OBJECTIVES: To access reimbursement and a price in France, medications must be evaluated by the Transparency Committee (TC). They are assigned a Clinical Benefit (SMR), which defines a reimbursement rate, and a clinical added value (ASMR), which will guide price negotiations with the Economic Committee for Health Products (CEPS). However, the draft opinion issued by the TC can be challenged, leading to a hearing.

METHODS: We conducted a retrospective analysis of all TC hearings reports published between January 1, 2021 and December 31, 2023.

RESULTS: Among 158 hearings conducted, mostly for oncology products (30%), 36% led to at least a partial modification of the draft opinion issued by the TC. Most hearings requested modifications of the SMR and ASMR, with respectively 73 (35%) requests and 80 (39%) requests out of 208. Fifty-eight out of 73 (77%) SMR requests were to obtain a significant SMR, 6/73 (8%) a moderate SMR, and 11/73 (15%) a low SMR. Fifty out of 80 (63%) ASMR requests were for an ASMR IV, and 30/80 (37%) were for an ASMR III. Among the medications that were initially assessed with an insufficient SMR, there was no change for 28/41 (68%), while 13/41 (32%) received a sufficient SMR qualifying for reimbursement. Regarding ASMR, 86 modifications requests were done. A modification of ASMR was accepted in 26 cases (30% of requests). In most cases, the change was 1 level of ASMR (mainly V to IV), however in 2 cases the modification was of 2 levels (i.e. ASMR V to III).

CONCLUSIONS: The contradictory phase and the hearing of the pharmaceutical company is an opportunity to modify the initial evaluation by the CT which can have an impact on the reimbursement access and price negotiations with the CEPS.