Dr. François MeyerDirector, Healthcare Products and Procedures Assessment

Haute Autorité de santé

AIFA March 2007

Assessment, Pricing of Pharmaceuticals in France

2F. Meyer AIFA March 2007

Introducing a New Drug

Introducing a new drug in the healthcare system in France :

•1st step: Marketing authorization.

- Assessment : CHMP / EMEA / Afssaps

- Decision : European Commission / Afssaps

•2nd step: Introduction into national healthcare systems

- Assessment: « Health Technology Assessment »

Some common principles, many national specificities

- Decision: Country specific

- France : “Formulary” = Positive list of reimbursed drugs

3F. Meyer AIFA March 2007

European Medicines Agency /Afssaps benefit/risk assessment

European Commission /Afssaps : Marketing Authorization

Transparency Committee (TC): medical benefit, added value, importance for public health, target population

Healthcare Products Economic Committee: agreement / price -volumes

Public Price

Product Launch

Advertising Control

-Pharmacovigilance, Risk Management Plans- Observational Studies

Periodic Reassessment

Haute Autorité de santé

Ministre de la santé et de la SSMinister: inscription

Nat. Health InsuranceLevel of co-payment

Ag. Française de sécurité sanitaire des produits de santé

Medicinal Products in France

4F. Meyer AIFA March 2007

The HAS, new body created in 2005

BoardChair:

Prof. L. Degos7 committees Cabinet

Managing directorMr François Romaneix

Accredi-tation

Guidelines

Disease management

Healthcare procedures and Products Assessment

Information

Communi-cation

General secreta-riat

Practice appraisalCPD Accountancy

Network of experts and health professionals throughout France

HAS = French National Authority for Health, created 2005

Medical devices Drugs Diagnostic & therapeuticprocedures

IndustryTeaching hospitals - Health

professionals ± IndustryIndustry

Notified bodies

AFSSAPS1: - Competent authority- Post-market surveillance

EMEA2 /European commissionor AFSSAPS (National Agency)

Clinical studiesClinical studies

HTA :HTA : AssessmentAssessment of of clinical and societal clinical and societal value value

Coverage decisionCoverage decision

Ministry of Health • establishes list of reimbursable drugs and medical devices

UNCAM

• Establishes list of reimbursable procedures

1. AFSSAPS: French Health Products Safety Agency; 2. EMEA: European Medicines Agency; 3. CEPP: Committee for the assessment of medical devices; 4. CEAP: Committee for the assessment of diagnostic and therapeutic procedures; 5. CEPS: Committee for pricing and reimbursement of healthcare products (reports to the Ministry of Health, Industry and Finances); 6. UNCAM: Association of National Health Insurance funds

Introduction to Introduction to the marketthe market

PricingPricing

Economic Committee CEPS5

• fixes price of drugs and devices after negotiation with Industry

National Health Insurance Funds (UNCAM)6

• fixes reimbursement rate for drugs• fixes reimbursement tariffs and rates for procedures

after negotiation with Health Professionnals' Unions

HAS Specialised committees

Procedures:CEAP4

Drugs:Transparency committee

DevicesCEPP3

6F. Meyer AIFA March 2007

HAS internal assessors

HAS Transparency

Committee

+ Health Professionals

HAS opinion

Review of available data

Dossier from Pharma-ceutical

Company

“ ASSESSMENT ” “ APPRAISAL ”Literature

Ministry

Economic Committee

HTA procedures in France

Working Group for Public Health

7F. Meyer AIFA March 2007

Criteria for Drug Appraisal

HAS performs medicinal products appraisal according to criteria defined in French regulation

• cost-effectiveness assessment not part of the « legal » criteria

• SERVICE MEDICAL RENDU (SMR) = Actual Benefit 

- « Clinical benefit » • severity of the disease • clinical effectiveness

- « Benefit to Public Health » : • Impact on Health Status of the global population,

Impact on Healthcare organisation and/or Use of healthcare resources...

• AMELIORATION DU SMR (ASMR) Improvement in Actual Benefit

- Comparison to other existing therapies

- 4-level scale: from MAJOR improvement (ASMR I) to minor improvement (ASMR IV)

- No improvement over existing therapies : (ASMR V)

8F. Meyer AIFA March 2007

Criteria for Pricing

Criteria for drug pricing

• Pricing : Economic Committee for Healh Products = contract negociating committee.

• Strong link with appraisal results on added value

- no added value (ASMR V) : listed only if they bring some savings to the medial treatment

- added value (ASMR I to IV) : Price higher than comparators can be accepted

• Price/volumes agreement : Target population, as assessed by HAS, is taken into account.

