81
INNOVATION COMMERCE - YOUR BLUEPRINT FOR SUCCESS ENABLING BETTER HEALTH FROM IDEA TO REVENUE ENABLING BETTER HEALTH FROM IDEA TO REVENUE INNOVATION COMMERCE - YOUR BLUEPRINT FOR SUCCESS www.qmed-consulting.com

INNOVATION ENABLING COMMERCE - BETTER HEALTH … · BLUEPRINT FOR SUCCESS ENABLING BETTER HEALTH FROM IDEA TO REVENUE ... Hospital Payer ... Membership (Invoices, assumption of costs)

  • Upload
    vuphuc

  • View
    217

  • Download
    0

Embed Size (px)

Citation preview

INNOVATION

COMMERCE -YOUR BLUEPRINTFOR SUCCESS

ENABLING BETTER HEALTH

FROM IDEA TO REVENUE

ENABLING BETTER HEALTH FROM IDEA

TO REVENUE

INNOVATION

COMMERCE -YOUR BLUEPRINT

FOR SUCCESS

www.qmed-consulting.com

©2013 Qmed Consulting

Part 1:

Introduction to medical device EU funding and reimbursement -What is reimbursement?

Part 2:

Review of Germany, France, UK and Spain´s healthcare systems by Stephan Heumann

©2013 Qmed Consulting

The Fourth Hurdle

Reimbursementor

Funding

Market Authorisation (CE Mark) Fourth Hurdle forMarket Access

Safety EfficacyQuality

The fourth hurdle

Regulatory StrategyDesign Phase

©2013 Qmed Consulting

Major Global Themes

Major markets are struggling with rising health care costs

Politicians say “STOP, we want more economic treatment”

Health systems are looking closely at new (and sometimes old) technologies before they’ll decide to reimburse

The demands for evidence (clinical and cost effectiveness) are increasing

- The most significant issues arise with new technologies

©2013 Qmed Consulting

Demand for Evidence

Document the effectiveness of the technology by e.g.:

• Improved quality of life

• Reduced length

of stay (LOS)

• Reduced procedure

time

• Less traumatic

treatment for the patient

• The patient can

return quickly to

daily activities 0

200000

400000

600000

800000

1000000

1200000

Old technology New technology

Cost savings

Cost of complications

Cost of treatment

Length of Stay

©2013 Qmed Consulting

What is Reimbursement?

”Reimbursement” ≠ ”Funding”

”Reimbursement” is about how healthcare providers are paidfor the services they provide:

No Reimbursement = No Payment To Provider

”Reimbursement” varies from country to country and someplaces from healthcare plan to healthcare plan

Hvad er reimbursement?

©2013 Qmed Consulting

What is Reimbursement?

Hvad er reimbursement?

DRG = Diagnosis Related Groups

HCFA-DRGUS 1983

Yale-DRGUS 1977

HCFA-DRGItaly 1995

Australia-DRG1992

D-DRGGermany 2003

Nord-DRGScandinavia 1996

GHMFrance 1986/99

HRGUK 1991/2003

©2013 Qmed Consulting

What is DRG?

DRG = Diagnosis Related Groups,

Categorization of patients

Requirements:- Clinically meaningful

Discharges (or visits) that are clinically somehow alike – both diagnosis and

treatment

- Resource homogeneousThe discharges (visits) have to cost fairly the same

- Not too many groups (average), normally 500-1.000 groups/country, applied in different ways

Only a few discharges give high uncertainty when average costs are

calculated

©2013 Qmed Consulting

What is Reimbursement? – Markers in the DRG System

Hvad er reimbursement?

