Payors Gradually Increasing Coverage of Liquid Biopsies but Obstacles Remain

Gaining the acceptance of insurers and payors for new tests and testing technology is a perennial challenge for laboratories and test developers. This has been especially true with liquid biopsy cancer testing, for which positive coverage determinations have been few and typically restricted to particular types of cancer. However, a new study suggests that payor attitudes have changed significantly in recent years. Here is a look at the progress that has been made and the obstacles that laboratories and test makers must still be overcome to maximize coverage of liquid biopsy cancer testing.

The Diagnostic Challenge

Blood-based circulating tumor DNA (ctDNA) sequencing tests, often referred to as “liquid biopsy tests,” are used to select targeted cancer therapy and monitor nonresponding or progressive tumors. Although somatic (tumor) testing is usually performed on resected biopsy specimens, ctDNA tests can be used at the time of a cancer diagnosis to identify genomic alterations that may be effectively treated using targeted therapies. ctDNA tests are frequently used after a patient experiences disease progression on targeted therapy to determine the mechanism of therapeutic resistance, as well as after definitive therapy to detect recurrence.

Utilization of ctDNA tests has increased rapidly since 2014 when Guardant Health launched the first commercially available product for cancer. However, as with any new test, payor coverage plays a crucial role in determining patients’ access to and utilization of ctDNA testing. Even so, nobody had ever done a study to analyze historical and current coverage of private and Medicare policies for ctDNA-based panel tests.

The ctDNA Cancer Coverage Study

The void in historical analysis of payor coverage of ctDNA cancer testing has now been filled, thanks to a new study in Journal of the National Comprehensive Cancer Network. Researchers from the University of California, San Francisco and City of Hope, reviewed data on both private and public payor coverage policies for ctDNA-based testing panels in cancer over a four-year period, from 2015 to 2019.

The researchers used the Canary Insights Database, a public library of more than 40,000 medical policies from commercial and public payers, to track private payor policies, Medicare National Coverage Determinations (NCDs) and Medicare Administrative Contractor (MAC) Local Coverage Determinations (LCDs). The authors note that the Canary Insights Database includes data from more than 200 payors, which makes it possible to analyze payment policies covering approximately 75 percent of the US population.

The Study Findings

The researchers found steady growth in both public and private payor coverage. Thus, at the start of 2016, not a single payor in the database provided coverage for liquid biopsies. However, by mid-2019, 65 private payors and 4 MACs had published policies about ctDNA testing, an increase in the coverage rate of 38%. Medicare policies specifically expanded from no LCDs for the use of ctDNA-based cancer panel tests in 2017 to eight final LCDs, two draft LCDs, and two future effective final LCDs in 2019.

Additionally, although there have not yet been any NCD policies issued explicitly providing coverage for ctDNA-based panel tests, CMS’s NCD on sequencing for advanced cancer includes ctDNA-based panel test coverage if the test is FDA-approved. There are currently no FDA-approved ctDNA-based panel tests, but several companies, including Guardant Health, Foundation Medicine, Personal Genome Diagnostics and Resolution Biosciences, have said they are bringing their products through FDA review.

The study authors also reported that individual coverage policies appear to have become more expansive from 2017-2019. In terms of tumor types covered, for example, there was a shift from just a single type (non-small cell lung cancer) to 12 solid and hematologic cancers by the end of the study period. Early coverage decisions, which were limited to a single gene, EGFR, have also transitioned to current coverage of multi-gene tests like Guardant’s 73-gene panel.

The study also found that policies for liquid biopsy have trended in recent years from mainly cancer-specific indications to more agnostic use, mirroring the increasing emphasis on pan-cancer genotyping that has occurred for more traditional, tissue-based genomic tests.

Conclusions

The first and only study on the subject finds that both public and private coverage of liquid biopsy tests has grown significantly in recent years but that notable limitations remain, including policies that restrict testing to specific genes or endorse only certain branded test technologies.

The stakes are incredibly high. Growth and adoption of ctDNA-based testing for cancer is expected to increase, as is the number of genes included in the test. In addition, utilization of such testing is increasing beyond the targeting of cancer treatments to include the early detection of cancer in healthy populations. Payor coverage policies will go a long way in determining patient access to these new products and applications.