Abstract

To evaluate the cost-effectiveness of nivolumab plus ipilimumab plus two cycles of platinum doublet chemotherapy (NIVO+IPI+PDC) versus four cycles of PDC in the first-line (1L) treatment of stage IV or recurrent non-small cell lung cancer (NSCLC) from a health insurance perspective in the United States (US). A partitioned survival model with three health states (progression-free, progressed disease and death) was developed. Efficacy, safety and quality of life data were derived from the Phase-III CheckMate 9LA trial (CM9LA), with a minimum follow-up (FU) of 12.7 months for overall survival (OS)). Data from a more mature trial involving NIVO+IPI in 1L NSCLC, CM227 (37.7 months minimum FU for OS), were used to inform long-term OS over the 25-year (lifetime) horizon to capture the long-term survival effect observed from dual Immune-Oncology therapy. OS and progression-free survival was estimated based on CM9LA Kaplan Meier (KM) data up to 13 months then extrapolated using the conditional survival estimates from CM227. The CM9LA duration of treatment KM curves were used to estimate treatment costs. Resource use and direct medical costs (2020 USD) were included. EQ-5D based treatment-specific utility weights (US tariffs) were used. Annual discount rates of 3.5% for costs and outcomes were applied. Probabilistic sensitivity analyses (PSA) were conducted. The incremental cost per quality-adjusted life-year (QALY) gained was $132,960. NIVO+IPI+PDC vs. PDC resulted in increased life-years (3.71 vs. 1.89), QALYs (2.86 vs. 1.37), and costs ($317,497 vs. 119,932). Drug acquisition cost for NIVO+IPI+PDC was the key driver of the difference in total costs. PSA results were consistent with the base case. NIVO+IPI+PDC offers a new cost-effective treatment option for patients in 1L NSCLC. Estimated incremental cost-effectiveness ratio is within the range of what is considered acceptable value for money within the metastatic cancer setting in the US.

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