Presentation (CTI)

OBJECTIVES: This study examines why the French Haute Autorité de Santé (HAS) does not acknowledge health benefit improvements in cases where the Scottish Medicines Consortium (SMC) does, with a focus on the role of indirect treatment comparisons (ITCs).
METHODS: Health Technology Assessment (HTA) outcomes were extracted from the NaviHTA database for products assessed by both SMC and HAS, of which those with "no improvement of health benefit", defined as Service Médical Rendu (SMR) insufficient or Amélioration du Service Médical Rendu (ASMR) V by HAS, were selected. For these indications, justifications for the ratings were analysed. Then, in cases when ITCs contributed to benefit recognition by SMC, their use and acceptance by HAS were evaluated.
RESULTS: Of the 118 reports analysed by both agencies, all received full or restricted recommendations from SMC. Contrary to that, HAS indicated no improvement of health benefit for 66 indications, including 13 with insufficient SMR and 53 (50 reports) rated ASMR V. The most frequent reasons for SMR insufficiency included no/limited medical need (77%), uncertain/limited benefit-risk ratio (69%), and study design limitations (62%). For ASMR V, key factors were study design limitations (85%), uncertain/limited benefit-risk ratio (69%), and lack of long-term data (40%). Among these 66 indications, ITCs supported SMC decisions in 40 cases as either main (50%) or additional evidence. ITCs were submitted to HAS for 22 corresponding indications; 64% were rejected due to methodological limitations, while the remaining were accepted with (18%) or without (18%) reservations.
CONCLUSIONS: This analysis shows that ITC submissions to HAS were much lower than to SMC, likely due to low acceptance. Among SMC cases using ITC, all were accepted, driving the decision in half of the cases, while HAS rejected 68% of analysed ITCs. Notably, HAS often reaches different benefit-risk conclusions than the European Medicines Agency (EMA).