Presentation (CTI)

OBJECTIVES: Identify factors differentiating clinical added benefit levels (ASMR III, IV, V) in French oncology health technology assessments by the Haute Autorité de Santé (HAS) and derive implications for evidence generation strategies.
METHODS: A retrospective descriptive analysis of publicly available French HAS oncology assessments from 2023 to 2026 was conducted. Line extensions, biosimilars, and hybrid submissions were excluded, and combination regimens counted once. Assessments were stratified by ASMR level, clinical benefit rating (SMR), trial phase, primary and secondary endpoints (overall survival [OS], progression-free survival [PFS], or other), and OS hazard ratio (HR) thresholds to characterize treatment effect.
RESULTS: Of 164 assessments, 21% received ASMR III, 40% ASMR IV, 28% ASMR V, and 10% insufficient SMR. ASMR III and IV relied on Phase III trials (97% and 83%), nearly all with "Important" SMR; 48% of ASMR V used Phase II data. With OS as primary endpoint, 42% reached ASMR III vs 8% ASMR V; with PFS primary, 54% reached ASMR IV vs 7% ASMR III. Without OS/PFS, 55% were ASMR V and 6% ASMR III. Also, 70% with OS HR <0.75 reached ASMR III, 56% with PFS HR <0.7 reached ASMR IV, and 42% with PFS >0.8 reached ASMR V. QoL was primary once; as secondary, it halved ASMR V (45% to 25%) and raised ASMR III (23%) and IV (33%).
CONCLUSIONS: Robust OS outcomes drive higher added benefit. ASMR III was characterized by Phase III evidence, OS primary, and marked OS effect (HR <0.7). ASMR IV was Phase III-supported but linked to PFS primary with substantial benefit (HR <0.6). ASMR V was often linked to Phase II evidence or absence of OS/PFS, highlighting the limited ability of less mature evidence to support added benefit in French oncology HTA. Future research should assess whether EU Joint Clinical Assessment modifies ASMR determinants.