UK Department of Health Guidance on Prescribing for Impotence Following the Introduction of Sildenafil

UK Department of Health Guidance onPrescribing for Impotence Followingthe Introduction of SildenafilPotential to Contain Costs in the Average Health Authority District

Martin Ashton-Key,1 Michael Sadler,2 Byron Walmsley,3 Simon Holmes,3 Sarah Randall 4and Michael H. Cummings 5

1 Brighton and Hove City Primary Care Trust, Vantage Point, Brighton, England2 NHS Direct Hampshire and Isle of Wight, Hedge End, Southampton, England3 Department of Urology, St Mary’s Hospital, Portsmouth, England4 Department of Reproductive Health, St Mary’s Hospital, Portsmouth, England5 Academic Department of Diabetes and Endocrinology, Queen Alexandra Hospital, Cosham,

Portsmouth, England

Abstract Objectives: To evaluate the effectiveness at containing service costs of the UK’sDepartment of Health (DoH) guidance on prescribing for impotence implementedafter the introduction of sildenafil and taking effect from 1 July 1999.

Design: A pragmatic economic analysis of the impact of the DoH guidance onspecialist-care activity and costs and primary-care prescribing costs from theperspective of the UK National Health Service. Primary-care prescribing costsand specialist-care activity and cost data were collected for 12-month periodsbefore and after the introduction of the guidance.

Setting: Portsmouth and South East Hampshire Health Authority.

Results: Specialist-care activity and associated costs fell by 70% in the first yearfollowing the introduction of the DoH guidance while primary-care prescribingcosts doubled. The overall cost for providing impotence services in Portsmouthand South East Hampshire in 1999–2000 was £232 619, and is similar to the costincurred in 1998–1999 of £225 108 (uplifted to 1999–2000 values).

Conclusions: The DoH guidance on prescribing for impotence has effectivelyreduced specialist-care activity and costs in Portsmouth and South East Hamp-shire. It offers the potential to allow the overall costs of impotence services in thedistrict to be contained even with the use of higher cost drugs, such as sildenafil.

ORIGINAL RESEARCH ARTICLE Pharmacoeconomics 2002; 20 (12): 839-8461170-7690/02/0012-0839/$25.00/0

© Adis International Limited. All rights reserved.

Impotence, or erectile dysfunction (ED), is acommon problem and has been defined by a USNational Institutes of Health conference as ‘the in-ability to achieve, or maintain, an erection suffi-cient for satisfactory sexual performance’.[1] Sil-denafil, the first effective licensed oral agent fortreating ED, was licensed in the UK on 15 Septem-ber 1998. This raised both the profile of the treat-ment of ED and the issue of rationing treatments ina cash-limited National Health Service (NHS). TheUK Department of Health (DoH) issued guidanceon prescribing for ED on 7 May 1999 amid con-cerns about the potential financial risk this new drugcould place on the NHS.[2] This guidance came intoeffect on 1 July 1999 and restricted ED treatmentsto certain clinical groups. The explicit aim was tocontain any potential increase in resources re-quired following the introduction of sildenafil. Theguidance was as follows:• General practitioners (GPs) to prescribe impo-

tence treatments on the NHS for men who have:had radical pelvic surgery; had their prostate re-moved and/or been treated for prostate cancer(surgery and other treatments); been treated forrenal failure (transplant and dialysis); spinalcord and severe pelvic injury; diabetes mellitus;multiple sclerosis; single gene neurological dis-ease; poliomyelitis; spina bifida; or Parkinson’sdisease.

• GPs to prescribe impotence treatments on theNHS to those men not included in the abovecategories but who were receiving treatment forimpotence on 14 September 1998.

• Treatment to be available, subject to specialistassessment, in exceptional circumstances whenimpotence is causing severe distress.

• Prescription to be limited to no more than onetreatment per week.

• Men who do not fall into the above categoriesto receive private prescriptions from their GP.

• The drug treatments affected by this decisionare oral sildenafil, intracavernous or transure-thral alprostadil and intracavernous moxisylyte.Moxisylyte has since been withdrawn from themarket in the UK.

Prior to the time the DoH guidance was intro-duced specialists in secondary care assessed allmen with ED in the district requesting treatment.Patients were assessed and test doses of invasivetreatments were administered within the clinic. Anytreatments recommended were then prescribed bythe patient’s GP. The NHS departments of genito-urinary medicine, family planning, urology and di-abetic medicine all provided local ED services.

