IS THE CLINICAL ADDED VALUE A RELEVANT CRITERION FOR ECONOMIC EVALUATION ELIGIBILITY IN FRANCE? INSIGHTS FROM CEESP APPRAISALS (2014-2026)
Author(s)
Hadrien DUPOMMIER-ROUILLARD, MSc1, Paul Casabianca, MSc, PharmD2, FRANCOIS-EMERY COTTE, MA, MPH, PharmD, PhD2, Isabelle BORGET, PharmD, PhD3.
1Master 2 Market Access and Health Economic Evaluation, Gif-sur-Yvette, France, 2HEOR, Bristol Myers Squibb France, Rueil-Malmaison, France, 3Biostatistics and Epidemiology Office, Gustave Roussy, Villejuif, France.
1Master 2 Market Access and Health Economic Evaluation, Gif-sur-Yvette, France, 2HEOR, Bristol Myers Squibb France, Rueil-Malmaison, France, 3Biostatistics and Epidemiology Office, Gustave Roussy, Villejuif, France.
OBJECTIVES: In France, economic evaluation is mandatory for health products seeking reimbursement when the manufacturer claims a high level of clinical added value (CAV; I to III out of five levels). This criterion assumes that greater clinical benefit warrants economic evaluation. Little evidence supports this assumption, yet this criterion is highly selective: in 2025, the Economic and Public Health Evaluation Committee (CEESP) adopted only 20 such opinions. This study examined whether the results of cost-utility analyses assessed by the CEESP differed across CAV levels assigned by the Transparency Committee (CT) for drugs or the CNEDiMTS for medical devices.
METHODS: All CEESP economic opinions from inception to April 2026 were reviewed and linked to the corresponding CT or CNEDiMTS clinical assessments. Each observation corresponded to a unique combination of clinical benefit (CB) level, assigned CAV level, and population for which an incremental cost-utility ratio (ICUR) was reported. Records with insufficient CB or ICUR invalidated by the CEESP were excluded. ICUR distributions were compared across CAV categories (I-III, IV-V) using descriptive statistics. For dominant outcomes, ICURs were calculated from incremental costs and QALYs reported.
RESULTS: Among the 360 records, 151 met inclusion criteria: 130 (86%) concerned medicines, 11 (7%) medical devices, and 10 (7%) vaccines. Overall, 77 (51%) technologies were assigned I-III CAV and 74 (49%) IV-V CAV. The median ICUR across all technologies was €113,418/QALY. Technologies assigned IV-V CAV exhibited a lower median ICUR than those assigned I-III CAV (€88,116 vs €130,476/QALY). Similar findings were observed when analyses were restricted to medicines (€126,418 vs €142,131/QALY).
CONCLUSIONS: Across all technologies and among medicines only, median ICURs were lower for assigned CAV IV-V than I-III, suggesting that lower-CAV health products tended to demonstrate more favorable ICURs. These findings question the use of the claimed CAV as an eligibility criterion, and support consideration of alternative or complementary criteria.
METHODS: All CEESP economic opinions from inception to April 2026 were reviewed and linked to the corresponding CT or CNEDiMTS clinical assessments. Each observation corresponded to a unique combination of clinical benefit (CB) level, assigned CAV level, and population for which an incremental cost-utility ratio (ICUR) was reported. Records with insufficient CB or ICUR invalidated by the CEESP were excluded. ICUR distributions were compared across CAV categories (I-III, IV-V) using descriptive statistics. For dominant outcomes, ICURs were calculated from incremental costs and QALYs reported.
RESULTS: Among the 360 records, 151 met inclusion criteria: 130 (86%) concerned medicines, 11 (7%) medical devices, and 10 (7%) vaccines. Overall, 77 (51%) technologies were assigned I-III CAV and 74 (49%) IV-V CAV. The median ICUR across all technologies was €113,418/QALY. Technologies assigned IV-V CAV exhibited a lower median ICUR than those assigned I-III CAV (€88,116 vs €130,476/QALY). Similar findings were observed when analyses were restricted to medicines (€126,418 vs €142,131/QALY).
CONCLUSIONS: Across all technologies and among medicines only, median ICURs were lower for assigned CAV IV-V than I-III, suggesting that lower-CAV health products tended to demonstrate more favorable ICURs. These findings question the use of the claimed CAV as an eligibility criterion, and support consideration of alternative or complementary criteria.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EE607
Topic
Economic Evaluation, Health Policy & Regulatory, Health Technology Assessment
Disease
No Additional Disease & Conditions/Specialized Treatment Areas