Presentation (CTI)

OBJECTIVES: In 2020, the French HTA body (HAS) published guidelines encouraging consideration of clinical and organizational outcomes beyond the conventional cost‑effectiveness framework. However, these outcomes are rarely incorporated into economic models, and their contribution to decision‑making remains unclear. This study assessed how such outcomes are considered by both the economic (CEESP) and technical bodies (CT or CNEDiMTS).
METHODS: A database of all CEESP appraisals published between 2020 and 2026 was developed, including administrative data and reported outcomes beyond ICER, life-years gained, and QALYs. Relevant appraisals were identified and reviewed. Corresponding technical appraisals were analyzed to evaluate how these outcomes were reflected in discussions, conclusions, and deliberation transcripts when available.
RESULTS: Among 141 appraisals screened, although 56 claimed a potential organizational impact, only 7 included outcomes beyond standard cost‑effectiveness metrics: 6 reported additional clinical outcomes and 1 presented an alternative metric (cost per avoided hospitalization). Only 2 were deemed acceptable by CEESP. Across these appraisals, a total of 13 additional outcomes were identified, most of which related to intercurrent events avoided (n=8), organizational outcomes (avoided hospitalizations, transfusions, or blood packs; n=3), and treatment response (n=2). Half of the reported outcomes corresponded to primary or secondary endpoints from pivotal trials and were also presented in the corresponding technical appraisal. Although retained in final CEESP opinions, these outcomes were never discussed in deliberation transcripts, suggesting limited integration into the economic evaluation debate.
CONCLUSIONS: Despite HAS guidelines promoting broader outcome consideration, outcomes beyond ICER, particularly those related to safety and organizational impact, remain infrequently reported and appear to have limited influence on CEESP deliberations. In the context of limited resources, better integration of these dimensions could help capture the full value of health technologies, especially in cases where the cost/QALY framework does not fully reflect clinical or health system benefits.