MARKET ACCESS OF DRUGS IN FRANCE- EVOLUTION OR REVOLUTION?

Author(s)

Rémuzat C1, Toumi M21Creativ-Ceutical France, Paris, France, 2University Claude Bernard Lyon 1, Lyon, France

OBJECTIVES: Describe and analyze recent changes in the French drug market access in which a dramatic shift in practice is undergoing and impacted by two laws entered into force in December 2011. METHODS: Literature review was performed to provide core understanding of the current and future trends in French drug market access to anticipate its impact for pharmaceutical industry. RESULTS: Condition severity used to be main driver of reimbursement level is now replaced by drug efficacy criterion. Moreover,  the effect size requested for acknowledging drug innovation has substantially increased. Perceived evidence might also be more important than actual evidence. Currently, the French National Authority (HAS) is working on a new therapeutic index that will drive the pricing and reimbursement.  Comparative evidence and real world data are pointed as critical, conditioning marketing authorization, and will be increasingly requested at the light of the new drug safety law n.2011-2012. Moreover, within this new legal framework there is a reinforcement of the regulation about conflicts of interest, a much closed regulation of off-label prescription and early entry of drugs as well as a wide promotion of generic drugs. The new social security funding law n.2011-1906 pursues the cost containment measures to control health insurance expenses. This law includes the Economic and Public Health Assessment Committee (CEESP) in the social security code. CEESP, that will operate independently of the Transparency Committee, is in charge of health economics evaluation to determine the most efficient therapeutic strategies and edit recommendations for decision makers. CONCLUSIONS: French drug market access will be more and more driven by comparative cost-effectiveness data and post-marketing studies. Companies will need to anticipate these requirements during the drug development. However in France, there exists little or no culture of using health economics for decision making and rather resistance to it.

Conference/Value in Health Info

2012-11, ISPOR Europe 2012, Berlin, Germany

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

Code

PHP89

Topic

Economic Evaluation

Topic Subcategory

Cost/Cost of Illness/Resource Use Studies

Disease

Multiple Diseases

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