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

Abstract

Patients with anaplastic lymphoma kinase-positive (ALK D) advanced nonesmall-cell lung cancer should benefit from targeted therapy. The effect of increased use of an immunohistochemical technique was estimated using a health careeeconomics 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 (D20%). Background: To ensure identification of anaplastic lymphoma kinase-positive (ALK þ) 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 nonesmall 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 þ patients were evaluated. Results: A more extensive use of D5F3 in the alternative scenario showed a decrease in diagnostic costs of wV468,000 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 þ patient of V63 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 þ patients.

Full cost of diagnostic pathology for lung carcinoma in Italy: results from four Pathology Units

“…The relationship between NSCLC tissue sample processing and labour intensity in the Italian setting was previously highlighted 16 , 17 .…”

“…A 5-year budget impact analysis proved the Ventana ALK (D5F3) CDx assay to reduce the oncologists’ work load in detecting ALK positive NSCLC patients eligible to crizotinib 16 .…”

Clinical and economic impact of current ALK rearrangement testing in Spain compared with a hypothetical no-testing scenario

“…Doshi et al [ 10 ] concluded that both in the United States (U.S.) and Europe, ALK testing only by IHC is the lower-cost strategy compared with using only FISH, reflex testing, or performing both tests in parallel. Paolini et al [ 13 ] assessed the clinical and economic benefits of using IHC for ALK rearrangement testing in Italy, and concluded that increased use of D5F3 would provide savings of € 468,000, due to its lower acquisition cost compared with FISH and a comparable detection rate. Lu et al [ 60 ] evaluate the cost-effectiveness of the ALK tests followed by crizotinib compared to the standard chemotherapy in advanced NSCLC from the Chinese healthcare system perspective.…”

“…For some years, FISH has been the reference standard for detecting tumors carrying ALK rearrangement. However, growing evidence has shown that IHC testing is an efficient tool in the detection of ALK rearrangement, and confirmation of positive results by FISH is no longer needed [ 10 , 13 ].…”

Clinical Impact of two Different Diagnostic Strategies in the First- and Second-Line Treatment of Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

“…Since they were not present in the literature, it was not possible to compare these results with those of other evaluations, with the sole exception of those of a recent study conducted on the determination of the ALK mutation in NSCLC patients [30]. According to the authors, a greater use of a specific immunohistochemical test (Ventana ® ), compared to other tests and FISH, would allow to increase the correct identification of the ALK+ mutation, with a consequent increase in the overall survival from 27.1 months to 32.4 months.…”