DRG

Diagnosis (ICD)

Procedure

Complications

Gender, <18 y. and co-morbidities

Status at Discharge

Length of stay

©2013 Qmed Consulting

Summary

”Reimbursement” is about how the ”provider” is paid by the ”payer” for the services they deliver

”Reimbursement” varies from country to country

DRG ⇒ Payment of a predetermined lump sum paid to “provider" by the "payer"

DRG = diagnosis code + procedure code + othersDiagnosis code = ICD-kode, International Classification of Diseases, publicated by WHO

Procedure code, varies from country to country

Others, e.g. LOS, complications, co-morbidities

©2013 Qmed Consulting

Summary

The payment covers the full consumption of resources during hospitalization (ward, personnel, devices, medicine, radiology, operating room, etc.)

Some healthcare systems have ”pass-through” systemer ⇒additional payment for some medical devices.

©2013 Qmed Consulting

Stephan Heumann

- Qmed Commercial Healthcare Expert

- Responsible for Qmed’ reimbursement projects

- Experience from international hospital systems

- Commercial experience, medical devices

Review of Germany, France, UK and Spain´s healthcare systems by Stephan Heumann

©2013 Qmed Consulting

Qmed Consulting ApS

Ørnevej 2 • 4600 Køge

TEL.: +45 65 64 10 10Mail: [email protected]

www.qmed-consulting.com

1 ©2013 Solve2Access, All rights reserved 1 ©2013 Solve2Access, All rights reserved

Go-home-meeting:

Medical device reimbursement systems in the EU Medicoindustrien and Medico Innovation

Wednesday, November 27, 2013, Lyngby, Denmark

Presented by: Stephan Heumann, Founder of solve2access and Commercial Healthcare Expert at QmedConsulting

2 ©2013 Solve2Access, All rights reserved 2

Solve2Access Holding B.V – Member of the Global Alliance Team

Sung koo Tompot Stephan Heumann

“”We help medical companies to demonstrate the value of their products, develop market access and increase sales””

Making a difference with a long history in the healthcare sector. We have extensive knowledge & experience in reimbursement, clinical and economic evidence and HTA strategies. Helping companies to implement the right strategy to access the market with their product is our goal.

We are Commercial Healthcare Experts at QmedConsulting

3 ©2013 Solve2Access, All rights reserved 3 3 ©2013 Solve2Access, All rights reserved 3

The healthcare market is evolving

Ageing population demanding solutions

High rate of innovation

and product launches

Pressure of Health Care

budget constraints Economic trend

Social trend

Innovation trend

4 ©2013 Solve2Access, All rights reserved 4 ©2013 Solve2Access, All rights reserved

Barriers for medical innovation

EVIDENCE

VALUE

REIMBURSEMENT

MARKET

Revenues from

customers

Medical products

5 ©2013 Solve2Access, All rights reserved 5 ©2013 Solve2Access, All rights reserved

Become opportunities for companies

6 6

Different markets require specific actions

Germany England

France Italy Spain

7 ©2013 Solve2Access, All rights reserved 7

Reimbursement as a part of the Market Access Strategy

Market Access = CE Mark or AHRQ approval + HTA process + Reimbursement

Market Access is the process in which a company brings a medical product to market which becomes available for patients. Access is defined as a patient's ability to obtain medical care. There is a process to get the allowance to use a product on a market (CE Mark, AHRQ, etc.)

Because of the limited budgets in each country, HTA bodies approve on a national level if the

treatment, device or drug should be covered for reimbursement

If the product has the permission to be used, someone has to pay for it

Reimbursement is necessary, but not for all products

8 ©2013 Solve2Access, All rights reserved 8

Why does it make sense to think about the different reimbursement requirements?

Different countries requires different market access keys

General EU or country specific laws and regulations for medical devices EC Directive 93/42, 98/79, 90/385 EEC etc. Medizinproduktegesetz (MPG; Germany), Dänemark?

Country specific HTA (Health Technology Assessment) HAS France, GBA Germany, NICE England, AHRQ USA, mini HTA Denmark (no national HTA anymore) etc.

Country specific reimbursement G-DRG and EBM Germany HRG and Drug Tariff list England Swiss DRG DK-DRG

9 ©2013 Solve2Access, All rights reserved 9

Why does it make sense to think about the different reimbursement requirements?

