[Drug evaluation by the French National Health Authority for reimbursement decisions].
The French National Health Authority (NHA) is a scientific agency created by the French government in order to provide independent information and recommendations on health-related issues, and a coherent framework for improving healthcare practices. NHA's responsibility for periodically reviewing medicinal products for inclusion on the list of products eligible for reimbursement by the national health insurance system has been delegated to the Transparency Commission. The latter appraises the therapeutic value of medicinal products, based on clinical performance (efficacy and tolerability), the therapeutic contribution, and the expected impact on public health. If the Transparency Commission deems that a product has sufficient therapeutic value to warrant reimbursement, and if this opinion is approved by the Health Ministry, the Union of National Health Insurance Funds sets the refunding level according to the product's therapeutic value. The latter is re-assessed every 5 years, based on contemporary medical knowledge. The Transparency Commission also assesses the possible added therapeutic value of new products, i.e. their advantages over existing treatments. This is taken into account in setting the approved price. Transparency Commission opinions become part of the product's credentials, and are used by other NHA commissions to formulate "Recommendations for improving medical practices" and "Quality and distribution of medical information".
Bouvenot
Gilles
G
Membre du College de la Haute Autorité de santé, President de la commission de la transparence 2, avenue du Stade de France 93218 Saint-Denis la Plaine Cedex.
D004341:Drug Evaluation; D005602:France; D033161:Government Regulation; D006801:Humans; D009313:National Health Programs; D012051:Reimbursement Mechanisms