How to differentiate between clinical added value (CAV) V drugs: What are the implications, and what is the access pathway?

Level V clinical added value (CAV) refers to a lack of CAV improvement of a new medicine, as assessed by the French Transparency Committee, compared to a standard of care therapeutic strategy. In 2024, 56% of medicines evaluated in primary registration or extended indication (excluding simplified procedures) were assigned an CAV V, compared with 44% in 2023. Obtaining an CAV V sometimes leads to the product not being available to patients, especially in the event of non-inclusion on the costly drug list for hospital products or after failure of negotiation between the drug manufacturers and the Health Products Economic Committee. The Giens workshops wished to devote a round table to the study of these drugs and analyse the different situations leading to CAV V to make proposals allowing access for patients to these drugs that are the subject of very specific CAV V situations. Three situations could benefit from specific attention: (i) Medicinal products for which the submitted clinical data does not allow the French Health Authority (HAS), at the time of evaluation, to decide on the quantity of clinical effect; (ii) Drugs for which the clinical effect is low or for which clinical relevance is discussed; (iii) Drugs for which no added clinical benefit is demonstrated but for which non-clinical benefits (such as organisational impact on care, or long-term savings) are identifiable. Following the analysis of these different situations and using examples, the members of the round table made eight concrete proposals to allow patients to access these products, in certain blocking situations.