Insights From a French Postmarketing Authorization Early Access (MA EA) Mechanism: Projecting Clinical and Economic Benefits of Neoadjuvant Nivolumab–Platinum-Based Chemotherapy (PDC) in Resectable Non-Small Cell Lung Cancer
Author(s)
Paul Casabianca, PharmD1, Jérémy CARETTE, PharmD2, Stefano Lucherini, PharmD3, Melanie Chartier, MSc1, Henri Leleu, MD2, Christos CHOUAID, MD4, FRANCOIS-EMERY COTTE, PharmD1.
1Bristol Myers Squibb, Rueil Malmaison, France, 2public health expertise, Paris, France, 3Bristol Myers Squibb, London, United Kingdom, 4CHI Creteil France, Créteil, France.
1Bristol Myers Squibb, Rueil Malmaison, France, 2public health expertise, Paris, France, 3Bristol Myers Squibb, London, United Kingdom, 4CHI Creteil France, Créteil, France.
OBJECTIVES: In France, there are different types of EA mechanisms authorized by the Haute Autorité de Santé (HAS): pre-MA EA and post-MA EA. A total of 1,309 patients received neoadjuvant nivolumab+PDC for resectable non-small cell lung cancer (NSCLC) with PD-L1≥1% through post-MA EA between September 2023 and February 2025. The Health Technology Assessment conducted by the HAS concluded that nivolumab+PDC was a dominant strategy in neoadjuvant NSLC, as it is associated with quality-adjusted life year (QALY) gain and cost savings over PDC alone. This study assesses the clinical and economic benefits of neoadjuvant nivolumab+PDC versus PDC over 5 years from the French Health Insurance perspective.
METHODS: A semi-Markov model with four health states (event-free, locoregional-recurrence, distant-recurrence, death) was used to simulate the clinical trajectories of 1,309 patients included in the post-MA EA. The model compared the real-world scenario in which patients were treated with neoadjuvant nivolumab+PDC, and a theoretical scenario where patients received neoadjuvant PDC. Transition probabilities and subsequent treatments were based on CheckMate-816 trial. Costs were informed by a published study from French hospital discharge database and French tariffs.
RESULTS: Over 5 years, nivolumab+PDC was estimated to prevent 222 recurrences and subsequent treatments (-17%) and 144 deaths (-11%) compared to PDC, generating 374 additional QALY (+9,4%). Moreover, nivolumab+PDC was associated with 398 additional complete pathologic responses and 103 additional lung resections. Adjuvant therapies were avoided by 346 patients. In total, this resulted in €3.65 million in saving for French Health Insurance.
CONCLUSIONS: Neoadjuvant nivolumab+PDC is estimated to lead to significant clinical and economic benefits. This result is explained by the better efficacy of nivolumab+PDC compared to PDC, avoiding recurrences and associated subsequent treatments, which is consistent with nivolumab+PDC dominant cost-effectiveness outcome. Expanding access to nivolumab+PDC to more patients in France, beyond the post-MA EA, will lead to even greater clinical and economic benefits.
METHODS: A semi-Markov model with four health states (event-free, locoregional-recurrence, distant-recurrence, death) was used to simulate the clinical trajectories of 1,309 patients included in the post-MA EA. The model compared the real-world scenario in which patients were treated with neoadjuvant nivolumab+PDC, and a theoretical scenario where patients received neoadjuvant PDC. Transition probabilities and subsequent treatments were based on CheckMate-816 trial. Costs were informed by a published study from French hospital discharge database and French tariffs.
RESULTS: Over 5 years, nivolumab+PDC was estimated to prevent 222 recurrences and subsequent treatments (-17%) and 144 deaths (-11%) compared to PDC, generating 374 additional QALY (+9,4%). Moreover, nivolumab+PDC was associated with 398 additional complete pathologic responses and 103 additional lung resections. Adjuvant therapies were avoided by 346 patients. In total, this resulted in €3.65 million in saving for French Health Insurance.
CONCLUSIONS: Neoadjuvant nivolumab+PDC is estimated to lead to significant clinical and economic benefits. This result is explained by the better efficacy of nivolumab+PDC compared to PDC, avoiding recurrences and associated subsequent treatments, which is consistent with nivolumab+PDC dominant cost-effectiveness outcome. Expanding access to nivolumab+PDC to more patients in France, beyond the post-MA EA, will lead to even greater clinical and economic benefits.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EPH148
Topic
Economic Evaluation, Epidemiology & Public Health, Real World Data & Information Systems
Topic Subcategory
Public Health
Disease
Oncology, Surgery