Cost-effectiveness analysis comparing companion diagnostic tests for EGFR, ALK, and ROS1 versus next-generation sequencing (NGS) in advanced adenocarcinoma lung cancer patients

Abstract

Background The treatment of choice for advanced non–small cell lung cancer is selected according to the presence of specific alterations. Patients should undergo molecular testing for relevant modifications and the mutational status of EGFR and translocation of ALK and ROS1 are commonly tested to offer the best intervention. In addition, the tests costs should also be taken in consideration. Therefore, this work was performed in order to evaluate the cost-effectiveness of a unique exam using NGS (next generation sequencing) versus other routinely used tests which involve RT-PCR and FISH. Methods The target population was NSCLC, adenocarcinoma, and candidates to first-line therapy. Two strategies were undertaken, strategy 1 corresponded to sequential tests with EGFR RT-PCR, then FISH for ALK and ROS1. Strategy 2 differed from 1 in that ALK and ROS1 translocation testing were performed simultaneously by FISH. Strategy 3 considered single test next-generation sequencing, a platform that includes EGFR, ALK and ROS1 genes. A decision tree analysis was used to model genetic testing options. From the test results, a microsimulation model was nested to estimate survival outcomes and costs of therapeutic options. Results The use of NGS added 24% extra true cases as well as extra costs attributed to the molecular testing. The ICER comparing NGS with sequential tests was US$ 3479.11/correct case detected. The NGS improved a slight gain in life years and QALYs. Conclusion Our results indicated that, although precise, the molecular diagnosis by NGS of patients with advanced stage NSCLC adenocarcinoma histology was not cost-effective in terms of quality-adjusted life years from the perspective of the Brazilian supplementary health system.

Budget Impact Analysis of Comprehensive Genomic Profiling in Patients With Advanced Non–Small-Cell Lung Cancer

“…The second CEA that we identified was developed from the Brazilian payer perspective; thus, it is difficult to compare and contrast costs directly. 65 In addition, the two CEA models were state-transition models; consequently, we would caution against comparison of the results of our model. In the third economic study that we identified, a budget impact analysis was developed from the Canadian perspective and used a model structure similar to that used in our analysis.…”

Vasculogenic mimicry, a negative indicator for progression free survival of lung adenocarcinoma irrespective of first line treatment and epithelial growth factor receptor mutation status

“…Whether anti-angiogenesis therapy could improve the prognosis of patients with VM remains to be determined. Now in the world, especially in developing countries, the public health burden caused by cancer is relatively heavy [35]. However, because of the advantages of targeted therapy in perfect disease control and diseasefree survival in lung adenocarcinoma, many guidelines still recommend TKIs as the first-line treatment in EGFR mutated NSCLC [36].…”

Companion Diagnostics: State of the Art and New Regulations

“…Technical limitations of these platforms and the restrictions imposed by the limited amount of material obtained from biopsies resulted in the development of parallel multi-genic DNA sequencing platforms, such as next-generation sequencing (NGS), which enable the simultaneous analysis of hundreds of genetic alterations in a single test. 36 - 39 The first FDA-approved assay based on NGS was the FoundationFocus CDx BRCA Assay for the detection of BRCA1 and BRCA2 alterations in tissues from ovarian cancer patients potentially eligible for treatment with rucaparib (Rubraca). In 2017, the FDA approved FoundationOne CDx (Foundation Medicine) as the first FDA-approved comprehensive genomic profiling (CGP) assay for all solid tumors incorporating multiple companion diagnostics.…”