PMD97 - Reimbursement Landscape for Molecular Testing in Non-Small Cell Lung Cancer (NSCLC) in the United States

Abstract

Molecular diagnostic testing in non-small cell lung cancer (NSCLC) is rapidly evolving, and medical coverage policies may not reflect current guidelines or scientific and medical consensus. National Comprehensive Cancer Network (NCCN) guidelines for NSCLC support broad molecular profiling and recommend testing for EGFR, ALK, ROS-1, and BRAF mutations. The objective of this study was to evaluate payer medical policies of US healthcare plans to determine whether coverage for molecular testing of common oncogenic genomic alterations changed over an 18-month period. Payer medical policies were identified by searching the websites of US healthcare plans in June 2016 and again 18 months later in December 2017. Medical policies were analyzed for medically necessary coverage of select genomic alterations (EGFR, ALK, BRAF, HER2, KRAS, ROS-1, MET, and RET) in NSCLC. A total of 13 healthcare plans were identified and analyzed. During the 18-month study period 12/13 policies were updated and 1 was unchanged. In June 2016 molecular testing was considered medically necessary in 13/13 policies for EGFR, 12/13 for ALK, 4/13 for ROS-1, 2/13 for each KRAS, HER2, and RET, and 1/13 for each BRAF and MET. In December 2017, coverage was expanded to include molecular testing that was considered medically necessary in 4 additional policies for BRAF, 3 for each ROS-1 and MET, and 1 for each ALK and KRAS. In 2017, the FDA approved additional targeted therapies for NSCLC as well as several multi-analyte panel tests, providing patients with potential new diagnostic and treatment options. Patients are subject to medical policies that may not reflect current recommended testing and treatment options. While coverage expanded for certain genomic alterations in the 18-month study period, health plans are challenged to keep up with rapidly evolving diagnostic technology and practice guidelines.