• Innovative drugs : Price deposit instead of negotiation, faster access and « European » price guaranteed

• Incremenal progress taken into account : Price deposit open to Drugs with minor improvent of actual benefit. Pharmaco-economic studies: optional, only on a case by case basis

9F. Meyer AIFA March 2007

SMR: Actual Benefit

Actual Benefit of Drugs in 2005 and 2006

0

20

40

60

80

100

120

140

160

2006 2005 2006 2005 2006 2005 2006 2005

important moderate minor insufficient

EI

Ins

83%

5%3%

10% 6%3%

8%

82%

10F. Meyer AIFA March 2007

ASMR: Improvement in Actual Benefit

Improvement in Actual Benefit for Drugs

0

10

20

30

40

50

60

70

2006 2005 2006 2005 2006 2005 2006 2005 2006 2005 2006 2005

Major Important Moderate Minor None Not rated

EI

Ins

4%2%6% 11%

46% 43%

14% 14%18% 16%

12% 8%

11F. Meyer AIFA March 2007

From efficacy to effectiveness…From efficacy to effectiveness…

Efficacy

• explanatory trials

• highly selected populations

• comparator: often placebo

• outcomes: clinical, often surrogates, adverse effects

‘is the therapy effective’

Effectiveness

• pragmatic trials

• few exclusions

• comparator: ‘current (best) practice’

• outcomes: patient-focused, down-stream resources

‘real world added value’

Taylor R.S. Value in Health 2001;4:8-11

12F. Meyer AIFA March 2007

HAS opinions on Drugs

Content :

• Assessment of Actual benefit

• Assessment of Added value (Improvement in actual benefit)

• Target Population estimate

• Advice to Prescribers : place in therapy

• Limits of currently available data and Request for additionnal data collection

Availability

• www.has-sante.fr

• Information and communication

13F. Meyer AIFA March 2007

Time from Licensing to Reimbursement

Drugs can be made available before Marketing Authorisation

- products without MA : ATU, clincical trials

- Extension of indications : Temporary coverage (HERCEPTIN)

Usual procedure : Time from licensing to listing

• Time to application submission by Pharmaceutical Company

• Time of assessment by HAS

• Time of price negotiation and decision publicationLegal limit :

• Max. 180 days from dossier submission to decisionRecent trends

• Time for issuing HAS opinion reduced

• Average 2005: 150 days, 2006 100 days

• 65% in less than 90 days

• Innovative products : anticipated assessment, opinion issued within one month after licensing

• Possible access before licensing for innovative products in severe disease

14F. Meyer AIFA March 2007

Some Innovative Drugs

Drug Marketing Authorisation

Application Submission

Improvement in Actual Benefit

Final Opinion

Time to Final Opinion

X…neuro28/07/2005 03/08/2005 III – IV 25/10/2005 83 days

T…cancer 19/09/2005 27/10/2005 IV – V 20/03/200698 days

K…cancer 25/10/2005 20/12/2005 III 13/03/200683 days

N…cancer 19/07/2006 28/07/2006 II 22/09/2006 50 days

E…metab 28/08/2006 11/09/2006 II - III 9/10/2006 27 days

15F. Meyer AIFA March 2007

No of Drugs taken during the previous 7days

No of Visits / 12 months

No of visits without Drug prescription (out of 100)

December 2004, 1000 Patients and 250 GPs per country

France Germany Spain Netherlands

Drug prescription in France

16F. Meyer AIFA March 2007

www.eunethta.net

Thank You

18F. Meyer AIFA March 2007

French Healthcare System in a Nutshell

Unitary centralized state

NHI

• Mandatory, coverage for the entire population

• List of 30 ‘long term conditions’ with 100% coverage

- 13% of French population, 60% of expenses

Supplementary Health Insurance:

• 90 percent of the population subscribe to supplementary health insurance to cover other benefits not covered under NHI

Pharmaceuticals :

• Positive list of reimbursed products

• Supplementary insurance : 100% reimbursement rate for all listed drugs, no money to be paid to pharmacist in most cases

• Some recent delistings of ‘old’ products

19F. Meyer AIFA March 2007

French System in a Nutshell – Cont.

French healthcare organization

• Ambulatory care : dominated by solo-based, fee-for-service private practice

• Mix of public and propietary hospitals for acute institutional care

• Patients free to navigate and be reimbursed under NHI.

Pharmaceutical expenditure

• Percentage of total health care expenditureFrance > UK > Netherlands > Norway

• Per capita drug expenditure Highest level in Europe

20F. Meyer AIFA March 2007

Healthcare reform 2004

‘Health insurance system losing 23,000 € a minute’..

Healthcare reform 2004

• “to provide better care while spending less.”

• creation of HAS, independent scientific body

- HTA for drugs, medical devices, procedures

- clinical guidelines, DMP for long term conditions

- hospital accreditation, practice appraisal, CPD…

- improvement in Health Professionals and Public information

• National Union of Health Insurance Funds (UNCAM)

• Shared, computerized medical record

• Treating physician …

21F. Meyer AIFA March 2007

First results, perspectives

Results obtained :

• Antibiotics consumption : longstanding decrease in use

• Generics: end of the French exception ?

• Drugs delistings : not welcome but moreless accepted

Perspectives

• Self medication

• Rational use of pharmaceuticals

• Improvement in methodology of drugs assessment/appraisal

• Post marketing monitoring of drugs

- safety

- clinical and cost effectiveness

• Risk sharing

International cooperation

• EUnetHTA, Euroscan, HTAi, Nice-Iqwig-HAS cooperation…

• European Commission