The huge one US market vs.

The different EU markets

All markets have

different requirements for accessing the market

10 ©2013 Solve2Access, All rights reserved 10 ©2013 Solve2Access, All rights reserved

What is Reimbursement?

• For Medical Device- and Pharma companies there is no automatisms to get reimbursement after CE-market

• New products can fit into existing or it is necessary to apply for new reimbursement or there will be no reimbursement

Reimbursement is an act of compensating someone for an expense

Examinations, diagnostics, treatments Medical Devices, drugs, disposables Medical infrastructure Capital sales devices Physiotherapy, speech therapy,

occupational therapy Etc.

Patient

Physician Hospital

Payer Insurance

State, Government, Country

Membership (Invoices, assumption of costs)

Fun

din

g Rep

ort

Payment way Service way

Supply of products

What can be reimbursed?

There might be some reimbursement limits, analysis needed!

11 ©2013 Solve2Access, All rights reserved 11 ©2013 Solve2Access, All rights reserved

Different elements of Reimbursement

• Reimbursement via HTA ( Health Technology Assessment)

• Reimbursement via DRG (Diagnostic Related Groups)

12 ©2013 Solve2Access, All rights reserved 12 ©2013 Solve2Access, All rights reserved

Economic + Clinical Evidence = Reimbursement

• Decisions on the use of technology are made at all levels in the health care system. They often include a unification of complicated medical, patient-related, organizational and economic information in a context where there may also be ethical problems. …

• Decisions must be made on an evidence-based foundation where all relevant circumstances and consequences are systematically illustrated by means of scientific methods.

13 ©2013 Solve2Access, All rights reserved 13 ©2013 Solve2Access, All rights reserved

HTA Process in Germany - What is the GBA?

• The Federal Joint Committee (G-BA) is the highest decision-making body of the joint self-government of physicians, dentists, hospitals and health insurance funds in Germany.

• It issues directives for the benefit catalogue of the statutory health insurance funds (GKV) for more than 70 million insured persons and thus specifies which services in medical care are reimbursed by the GKV. In addition, the G-BA specifies measures for quality assurance in inpatient and outpatient areas of the health care system.

14 ©2013 Solve2Access, All rights reserved 14 ©2013 Solve2Access, All rights reserved

HTA process in Germany

• The GBA delegates assessments for new treatments/therapies to the IQWIG institute. The IQWIG institute will provide recommendations to the GBA regarding those assessments. The GBA will make a decision with the body of the joint self-government organization in which each may provide comments after which the GBA makes a final decision.

Federal Joint Committee (GBA)

Initiation of advise

Consultation

Review of plausibility

Exploitation of the results

Decision

Implementation of

the guidelines

Scientific question

Research and evaluation of scientific

materials (Studies)

Result

order

Institute for Quality and Efficiency in Health Care

(IQWIG)

Results

15 ©2013 Solve2Access, All rights reserved

Assessment and reimbursement of medical devices in Germany

16 ©2013 Solve2Access, All rights reserved

17 ©2013 Solve2Access, All rights reserved 17 ©2013 Solve2Access, All rights reserved

What should not happen in a publication?

What kind of costs? - Doctor time - Nurse time - Treatment time - Operation time - Intensive care unit time - Materials - … - Compare to what other

treatment method

It is important to demonstrate the value of your product to get it reimbursed in the entire treatment process / clinical pathway

The cost of pressure ulcers in the UK, GERRY BENNETT, CAROL DEALEY, JOHN POSNETT, Age and Ageing 2004; 33: 230–235, DOI: 10.1093/ageing/afh086, Age and Ageing Vol. 33 No. 3 British Geriatrics Society 2004; all rights reserved

18 ©2013 Solve2Access, All rights reserved 18 ©2013 Solve2Access, All rights reserved

Is the evidence to obtain CE mark sufficient to achieve market access or reimbursement?

