Market Access Overview
Once a pharmaceutical product is granted MA (Marketing Authorisation) for France the company can file an application for national reimbursement.
Reimbursement in France is based on three major steps:
Step 1: choose which reimbursement list to be placed on, depending on the company’s strategy
Step 2: technical assessment by the CT – Commission de la Transparence (Transparency Committee) and the economic assessment by the CEESP – Commission Évaluation Économique et de Santé Publique (Committee for Economic and Public Healthcare Evaluation), if needed
Step 3: fixing the reimbursement rate by the NHI – (National Health Insurance) and the pricing negotiation with the CEPS – Comité Economique des Produits de Santé (Economic Committee of Healthcare Products)
The price of a new pharmaceutical product is set following the reimbursement rate fixation, given the reimbursement rate proposed by the UNCAM – Union Nationale des Caisses d’Assurance Maladie (National Association of Health Insurance Funds). Final drug lists, reimbursement rates and prices are decided upon under the MoH (Ministry of Health).
MAP provides insights on:
- Decision makers – Sésame online filing platform
- Pricing – negotiation process, ASMR levels
- Reimbursement – P&R sequencing, SMR & ASMR 2016, CT requirements, recent trends, meeting with HAS, CT recommendation, early deposit, budget impact, reassessment of class products, biosimilars, scientific advice
- Early Access – ATU price, ATU reimbursement, ATUn, e-Saturne platform
- Vaccines – new entries