Insights into Health Technology Reassessment in France: A Comprehensive Analysis of Key Outcomes and Manufacturers Engagement (2022-2023)

OBJECTIVES: This study aims to investigate the key outcomes of health technology reassessment (HTR) conducted by the Haute Autorité de Santé (HAS) in France, shedding light on the type of additional evidence provided by manufacturers before reassessment.

METHODS: The review focused on HTR reports published by the HAS from January 2022 to December 2023, excluding those related to generics. The analysis examined changes in initially granted clinical benefit (SMR) and added clinical value (ASMR) levels. Additionally, the study categorized the supplementary data provided by manufacturers.

RESULTS: Reassessments were predominantly initiated by the HAS' Transparency Committee (46/82) and manufacturers (26/82), with an additional 10 initiated by the Ministry of Health. The reassessment involved at least the SMR and/or ASMR in 77 out of 82 reports. The analysis revealed that among the 68 drugs undergoing SMR reassessment, 14 showed improvement, while one experienced a downgrade. Furthermore, nine drugs had reimbursement restrictions lifted, and five products gained access to reimbursement. Regarding ASMR reassessment, 13 out of 64 showed improvement, while one experienced a downgrade. The probability of an upgraded SMR and ASMR was 20.5% and 20.3%, respectively. This probability rises to 35.2% for SMR and 36.8% for ASMR in reassessments initiated by pharmaceutical companies. Manufacturers supplied additional evidence in 87% of cases (e.g., updated safety and/or efficacy results, data from post-registration studies, data generated by early access programs, new indirect comparisons, utilization data, etc.). However, there was no discernible pattern regarding the type of additional evidence leading to an upgraded SMR or ASMR level.

CONCLUSIONS: A noticeable trend of improvement in SMR and ASMR outcomes was observed, particularly in reassessments initiated by manufacturers indicating that engaging in reassessment provides pharmaceutical companies with the opportunity to gather additional evidence, ultimately enhancing reimbursement and pricing conditions for their technologies in the French market.