Functionality Safety Risk assessment

Medical necessity Therapeutic benefit Economic benefits

19 ©2013 Solve2Access, All rights reserved 19 ©2013 Solve2Access, All rights reserved

Different elements of Reimbursement

• Reimbursement via HTA ( Health Technology Assessment)

• Reimbursement via DRG (Diagnostic Related Groups)

20 ©2013 Solve2Access, All rights reserved 20 ©2013 Solve2Access, All rights reserved

DRG’s in general!

Side diagnosis

Side diagnosis

Side diagnosis

Side diagnosis

Age

Gender

Ventilation hrs.

Birth weight*

Main diagnosis

Procedure

Procedure

Patient exit reason (normal, died, transferred)

The combination of these components lead into hundred sometimes more then thousand different DRGs. Your product can be classified into an ICD or Procedure code and may lead into a higher reimbursement/DRG.

21 ©2013 Solve2Access, All rights reserved 21 ©2013 Solve2Access, All rights reserved

Nordic DRG

22 ©2013 Solve2Access, All rights reserved 22 ©2013 Solve2Access, All rights reserved

Reimbursement Analysis – example NORD DRG

23 ©2013 Solve2Access, All rights reserved 23 ©2013 Solve2Access, All rights reserved

Reimbursement Analysis – example NORD DRG

With a click in the different boxes you get more information's about the procedures and diagnosis which guide into the different DRGs

24 ©2013 Solve2Access, All rights reserved 24 ©2013 Solve2Access, All rights reserved

Reimbursement Analysis – example NORD DRG

Diagnosis

25 ©2013 Solve2Access, All rights reserved 25 ©2013 Solve2Access, All rights reserved

Reimbursement Analysis – example NORD DRG

Procedures

26 ©2013 Solve2Access, All rights reserved 26 ©2013 Solve2Access, All rights reserved

Reimbursement Analysis – example NORD DRG

Clinical Pathways

27 ©2013 Solve2Access, All rights reserved 27 ©2013 Solve2Access, All rights reserved

Reimbursement Analysis – example NORD DRG

These information's / data's show us, in which North DRG medical devices, pharmaceuticals and clinical pathways are reimbursed or can be reimbursed in the future. When it is identified, where your product should be placed, it is possible to apply for reimbursement via the North DRGs. It is an complex process and you need to have:

- An understanding where your product is placed in the treatment process / Nord DRG process

- A strategy where it could be placed in the future - An understanding of the diagnosis and procedure codes

application process - An understanding of the cost calculation process - Strong evidence to apply for reimbursement - An network which will make it happen

28 ©2013 Solve2Access, All rights reserved 28 ©2013 Solve2Access, All rights reserved

NORD DRG timelines 2013-2014

http://www.norddrg.net/NordDRG_2015_Timetable.pdf

It is important to understand the total reimbursement application process when developing a Market Access Strategy to achieve reimbursement for new products leading to revenues from the customers.

29 ©2013 Solve2Access, All rights reserved 29

Germany

30 ©2013 Solve2Access, All rights reserved 30 ©2013 Solve2Access, All rights reserved

Germany

• Decentralized health insurance system – A health insurance is mandatory for any German person (public or private)

– Medical devices funded via medical procedure (DRG payment), additional remuneration (Zusatzentgeld, ZE) or different post acute tariff lists (GOÄ, EBM, etc.).

31 ©2013 Solve2Access, All rights reserved 31 ©2013 Solve2Access, All rights reserved

Main reimbursement options Medical devices

Hospital / Acute

DRG Investment Capital

by federal state Hospital Budget

OPS, ICD Application by

Hospital Hospital board

decision

Ambulant / post acute

EBM / GOÄ tariff

Consumables list

Different remuneration lists

for therapists

Consumables list

32 ©2013 Solve2Access, All rights reserved 32 ©2013 Solve2Access, All rights reserved

Side diagnosis (ICD)

Side diagnosis (ICD)

Side diagnosis (ICD) Side diagnosis (ICD)

