Insurance Coverage Policies for Guideline-Recommended Genetic Testing for Targeted Cancer Therapies: Preliminary Results

Background/Aims: Modern medicine is transitioning from empirical treatment to treatment on the basis of the underlying biology of the disease through the use of genomics-based technologies. Genomic tests are the fastest growing sector of medicine and medical science and have the potential to improve clinical practice. This study examined differences in patient access to guideline-recommended genetic tests that guide cancer treatment. Methods: We reviewed publicly available coverage policies for 20 gene-cancer drug pairs (e.g. HER2, EFGR, BRAF tests), including 10 large private insurers and 12 Medicare contractors. We searched gene and drug names and key terms including gene, genomic and biomarker. We reviewed and extracted the following features: type of policy (gene-specific, drug-specific, generic policy for genetic testing); medical condition for which the test is covered; requirements for prior authorization; test methods and test result definition; and evidence basis for coverage. Results: Across 10 private insurers, we identified 18 gene-specific policies, 63 drug-specific policies, 41 prior authorization requirements (for genetic test, drug or both) and 16 general policies for groups of genetic tests. Overall, some insurers have established gene-specific coverage policies that guide use of such tests, while most relied on policies guiding coverage of genetic testing more generally that may or may not include guideline-recommended genetic tests of interest. A few insurers only have drug coverage policies, and some of these did not recommend use of evidence-based genetic testing. Further analysis of policies is underway. Conclusion: These preliminary findings of substantial variation in how insurers address guideline-recommended genetic tests underscore the need for additional research into the impact of these variations on cancer care and utilization