The aim of this project was to evaluate the ef-fectiveness of the DoH guidance on prescribing forED at containing the overall costs of the ED ser-vices in Portsmouth and South East HampshireHealth Authority, a single Health Authority on thesouth coast of England. There were two phases.The first was a review of the ED services providedin Portsmouth and South East Hampshire and anestimate of the potential financial impact of theDoH guidance from the perspective of the healthauthority. All GPs and specialists in Portsmouthand South East Hampshire agreed to adopt the localstrategy for implementing the DoH guidance,along with locally developed pathways for the re-ferral to specialists services of men with severedistress as a result of their ED, to take effect on 1July 1999. As previously reported, this initial worksuggested that the introduction of the DoH guid-ance would be cost-neutral because of the shiftfrom specialist assessment to assessment and man-agement in primary care.[3] This article reports theresults of the second phase, which aimed to evalu-ate the financial impact of the DoH guidance onlocal ED services during the first year following itsintroduction.

Methods

Demographic data were obtained from routinesources held by the Portsmouth and South EastHampshire Health Authority.

The NHS departments of genitourinary medi-cine, family planning, urology and diabetic medicineall provide local specialist ED services. Informa-tion on the following was gathered retrospectivelyfrom clinic and pharmacy databases for the periodApril 1998 to March 1999:

840 Ashton-Key et al.

© Adis International Limited. All rights reserved. Pharmacoeconomics 2002; 20 (12)

• Number of patients seen by specialist serviceswith ED.

• Whether they were seen in general or dedicatedspecialist clinics.

• The drug treatments prescribed.• The arrangements for continued prescriptions

made.The perspective was that of the UK NHS.

Outpatient tariffs for each of the clinics provid-ing ED services were obtained from the Health Au-thority finance department. For attendances at thegenitourinary and family planning clinics, wherepsychosexual counselling alone was provided, thecost was based on a fee for each face-to-face con-sultation. For urology and diabetic ED clinicsthese costs were based on a set of outpatient ap-pointments at average speciality price for each ofthe named clinics. The total cost incurred in thespeciality setting was then calculated, includingthe cost of any drugs prescribed in the clinics.

Data on GP prescribing were obtained from thePrescription Pricing Authority (PPA) for April1998 to March 1999, in the form of PrescribingAnalysis and Cost (PACT) data for the ED drugscurrently available. Consultation costs for primarycare were not included.

The impact of the introduction of sildenafil andthe DoH guidance on prescribing for ED was eval-uated by assessing trends in specialist-care activityand costs, and primary-care prescribing costs, forthe first year following the introduction of the DoHguidance, July 1999 to June 2000. Costs were cal-culated retrospectively using the same methods asfor the period 1998 to 1999. The derived data wereused to evaluate the effectiveness of the DoH guid-ance at containing service costs in Portsmouth andSouth East Hampshire. Costs for the different timeperiods were compared descriptively, without sta-tistical analysis.

Results

Portsmouth and South East Hampshire HealthAuthority has a total population of approximately550 000 of which approximately 206 000 are adult

males, the age distribution of which is given intable I.

Erectile Dysfunction Services 1998–1999 (Pre-Guidance)

The number of men newly referred with ED tospecialist services during April 1998 to March1999 is shown with associated outpatient and pre-scribing costs in table II. The 661 men newly re-ferred in this period represent an annual incidentreferral rate of approximately 0.3% of the adultmale population. The majority of men within thedistrict with ED requesting treatment were referredto urology for assessment. Men with diabetes mel-litus were assessed in the diabetic ED clinic. Thecosts of prescribing ED treatments in primary careare given in table III. Additionally, the cost of pe-nile implants was £8000.

The total cost of providing ED services in Ports-mouth and South East Hampshire can be calcu-lated using the outpatient costs and drug costs inhospital and primary care (in 1998–1999 values):• drug costs £110 652• outpatient costs £100 538• implant costs £8000• total costs £219 190.

Erectile Dysfunction Services 1999–2000 (Post-Guidance)

Specialist-care new-patient attendances andprescribing costs for July 1999–June 2000 areshown in table IV. The allocated budget for penile

Table I. Estimated adult male population in Portsmouth and SouthEast Hampshire Health Authority in 1999a

Age-group (y) Estimated male population

18–24 26 001

25–44 83 814

45–64 60 474

65–74 21 071

75–84 11 557

85+ 2821

All ages 205 738

a Source: Hampshire County Council 1995 based on small areapopulation forecasts.

Sildenafil - DoH Guidance on Prescribing 841


implants during this period was unchanged at£8000. Primary-care prescribing costs are given intable V.

The total cost of providing ED services in Ports-mouth and South East Hampshire for the July 1999to June 2000 period (outpatient costs plus drugcosts in hospital and primary care) was as follows:• drug costs £197 007• outpatient costs £27 612• implant costs £8000• total costs £232 619.