Age Gender

Ventilation hrs. Birth weight*

Main diagnosis (ICD)

Procedure (OPS)

Procedure (OPS)

Patient exit reason (normal, died, transferred)

- Over 1,200 different DRG’s in Germany in 2013 - The InEK institute calculates every year a new

catalogue - Solve2Access has direct contact to one of the decision

makers

Grouping Process – opportunities for Reimbursement

*only for children

- Thousands of different diagnosis (ICD) and procedures (OPS) codes

- DIMDI institute is organizing the application process for new ICD and OPS codes

- Solve2Access has two direct contacts at DIMDI

- The whole process (DIMDI) of new ICD and OPS code compared with the reimbursement (InEK) is controlled by the GBA (joint federal committee), which is responsible for the HTA (Health Technology Assessment) process in Germany. GBA will allow and forbid new treatment options, check the existing ones, and decide who should pay-

Reimbursement pathway and timelines for Germany

What does Reimbursement mean?

or / and

or / and

Which reimbursement pathway you take could be different for

each of the Verathon products. It could also be, that there will be

no special reimbursement

34 ©2013 Solve2Access, All rights reserved 34

Reimbursement example

Patient: Max Mustermann Age: 47 years Lenght of stay: 30 days

Baserate: 3.068.37 €

Reimbursement example 1.0

Diagnosen

Maindiagnosis: L03.10 Phlegmon of the upper extremity

Sidediagnosis: M72.65 Necrotizing fasciitis: pelvic region and thigh [pelvis, femur, hip, sacroiliac joint]

35

Reimbursement example 1.0

Procedures:

OPS: 5-916.a1 Temporary soft tissue cover: installation or change of a system for NPWT Reaching deep, subfascial, or the bones and joints of the extremities 5-850.d8 Incision of muscle, tendon and fascia: debridement of fascia: thigh and knee

8-190.21 Special bandaging techniques: Continuous negative pressure with pump system with a NPWT: 8 to 14 days

36

4x an 4 verschiedenen Tagen

3x an 3 verschiedenen Tagen

1x pro stationären Aufenthalt

Reimbursement example 1.0

37

Result:

DRG: J22B Other skin graft or debridement without complex operation, without complex diagnosis, without extremely severe or severe CC, without soft tissue coverage

eff. Cost Weight: 2.122

eff. Reimbursement: 6.511.08 €

Reimbursement example 2.0

Diagnosen

Maindiagnosis : M72.65 Necrotizing fasciitis: pelvic region and thigh [pelvis, femur, hip, sacroiliac joint]

Sidediagnosis: L03.10 Phlegmon of the upper extremity

38

Reimbursement example 2.0

39

Procedures:

OPS: 5-916.a1 Temporary soft tissue cover: installation or change of a system for NPWT Reaching deep, subfascial, or the bones and joints of the extremities

5-850.d8 Incision of muscle, tendon and fascia: debridement of fascia: thigh and knee

8-190.21 Special bandaging techniques: Continuous negative pressure with pump system with a NPWT: 8 to 14 days

4x an 4 verschiedenen Tagen

3x an 3 verschiedenen Tagen

1x pro stationären Aufenthalt

Reimbursement example 2.0

40

Result:

DRG: I22B Tissue / skin grafting, except by the hand, with a small area or the tissue transplantation with extensive tissue transplantation without complications, without treatment at several local., without soft tissue damage, without compl. tissue transplantation, with complications

eff. Cost Weight: 2,775

eff. Reimbursement: 8.514,73 €

Reimbursement example 3.0

41

Prozeduren

OPS: 5-916.a1 Temporary soft tissue cover: installation or change of a system for NPWT Reaching deep, subfascial, or the bones and joints of the extremities 5-850.d8 Incision of muscle, tendon and fascia: debridement of fascia: thigh and knee

8-190.21 Special bandaging techniques: Continuous negative pressure with pump system with a NPWT: 8 to 14 days

