International cost-effectiveness analysis of nivolumab plus ipilimumab-based for metastatic non-small cell lung cancer with PD-L1 lower than 1.

Background: Dual immunotherapy has demonstrated efficacy in treating non-small cell lung cancer (NSCLC) with tumor programmed cell death ligand 1 (PD-L1) lower than 1%. However, its widespread clinical implementation has been hindered by high costs, necessitating cost-effectiveness evaluations in the context of national healthcare payers. This study aims to evaluate the cost and clinical effect of nivolumab plus ipilimumab versus chemotherapy for NSCLC with PD-L1 lower than 1% from the perspective of payers in the USA and China.

Methods: The CheckMate 227 and CheckMate 9LA trials were leveraged to devise a three-state Markov model using pooled data to simulate the disease trajectory in NSCLC with PD-L1 lower than 1%. The model assessed the lifetime total costs, incremental cost-effectiveness ratios (ICERs), and incremental net health benefit (INHB) of nivolumab plus ipilimumab versus chemotherapy in the contexts of American and Chinese payers. The respective willingness-to-pay (WTP) thresholds were set at $100,000 and $36,255 per quality-adjusted life-year (QALY). Sensitivity and subgroup analyses were performed to assess the robustness of the model.

Results: Nivolumab plus ipilimumab provided an incremental gain of 1.11 and 0.96 QALYs over chemotherapy in the USA and China, respectively. However, this regimen was related to significantly higher total costs ($262,974 versus $146,772 in the USA and $43,217 versus $15,269 in China), yielding ICERs of $104,126/QALY and $29,143/QALY in the USA and in China, respectively. Among various influencing factors, patient body weight emerged as the most significant determinant. Subgroup analyses suggested that patients with brain metastases and squamous carcinoma were associated with greater benefits from the dual-immunotherapy approach.

Conclusions: First-line nivolumab plus ipilimumab was deemed cost-effective for metastatic NSCLC with PD-L1 lower than 1% in China but did not meet cost-effectiveness in the USA.