MARKET ACCESS OF DRUGS IN FRANCE AND MEDICO-ECONOMIC ASSESSMENT

Author(s)

Rémuzat C1, Toumi M2, Aballea S31Creativ-Ceutical France, Paris, France, 2University Claude Bernard Lyon 1, Lyon, France, 3Creativ-Ceutical, Paris, France

OBJECTIVES: Describe and analyze the impact of the recognition of the Economic and Public Health Assessment Committee (CEESP) as an official committee, part of the French National Authority for Health (HAS), within the new code of social security for drug market access. METHODS: We browsed website of French government, reviewed grey literature relating to the introduction of health economic criteria in the recommendations of the CEESP and interviewed decision-makers. RESULTS: The remit of CEESP is to determine efficient strategies and edit recommendations to support price negotiations.  Products eligible for economic assessment will be selected based on criteria to be defined and some areas of uncertainty remain to be addressed. (1) Criteria for product selection: all products that state innovative improvement, product with sales above €10 million per year, new mode of action and products with potential extension of  target population are likely to be assessed; orphan designated product are not. At time of approval, the scope of assessment will be relatively narrow and outstanding questions addressed during reassessments 3 to 5 years later. (2) How the Transparency Committee (TC) and CEESP will resolve divergent opinions: While TC only focus on clinical trials, CEESP is expected to have a broader perspective. As both committees operate independently, it is urgent that a clear process is established to clarify the resolution of divergent opinion. (3) Methodology used for economic assessment: HAS published guidelines for economic analysis. They remain very flexible even if some specific recommendations were made (e.g. no cost benefit analysis, loss of productivity not included in reference case, deterministic and probabilistic sensitivity analysis required). Finally no information is available to inform how CEEPS opinion will impact pricing negotiation. CONCLUSIONS: Although application decrees are still to be issued, there are important areas of uncertainty  surrounding introduction of health economics in market access of drugs in France.

Conference/Value in Health Info

2012-11, ISPOR Europe 2012, Berlin, Germany

Value in Health, Vol. 15, No. 7 (November 2012)

Code

PHP133

Topic

Health Policy & Regulatory

Topic Subcategory

Reimbursement & Access Policy

Disease

Multiple Diseases

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