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

Patients with anaplastic lymphoma kinase-positive (ALK(+)) advanced non small-cell lung cancer should benefit from targeted therapy. The effect of increased use of an immunohistochemical technique was estimated using a health care economics analysis. Extensive use of D5F3 has resulted in a diagnostic costs decrease. These savings could be reinvested to test a greater number of patients (53% vs. 75%). Reinvesting the saving would lead to an overall survival gain (+20%). 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 similar to(sic)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 (sic)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.