes. Opinion regarding treatment of convexity.

Boyles 2010 Does not report data for any patient relevant outcomes. Clinical update. Not systematic review.

Burch 2004 Does not report data for any patient relevant outcomes. Publication is a product update.

Burch 2004b Does not report data for any patient relevant outcomes. Clinical update. Not systematic review.

Burch 2005 Does not report data for any patient relevant outcomes. Clinical update. Not systematic review.



Burch 2009 Does not include information about Group 9 products.


Burch 2011 Does not report data for any patient relevant outcomes. Editorial comment.


Burch 2011c Does not report data for any patient relevant outcomes. Clinical update. Not systematic review.

Burch 2011d Does not report data for any patient relevant outcomes. Clinical update. Not systematic review.

Burch 2012 Does not report data for any patient relevant outcomes. Clinical update. Not

91


systematic review.

Burch 2013 Does not report data for any patient relevant outcomes. Expert opinion.


Burch 2013c Does not report data for any patient relevant outcomes. Clinical update. Not systematic review.

Colwell 2011 Does not report data for any patient relevant outcomes. Expert opinion based on consensus.

Cronin 2008 Does not report data for any patient relevant outcomes. Provides an expert opinion on the use of convex products for patients.

Cronin 2010 Does not report data for any patient relevant outcomes. Expert opinion.

Davis 2012 Duplicate publication of Erwin-Toth 2012

Dorothy 2013 Duplicate publication of Gray 2013b

Gray 2013 Does not report data for any patient relevant outcomes. Expert opinion based on consensus.

Haughan 2005 Does not include information about Group 9 products.

Herlufson 2006 Does not include information about Group 9 products.

Johnson 2012 Does not include information about Group 9 products.

Mangnall 2013 Does not report data for any patient relevant outcomes. Expert opinion.

Martins 2011 Does not include information about Group 9 products.

Maxwell 2010 Does not include information about Group 9 products.

Meisner 2008 Does not report data for any patient relevant outcomes. Clinical update. Not systematic review.

Nazarali 2013 Duplicate citation of Recalla 2013

Nichols 2012 Does not include information about Group 9 products.

Nybaek 2004 Does not include information about Group 9 products. Silicone dressings mentioned but unclear if stoma-specific product.

Nybaek 2010 Systematic review of causes of skin problems in patients with stoma (not systematic review of interventions or therapeutic outcomes from Group 9 products).

Pontieri-Lewis 2006

Does not report data for any patient relevant outcomes. Clinical update. Not systematic review.

Porrett 2011 Study about appliances rather than accessories. Although authors report reduced use of accessories with double-layer adhesive appliances, the type of accessory was not described in sufficient detail to enable Group 9 comparisons to be made.

Redmond 2009 Narrative summary of unpublished data.

Ross 2010 Does not report data for any patient relevant outcomes. Editorial comment.

92


Rudoni 2009 Does not report data for any patient relevant outcomes. Workforce survey.

Rudoni 2011 Does not report data for any patient relevant outcomes. Clinical update. Not systematic review.

Salvadalena 2008

Does not include information about Group 9 products.

Subramaniam 2009


Taylor 2012 Does not include information about Group 9 products.

Teniere 2007 Does not include information about Group 9 products.

Voergaard 2007


Vunjovich 2006 Does not report data for any patient relevant outcomes. Clinical update. Not systematic review.

Watson 2013 Does not report data for any patient relevant outcomes. Clinical update. Not systematic review.

Welser 2009 Does not include information about Group 9 products.

White 2005 Does not include information about Group 9 products.

Williams 2006 Does not report data for any patient relevant outcomes. Clinical update. Not systematic review.

Williams 2008 Does not report data for any patient relevant outcomes. Editorial comment.

Williams 2011 Does not report data for any patient relevant outcomes. Clinical update. Not systematic review.

Williams 2013 Does not include information about Group 9 products.

Youngberry 2011


Excluded 'grey' literature

Publication Reason for exclusion

Practice ManualsStoma Care (Burch 2008)Stoma Care – Essential Clinical Skills for Nurses (Porrett 2005)

Does not report data for any patient relevant outcomes

Conference PresentationRegular assessment of patients needs using up to date accessories and equipment (Ross 2010) Wound Ostomy and Continence Conference

Does not report data for any patient relevant outcomes

93

Attachment 2 (Appendix 1): Included 'grey' literature

Publication type Publication titlePeer reviewed literature for inclusion in the systematic literature review

46 peer reviewed journal articles. All articles were included in the systematic review (part A of this report) at the abstract review stage.

Position Papers Colostomy Association UK. Obtaining Prescription Supplies Ostomy New South Wales

Other literature reviews

1 systematic review. Included in part A of this report at the abstract review stage.

Documentation for International Stoma Schemes

NHS Scotland Stoma Supply Fees Provision of Appliances for Stoma Care, Scottish Government

Conclusions Following Meetings of Stoma National Review Group 2006-2009

NHS Scotland Service Standards Relating to the Supply and Provision of Stoma Care Appliances to Patients in the Community 2005

Scottish Executive Health Department Appliance Contractors Consultation Document 2003

Scottish Executive Health Department Appliance Contractor Consultation Summary Report 2004

NHS England Help With NHS Costs Australian Department of Health Stoma Appliance Scheme Australian Department of Health Information for Stoma Associations British Columbia PharmaCare Ostomy Benefits 2012 Continence Services in New Zealand Waitemata District Health Board Ostomy Service

Guidelines and best practice manuals

Arden Cluster Prescribing Guidelines for Stoma Appliances NHS Northamptonshire Prescribing Guidelines for Stoma

Appliances Leicestershire Medicines Strategy Group Guidelines to Prescribing

Stoma Care Appliances and Stoma Nurse Referral Gray 2013 Peristomal Moisture Associated Skin Damage in Adults

with Fecal Ostomies Colwell 2011 Peristomal Moisture Associated Dermatitis and

Periwound Moisture Associated Dermatitis

Product pricing Australian Department of Health Stoma Appliance Scheme Schedule

NHS Scotland Stoma Appliances Price List March 2014 NHS England and Wales Electronic Drug Tariff March 2014 Hollister Ostomy Product Catalogue (Australian and New Zeland) Statina Healthcare Australia (website) CH2 Direct Intouch (electronic ordering website) My Ostomy (electronic ordering website) Total Home Care Supplies (electronic ordering website) STL Medical (electronic ordering website)

94

Peer reviewed publications

Grey literature searches identified 46 potentially relevant peer reviewed publications. Publications were included in the systematic review of peer reviewed publications immediately prior to the abstract review stage.

Other literature reviews

One potentially relevant systematic literature review document was identified and included in the systematic review of peer reviewed publications immediately prior to the abstract review stage.

Companies and Distributors

Search key word Results Publications identified for reviewColoplast 6 peer

reviewed journal articles

Martins (2008, 2010, 2011), Porrett (2011), Erwin Toth (2012) Meisner (2012). Included in the systematic review at abstract review stage.

