The use of liquid biopsy to detect circulating tumor DNA (ctDNA) to help guide treatment and monitor responses to therapy has increased sharply over recent years. A new study finds that while insurance coverage from private payers and Medicare has also risen and expanded in the types of tests covered, it has not kept pace with most limiting the type or scope of tests covered. At the start of the study in 2016, no payers covered ctDNA tests. By mid-2019, nearly 40 percent offered some coverage.

The study examined trends from 2015 to 2019, with 2015 being the first instance of an available payer coverage policy. Findings from the study are published in a paper in JNCCN.

The researchers used the Canary Insights Database (CID) to analyze private, commercially available payer coverage policies. The CID is a medical policy library containing >40,000 medical policies from >200 commercial payers and links to public payer policies with >100,000 members.

For public policies, they reviewed Medicare plans.

They found that no provider covered liquid biopsies in 2015 and 2016. But by mid-July 2019, 38% (28/73) of private payer policies provided coverage of ctDNA-based panel testing for some clinical indications. Of the 200 payers in the Canary Insights Database, 33% of private payers had explicitly positive or negative coverage policies.

Over that time frame, policies also increased in scope from 2017-2019, going from one cancer type (non-small cell lung cancer, or NSCLC) to 12, and going from a single gene (EGFR) to 73 genes. They also found 45 payers with specific policies against coverage. Medicare coverage policies were found to be evolving toward use across all cancer types, signifying a major shift.

Loopholes Found

While the authors found increasing coverage for ctDNA panel testing, they also found that some policies were written with carefully-defined and limited clinical scenarios such as EGFR gene analysis for non-small cell lung cancer (NSCLC) or specific brand name tests (e.g. Guardant 360 or InVisionFirst). And coverage differed depending on the intended use and from state to state.

By mid-2019, of the policies covering ctDNA tests, 87% (24/28) were for NSCLC only, not surprising since the only FDA-approved ctDNA test is for NSCLC. Nearly half (47%; 13/28) were written for  EGFR gene analysis only.

Further, nearly 80 percent (22/28) named coverage only for specific tests (cobas EGFR Mutation Test v2, Guardant360, or OncoBEAM). Also, of all of the ctDNA coverage policies, just 11% (3/28)  stated coverage for monitoring (e.g., no prior testing and progression, or progression on tyrosine kinase inhibitors).

One of the most interesting findings was in the case of EGFR gene analysis, in which 43% (12/28) payers stated that multigene panel tests (Guardant360 and OncoBEAM) would be a covered benefit for EGFR gene analysis only. Given that tests such as these are panel tests that evaluate multiple genes, the “limited” coverage decision may actually result in testing that is far more comprehensive than intended.

Push for expanded coverage

While most ctDNA policies had specific limitations, the study revealed Medicare coverage policies were evolving to pan-cancer uses, signifying a significant shift toward broader coverage. In comparison, private payer policies vary widely from covering just a specific condition, gene or test to others that are more inclusive. And some policy exclusions do not match current standard of care treatment guidelines for all possible testing environments.

As an example, although ctDNA testing in NSCLC is ‘covered’ by  both private payers and Medicare, the coverage has been primarily for treatment selection, with only 11% of payers with positive coverage including any monitoring indications.

Because of these pockets of inconsistent or dropped coverage, the authors strongly push for payers and policymakers to approve policies that keep up with the advances made in molecular profiling and clinical care. They especially look for expanded policies for monitoring of minimal residual disease after therapy or for detecting recurrence.