OBJECTIVES : Necitumumab is an unapproved fully human IgG1 monoclonal antibody in Japan and has been shown to be efficacious in the Phase III trial. The purpose of this analysis was to evaluate the cost-effectiveness of combination therapy of necitumumab, gemcitabine and cisplatin (NGC) in patients with stage IV squamous non-small-cell lung cancer, comparing with combination therapy of gemcitabine and cisplatin (GC).

METHODS : Partitioned survival model was developed to predict costs and quality-adjusted life years (QALYs) in NGC and GC arms. Direct medical costs were considered from the perspective of the Japanese healthcare system. Time horizon and cycle length of the model was set to 10 years and 1 month, respectively. An annual discount rate of 2% for both costs and QALYs was applied. Data on overall survival and progression-free survival was derived from the SQUIRE trial. Cost parameters were estimated by using the JMDC claims database. All costs were estimated in Japanese yen and converted to US dollars with the currency exchange rate of $ 1 = JPY100. Utilities were derived from published sources other than Japan. The incremental cost-effectiveness ratio (ICER) of NGC therapy compared with GC therapy was estimated. Deterministic sensitivity analysis was performed to assess uncertainty in parameter settings.

RESULTS : Compared with GC therapy, NGC therapy incurred an additional cost of $ 30,593 and conferred an additional 0.217 QALY. This resulted in the ICER of $ 141,275 per QALY gained. Costs for post-progression had a relatively large impact on the base case result, but the ICERs remained higher than $ 50,000 per QALY over the full range of model parameters.

CONCLUSIONS : Applying the willingness to pay threshold of $ 50,000 per QALY, NGC therapy as first-line therapy might not be cost-effective. Further research is required on utilities of Japanese patients with lung cancer.