Hollister 1 pricing catalogue

Ostomy catalogue

Statina Healthcare Australia

Garment pricing information

Corsinel

Ainscorp, Coloplast, Convatec, Dansac, Future Environmental Services, 3M, Smith and Nephew, Omnigon, Ebos

Nil Nil

Clifford Hallam Healthcare

Product pricing direct to consumer

Intouch Direct

95

http://direct.ch2.net.au/index.php?mode=intouch

http://www.statina.com.au/brands/corsinel.html

http://www.hollister.com/anz/files/pdfs/Ostomy-Catalogue_2014-15.pdf

International Schemes and Pricing

Search key word Results Publications identified for reviewScotland 1 pricing

schedule

1 fees schedule

NHS Scotland. Stoma Appliances Price List Scotland March 2014.ISD Scotland Stoma Supplies

NHS Scotland Stoma Supply FeesEngland and Wales 1 pricing

schedule

1 stoma schemedocument

1 position statement

National Health Service England and Wales Electronic Drug Tariff Section IXC – Stoma appliances

Colostomy Association. Obtaining Prescription Supplies March 2013 www.colostomyassociation.org.uk

NHS England. Help with NHS costs

Australia 1 pricing schedule

2 stoma scheme documents

1 position statement

Stoma Appliance Scheme

Stoma Appliance Scheme Schedule

Information for Stoma Associations

Ostomy NSW

United States of America

2 wholesaler direct to consumer pricing websites

Total Homecare Supplies

Coloplast Ostomy Accessories

Canada 1 product schedule

1 pricing website

PharmaCare Ostomy Benefits October 2012

New Zealand 2 scheme documents

Continence Services in New Zealand

Waitemata District Health Board Ostomy Service

96

http://www.healthpoint.co.nz/specialists/older-peoples-health/waitemata-dhb-ostomy-service/

http://www.continence.org.nz/user_files/Continence_Services_in_New_Zealand_FINAL_Oct_2009.pdf

http://www.health.gov.bc.ca/pharmacare/pins/pdf/Ostomy.pdf

http://www.stlmedical.com/store/coloplast-ostomy-accessories.html

http://www.totalhomecaresupplies.com/

http://www.ostomynsw.org.au/



http://www.health.gov.au/internet/main/publishing.nsf/Content/Stoma+Appliance+Scheme-3

http://www.nhs.uk/NHSEngland/Healthcosts/Pages/Prescriptioncosts.aspx



https://isdscotland.scot.nhs.uk/Health-Topics/Prescribing-and-Medicines/Stoma-Supplies/Docs/2014-01-Stoma_fees.pdf


Attachment 3 (Appendix 1): References from peer-reviewed literature review

Included references

1. Al-Niaimi F, Beck M, Almaani N, Samarasinghe V, Williams J, Lyon C. The relevance of patch testing in peristomal dermatitis. The British journal of dermatology. 2012;167(1):103-9. Epub 2012/03/06.

2. Berry J, Black P, Smith R, Stuchfield B. Assessing the value of silicone and hydrocolloid products in stoma care. British Journal of Nursing (Mark Allen Publishing). 2007;16(13):778, 80, 82 passim. Epub 2007/09/14.

3. Cowin C, Redmond C. Living with a parastomal hernia. Gastrointestinal Nursing. 2012;10(1):16-24.

4. Erwin-Toth P, Thompson SJ, Davis JS. Factors impacting the quality of life of people with an ostomy in north america: results from the dialogue study. Journal of Wound, Ostomy & Continence Nursing. 2012;39(4):417-4.

5. Field S, O'Sullivan C, Murphy M, Bourke JF. Peristomal allergic contact dermatitis to stoma-adhesive paste containing Monobutyl ester/maleic acid of Polymethylvinylether (Gantrez(registered trademark) 425) but not to Isopropyl ester/maleic anhydride of Polymethylvinylether (Gantrez(registered trademark) 335). Contact dermatitis. 2010;62(2):120-1.

6. Hoeflok J, Guy D, Allen S, St-Cyr D. A prospective multicenter evaluation of a moldable stoma skin barrier. Ostomy Wound Management. 2009;55(5):62-9.

7. Martin JA, Hughes TM, Stone NM. Peristomal allergic contact dermatitis--case report and review of the literature. Contact dermatitis. 2005;52(5):273-5. Epub 2005/05/19.

8. Martins L, Tavernelli K, Sansom W, Dahl K, Claessens I, Porrett T, et al. Strategies to reduce treatment costs of peristomal skin complications. Gastrointestinal Nursing. 2012;10(10):24-32.

9. Meisner S, Lehur PA, Moran B, Martins L, Jemec GBE. Peristomal skin complications are common, expensive, and difficult to manage: A population based cost modeling study. PloS one. 2012;7(5).

10. Park S, Lee YJ, Oh DN, Kim J. Comparison of standardized peristomal skin care and crusting technique in prevention of peristomal skin problems in ostomy patients. Journal of Korean Academy of Nursing [Internet]. 2011; (6):[814-20 pp.]. Available from:.

11. Recalla S, English K, Nazarali R, Mayo S, Miller D, Gray M. Ostomy Care and Management: A Systematic Review. Journal of Wound Ostomy & Continence Nursing. 2013;40(5):489-500.

97

http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/721/CN-00895721/frame.html



12. Rudoni C. A service evaluation of the use of silicone-based adhesive remover. British Journal of Nursing. 2008;17(2):S4.

13. Thompson H, North J, Davenport R, Williams J. Matching the skin barrier to the skin type. British Journal of Nursing (Mark Allen Publishing). 2011;20(16):S27-30. Epub 2011/11/22.

Excluded references

1. Bafford AC, Irani JL. Management and complications of stomas. The Surgical Clinics of North America. 2013;93(1):145-66. Epub 2012/11/28.

2. Basil N. Stoma care: the market in products lets patients down. BMJ (Clinical research ed). 2013;347:f6129. Epub 2013/10/19.

3. Black P. Peristomal skin care: an overview of available products. British Journal of Nursing (Mark Allen Publishing). 2007;16(17):1048, 50, 52-4 passim. Epub 2007/11/21.

4. Black P. Stoma care nursing management: cost implications in community care. British Journal of Community Nursing. 2009;14(8):350.

5. Black P. The role of accessory product in patients with a stoma. British Journal of Nursing (Mark Allen Publishing). 2013;22(5):S24. Epub 2013/05/17.

6. Black P, Chalmers F. Caring for stoma patients: Best practice guidelines and gaining RCN accreditation of this resource. World Council of Enterostomal Therapists Journal. 2011;31(1):9-13.

7. Bolton L. DO Products Affect Wound Outcomes When Using Standardized Algorithms?: 2304. Journal of Wound Ostomy & Continence Nursing. 2008;35(3):S31.

8. Boyd K, Thompson MJ, Boyd-Carson W, Trainor B. Use of convex appliances. Nursing standard. 2004;18(20):37-8.

9. Boyles A. Keeping up to date with stoma care accessories: Enabling informed choice. Gastrointestinal Nursing. 2010;8(6).

10. Burch J. The management and care of people with stoma complications. British Journal of Nursing. 2004;13(6):307-18.

11. Burch J, Sica J. Urostomy products: an update of recent developments. British Journal of Community Nursing. 2004b;9(11):482-6. Epub 2004/12/08.