4x an 4 verschiedenen Tagen

4x an 4 verschiedenen Tagen

1x pro stationären Aufenthalt

Reimbursement example 3.0

42

Resultat

DRG: I98Z Komplexe Vakuumbehandlung bei Krankheiten und Störungen an Muskel-Skelett-System und Bindegewebe

eff. Kostengewicht: 6.147

eff. Erlös: 18.861.27 €

43

Review period

To achieve Reimbursement it could take time. Depending on where you are in the process! (Example Germany)

Reimbursement application ICD / OPS application

Dec. year 0 – Feb. year 1 ICD & OPS

Application period

Jan. year 2 Official ICD / OPS

catalog

March year 3 reimbursement

application time ends for the following year

Dec. year 3 reimbursement

approval and Announcement

for year 4

Jan. Year 4 Code + Reimbursement

Sep. - Oct. year 1 announcement of new ICD and

OPS codes

Total time period

Best case scenario: 13 month to get an

ICD or OPS code into the system

Preparing Influencers and decision makers to be successful with the first application: up to 20 months

Treatment + ICD / OPS documentation

Period to apply for Reimbursement for year 4

Calculation Period for year 4

Feb. year 3 reimbursement

application time ends If discussion period is needed

Data period for calculation y. 3

Best case scenario: 37 (44 incl. lobbying) months to get reimbursement from scratch

44 ©2013 Solve2Access, All rights reserved 44 ©2013 Solve2Access, All rights reserved

United Kingdom

45 ©2013 Solve2Access, All rights reserved 45 ©2013 Solve2Access, All rights reserved

United Kingdom -England

• England is the biggest country* of the United Kingdom** Centralized healthcare system for 90% funded via taxes

Care delivery coordinated by GPs who are grouped in GP practices, who are grouped into 211 clinical commissioning groups, which hold +/-80% of the total healthcare budget

*>80% of population of the United Kingdom lives in England ** England, Scotland, Northern Ireland and Wales form the United Kingdom

46 ©2013 Solve2Access, All rights reserved 46 ©2013 Solve2Access, All rights reserved

Overview of healthcare system (England)

Budget £80,000,000,000

211 Clinical Commissioning Groups

GPs GPs

Patient Patient Patient

Hospitals

Hospitals

Buy care

Buy care

Budgetholders Previous situation Situation 2013

GP practises

47 ©2013 Solve2Access, All rights reserved 47 ©2013 Solve2Access, All rights reserved

Main payment pathways

Hospital (acute care) Out patient facilities Home care (primary care)

Payment by Results - HRGs (DRG like system): • Payment system for treated/seen patients • Covers all patient costs • Covers capital expenditure

Drug Tariff: • List of medical devices, appliances and chemical reagents that can be

prescribed and dispensed in primary care

Local Tariff not covered by Payment by Results: • When not covered by Payment by Results • Negotiated between provider and commissioner • Flexibility in what is reimbursed

Block contracts: • Simple funding system for Payment/lump sum for a specific – usually broadly defined – service independent of number of

patients

HRG English DRG payment system

Payment system for hospital and out patient clinic care: • Includes capital investment costs •Coding for similar levels of NHS resource use

Are existing codes available that could be used? •Process takes 1 month to get confirmation

Process to apply for a new code: •Anybody can apply for a new code (companies, medical societies) •Application is at least 1 year until new code may be published •Another 3 years to set a tariff

Drug Tariff

Application until listing 3-6 months when: 1. Products are safe and of good quality 2. Appropriate for GP and nurse prescribing 3. They are cost effective It doesn’t mean that you make revenues when you are listed on the drug tariff list. You have to win tenders with your products.

