Basic principles of pharmaceutical products reimbursement in France
The main feature of the French health care system is the quasi-universal coverage (99% of the population) of the health care by the National Health Insurance, a branch of the National social security system. The general framework of the French National Health Insurance reimbursement is fixed by law.
Patients with chronic severe conditions registered on the Long Duration Disease list (ALD) benefit from full coverage of their health care by the National Health Insurance. For all remaining cases, the reimbursement rate of pharmaceutical product primarily depends on the medical value as assessed by the HAS (Haute Autorité de Santé, the French Health Technology Assessment body). Private insurance companies can provide additional payment for products and services on top of the amount reimbursed by the National Health Insurance. In general, private insurance companies do not offer any payment for products that are not reimbursed by the National Health Insurance though some of them now offer restricted envelops for coverage of patient’s expenses on OTC products.
For any pharmaceutical product to be sold in France, it should have Marketing Authorization obtained through EMA centralised procedure, through European mutual recognition procedure or be granted by the French Drug Agency (ANSM).
In order to access reimbursed market, medical assessment by the HAS is mandatory for any new pharmaceutical product, except for generics of already registered original drugs with the same marketing authorization indications and the same packaging. After thorough assessment of available clinical evidence, the HAS determines the medical value and added medical value levels and issues its official opinion for admission to reimbursement by the National Health Insurance (Y/N) , reimbursement rate, reimbursed indication and eligible target population.
For some products, submission of the pharmacoeconomic dossier in addition to the technical dossier is mandatory. This requirement applies to manufacturers claiming a high level of added medical value for their product (I, II or III), when the product is expected to generate in France more than 20 million Euros revenue in the second full year following the launch (mandatory) or may have a significant impact on the health care structure and organization (the need for a pharmacoeconomic assessment is determined on a case by case basis by the HAS Medico-Economic Commission, CEESP).
The final decision on the registration of new pharmaceutical products on the positive reimbursement list is under the responsibility of the Ministry of Health and Social Affairs; the reimbursement rate is fixed by the UNCAM*.
The reimbursement price is negotiated between manufacturer and the inter ministerial Economic Committee of Health Products (CEPS) within the Ministry of Health and Social Affairs, on the basis of the HAS opinion regarding medical value and added medical value, and under the terms of the framework agreement between the Economic Committee and the French association of pharmaceutical product manufacturers (LEEM). In case of positive negotiation outcome, a price contract is signed by the manufacturer and the Economic Committee. The registration on the positive reimbursement list and the reimbursement tariffs are then published in the Official Journal.
Conditional pricing strategies have seen a substantial development in France over the last decade. Most of pricing contracts include specific clauses such as non-transparent rebates, price-volume agreements, revenue caps etc. Prices are increasingly conditioned by real-world evidence data to be collected by the manufacturer within a pre-specified timeframe.
Updated on December 15th, 2016