12. Burch J, Sica J. Stoma care accessories: an overview of a crowded market. British Journal of Community Nursing. 2005;10(1):24-31. Epub 2005/03/08.

13. Burch J. Stoma complications encountered in the community, A-Z. British Journal of Community Nursing. 2005b;10(7):324, 6, 8-9. Epub 2005/07/13.

98

14. Burch J, Sica J. Common peristomal skin problems and potential treatment options. British Journal of Nursing 2008;17(17):S4, S6, S8 passim. Epub 2008/10/25.

15. Burch J. An update on available stoma appliances in the community. British Journal of Community Nursing. 2009;14(4):146.

16. Burch J. Caring for peristomal skin: what every nurse should know. British Journal of Nursing. 2010;19(3):166.

17. Burch J. Stoma care-related skin problems and solutions. British Journal of Nursing (Mark Allen Publishing). 2011;20(21):1358. Epub 2012/01/14.

18. Burch J. Resuming a normal life: holistic care of the person with an ostomy. British Journal of Community Nursing. 2011b;16(8):366-73. Epub 2011/08/16.

19. Burch J. Peristomal skin care and the use of accessories to promote skin health. British Journal of Nursing (Mark Allen Publishing). 2011c;20(7):S4.

20. Burch J. Choosing the correct accessory for each stoma type. Gastrointestinal Nursing. 2011d;9(3).

21. Burch J. Spoilt for choice: stoma accessories and appliances. Nursing and Residential Care. 2012;14(10):510.

22. Burch J. When to use a barrier cream in patients with a stoma. British Journal of Nursing (Mark Allen Publishing). 2013;22(5):S12. Epub 2013/05/17.

23. Burch J. Stoma complications: an overview. British Journal of Community Nursing 2013b; 18 (8): 375-378.

24. Burch J. Choosing the correct accessory for each stoma type: an update. British Journal of Nursing. 2013c;22(16 Supplement):S10-S3.

25. Colwell JC, Ratliff CR, Goldberg M, Baharestani MM, Bliss DZ, Gray M, et al. MASD part 3: peristomal moisture- associated dermatitis and periwound moisture-associated dermatitis: a consensus. Journal of wound, ostomy, and continence nursing : official publication of The Wound, Ostomy and Continence Nurses Society / WOCN. 2011;38(5):541-53; quiz 54-5. Epub 2011/08/30.

26. Cronin E. A guide to the appropriate use of convex stoma care products. Gastrointestinal Nursing. 2008;6(2).

27. Cronin E. An overview of stoma bridges and a case study on their management. British Journal of Nursing (Mark Allen Publishing). 2010;19(17):S16-S20. Epub 2010/09/28.

28. Davis JS, Erwin-Toth P, Thompson SJ. Factors Impacting the Quality of Life of People With an Ostomy in North America Results From the Dialogue Study. Diabetes. 2012.

99

29. Dorothy MGJCC, Hoeflok DMGJ, Rao AMLMS. Peristomal Moisture–Associated Skin Damage in Adults With Fecal Ostomies. 2013.

30. Gray M, Colwell JC, Doughty D, Goldberg M, Hoeflok J, Manson A, et al. Peristomal Moisture–Associated Skin Damage in Adults With Fecal Ostomies: A Comprehensive Review and Consensus. Journal of Wound Ostomy & Continence Nursing. 2013;40(4):389-99.

31. Haughan M, O’Neill A. The National Neonatal Surgical Benchmarking Group: Development of a benchmark for stoma management. Infant. 2005;1(3):84-6.

32. Herlufsen P, Olsen A, Carlsen B, Nybaek H, Karlsmark T, Laursen T, et al. Study of peristomal skin disorders in patients with permanent stomas. British Journal of Nursing. 2006;15(16):854-62.

33. Johnson T. Follow-up care of stoma patients: a systematic literature review. Gastrointestinal Nursing. 2012;10(9):30-6.

34. Mangnall J, Lakin S, Burke D, Midgley K. An alternative model of prescribing stoma appliances. British Journal of Community Nursing. 2013;18(10):485-6, 8-91. Epub 2014/01/30.

35. Maxwell TR, Taylor D, Durnal AM, Wills R, Kommala D, Wade S. Safety and efficacy of a novel continence device in colostomy patients. Diseases of the colon and rectum. 2010;53(10):1422-31. Epub 2010/09/18.

36. Martins L, Samai O, FernÃ¡ndez A, Urquhart M, Hansen AS. Maintaining healthy skin around an ostomy: peristomal skin disorders and self-assessment. Gastrointestinal Nursing. 2011:9-13.

37. Meisner S, Balleby L. Peristomal Skin Complications. Seminars in Colon and Rectal Surgery. 2008;19(3):146-50.

38. Nazarali SRKER, Gray SMDMM. Ostomy Care and Management. Journal of wound, ostomy, and continence nursing : official publication of The Wound, Ostomy and Continence Nurses Society / WOCN. 2013;40(5):1-12.

39. Nichols T, McPhail J. Ostomy appliance with an integral adhesive border: luxury or necessity? Gastrointestinal Nursing. 2012;10(6).

40. Nybaek H, Jemec GB. Skin problems in stoma patients. Journal of the European Academy of Dermatology and Venereology : JEADV. 2010;24(3):249-57. Epub 2010/05/15.

41. Nybaek H, Olsen AG, Karlsmark T, Jemec GB. Topical therapy for peristomal pyoderma gangrenosum. Journal of cutaneous medicine and surgery. 2004;8(4):220-3. Epub 2005/08/11.

42. Pontieri-Lewis V. Basics of ostomy care. Medsurg Nursing 2006; 15(4): 199-202.

100

43. Porrett T, NovÃ¡kovÃ¡ S, Schmitz K, Klimekova E, Aaes H. Leakage and ostomy appliances: results from a large-scale, open-label study in clinical practice. Gastrointestinal Nursing. 2011:19-23.

44. Redmond C. Dermacol®: A unique stoma collar to protect the skin from leakages. Gastrointestinal Nursing. 2009;7(7).

45. Ross J, editor. Regular assessment of patients’ needs by using up to date stoma accessories and equipment continues to enhance the ostomates quality of life. Journal of Wound, Ostomy and Continence Nursing 2010; Lippincott Williams & Wilkins.

46. Rudoni C. Peristomal skin irritation and the use of a silicone-based barrier film. British Journal of Nursing (Mark Allen Publishing). 2011;20(16):S12, S4, S6 passim. Epub 2011/11/22.

47. Rudoni C, Dennis H. Accessories or necessities? Exploring consensus on usage of stoma accessories. British Journal of Nursing. 2009;18(18):1106.

48. Salvadalena G. Incidence of complications of the stoma and peristomal skin among individuals with colostomy, ileostomy, and urostomy: a systematic review. Journal of Wound, Ostomy & Continence Nursing. 2008;35(6):596-609.

49. Subramaniam R, Taylor C. The use of an antegrade continence enema stopper in catheterizable channels virtually eliminates the incidence of stomal stenosis: preliminary experience. The Journal of urology. 2009;181(1):299-301. Epub 2008/11/18.