Changes in the primary-care prescribing costsfor ED therapies in Portsmouth and South EastHampshire are shown in figure 1. This demon-strates the doubling of monthly costs since the in-

troduction of sildenafil, and a shift away from us-ing alprostadil over the same period.

Figure 2 demonstrates an overall fall in atten-dances at secondary-care specialist providers be-tween the two periods of 70%, with similar falls forall specialist providers offering ED services.

To allow comparison between the known levelsof expenditure in 1998–1999 and in 1999–2000 thecosts for 1998–1999 were uplifted to 1999–2000values using the Hospital and Community HealthServices (HCHS) pay and price inflation index be-tween these periods of 2.7%.[4]

Cost comparisons for the two periods are givenin table VI and demonstrate that although the pri-mary-care prescribing costs have doubled, theoverall cost for 1999–2000 is similar to the cost for1998–1999 uplifted to 1999–2000 values becauseof reduced specialist-care costs.

Discussion

The principal finding of this study is that fol-lowing the introduction of sildenafil and the DoHprescribing guidance for erectile dysfunction newpatient referrals to all specialist-care providers inPortsmouth and South East Hampshire fell by ap-proximately 70%, clearly demonstrating the shiftaway from specialist assessment. A similar fall inspecialist-care prescribing costs was observed. Pre-

Table III. Costs of erectile dysfunction treatments prescribed inprimary care in Portsmouth and South East Hampshire HealthAuthority, 1998–1999a

Drug Total cost (£)

Alprostadil (all forms) 82 309

Sildenafil 8768

Papaverine ± phentolamine 2163

Thymoxamine 1000

Yohimbine 22

Total 94 262

a Source: Prescribing Analysis and Cost (PACT) data 1999 ob-tained from the Prescription Pricing Authority.

Table II. Outpatient activity and costs for erectile dysfunction (ED) services in Portsmouth and South East Hampshire Health Authority,1998–1999a

Outpatientclinic

Number ofnew patientsattending clinic

Cost for each newpatient episode or perface to face contact (£)

Average number ofappointments where costbased on total number offace to face contacts

Cost incurredfor outpatientattendances(£)

Cost of drugtreatmentprescribed atoutpatient clinic (£)

Total costfor clinic (£)

Genitourinarymedicine

91 Nilb 6 Nil Nil Nil

Familyplanning

176 17 for each face toface contact

6 17 952 Nil 17 952

Urology 268 161 per new patientepisode

N/A 43 148 15 164 58 312

Diabetic 126 313 per new patientepisode

N/A 39 438 1226 40 664

Total 661 100 538 16 390 116 928

a Sources: Outpatient activity data supplied by secondary-care ED clinics. Finance department, Portsmouth and South East HampshireHealth Authority. Portsmouth National Health Service Hospitals Trust Pharmacy department.

b No cost incurred for counselling because counsellors attend as part of a training programme organised by Southampton University.

N/A = not applicable.



scribing for ED treatments in primary care in-creased from approximately £8000 per month atthe time of the original review to £18 000 permonth at the end of the first year following theintroduction of the DoH guidance. During this pe-riod there was also a shift away from using al-prostadil towards using sildenafil, indicating thatmany patients originally treated with alprostadilchanged to sildenafil over the course of the year.This shift towards the use of sildenafil in estab-lished alprostadil users has also been reported intwo recently published studies.[5,6] The trend in theoverall prescribing budget for ED treatment inPortsmouth and South East Hampshire followingthe introduction of sildenafil is consistent with na-tional figures published by the DoH.[7]

The overall cost of ED services in Portsmouthand South East Hampshire for the first year followingthe introduction of the DoH guidance was £232 619based on secondary-care activity costs and prescrib-ing costs in both primary and secondary care, andis similar to the expenditure in 1998–1999 upliftedusing the HCHS pay and price inflation index to1999–2000 values of £225 108. Although theHCHS pay and price inflation index reflects thelevel of increased investment agreed nationally tomaintain health services it does not mean that allservices require or receive this level of investment.

Thus this index can be used as a proxy of the in-crease in service costs necessary to maintain thatservice between 1998–1999 and 1999–2000, al-though the service may not have received this ac-tual level of investment.

