HTA in France: pharmaceutical assessment and market access

Pharmaceutical assessment in France includes, in particular, the evaluation conducted by the Transparency Committee (Commission de la Transparence, CT) of the French National Authority for Health (Haute Autorité de santé, HAS). Following marketing authorisation, the Transparency Committee assesses, among other aspects, the Service Médical Rendu (SMR) and the Amélioration du Service Médical Rendu (ASMR). Its assessment informs decisions on reimbursement and the subsequent price-setting process.

The French system therefore connects clinical assessment, reimbursement and pricing. For pharmaceutical companies, this creates specific requirements for evidence strategy, dossier preparation, procedural planning and market access in France.