50. Taylor L. Peristomal sore skin: assessing the effect of an alginate wafer. British Journal of Nursing (Mark Allen Publishing). 2012;21(16):S41-2, S4-6. Epub 2012/11/06.

51. Tenière P, Welser M, Martinet C. Ostomy pouch management: two comparative studies of one-piece pouches. World Council of Enterostomal Therapists Journal. 2007;27(2):10-6.

52. Voergaard LL, Vendelbo G, Carlsen B, Jacobsen L, Nissen B, Mortensen J, et al. Product focus. Ostomy bag management: comparative study of a new one-piece closed bag. British Journal of Nursing. 2007;16(2):95.

53. Vujnovich A. The management of stoma-related skin complications. Wounds UK. 2006;2(3):36-47.

54. Watson AJ, Nicol L, Donaldson S, Fraser C, Silversides A. Complications of stomas: their aetiology and management. British Journal of Community Nursing. 2013;18(3):111-2, 4, 6. Epub 2013/05/10.

55. Welser M, Riedlinger I, Prause U. A comparative study of two-piece ostomy appliances. British Journal of Nursing. 2009;18(9):530-8.

56. White M, Berg K. A new flangeless adhesive coupling system for colostomy and ileostomy. British Journal of Nursing. 2005;14(6):325-8.

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57. Williams I. Cost-efficiency in prescription reviews: pilot study of stoma patients in one health board in Wales. Gastrointestinal Nursing. 2013;11(7):36-44.

58. Williams J. Stoma care part 2: choosing appliance accessories. Gastrointestinal Nursing. 2006;4(7):16-9.

59. Williams J. Choosing devices for stoma patients. Practice Nursing. 2011;22(12):646.

60. Williams J, Rudoni C, Thompson MJ, Fulham J. Provision of products: should we be concerned? Nursing and Residential Care. 2006;9(11):528-30.

61. Youngberg DRM. Individuals with a permanent ostomy: quality of life, preoperative stoma site marking by an ostomy nurse, six peristomal complications, and out-ofpocket financial costs for ostomy management. Journal of Wound, Ostomy & Continence Nursing. 2011;38(3S):S5-6.

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Appendix 2 - Analysis of available financial information regarding Group 9 products

Introduction

Appendix 2 provides comparative pricing of products for each sub-group within Group 9 of the Stoma Appliance Schedule. Two categories of information are provided for each sub-group. These include:

direct domestic comparators; and

direct international comparators.

In summary, product pricing information was identified by systematically reviewing the 'grey' literature (described in Appendix 1). The domestic comparator data set includes comparisons from private consumer and company direct information sources. International comparators include US consumer, NHS Scotland, England and Wales prices.

Domestic pricing

Publically available pricing for SAS Group 9 products in Australia, outside of the price paid by Government as listed in the SAS Scheme, was identified in the following publications:

Pricing direct to the consumers through online purchase from a national medicines and medical supplies wholesaler; and

Pricing direct from the supply companies Hollister and Statina Healthcare Australia to the public.

Pricing direct to consumers was publicly available for one company (CH2 Australia). The company does not stock the full range of Group 9 accessories. A selection of products from the sub groups within Group 9 of the SAS are held by the wholesaler with the exception of stoma support wear which is not available. Product prices for companies without national supply capability were excluded.

Pricing direct from supply companies is generally not publically available. Searches of supply company websites did not include pricing information. The only exceptions being Statina HeathCare Australia and Hollister; Hollister’s product catalogue includes pricing for items equal to the SAS Scheme price to government.

International product pricing

International stoma product pricing was identified for three countries:

United States of America;

England and Wales; and

Scotland

Identified product pricing in the USA include prices direct to consumers via national medicines and medical supplies warehouses. Many USA warehouse websites do not include

103

the price per item of products but rather require consumers to select items and enter health insurance plan details so that a computerised algorithm can calculate the gap price between the insurance payment and item price. Only those websites identified with direct price per product were included.

Product prices for stoma appliance items available through the NHS England and Wales are publically available through the Electronic Drug Tariff (EDT)68. Stoma products are listed in part IXC. There are a number of products listed on the EDT that are also listed in SAS Schedule Group 9.

Product reimbursement prices for stoma appliance items available in Scotland are publically available through the Stoma Appliances Price List69. There are a number of products listed on the Stoma Appliances Price List that are also listed on Group 9 of the Australian SAS Schedule and listed on the NHS England and Wales EDT. This commonality allows for direct and indirect price comparison.

Sub-group price comparison

In summary, we describe the following domestic comparators:

Private consumer - this is the price to an Australian consumer purchasing from a national on-line wholesaler website70

Company Direct – this is the price displayed on the company’s Australian website or electronic brochure.

International comparators include the following:

US Consumer (AUD) – this is the equivalent price expressed in Australian dollars71,72 for an American consumer purchasing from an on-line wholesaler.

NHS Scotland (AUD) Price and Variance – this is the equivalent price expressed in Australian dollars73 to that listed on the NHS Scotland Stoma Appliance Scheme74 followed by the variance between the NHS Scotland Stoma Appliance Scheme price and the Australian SAS price, expressed as a percentage.

NHS England and Wales (AUD) Price and Variance – this is the equivalent price expressed in Australian dollars to that listed on the NHS England and Wales Electronic Drug Tariff75 followed by the variance between the NHS England and Wales price expressed in equivalent Australian dollars and the Australian SAS price, expressed as a percentage.

68 NHS Electronic Drug Tarriff69 ISD Scotland Stoma Supplies70 http://direct.ch2.net.au/index.php?mode=intouch71 Conversion rate $1US=$1.11AUD (Mar. 21, 2014).72 http://continentostomymystore.com73 Conversion rate1 Scottish Pound = 1.84 Australian Dollar (Mar. 13, 2014) 74 NHS Scotland. Stoma Appliances Price List Scotland March 2014. (Mar. 12, 2014). 75NHS Electronic Drug Tarriff (Mar. 29, 2014).

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https://www.google.com.au/search?q=converting+us+dollar+to+australian+dollar



Products are listed as direct comparators in the event of direct match of manufacturer code or when the product name and descriptor match with certainty. For the purpose of providing additional information, sub-groups 9b and 9h include data that provide an indirect comparison. This includes comparison of the same product brand and type with a different pack size inclusion (9b) or differing brands with the same dimensions, use and general presentation (9h).

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1. SAS Group 9a – Skin care and protection

Of the 13 items listed in 9a direct domestic comparators were available for five items. All comparator item prices were equivalent or greater than SAS prices (Table 1.1).

In comparison with SAS prices:

Hollister company direct prices were equivalent.

Private prices were 92% to 328% higher.

Table 1.1: Direct Domestic Comparators

SAS Code

Brand Name Pack Size

Max Qty

Pack Price (AUD)

Private Consumer (AUD)

Company Direct76 (AUD)

3509Q

Coloplast Protective Sheet Dispenser

1 1m 47.14 201.70 n/a

3530T Hollister Hollihesive 5 30m 14.38 n/a 14.38

3558G Hollister Flextend 5 30m 14.38 n/a 14.38

3580K ConvaTec Skin Barrier 3 30m 43.74 83.80 n/a

3944N


10 30m 28.77 62.70 n/a

*n/a pricing not available

Of the 13 items listed in 9a direct international comparators were available for 11 items (Table 1.2). Seven items had comparator prices greater than SAS prices. Four items had comparator prices less than SAS prices.


