OBJECTIVES: To analyze the clinical outcomes, cost and cost effectiveness of two ALK mutation tests (FISH and Ventana IHC) to guide targeted therapy for patients with non-small cell lung cancer.

METHODS: Decision tree model was adopted to simulate 2 groups of 100,000 NSCLC patients who adopted FISH and Ventana IHC respectively recommended by China guideline and were treated with Crizotinib as first line treatment if ALK was positive. Test performance of FISH and Ventana IHC were based on the latest published literature and SFDA registered clinical trial data of Ventana ALK (D5F3). Medical costs occurred and clinical outcomes acquired in 5 years were calculated to carry out cost effectiveness analysis. Clinical and economic data were mainly retrieved from literature summary, and part of the cost data was based on Shanghai medical service price standards.

RESULTS: Ventana IHC guided therapy group cost more but achieved more effective clinical results compared with FISH guided therapy group. In addition, the ICER of Ventana IHC guided therapy group versus FISH guided group was US$ 15,603 /QALY, less than Shanghai GDP per capita in 2014 which was US$ 15,851. Therefore, compared with FISH, Ventana IHC was high cost-effective as ALK mutation test.

CONCLUSIONS: Rather than FISH, Ventana IHC should be optimally selected as the companion diagnosis method and be introduced into NSCLC targeted therapy management scheme.