Molecular Testing Coverage Decisions in Lung Cancer
Bhuvana Sagar, MD: Genetic testing, in lung cancer, that looks for mutations is a hot area of research at this time. We cover testing when the end result is tied to drug policy coverage. So, if the mutation requires broad-based next-generation sequence mutation testing, where multiple genetic tests are being done at the same time and the test results are not directly tied to a drug approval in that particular setting, we do not cover that testing. The reason is that there are several mutation studies that can be done. The quality of these need to be verified. Interpretation of those test results also has to be verified, and several providers, at this time, do not have a clear understanding of how to interpret those tests and tie them to treatment decisions. At this point in time, we don’t have enough evidence to support multiple genetic mutation studies where there’s no clear evidence of benefit in that particular tumor.
If a drug is approved along with companion diagnostic testing, we cover the companion diagnostic testing. And we typically cover the drug therapy when the test results or test mutation is positive. It is not a very complicated decision for us. When the FDA typically approves it, we generally cover it. At Cigna, we do not cover tests at this time just for clinical trial enrollments. We have looked at that approach, but we feel that, in general, our coverage policy has always been directed to cover tests and treatments that have enough clinical trial evidence to support [their] clinical utility or benefit in that particular setting. So, we do not cover tests where that clinical utility has not been clearly defined.