Market Access in France Agency

Exploring France’s Early Access Programs: Navigating AAP and AAC for Medicinal Products and Medical Devices

Early access authorization enables the early access, availability and reimbursement of a medicinal product indicated for a severe, rare or incapacitating disease. There are two early access programs in France known as the Early Access Authorization or AAP (Autorisation d’accès précoce) and Compassionate Access Authorization or AAC (autorisation d’accès compassionel). AAP allows the reimbursed use of an innovative medicine before marketing authorization (MA) has been granted and between MA and reimbursement decision. The AAC (or CPC cadre de prescription compassionnel) is intended for non-innovative medicines or for medicines that are not initially intended for marketing authorization that allows the use in a small number of cases but this can also apply to innovative medicines, especially prior to approval of an AAP. While the ANSM is responsible of granting compassionate access authorizations (AAC), both ANSM and HAS hold the responsibility of granting early access authorizations (AAP). The ‘Forfait innovation’ also allows for early access to health technologies other than medicines such as medical devices in the early phase of clinical development. For more information visit our French reimbursed early access programs page.

Decoding the French P&R Dossiers: The Roles of the Transparency Commission and CEESP in Medicine Assessment and Pricing

For regular Pricing & Reimbursement decisions, the assessment of medicines and the determination of their added value are entrusted to the Transparency Commission (TC) of the Haute Autorité de Santé (HAS). Medicines meeting certain conditions also undergo a health economic assessment by the CEESP, another commission within the HAS. Following this assessment, manufacturers engage in price negotiations with the Economic Committee (CEPS). For more information visit our French P&R dossiers page.

Understanding France’s P&R Pathways: Differentiating Pricing Strategies for Hospital-Only Drugs and Retail Medicines

Unlike hospital-only drugs, medicines in a retail setting do not have free pricing. While hospital-only drugs can be priced freely, the cost of medicines must be covered within the scope of the Diagnosis-Related Group (DRG) system, which emphasizes price sensitivity in a hospital setting. However, for expensive but innovative medicines there are pathways for extra funding such as the liste en sus and the retrocession list.
France also offers reimbursement pathways for medical devices and eHealth products. The CNEDiMTS is the commission within the HAS appraising medical devices. For more information visit our French P&R Pathways page.