ABSTRACT
The National Union of Health Insurance Funds (Union nationale des caisses d’assurance maladie [UNCAM]) is a third party payer (the head of health insurance funds). This body is in charge of setting the reimbursement rate (%) of pharmaceuticals.1,2
The French National Authority for Health (Haute Autorité de Santé [HAS]) is an independent body that makes technical advice for including a pharmaceutical on the positive list but also recommendations and pharmacoeconomic evaluations. The following two HAS committees are involved in HTA1,2:
• The Transparency Committee (Commission de la Transparence [CT])
• The Economic and Public Health Assessment Committee (Commission Evaluation Economique et de Santé Publique [CEESP])
• Regional Health Agencies (Agences Régionales de Santé [ARS]) are responsible for in-patient and outpatient organization of care for both public and private sectors2
• Public and private health establishments1,2
The marketing authorization is granted at the European level by the EMA (European Agency of Medicines) and at national level by French National Agency for Drug Safety (Agence nationale de sécurité du médicament et des produits de santé [ASNM]).* Following the marketing approval, manufacturers are required to submit a combined pricing and reimbursement application to both the CT and the CEPS. There are two positive reimbursement lists in France for drugs:
• List for drugs dispensed by retail pharmacies (“Liste des spécialités remboursables aux assurés sociaux”).