US web-based wholesale prices to consumers were 216% to 282% higher.

Six NHS item prices were 23% to 270% higher.

Four NHS item prices were 20% to 57% lower.

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Table 1.2: Direct International Comparators

SAS Code Brand Name

Pack Size

Pack Price (AUD)

US Consumer (AUD)77

NHS Scotland Price (AUD) & Variance

NHS England & Wales Price (AUD) & Variance

3508P


5 14.38 n/a 51.17(256%)

53.10(270%)

3530T Hollister Hollihesive 5 14.38 31.19 21.34

(48%)22.15(54%)

3532X Convatec Skin Barrier 5 14.38 n/a n/a 21.91

(52%)

3558G

Hollister Flextend 5 14.38 40.56 n/a n/a

3580K Convatec Skin Barrier 3 43.74 n/a n/a 53.69

(23%)

3581L


5 72.90 n/a 93.10(28%)

96.66(33%)

3897DColoplast Brava Elastic Tape

20 29.16 n/a 23.09(-21%)

23.39(-20%)

3944N


10 28.77 n/a 43.22(50%)

44.36(54%)

3599E

Omnigon Welland Hydroframe Mini

30 42.84 n/a n/a 18.29(-57%)

5691M

Ainscorp Salts SecuPlast Hydro Aloe

30 43.74 n/a 22.72(-48%)

23.79(-46%)

9853NAinscorp Salts Secu Plast Hydro

30 43.74 n/a 21.16(-52%)

21.96(-50%)

Ainscorp is an Australian company that imports and distributes Salts products in Australia. It is worth noting that the SAS Ainscorp Salts prices are often greater than NHS Salts prices. This probably reflects the additional cost of indirect supply from a manufacturer through a third party.

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2. SAS Group 9b – Stoma support garments

Of the 23 items listed in 9b, direct domestic comparators were available for one item. The direct purchase from company price was equal to the SAS listed price (Table 2.1).


SAS Code Brand Name Pack

Size Max QtyPack Price (AUD)

Company Direct (AUD)78

3887N Hollister Adapt 1 4 annually 5.98 5.98

Of the 23 items listed in 9b, direct international comparators were available for 10 items (Table 2.2). For three items with the same brand name there were different pack sizes but the same comparator price per item across pack sizes. Duplicates for these products are therefore omitted in Table 2.2.

For all 10 products the comparator price was greater than the SAS price. In general the comparator price was more than twice that of the SAS price.

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SizePack Price (AUD)

US Consumer (AUD)79,80

NHS Scotland Price (AUD) & variance

NHS England & Wales Price (AUD) & variance

3816W Omnigon Braun Stomacare Belt 1 5.98 n/a 13.89

(132%) n/a

3887N Hollister Adapt 1 5.98 11.98 13.89(132%)

14.30(139%)

3890R Dansac Beige Ostomy Belt 1 5.98 n/a 13.41

(124%) n/a

3898EColoplast Brava Belt Standard 100cm

1 5.98 12.70 11.9(99%)

12.36(107%)

3898EColoplast Brava Belt Extra Large 135cm

1 5.98 12.70 12.02(101%)

12.16(104%)

9760QAinscorp Salts Adjustable Ostomy Belt

1 5.98 n/a 13.56(127%) n/a

9834N Omnigon Flair Belt Pack 1 5.98 n/a 13.25

(122%)13.41(124%)

There are 10 items listed within 9b with SAS Code 9834N for which indirect international comparators have been found. The listed items consist of a belt with a single belt ring of varying sizes. The SAS reimbursement price for a pack of one belt and one ring is $5.98. The NHS schemes reimburse for a pack of one belt with five rings*; whilst a direct comparison of price cannot be made it is clear the SAS price is better value for money at $5.98 for one belt and ring compared with the NHS price for one belt and five rings at $64.16 or more (Table 2.3).

Table 2.3: Indirect International Comparators

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Company Code Brand Name Pack

SizeMax Qty

Pack Price (AUD)

NHS Scotland (AUD)

NHS England & Wales (AUD)

XBLT073 Omnigon Flair Belt Pack 1 4

annually 5.98 64.16* 66.06*


annually 5.98 64.16* 67.18*


annually 5.98 64.16* 67.18*


annually 5.98 64.16* 67.18*


annually 5.98 64.16* 66.06*


annually 5.98 64.16* 66.06*


annually 5.98 64.16* 67.18*


annually 5.98 64.16* 67.18*


annually 5.98 64.16* 67.18*


annually 5.98 64.16* 66.06*

3. SAS Group 9c – Clamps & clips

Of the five items listed in 9c, direct domestic comparator prices were available for four items (Table 3.1).


Hollister company direct prices were equivalent

110

Private prices were 91% to 121% higher



SizeMax Qty

Pack Price (AUD)



3651E Hollister Clamps 2010 annually

46.10 n/a 46.10

3760X ConvaTec Clips 1010 annually

23.05 44.20 n/a

3810M Coloplast Alterna Slimline 20

10 annually

46.10 102.00 n/a

9915W Hollister ModermaFlex 110 annually

2.30 n/a 2.30

Of the five items listed in 9c, direct international comparator prices were available for two items. In comparison with SAS prices NHS reimbursement prices are 15% to 19% lower (Table 3.2).






3651E Hollister Clamps 20 46.10 37.46(-19%)

38.90(-16%)

3810M Coloplast Alterna Slimline 20 46.10 37.46(-19%)

39.43(-15%)

4. SAS Group 9d – Cleansers and adhesive removal

Of the 17 items listed in 9d, direct domestic comparators are available for six items (Table 4.1). For all six products the comparator price was equivalent or greater than the SAS price.




111



SizeMax Qty

Pack Price (AUD)



3520G Coloplast Comfeel Wipes 30

100 per month

14.34 34.90 n/a

3522J ConvaTec ConvaCare Wipes 100

100 per month

32.00 59.70 n/a

3542K Smith & Nephew Remove Wipes 50

100 per month

16.00 40.00 n/a

3554C Hollister Universal Wipes 50

100 per month

16.00 29.90 16.00

3555D Hollister Cleanser Spray 1 1 per

month 8.35 16.90 8.35

3775Q Coloplast Comfeel Spray 1 1 per

month 8.35 16.63 n/a

Of the 17 items listed in 9d, direct international comparator prices were available for seven products (Table 4.2). In comparison with SAS prices:

The US comparator product price was 10% higher.

One NHS Scotland product was priced 1% lower.

All other NHS product prices were 3% to 286% higher.


