Ventana ALK (D5F3) in the Detection of Patients Affected by Anaplastic Lymphoma Kinase-positive Non-Small-cell Lung Cancer: Clinical and Budget Effect

Abstract

Background: To ensure identification of anaplastic lymphoma kinase-positive (ALK⁺) patients, the Italian Drug Agency suggested a testing algorithm based on the use of fluorescence in situ hybridization (FISH) and/or immunohistochemistry. The aim was to evaluate the clinical and economic effects of adopting an immunohistochemical test (Ventana ALK D5F3) as an option for detecting ALK protein expression in advanced non-small cell lung cancer (NSCLC) patients.

Materials and methods: A budget impact model was developed by adopting the Italian National Health Service (NHS) perspective and a 5-year period to compare 2 scenarios: the current use of D5F3 (28%; current scenario) and increased use of D5F3 (60%; alternative scenario). The testing cost and the number and cost of the identified ALK⁺ patients were evaluated.

Results: A more extensive use of D5F3 in the alternative scenario showed a decrease in diagnostic costs of ∼€468,000 compared with current scenario when considering all advanced NSCLC patients. If these savings were allocated to test more NSCLC patients (75% vs. 53%), an incremental cost per identified ALK⁺ patient of €63 would be required, leading to an overall survival gain for the alternative scenario compared with the current scenario (32.4 vs. 27.1 months; relative increase, 20%).

Conclusion: The use of D5F3 would provide a cost savings for the NHS owing to a lower acquisition cost than FISH and a comparable detection rate. The savings could be reinvested to test a greater number of patients, leading to more efficient identification, use of targeted therapy, and improvement in clinical outcomes of ALK⁺ patients.

Keywords: ALK; Budget; FISH; IHC; NSCLC.