OBJECTIVES: Envonalkib, a novel anaplastic lymphoma kinase(ALK) inhibitor, demonstrated promising anti-tumor activity and safety in advanced ALK-positive non-small cell lung cancer (NSCLC) in the first-in-human phase III study. Iruplinalkib is a second-generation ALK tyrosine kinase inhibitor (TKI) with efficacy in patients with ALK-positive advanced NSCLC. This study examined the cost-effectiveness of envonalkib, iruplinalkib and critizonib in the Chinese healthcare setting.

METHODS: Based on two phase III randomized, double-blind, multi-center clinical trials comparing envonalkib to critizonib (NCT04009317) and envonalkib to critizonib (NCT03635749) for the treatment of Chinese NSCLC use in ALK-positive patients. A three-health state partitioned survival model (PartSA) was developed to simulate the progression of disease, with model cycle of 3 weeks and a lifetime range; the main output indicators of the model were total cost, quality-adjusted life year(QALY), and incremental cost-effectiveness ratio(ICER); the cost and health output were discounted using 5.0% discount rate. Using 1~3 times China’s per capita gross domestic product(GDP)(12 295.7~36 887.0 dollar) in 2023 as the willingness-to-pay(WTP) threshold, the cost-utility analysis method was used for analysis, sensitivity analysis and scenario analysis were conducted to assess model robustness.

RESULTS: The cost of envonalkib iruplinalkib and critizonib were $193 811.2, $232 637.3, and $196 493.6 and the outcomes were 4.62 3.60 and 2.38 QALY, respectively. Envonalkib and iruplinalkib were dominant compared with critizonib, and the ICER of envonalkib compared with iruplinalkib was $16 309.7, which was much greater than WTP; therefore, envonalkib was the most cost-effective option.

CONCLUSIONS: Envonalkib is the more economical compared with iruplinalkib and critizonib at the set price(1161.78 dollar), and iruplinalkib are cost-saving and utility-increasing compared to critizonib, which can help healthcare system in making optimal policies and help clinicians in the medication of patients.