Dr. Fran

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Dr. François MeyerDirector, Healthcare Products
and Procedures AssessmentHaute Autorité de
santéAIFA 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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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
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The HAS, new body created in 2005
HAS French National Authority for Health,
created 2005
Board ChairProf. L. Degos
7 committees
Cabinet
Managing directorMr François Romaneix
Practice appraisalCPD
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
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(No Transcript)
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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
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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

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ASMR Improvement in Actual Benefit

• Improvement in Actual Benefit for Drugs

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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 200148-11
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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 Improvement in Actual Benefit Final Opinion Time to Final Opinion
Xneuro 28/07/2005 03/08/2005 III IV 25/10/2005 83 days
Tcancer 19/09/2005 27/10/2005 IV V 20/03/2006 98 days
Kcancer 25/10/2005 20/12/2005 III 13/03/2006 83 days
Ncancer 19/07/2006 28/07/2006 II 22/09/2006 50 days
Emetab 28/08/2006 11/09/2006 II - III 9/10/2006 27 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
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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 gt UK gt Netherlands gt 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