Whereas the increase in prescribing costs in pri-mary care have had a direct and immediate impacton local prescribing budgets, the savings resultingfrom reduced specialist-care activity need furtherconsideration. These potential savings are onlyreal if they can be realised and used to counter theincreased prescribing costs in primary care. Thisrequires local initiatives such as renegotiating ser-vice contracts in the light of the reduced need forspecialist-care referrals, although in reality suchrenegotiation to release cost savings may not bepossible. An alternative approach would be to re-allocate the time previously used by specialist pro-

Table IV. Outpatient activity and costs for erectile dysfunction (ED) services in Portsmouth and South East Hampshire Health Authority,1999–2000a

Outpatient clinic Number ofnew patientsattending clinic

Cost for each newpatient episode or perface to face contact (£)

Average number ofappointments where costbased on total number offace to face contacts

Cost incurredfor outpatientattendances(£)

Cost of drugtreatmentprescribed atoutpatient clinic (£)

Total costfor clinic (£)

Genitourinarymedicine

47 Nilb 6 Nil Nil Nil

Family planning 43 18 for each face toface contact

6 4644 Nil 4644

Urology 84 168 per new patientepisode

N/A 14 112 3813 17 925

Diabetic 27 328 per new patientepisode

N/A 8856 465 9321

Total 201 27 612 4278 31 890

a Sources: Outpatient activity data supplied by secondary-care ED clinics. Finance department, Portsmouth and South East HampshireHealth Authority. Portsmouth National Health Service Hospitals Trust Pharmacy department.

b No cost incurred for counselling because counsellors attend as part of a training programme organised by Southampton University.

N/A = not applicable.

Table V. Primary-care prescribing costs for erectile dysfunctiontreatments in Portsmouth and South East Hampshire Health Au-thority, July 1999–June 2000a

Drug Total cost (£)

Alprostadil (all forms) 49 710

Sildenafil 140 989

Other 2030

Total 192 729

a Source: Prescribing Analysis and Cost (PACT) data 2000 ob-tained from the Prescription Pricing Authority.



viders to assess all men in the district with ED thatis freed up as a result of the shift from specialist toprimary-care assessment. This would allow bothrapid access for those men with ED and with com-plex co-morbid states that need to see a specialistbefore commencing treatment, and should also freeup clinic time to reduce outpatient waiting lists andwaiting times for other patients referred to thosespecialities for non-ED related conditions. Al-though this approach makes it difficult to realisecash savings that can be used to counter increasedprimary-care prescribing costs the local healtheconomy gains overall from the improved accessto secondary-care specialists and the more efficientand appropriate use of specialist time.

Specialist-care costs were considered becauseof the possibility of freeing up any savings eitherin terms of money released or as time that could beused for other activities. Because no such arrange-ment exists in primary care, no consultation costanalysis was undertaken. No assessment has beenmade to establish whether the introduction of theguidance has resulted in any increase in workloadin primary care, but it would seem likely that thereduction in specialist referrals is a direct result ofmore assessments being carried out in primarycare.

No sensitivity analysis was undertaken in thisproject to assess the consequences of uncertainty

in the cost calculations for several reasons. Theprescribing costs obtained were aggregated costs,rather than patient specific, so that cost variance atan individual level was not available. This aggre-gated figure as provided by the PPA was consid-ered accurate and appropriate for the purpose ofthis project. Any parameters for sensitivity analy-sis would have been arbitrary rather than based onany available information, and would have beeninappropriate. In the same way, specialist-care ac-tivity data were considered accurate for the pur-pose of this project and sensitivity analysis was notconsidered to be necessary.

The Health Authority tariffs used to calculateoutpatient attendance costs were unit costs appli-cable to each new attendance, rather than patient-specific costs. Although clearly if outpatient tariffswere altered the total costs would change, sensitiv-ity analysis was not considered necessary becausethe tariffs used were unit costs set by the sameHealth Authority using the same formula over 2consecutive years, and no inter-patient cost vari-ance data were available. However, if the outpa-tient tariffs of different Health Authorities werebeing used, where unit cost variance could be es-tablished, then it would have been appropriate tocarry out a sensitivity analysis.

This study has taken a pragmatic approach toevaluating the financial impact of introducing the

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Fig. 1. Primary-care unadjusted monthly prescribing costs forerectile dysfunction treatments in Portsmouth and South EastHampshire, 1998-2000 (source: Prescribing Analysis and Cost(PACT) data from Prescription Pricing Authority).

0100200300400500600700

GUmedicine

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Urology Diabetic Total

Secondary care provider

No.

of p

atie

nts

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Fig. 2. New patients with erectile dysfunction (ED) attendingsecondary-care providers in 1998–1999 and 1999–2000(source: outpatient activity data supplied by secondary-care EDclinics). GU = genitourinary.



