OBJECTIVES: In France, the concept of hybrid medicines is defined as medicines that don’t meet the definition of generics, as they differ from the reference specialty in terms of therapeutic indication, dosage, pharmaceutical form, route of administration, or bioavailability. To date, no text addresses the evaluation procedures by the French National Authority for Health (HAS) or the pricing policy of the Economic Committee for Health Products (CEPS) for these medicines.

METHODS: We conducted (1) a systematic analysis of hybrid medicines evaluated in 2022 and (2) an analysis of hybrid medicines having achieved a clinical added benefit (AMSR) superior to V from 2014 to the end of 2022.

RESULTS: In 2022, 28 hybrid medicines were evaluated. The most common reasons for hybrid status were a different pharmaceutical form and a different dosage (43% each). All of them have obtained a clinical benefit (SMR) in line with the one of their reference specialty (sufficient) and no ASMR compared to their reference specialty. Of the 10 hybrid medicines with a negotiated published price, this price was on average 18% lower than the reference specialty. Hybrid medicines achieving ASMR superior to V are very rare, with a total of 7 medicines identified between 2014 and the end of 2022 (all ASMR IV). Of the 4 hybrid medicines with an ASMR IV and a negotiated published price, this price was on average 35% lower than the reference specialty and only one had a premium price (+3%).

CONCLUSIONS: Hybrid medicines appear to be consistently reimbursed by obtaining a SMR in line with the one of their reference specialty. Nevertheless, in most cases no ASMR is granted resulting in lower prices than the reference specialty. Additionally, achieving an ASMR superior to V doesn’t necessarily result in a systematic price increase.