Transcript PRISE EN CHARGE DU PATIENT ATTEINT DE MUCOVISCIDOSE

Assessment, Pricing
of Pharmaceuticals in France
Dr. François Meyer
Director, Healthcare Products and Procedures Assessment
Haute Autorité de santé
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
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Medicinal Products in France
European Medicines Agency /
Afssaps benefit/risk assessment
Ag. Française de sécurité
sanitaire des produits de santé
European Commission /Afssaps :
Marketing Authorization
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
Minister: inscription
Ministre de la santé et de la SS
Nat. Health Insurance
Level of co-payment
Product Launch
Advertising
Control
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-Pharmacovigilance, Risk
Management Plans
- Observational Studies
Periodic
Reassessment
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The HAS, new body created in 2005
HAS = French National Authority for Health, created 2005
Board
Chair:
Prof. L. Degos
7 committees
Practice appraisal
CPD
Accreditation
Managing director
Mr François Romaneix
Guidelines
Disease
management
Healthcare
procedures
and
Products
Assessment
Cabinet
Accountancy
Information
Communication
General
secretariat
Network of experts and health professionals throughout France
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Medical devices
Drugs
Diagnostic & therapeutic
procedures
Clinical studies
Industry
Industry
Teaching hospitals - Health
professionals ± Industry
Introduction to the market
Notified bodies
AFSSAPS1: - Competent authority
- Post-market surveillance
EMEA2 /European commission
or AFSSAPS (National Agency)
HTA : Assessment of clinical and societal value
HAS Specialised committees
Devices
CEPP3
Drugs:
Transparency committee
Procedures:
CEAP4
Pricing
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
Coverage 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
HTA procedures in France
Literature
“ ASSESSMENT ”
Review of
available data
Dossier from
Pharmaceutical
Company
HAS internal
assessors
“ APPRAISAL ”
HAS
opinion
Ministry
Economic
Committee
HAS Transparency
Committee
+ Health
Professionals
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. Pharmacoeconomic studies: optional, only on a case by case basis
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SMR: Actual Benefit
Actual Benefit of Drugs in 2005 and 2006
82%
83%
160
140
120
100
EI
80
Ins
60
40
20
8%
10%
2006
2005
3%
3%
2006
2005
6%
5%
2006
2005
0
2006
2005
important
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moderate
minor
insufficient
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ASMR: Improvement in Actual Benefit
Improvement in Actual Benefit for Drugs
46% 43%
70
60
50
40
EI
18% 16%
30
12% 8%
20
10
Ins
14% 14%
6%
2% 4%
11%
0
2006 2005 2006 2005 2006 2005 2006 2005 2006 2005 2006 2005
Major
Important Moderate
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Minor
None
Not rated
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From efficacy to effectiveness…
Efficacy
Effectiveness
• explanatory trials
• highly selected populations
• comparator: often placebo
• pragmatic trials
• few exclusions
• comparator: ‘current (best)
• outcomes: clinical, often
•
surrogates, adverse effects
‘is the therapy effective’
practice’
outcomes: patient-focused, downstream 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 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
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Some Innovative Drugs
Drug
Marketing
Authorisation
Application
Submission
Final
Opinion
Time to
Final
Opinion
28/07/2005
03/08/2005
III – IV
25/10/2005
83 days
T…cancer
19/09/2005
27/10/2005
IV – V
20/03/2006
K…cancer
25/10/2005
20/12/2005
III
13/03/2006
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
X…neuro
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Improveme
nt in Actual
Benefit
98 days
83 days
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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)
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www.eunethta.net
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Thank You
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 expenditure
France > 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
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