50 ©2013 Solve2Access, All rights reserved

Key stakeholders for reimbursement Hospital setting (Inpatient & Outpatient)

Stakeholder Level of Influence Role

Physicians

Pharmacist

Clinical Engineer

Purchasing manager

Hospital management

Advocate for products

Advises on medical equipment and devices

Responsible for reimbursement

Influencer Decision-maker

Supervises and decides on purchases Has close relationship with manufacturers and is aware of new product launches

Decides on budget allocation

User’s opinion will be critical in the

decision to acquire a device

Nurses Input on ease of use

Advises on disposables Mostly focused on cost

Hospital management

51 ©2013 Solve2Access, All rights reserved

Key stakeholders for reimbursement Homecare setting

Stakeholder Level of Influence Role

Influencer Decision-maker

Local GPs

CSUs (Commissioning Support Unit)

Local Pharmacist

CCG Board

Prescribe treatments Influence the composition of local formularies Manage own practice budget (report to CCG board)

Advise CCG boards on the choice of treatments offered locally (cost-effectiveness perspective)

Responsible for reimbursement

Makes purchasing decisions Negotiates prices

Decide on what treatments are offered locally Responsible for managing local budget

Nurses Advocate for wound care products Input on ease of use

CCGs

Secondary care ‘experts’ (e.g. plastic surgeons)

Advise CCG boards on the choice of treatments offered locally (clinical perspective)

52 ©2013 Solve2Access, All rights reserved 52 ©2013 Solve2Access, All rights reserved

Key success factors for reimbursement

Clinical Evidence

•Good high quality clinical evidence (methodologies, size of study, bias, etc.)

•Quality Adjusted Life Years

•Stakeholder involvement

•Review and implementation in the clinical guidelines

•Recommendation by NICE

Economic benefit

•Value for money

•Specific requirements to data collection

•Strong Health Economic Methodology

•QALY threshold of 30,000 GBP per life year gained

Medical Societies

•Create initial traction with technology use

•Strong initial support and continuous follow-up

•Consolidation of message to authorities

53 ©2013 Solve2Access, All rights reserved 53 ©2013 Solve2Access, All rights reserved

France

54 ©2013 Solve2Access, All rights reserved 54 ©2013 Solve2Access, All rights reserved

France

• Centralized system, funded by the National Healthcare Insurance – Care delivery coordinated by 22 regional healthcare agencies (ARS)

– Medical devices funded by medical procedure (DRG payment) or positive list (LPPR), depending upon care setting

55 ©2013 Solve2Access, All rights reserved 55 ©2013 Solve2Access, All rights reserved

GHS: French DRG payment system

• Expenditure of product typically integrated into hospital services – Hospitals must accept that product will reduce costs

– Health Economics play important role to demonstrate benefits

• Medical Societies can apply for new procedure codes – Specific payment must be negotiated separately

– Long and complex process, taking usually 2 to 3 years

– Demands intense follow-ups with Societies and authorities

– Benefit for authorities: control of the use of technology

56 ©2013 Solve2Access, All rights reserved 56 ©2013 Solve2Access, All rights reserved

LPPR: List of reimbursable products and services

• Considers the product and the required service for proper use – Evaluation period around 1 year (published 6 months)

• Complementary nature: additional funding for product

• Inclusion by generic name: easy access, lower payment

– Type of product according to its indications and technical specifications without mentioning the brand name or company

– No formal evaluation

• Inclusion by brand name: complex access; higher payment

– Innovative and/or high-cost products

– Reimbursement dossier evaluated by the CNEDiMTS

– Authorities always intend to shift products into the generic name

57 ©2013 Solve2Access, All rights reserved 57 ©2013 Solve2Access, All rights reserved

Key reimbursement decision-makers

•National Health Authority

•Commission of Evaluation of Medical Devices and Health Technologies (CNEDiMTS)

•Major decision-maker, regulates the healthcare market

•Provides scientific evaluations and recommendations

•Contact via Medical Societies

HAS

•National Union of Health Insurance Funds

•Defines the scope of procedures eligible for reimbursement and their tariffs

•Relies on scientific opinion from the CNEDiMTS

•Requires economic dossier with proposed price and estimated economic impact

UNCAM

•Economic Committee for Health Products

•Determines the tariff associated with new products

•Relies on scientific opinion from the CNEDiMTS

•Requires economic dossier with proposed price and estimated economic impact

CEPS

58 ©2013 Solve2Access, All rights reserved

Spain

59 ©2013 Solve2Access, All rights reserved 59 ©2013 Solve2Access, All rights reserved