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US Consumer83 (AUD)



3522J ConvaTec ConvaCare Wipes 100 32.00 n/a 31.61

(-1%)33.10(3%)

3554C Hollister Universal Wipes 50 16.00 17.64 24.03

(50%)24.95(56%)

3716N Dansac Skin Lotion (bottle) 1 8.35 n/a n/a 32.22

(286%)

3775Q Coloplast Comfeel Cleanser (bottle) 1 8.35 n/a n/a 32.16

(285%)

3902JColoplast Brava No Sting Adhesive Remover Spray

1 10.23 n/a 15.49(51%)

16.27(59%)

3903KColoplast Brava No Sting Adhesive Remover Wipes

30 11.94 n/a 25.69(115%)

26.97(126%)

9854P Ainscorp Salts Wipe Away Wipes 30 14.34 n/a 15.93

(11%)16.54(15%)

5. SAS Group 9e – Convexity inserts

Direct Domestic Comparators

Direct domestic comparator prices were unavailable for the eight items listed in 9e.

Direct International Comparators

Direct international comparator prices were unavailable for the eight items listed in 9e.

6. SAS Group 9f – Skin care and protection

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113

Of the 10 items listed in 9f, direct domestic comparators are available for seven items (Table 6.1). For all seven items the comparator price was equivalent or greater than the SAS price.

The Hollister company direct price was equivalent.




SizeMax Qty

Pack Price (AUD)



3528Q Coloplast Comfeel 1 2 per month 7.92 19.30 n/a

3557FHollister Skin Conditioning Cream

1 2 per month 7.92 16.10 7.92

3787H ConvaTec Orabase 1 2 per month 8.74 15.90 n/a

9821X Sudocrem Healing Cream 1 1 per

month 5.54 8.90 n/a

9907K Calmoseptine Ointment 20g 1 2 per

month 4.71 5.20 n/a

9933T Calmoseptine Ointment 75g 1 1 per

month 7.68 11.30 n/a

9934W Coloplast Conveen Critic 1 1 per

month 7.85 19.60 n/a

Of the 10 items listed in 9f, direct international comparators are available for two items. For both items the comparator price was greater than the SAS price (Table 6.2).






3528Q Coloplast Comfeel 1 7.92 8.52(8%)

8.85(12%)

9858W 3M Cavilon Durable 1 5.75 6.37(11%)

7.32(27%)

7. SAS Group 9g – Deodorisers & gas suppressants


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Of the 13 items listed in 9g, direct domestic comparators are available for three products (Table 7.1). In all cases the comparator price was equivalent to the SAS price.



Size Max QtyPack Price (AUD)


3872T Hollister M9 Drop 1 1 per month 8.13 8.13

9954X Hollister Adapt 236 ml bottle 1 1 per

month 9.91 9.91

9988Q Hollister Adapt sachets 50 100 annually 20.70 20.7

Of the 13 items listed in 9g, direct international comparator prices were available for four products (Table 7.2).


The US comparator prices were 90% to 189% higher.

One NHS product price was 37% to 39% lower.

Three NHS product prices were 13% to 98% higher.




US Consumer (AUD)86



3798X Dansac Nodor "S" 1 4.05 n/a 7.73(91%)

8.02(98%)

9855Q Ainscorp Salts No-Roma 1 8.13 n/a 4.95

(-39%)5.15(-37%)

9954X Hollister Adapt 236 ml bottle 1 9.91 28.64 16.5

(67%)17.13(73%)

9988Q Hollister Adapt sachets 50 20.70 39.32 23.44

(13%)24.34(18%)

8. SAS Group 9h – Stoma support garments

There are 164 items listed in 9h. These items can be summarised into nine groups:

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115

Omnigon stoma support belts (10 items).

Omnigon stoma support briefs (20 items).

Omnigon ‘kool-knit’ hernia support belts (27 items).

Omnigon mens hernia support boxers (10 items).

Omnigon Diamond Plus support pants for males and females (27 items).

Ainscorp Salts Simplicity support underwear (30 items).

Omnigon Total Control stoma and hernia support belt (15 items).

Statina Healthcare Corsinel abdominal support garments (16 items).

Sutherland Medical Abdominal Binder abdominal support belt (9 items).

Products are compared at the group level (rather than the individual item level) in this section where products are the same price across a range of product sizes or colours.

The SAS price for Statina Healthcare Corsinel abdominal support garments is 29% lower than the company direct price (Table 8.1).


SAS Code Brand Name Descriptor

Qty

Pack Price (AUD)


9958DStatina Healthcare Corsinel (16 product variants)

Abdominal support hernia garment, various sizes, for males and females

1 120.02 155.00

NHS Scotland reimbursement price for Salts Simplicity underwear varies slightly with size as summarised in the range provided in Table 8.2.

NHS reimbursement price for Salts Simplicity abdominal support underwear (boxers and briefs) are 62% to 63% lower than SAS prices.

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116


SAS Code Brand Name Descriptor

QtyPack Price

NHS Scotland (AUD) & variance

NHS England & Wales (AUD) & variance

9856R

Ainscorp Salts Simplicity (15 product variants)

Abdominal support (boxer) underwear for ostomates with hernias, two way stretch breathable fabric, various sizes,

1 60.0022.08 to 22.28(-63%)

22.93(-62%)

9856R

Ainscorp Salts Simplicity (15 product variants)

Abdominal support underwear (brief), for ostomates with hernias, two way stretch breathable fabric, Brief, Neutral, Medium/Large,

1 60.0022.08 to 22.28(-63%)

22.93(-62%)

Indirect International Comparators

Indirect comparisons have been made where item of differing brands have the same dimensions, use and general presentation. In the absence of a clear indirect comparator, comparisons have not been made.

Stoma Support Belts

There are no direct comparators to the Omnigon Stoma Support Belt. The Omnigon belts can be indirectly compared to a similar belt type from AMI Medical, on the NHS Scotland Stoma Appliance Price List.

Compared with SAS prices the NHS Scotland belt prices are 18% to 41% higher (Table 8.3.1). NHS England and Wales prices were 3% higher than NHS Scotland prices on all four Supportx product types.

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Table 8.3.1: Stoma Support Belts

SAS Code Brand Name Descriptor Qty

Pack Price (AUD)

3858C

Omnigon Stoma Support Belt (10 product variants)

Stoma support belt, specially knitted Isoflex breathable fabric, no latex allergy, adjustable 15cm velcro closure width, depth 20cm or 26cm width variable waist sizing.

1 71.01

NHS Scotland

Supportx Ostomy/Hernia Easy Peel Support Belt

20cm depth various waist sizes 1 83.57

NHS Scotland

AMI Medical Supportx Ostomy/Hernia Easy Peel Support Belt

20cm depth, with hole cutting, various waist sizes 1 100.10

NHS Scotland


26cm depth, various waist sizes 1 91.89

NHS Scotland


26cm depth, with hole cutting, various waist sizes 1 108.93

Stoma Support Briefs

There are no direct comparators to the Omnigon Stoma Support Briefs. The Omnigon briefs can be indirectly compared to a similar product type from Comfizz, on the NHS Scotland Stoma Appliance Price List.

Compared with SAS prices the NHS Scotland brief prices are 48% lower (Table 8.3.2).

Table 8.3.2: Stoma Support Briefs

SAS Code Brand Name Descriptor Qty Price (AUD)

9752G/9853P

Omnigon Support Briefs for (12 product variants)

hernia support garment, breathable fabric with 15cm wide Isoflex waistband, brief style pant, various waist size ,

1 60.00

NHS Scotland

Comfizz Stoma Support Briefs

Various colours and sizes , level 2 support rating 1 31.28

Omnigon Kool-Knit Hot Weather Hernia Support Belts

There are no clear indirect comparators available for this product.

