Presentation (CTI)

OBJECTIVES: Post-registration studies (PRS) may be requested by the Haute Autorité de Santé (HAS) Transparency Committee (TC) when uncertainties remain regarding a drug's use, effectiveness or safety in current practice. This study described the role of PRS in TC reassessments and evaluate how submitted evidence aligned with the authorities' initial requests.
METHODS: HAS reassessment opinions published between January 2023 and April 2026 were identified using the PRISMAccess database. Opinions referring to a previous TC request for post-registration evidence were screened for inclusion. For each eligible reassessment, the following data were extracted: therapeutic area, study design, time to reassessment, TC's appraisal of study’s contribution, and impact on SMR/ASMR ratings.
RESULTS: Among 173 reassessment opinions identified over the period, 44 included an assessed PRS and were retained for analysis. The median delay between request and reassessment was 6.7 years. Most PRS were cohort studies (66%) or registries (34%). Primary data were used in 75% of studies, while 14% relied on secondary data (e.g., SNDS) and 11% combined both. Overall, 45% of PRS were considered informative by the TC, with a higher proportion among registries than cohort studies (60% vs 38%). Requested objectives mainly related to conditions of use (68%), effectiveness (64%), safety (55%) and quality of life (18%). SMR and ASMR remained unchanged in 91% and 82% of reassessments, respectively. SMR improved in 3 cases; ASMR improved in 2 and worsened in 5; both SMR and ASMR were worsened in 1 case.
CONCLUSIONS: PRS requested by the French TC were predominantly non-comparative observational studies and rarely changed SMR or ASMR ratings. Registry-based studies were more often considered informative than cohort studies. The increasing use of effectiveness related objectives and secondary data sources, including SNDS, is consistent with HAS's 2021 real-world data guidance and may help inform future PRS design for HTA.