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

Luciene Schluckebier,Rosangela Caetano,Giuliana T Montenegro,Marcelo Custodio,Osvaldo Ulises Garay,Carlos Gil Ferreira,Veronica Aran

doi:10.1186/s12885-020-07240-2

Abstract

BackgroundThe 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.MethodsThe 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.ResultsThe 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.ConclusionOur 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.

Highlights

The treatment of choice for advanced non–small cell lung cancer is selected according to the presence of specific alterations
Our analysis show that the nextgeneration sequencing (NGS) strategy was not cost-effective compared to the others, it displayed a higher probability of correct diagnoses with 96.3% when compared to 72.6% for strategy 2 and 68% for strategy 1
NGS resulted in 34 inconclusive tests, and strategy 2 with Epidermal Growth Factor Receptor (EGFR) mutation kit resulted in 130 inconclusive cases, plus 55 inconclusive cases for In situ hybridization (FISH)

Summary

Introduction

The treatment of choice for advanced non–small cell lung cancer is selected according to the presence of specific alterations. The Epidermal Growth Factor Receptor (EGFR) was the first antigenic target used as a guideline for targeted lung cancer therapy, followed by other targeting markers, such as KRAS (Kirsten rat sarcoma viral oncogene homolog) and fusion of EML4-ALK1 (echinoderm microtubule-associated protein-like 4 – anaplastic lymphoma kinase), along with other ongoing clinical trials, such as MET, BRAF, RET (Echinoderm Microtubule Associated Protein like 4-AL-Kinase 1) and ROS1 (receptor tyrosine kinase 1) [4]. These genes are frequently mutated in non-small cell lung cancer (NSCLC) with variable frequencies: EGFR [5, 6], ALK [7]; ROS1 [8, 9] and RET [10]. This might occur since less accurate tests might lead to inadequate results, ineffective therapy, and lost time and resources

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Results

Discussion

Conclusion