118

Support Boxers

There are no direct comparators to the Omnigon Stoma Support Boxers. The Omnigon boxers may be indirectly compared to a similar product type from Comfizz, on the NHS Scotland Stoma Appliance Price List.

Compared with SAS prices the NHS Scotland boxers prices are 48% lower (Table 8.3.3).

Table 8.3.3: Support Boxers

SAS Code Brand Name Descriptor Qty Price

(AUD)

9785BOmnigon Mens Support Boxers

Hernia support garment, breathable fabric with 20cm wide Isoflex waistband, opening for crotch, mens brief style pant, various waist size,

1 60.00

NHS Scotland

Comfizz unisex boxers

Stoma support boxers, unisex, various sizes, level 2 support rating 1 31.28

Omnigon Diamond Plus Support Pants

There is insufficient detail on the NHS Scotland Stoma Appliance Price List to identify a clear indirect comparison between Omnigon Diamond Plus support pants and other possibly similar items available on the NHS Scotland Stoma Appliance List.

Omnigon Total Control stoma and hernia support belt

There is insufficient detail on the NHS Scotland Stoma Appliance Price List to identify a clear indirect comparison between the Omnigon Total Control stoma and hernia support belt and other possibly similar items available on the NHS Scotland Stoma Appliance List.

Sutherland Medical Abdominal Binder abdominal support belt

There are no clear indirect comparators available for this product.

119

9. SAS Group 9i – Night drainage

Of the 10 items listed in 9i, direct domestic comparator prices are available for four items (Table 9.1). In comparison with SAS prices:



Table 9.1: Direct Domestic Comparator

SAS Code

Brand Name Descriptor Pack

SizeMax Qty

Pack Price

Private Consumer

Company Direct88

3674J

Coloplast S3 Extended Term

urostomy night drainage bag, 2 litre, drainage tube, wide bore 100cm tubing, sterile,

1 5m 2.19 2.50 n/a

3863H

Coloplast Simpla S4

urostomy night drainage bag, 2 litre, drainage tube, wide bore 120cm tubing, sterile,

1 5m 2.19 6.40 n/a

3888P

Hollister T-Tap Night Drainage Collector

Non-sterile T-Tap Drainage Bag, 30 5m 65.70 n/a 65.70

9878X

Hollister Night Drainage Collector

2ltr non-sterile night drainage bag, connect to urostomy pouch tap, punch holes for stang, 120cm wide bore tube

1 5m 2.19 n/a 2.19

Direct International Comparators

Direct (and indirect) international comparators are not available for the items in 9i.

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120

Of the nine items listed in 9j, direct domestic comparators are available for five items (Table 10.1). In all cases the comparator price was equivalent or greater than the SAS price.





SizeMax Qty

Pack Price

Private Consumer

Company Direct89

3503J ConvaTec Paste 1 3m 11.28 21.70 n/a

3511T ConvaTec Powder 1 2 per month 8.70 18.10 n/a

3535C Hollister Karaya Paste 1 3m 11.28 n/a 11.28

3556E Hollister Premium Powder 1 2 per

month 8.70 17.40 8.70

9906J Hollister Adapt Paste 1 3m 11.28 n/a 11.28

Of the nine items listed in 9j, direct international comparator prices were available for all nine products (Table 10.2).


The US comparator product prices were 4% to 85% higher.

Four NHS Scotland product prices were 2% to 48% lower.

Three NHS England and Wales product prices were 37% to 46% lower.

Remaining NHS products were 3% to 38% higher.

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121



SizePack Price

US Consumer (AUD)90,91



3503J ConvaTec Paste 1 11.28 15.93 13.72

(22%)13.73(22%)

3511T ConvaTec Powder 1 8.70 13.25 n/a n/a

3534B Coloplast Paste Tube 1 11.28 11.72 11.04

(-2%)11.59(3%)

3535C Hollister Karaya Paste 1 11.28 20.9 14.94

(32%)15.51(38%)

3552Y Dansac Soft Paste 1 11.28 N/A 6.38

(-43%)6.62

(-41%)

3556EHollister Premium Powder

1 8.70 N/A 4.56(-48%)

4.73(-46%)

3571Y Coloplast Brava Strip Paste 10 11.28 N/A 13.6

(21%)14.35(27%)

9762T Ainscorp Salts Stoma Paste 1 11.28 N/A 12.77

(13%)12.80(14%)

9906J Hollister Adapt Paste 1 11.28 17.27 6.57

(-42%)7.10

(-37%)

11.SAS Group 9k – Skin care and protection

90Coloplast Ostomy Accessories 91 Hollister

122

http://www.totalhomecaresupplies.com/CategoryDetail.aspx?CategoryName=_z%20Brand%20Hollister


Of the 12 items listed in 9k, direct domestic comparators are available for three items. In all cases the comparator price was equivalent or greater than the SAS price (Table 11.1).





SizeMax Qty

Pack Price

Private Consumer

Company website92

3502H ConvaTec ConvaCare Wipes 100

100 per month

29.00 60.20 n/a

3544M 3M No Sting Spray 1 1 per month 15.31 28.70 n/a

3553B Hollister Skin Gel 50100 per month

14.50 33.10 14.5

Of the 12 items listed in 9k, direct international comparator prices were available for ten products (Table 11.2).


The US comparator product prices were 5% to 121% higher.

Five NHS product prices were 11% to 41% lower.

Four NHS products were 9% to 76% higher.


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SizePack Price

US Consumer (AUD)93



3502H ConvaTec ConvaCare 100 29.00 n/a 31.61(9%)

33.10(14%)

3504K Smith & Nephew Skin Prep Aerosol 1 8.45 18.64 n/a n/a

3544M 3M No Sting 1 15.31 n/a 10.62(-31%)

12.24(-20%)

3553B Hollister Skin Gel 50 14.50 15.20 24.60(70%)

25.54(76%)

3908QColoplast Brava No Sting Skin Barrier Wipes

30 31.95 n/a 38.2(20%)

40.11(26%)

3925NColoplast Brava No Sting Skin Barrier Spray

1 26.25 n/a 20.11(-23%)

21.12(-20%)

9775L 3M Cavilon 30 31.95 n/a 36.97(16%)

42.87(34%)

9798QSmith & Nephew SECURA No-Sting Barrier Film

50 52.10 n/a 30.80(-41%)

41.78(-20%)

9799R Smith and Nephew Skin Prep Spray 1 15.31 n/a n/a 10.25

(-33%)

9859X Ainscorp Salts Peri-Prep Sensitive 30 31.95 n/a 27.42

(-14%)28.47(-11%)

93 Hollister

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SAS Group 9l – Seals

Of the 37 items listed in 9l, direct domestic comparators are available for eight items. For all products the comparator price was equivalent to the SAS price (Table 12.1).


