Assessment, Pricing of Pharmaceuticals in France

1. Assessment, Pricing of Pharmaceuticals in France Dr. François MeyerDirector, Healthcare Products and Procedures AssessmentHaute Autorité de santéAIFA March 2007

2. 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 F. Meyer AIFA March 2007

3. Medicinal Products in France European Medicines Agency /Afssaps benefit/risk assessment European Commission /Afssaps : Marketing Authorization Ag. Française de sécurité sanitaire des produits de santé Transparency Committee (TC): medical benefit, added value, importance for public health, target population Haute Autorité de santé Healthcare Products Economic Committee: agreement / price -volumes Public Price Nat. Health Insurance Level of co-payment Minister: inscription Ministre de la santé et de la SS Product Launch Advertising Control • Pharmacovigilance, Risk Management Plans • Observational Studies Periodic Reassessment F. Meyer AIFA March 2007

4. The HAS, new body created in 2005 HAS = French National Authority for Health, created 2005 Board Chair:Prof. L. Degos 7 committees Cabinet Practice appraisalCPD Managing directorMr François Romaneix Accountancy Accredi-tation Guidelines Disease management Healthcare procedures and Products Assessment Information Communi-cation General secreta-riat Network of experts and health professionals throughout France F. Meyer AIFA March 2007

6. HTA procedures in France “ ASSESSMENT ” “ APPRAISAL ” Literature HAS opinion Ministry Economic Committee Review of available data Dossier from Pharma-ceutical Company • HAS Transparency Committee • + Health Professionals • HAS internal assessors Working Group for Public Health F. Meyer AIFA March 2007

7. 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) F. Meyer AIFA March 2007

8. 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 F. Meyer AIFA March 2007

9. SMR: Actual Benefit Actual Benefit of Drugs in 2005 and 2006 F. Meyer AIFA March 2007

10. ASMR: Improvement in Actual Benefit Improvement in Actual Benefit for Drugs F. Meyer AIFA March 2007

11. 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 F. Meyer AIFA March 2007

12. 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 F. Meyer AIFA March 2007

13. 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 publication • Legal limit : • Max. 180 days from dossier submission to decision • Recent 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 F. Meyer AIFA March 2007

14. Some Innovative Drugs F. Meyer AIFA March 2007

15. December 2004, 1000 Patients and 250 GPs per country Drug prescription in France France Germany Spain Netherlands No of Drugs taken during the previous 7days No of Visits / 12 months No of visits without Drug prescription (out of 100) F. Meyer AIFA March 2007

16. www.eunethta.net F. Meyer AIFA March 2007

17. Thank You

18. 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 F. Meyer AIFA March 2007

19. 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 F. Meyer AIFA March 2007

20. 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 … F. Meyer AIFA March 2007

21. 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 F. Meyer AIFA March 2007