Assessment, Pricing of Pharmaceuticals in France
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Transcript of Assessment, Pricing of Pharmaceuticals in France
Dr. François MeyerDirector, Healthcare Products and Procedures Assessment
Haute Autorité de santé
AIFA March 2007
Assessment, Pricing of Pharmaceuticals in France
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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
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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
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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
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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
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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)
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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
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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%
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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%
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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
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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
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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
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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
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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
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www.eunethta.net
Thank You
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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
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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
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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 …
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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