Abstract

Nivolumab is indicated for the treatment of adult patients with R/M SCCHN progressing during or after platinum-based chemotherapy. We conducted a cost-utility analysis to evaluate nivolumab efficiency compared to standard therapies according to methodological guidelines of the French ‘Haute Autorité de Santé’ (HAS). A three-state partitioned survival model was developed to simulate the evolution of a cohort of patients with R/M SCCHN over a lifetime horizon. Clinical data were obtained from pivotal phase III CheckMate 141 comparing nivolumab to investigator's choice (IC) of standard therapies: cetuximab, docetaxel or methotrexate. Progression-free and overall survival extrapolation was based on parametric models. Utility data were from CheckMate 141 (EQ-5D; French tariffs): 0.743 for nivolumab and 0.682 for IC in pre-progression state and, 0.628 for both comparators in post-progression state. Costs of disease management, treatment administration, adverse events, monitoring and palliative care were obtained from recently published real-world data in national health insurance databases. Treatment acquisition cost was based on public prices, flat dose for nivolumab (240 mg per patient) and the IC treatment mix in France: 32% cetuximab, 20% methotrexate, 28% docetaxel. A probabilistic sensitivity analysis (PSA) was performed. In the base-case scenario, nivolumab produced 1.12 life years (LY) and 0.76 Quality Adjusted Life Years (QALY) versus 0.64 LY and 0.42 QALY for standard therapies. Total costs of nivolumab were €58,232 and €29,706 for standard therapies. Incremental cost effectiveness ratios of nivolumab were €59,911/LY and €84,461/QALY versus standard therapies. PSA reported 89% probability that nivolumab would be an efficient strategy at a willingness to pay (WTP) of €100,000 per QALY. Our results suggest that nivolumab would be a cost-effective option to treat patients with R/M SCCHN in France at a WTP of €100 000 per QALY.

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