Ventana ALK (D5F3) Test Cost & Procedure

Background

The Italian Drug Agency instructed a testing technique established on the usage of flu

FISH and IHC to assure designation of ALK+ patients. The objective was to assess the clinical and financial impacts of using an immunohistochemistry test (Ventana ALK D5F3) as a potential method for identifying patients with advanced non-small cell lung cancer (NSCLC) who express the ALK protein.

Materials and Methods

The Italian NHS philosophy was utilized to develop a an economic consequence prototype that distinguished two strategies: the existing usage of D5F3 (28%; current scenario) and boosting usage of D5F3 (60%; alternative scenario). The price of the test as well as the quantity and price of the detected ALK+ patients were assessed.

Results

When all advanced NSCLC patients were taken into account, the alternative scenario's more extensive usage of D5F3 resulted in a 468,000 drop in diagnostic expenses as compared to the current scenario. If these savings were used to test more NSCLC patients (75% vs. 53%), an additional 63 dollars would be needed for each patient who was diagnosed as having ALK+, resulting in an increase in overall survival for the alternative scenario compared to the current situation.

Conclusion

Because D5F3 has a lower acquisition cost than FISH and a similar detection rate, using it would save money for the NHS. By using the savings to test more patients, it would be possible to identify ALK+ patients more quickly, employ targeted therapy more effectively, and enhance their clinical results.

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

Introduction

One of the most prevalent tumor types—lung cancer, which accounts for 11% of all cancer cases diagnosed in Italy—is also the top cause of cancer death for both men and women. Small-cell lung cancer and non-small-cell lung cancer are the two central varieties of lung cancer. The antidote of NSCLC has undergone a a considerable paradigm transition in contemporary years.

NSCLC can now be divided into subgroups based on histologic characteristics and driver mutations, if known or present. Relevant efforts have focused on the identification of EGFR mutations and the aberrant fusion of anaplastic lymphoma kinase throughout the past ten years (ALK). According to estimates, 4% of NSCLCs will contain an ALK gene rearrangement.

Most frequently, nonsmokers (or light smokers) with NSCLC adenocarcinomas exhibit this genetic rearrangement. The aberrant ALK protein that results from the ALK gene rearrangement drives the cells to proliferate and spread. Crizotinib, the only ALK-targeted therapy currently authorized in Italy, has recently received an extension of reimbursement for the treatment of newly diagnosed ALK+ NSCLC patients. The detection of an ALK mutation is essential for treating NSCLC patients with crizotinib.