DoH guidance on prescribing for impotence inPortsmouth and South East Hampshire. The find-ings not only reflect the guidance but also the localapproach taken to introduce them. The findings re-flect the first year’s experience following the in-troduction of the DoH guidance. Local data on theimpact of patients being referred with severe dis-tress as a result of their ED is limited and may beunder-represented in our data. A major concern isthat the demand placed on the service may increaseover time because of an increasing number of pa-tients being referred in this category because theydo not fall into the DoH eligibility criteria. A fur-ther concern is that our data suggest that only asmall number of men with ED were being referredfor assessment prior to the introduction of the DoHguidance, and it is possible that the number of menin eligible groups requesting NHS treatment mayrise as a result of the availability of sildenafil.

Conclusion

This project has demonstrated that the DoHguidance has effectively reduced the specialist-care activity in Portsmouth and South East Hamp-shire. This offers the potential for financial savingsas a result of reduced specialist-care activity thatcould offset the increase in primary-care prescrib-ing costs observed, and contain ED service costs.However, realising these potential savings can beextremely difficult and it may be more appropriate

to re-allocate clinic time in specialist care for otherclinical activities.

Acknowledgements

The project was devised by MS with MAK. MS providedleadership during the first phase of the project. MAK col-lected, collated and analysed the data and prepared the manu-script for submission. MAK, MS, BW, SH, SR, and MHCdeveloped the local prescribing guidelines and referral path-ways that were adopted in Portsmouth. BW, SH, SR andMHC provided data from their respective clinics and advisedand commented on the analysis of the data. MS, BW, SH,SR, and MHC all made contributory comments on the manu-script. MHC provided leadership during the second phase ofthe project and during the preparation of the manuscript.

The authors would like to thank Dr V. Harindra forsupplying data on attendances at the genitourinary medicineclinic.

MAK had no links with the pharmaceutical industryduring the time this work was carried out. Subsequent to thiswork he has acted as an adviser to Pfizer. MS, BW and SRhave no interests with the pharmaceutical industry. SH actsas an adviser to Lilly Icos and to Abbott. Declared interestsfor MHC are Pfizer-sponsored lectures, attendances at inter-national meetings and funding departmental developmentsupport.

References1. NIH Consensus Development Panel on Impotence. Impotence.

J Am Med Assoc 1993; 270: 83-902. Department of Health. Treatment for impotence. London: De-

partment of Health, 1999 (HSC 1999/115)3. Ashton-Key M, Cummings MH, Walmsley B, et al. The finan-

cial impact of a shift towards primary care management oferectile dysfunction in the portsmouth district. Oral Presenta-tion, British Society for Sexual and Impotence Research/Im-potence Association Conference; 2000 Mar 8-9; London

Table VI. Costs incurred in primary and secondary care for erectile dysfunction in Portsmouth and South East Hampshire Health Authority,1998-1999 and 1999-2000a

Annual costs (£)

1998-1999 (in 1998-1999 values) 1998-1999 (uplifted to 1999-2000valuesb)

1999-2000 (in 1999-2000values)

Secondary-care outpatientattendances

100 538 103 252 27 612

Secondary-care prescribing 16 390 16 833 4278

Primary-care prescribing 94 262 96 807 192 729

Penile implants 8000 8216 8000

Total 219 190 225 108 232 619

a Sources: Outpatient activity data supplied by secondary-care ED clinics. Finance department, Portsmouth and South East HampshireHealth Authority. Portsmouth NHS Hospitals Trust Pharmacy department. Prescribing Analysis and Cost (PACT) data obtained fromthe Prescription Pricing Authority.

b 1998–1999 costs uplifted to 1999–2000 values using the Hospital and Community Health Services pay and price inflation index.[4]



4. Netten A, Curtis L. Unit costs of health and social care 2000[online]. Available from URL: www.ukc.ac.uk/pssru/ [Ac-cessed 2002 May 20]

5. Hatzichristou DG, Apostolidis A, Tzortzis V, et al. Sildenafilversus intracavernous injection therapy: efficacy and prefer-ence in patients on intracavernous injection for more than 1year. J Urol 2000; 164: 1197-200

6. Giuliano F, Montorsi F, for the Sildenafil Multicenter StudyGroup. Switching from intracavernous prostaglandin E1 in-jections to oral sildenafil citrate in patients with erectile dys-function: results of a multicenter European study. J Urol 2000;164: 708-11

7. Department of Health. Consultation on the current statutoryframework for the treatment of impotence on the NationalHealth Service by GPs. London: Department of Health, 2000

Correspondence and offprints: Dr Martin Ashton-Key,Brighton and Hove City Primary Care Trust, Vantage Point,6th Floor, New England Road, Brighton, BN1 4GW, En-gland.E-mail: [email protected]



Documents

UK Department of Health Guidance on Prescribing for Impotence Following the Introduction of Sildenafil