SAS Code Descriptor Pack

SizeMax Qty

Pack Price

Company Direct94

3882H Hollister Oval Convex Barrier Rings sizes 22x38mm, 30x48mm, 38x56mm (3 items) 10

30 per month

45.31 45.31

9904G Hollister Adapt convex barrier ring 20mm, 30mm, 40mm (3 items) 10

30 per month

45.31 45.31

9979F Hollister Adapt barrier seals 48mm and 98 mm 10

30 per month

45.31 45.31

Of the 37 items listed in 9l, direct international comparator prices were available for 30 products (Table 12.2).


Two US comparator product prices were 44% lower.

Eight US comparator product prices were 68% higher.

All 30 NHS product prices were between 9% and 70% lower.

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SAS Code Descriptor Pack

PriceUS Consumer95,96 (AUD)



3539G/3567R

Dansac GX-TRA seals, sizes 20mm,30mm, 40mm, 50mm (4 items)

135.96 n/a 75.09(-45%)

77.94(-43%)

3879EDansac Novalife Seals 20mm, 30mm, 40mm, 50mm (4 items)

135.93 n/a n/a 122.14(-10%)

3882H

Hollister Oval Convex Barrier Rings sizes 22x38mm, 30x48mm, 38x56mm (3 items)

45.31 76.19 33.20(-27%)

34.22(-25%)

3905M Coloplast Brava Mouldable Ring 2.0mm thickness 135.93 76.37 99.25

(-27%)104.24(-23%)

3905M Coloplast Brava Mouldable Ring 4.2mm thickness 135.93 76.37 101.18

(-26%)106.28(-22%)

9763W Ainscorp Salts Secuplast mouldable seal sizes large 45.31 n/a 39.56

(-13%)41.44(-9%)

9764XAinscorp Salts Secuplast mouldable seal size standard

135.96 n/a 88.32(-35%)

92.50(-32%)

9765Y Ainscorp Salts Secuplast mouldable seal size thin 135.96 n/a 86.94

(-36%)91.04(-33%)

9782W

Ainscorp Salts Dermacol sizes 17.5-22mm, 20.5-23mm, 23.5-26mm, 26.5-29mm, 29.5-32mm, 32.5-35, 35.5-38mm, 38.5-41mm (8 items)

135.96 n/a 99.36(-27%)

100.22 to 103.15(-26% to -24%)

9904GHollister Adapt convex barrier ring 20mm, 30mm, 40mm (3 items)

45.31 76.19 31.28(-31%)

32.48(-28%)

9905H Hollister Adapt convex barrier strips 45.31 n/a 13.67

(-70%)14.19(-69%)

9979F Hollister Adapt barrier seals 48mm 45.31 76.19 31.1

(-31%)32.27(-29%)

9979F Hollister Adapt barrier seals 98mm 45.31 76.19 39.19

(-14%)40.68(-10%)

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12.SAS Group 9m – Miscellaneous

Of the five items listed in 9m, direct domestic comparators are available for three items (Table 13.1). For all products the comparator price was equivalent or greater than the SAS price.




SAS Code Brand Pack

SizeMax Qty

Pack Price

Private Consumer

Company Direct97

3670E Coloplast Cathstrap 1 2 per month 4.78 13.38 n/a

3927Q Ebos Group Vernagel 100 50 per

month 74.70 137.20 n/a

9880B Hollister Silicone Adhesive Spray 1 1 per

month 35.65 n/a 35.65

Of the five items listed in 9m, direct international comparator prices were available for two products (Table 13.2). In comparison with SAS prices:

One US comparator product price was 36% higher.

One NHS comparator product price was 126% to 134% higher.

One NHS comparator product price was 14% to 17% lower.


SAS Code Brand Pack

SizePack Price

US Consumer98 (AUD)



3570X Coloplast Filtrodor 50 17.95 n/a 40.48

(126%)42.03(134%)

9880BHollister Silicone Adhesive Spray

1 35.65 48.62 29.61(-17%)

30.73(-14%)

97 Ostomy catalogue98Hollister

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Financial studies identified in searches of peer-reviewed literature

Two studies were identified in Part A (a systematic review of the peer-reviewed literature) that reported the results of financial analyses relating to the cost of stomal accessory products (Martins 2012, Meisner 2012).

Martins 2012

Martins 2012 reported the results of a cost estimation study, the purpose of which was to assess the impacts of early detection and treatment of peristomal skin conditions and the use of a correctly fitted and appropriate pouching system on treatment costs.

The cost estimation was based on peristomal skin conditions among Dialogue study participants. The Dialogue study is a non-controlled clinical study that collected information about patient experience relating to Coloplast’s SenSura ostomy appliance. Dialogue collected data on 3,017 participants with an ostomy and included 500 wound and ostomy care nurses across 18 countries worldwide. There were 36 participants from Australia.

Peristomal skin conditions were assessed using an Ostomy Skin Tool – a validated skin assessment tool. Data from skin assessments performed on study participants who regularly or periodically visited a stoma care nurse or doctor was used for the cost modelling (2,560 participants in total). Of these, 67% of participants had a colostomy, 31% had an ileostomy and 2% had a urostomy. All used the SenSura ostomy appliance.

The estimated cost of a seven week treatment of an average case of a peristomal skin condition varied according to the cause of the skin condition and the condition’s severity. Sever disease-related peristomal skin conditions are the most expensive conditions to treat (Table 14).

Table 14: Cost of managing peristomal skin conditions (in UK £ and based on unit costs in 2012)

Mild Moderate SevereIrritant contact dermatitis 113.38 132.88 290.45Allergic dermatitis 196.81 267.36 371.84Mechanical trauma 106.29 118.38 219.60Disease related 142.73 336.36 618.69Infection 151.84 184.41 385.87The component of these costs that is attributable to Group 9 accessories was not reported by the study authors.

Frequency of appliance leakage is associated with the severity of a peristomal skin condition. Appliances that leak “often” are approximately £30 more expensive to treat over a seven week period than those that leak “rarely”.

Results of this study suggest that significant cost savings can be made in the treatment of peristomal skin conditions if peristomal skin conditions are prevented or minimised in people with a stoma and peristomal skin conditions are detected at an early stage.

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Meisner 2012

Meissner 2012 reported the application of a model to estimate treatment costs of peristomal skin conditions using the standardised assessment Ostomy Skin Tool as a reference. The costing model was applied to peristomal skin conditions among 2,914 Dialogue study participants (study described above) to estimate treatment costs for managing an average case of peristomal skin condition for all levels of severity over a seven week period.

The estimated total average cost for a seven week treatment period (including appliances and accessories) was 263€ for those with a peristomal skin condition (n = 1,742 participants) versus 215€ for those without peristomal skin conditions (n = 1,172 participants). The breakdown in costs for the Group 9 accessories component of the treatment was not provided.

The mean cost of treatment increased with the severity of the skin condition, from an additional treatment cost over seven weeks of 23.1€ and 31.5€ in patients with mild and moderate peristomal skin conditions (compared with those with no skin complaint) to an additional 141.2€ in patients with severe peristomal skin conditions.

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Documents

Executive Summary - Australian Government … · Web viewGroup 9 products represent the largest financial impost on the scheme overall and make-up 24% of the SAS’s cost in 2012-13,