Spain

• Fragmented system, funded by the National Healthcare System

– Each of the 17 regions have autonomy to allocate their healthcare budget

– DRG system only used for statistical purposes; medical devices funded almost entirely from hospital/providers’ budgets

– Economic crisis has created strong pressure on regions to reduce healthcare expenditure

Spanish Health Care System

• “Sistema Nacional de Salud” covers all Spanish Citizens

– “Cartera de Servicios”: basic health care package

– Budget allocation to each Region as the Funding source

• DRG used only for statistical purposes, not payment

– National HTA Agency: ISCIII

• Regional Health Authorities have autonomy to decide how to use their budgets

– Main criteria: previous year’s expenditures

– May add extra coverage

– 6 Regional HTA agencies

• Independent Evaluations and Guidelines

– National decisions don’t affect Regions unless it is included in the basic health care package

Main Decision Makers

Institution Role

National Health Care System (SNS) •Sets minimum standards for Health Care •Allocates budget across regions •Regulates Health Care

Regional Health Authorities (RHA) •Allocate budget to Hospitals •May act as GPOs •6 Regions perform HTA

Public Hospitals •Allocate budget to Services •Negotiates budget with RHA •May act together as GPOs

Private Hospitals

•Manage P&L •Agreement with Public Hospitals •Contracts with Private Plans •Out-of-pocket payments

Health Care expenditures per Region

6 Regions account for approximately 2/3 of the total Health Care Budget

Source: Ministerio de Sanidad, Política Social e Igualdad

63 ©2013 Solve2Access, All rights reserved

Medical Device Pathway

Market Access Reimbursement /

Funding Pricing Purchasing

•CE Mark •HTA for National and Regional Health Services Portfolio

•Hospitals typically fund Medical Devices though Budget

•RHA and Hospitals may provide extra budget (very rare)

•Relationship is fundamental

•No National Pricing list

•Regional and Hospital negotiations with Manufacturers

•Individual and GPOs

•Hospitals purchase directly from manufacturers

•Tenders for amounts above € 18,000

Spain: Key take-aways

• Regions are independent from each other

• Fundamental to establish presence in both Primary and Specialized Care

• Tenders drive Budget allocation and, in the longer term, Reimbursement

• Addressing stakeholders before Tenders are published is key to success

65 ©2013 Solve2Access, All rights reserved

An Health Economic Model could help to have sales and to collect data while waiting for reimbursement

Present in this App: - Reduction of complications - Patient benefits - Benefits for the hospital - Cost savings for the payer - Etc.

66 ©2013 Solve2Access, All rights reserved 66 ©2013 Solve2Access, All rights reserved

When to start thinking about reimbursement?

In which part of the process are you with your new product?

You should know the realistic market size of your product

You should start to think about how to overcome Market Access hurdles. (Design Phase)

You should be in the process of assessing the Market Access for different countries

If you did not plan your Market Access strategy, it could be too late to achieve your revenue targets.

67

Summary and takeaways

Reimbursement is more then getting paid for a Medical Device (Market Access Strategy)

Reimbursement can be covered via DRG or via different Health Care Budgets

In which country to start first? Where are the early adopters?

It is necessary to start as early as possible with the Reimbursement Strategy, because it takes time to achieve reimbursement

It is absolutely necessary to assess the different market requirements to achieve reimbursement and to ensure that these needs can be addressed. (HTA process, Regulatory)

Depending on the product or method a project budget to achieve reimbursement is required

Do your reimbursement analysis as early as possible in your regulatory strategy

During the process it is necessary to answer the question: What value for money do the customers get

Thank You