Payer Coverage for Liquid Biopsies Improves, but Gaps Remain, Study in JNCCN Finds

The role of circulating tumor DNA (ctDNA) in cancer care has advanced quickly over the past 5 years, allowing doctors to select targeted therapies or identify why treatments aren’t working. In some ways, payer coverage has followed—but it has lagged in important ways, according to research published today in JNCCN—the journal of the National Comprehensive Cancer Network (NCCN).

JNCCN is the official journal of NCCN, a group of cancer centers that develops treatment guidelines that are considered the “gold standard” for payers.

Because coverage for ctDNA-based testing panels, also known as “liquid biopsies,” can dictate access, authors from the University of California at San Francisco and City of Hope in Duarte, California, wanted to examine how coverage had changed over time as clinical adoption increased.

Using the Canary Insights Database to analyze 40,000 medical policies from both commercial and public payers, the authors found that coverage increased 38% between January 1, 2015, and July 1, 2019. The authors are Michael P. Douglas, MS, Department of Clinical Pharmacy, UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS); Stacy W. Gray, MD, Department of Population Sciences and Department of Medical Oncology and Therapeutics Research, City of Hope, Duarte; and Kathryn A. Phillips, PhD, Department of Clinical Pharmacy, TRANSPERS.

Highlights of their findings include:

• None of the policies provided coverage in 2016, and 38% did by mid-2019.
• The scope of policies increased from a single cancer type in 2017 to 12, and from a single gene to 73 genes.
• The review found a trend toward use of testing across all cancer types, which is an important shift.
• Researchers also found 45 payers with specific policies barring coverage.

“Genomic ctDNA or liquid biopsy tests hold great potential to improve patient outcomes although, as with any emerging test, it can be challenging to develop the most appropriate coverage policies,” Douglas said in a statement. “We think that the increased coverage, especially Medicare coverage of pan-cancer use, will expand the use of liquid biopsy in clinical practice in the future. The hope is that results in more targeted care with better treatment and diagnostic options, leading to long term benefits.”

The investigators noted a difference between the highly specific nature of policies in private plans compared with draft and future effective local coverage determinations, with Medicare Administrative Contractors, which are the policies that will cover Medicare beneficiaries, that cover testing across different cancer types, or “pan-cancer use.” Among the private plans, 87% were for non—small cell lung cancer, 47% were for EGFR testing, and 79% were for specific brand-name tests.

The authors describe the “conundrum” in payer coverage given how these blood-based tests are used. The ctDNA test can be used both at the time of diagnosis to find genomic alterations to direct targeted therapy and if the disease progresses to determine “the mechanism of therapeutic resistsance.”

A blood-based assay is faster and easier than a tissue-based test, and sometimes tissue based tests are unavailable, the authors wrote.

They concluded, “Given that genomic medicine is rapidly changing, payers and policymakers (eg, guideline developers) will need to continue to evolve policies to keep pace with emerging science and standards in clinical care.”

“The NCCN Guidelines for Non-Small Cell Lung Cancer currently state that ctDNA testing can be considered for monitoring purposes when a patient with a confirmed lung cancer diagnosis is Medically unfit for invasive tissue sampling,” said David S. Ettinger, MD, of The SidneyKimmel Comprehensive Cancer Center at Johns Hopkins,who chairsNCCN’s Guideline Panelfor Non-Small CellLung Cancer. Ettinger was not involved with this study.

“While coverage is expanding, it still takes too long to adapt policies which often vary from state to state,” he said. We recommend specific testing be conducted as part of a broad molecular profiling, at least for advanced or metastatic disease.”

Ettinger said a liquid biopsy can take less time than a diagnosis based on a tissue sample, and if positive, the liquid results are “unambiguous,” and can direct clinical decision making. If negative, there is a 30% chance the ctDNA results are not accurate and then a tissue sample should follow.

“I agree with the authors’ conclusions that payers and policymakers need to approve policies that keep up with the advances made in molecular profiling and clinical care in order to improve care for people with cancer,” Ettinger said.

Reference

Doulgas MP, Gray SW, Phillips KA. Private payer and Medicare coverage for circulating tumor DNA testing: a historical analysis of coverage policies from 2015 to 2019. J Natl Compr Canc Netw 2020;18(7):866-872. doi:10.6004/jnccn.2020.7