Coverage of liquid biopsies for cancer care increases greatly over 5 years
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Private and public coverage of liquid biopsy genomic testing for cancer increased significantly between 2015 and 2019, according to results of a retrospective study published in JNCCN — Journal of the National Comprehensive Cancer Network.
“Genomic [circulating tumor DNA] 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,” Michael P. Douglas, MS, program manager for the University of California, San Francisco Center for Translational and Policy Research on Personalized Medicine, said in a press release. “These tests can be used to guide initial therapy, identify relevant clinical trials, and help us understand and tailor therapy based on mechanisms of resistance. However, the emerging use of liquid biopsy tests for cancer screening and early detection — in addition to selecting targeted treatment and monitoring response — will require new assessments to develop appropriate coverage policies.”
Use of liquid biopsies has increased rapidly since 2014, when Guardant Health released the first commercially available test. These tests, which screen circulating tumor DNA (ctDNA) in the blood, generally are used to select targeted therapy and monitor nonresponding or progressive tumors. They also can be used at the time of a cancer diagnosis to identify genomic alterations that can be treated with targeted therapy, as well as to identify therapeutic resistance mechanisms after disease progression or detect recurrence after definitive therapy.
Douglas and colleagues retrospectively reviewed coverage policies for ctDNA-based testing panels in cancer to determine trends between 2015 — when the tests started being covered — and 2019. The analysis included commercially available private payer policies, Medicare, and Medicare Administrative Contractor coverage policies specifically for ctDNA-based panel tests for cancer.
Results showed 38% (n = 28 of 73) of private payer policies provided coverage of liquid biopsies as of July 2019, compared with none at the start of 2016. Private policies, however, appeared to be very specific in terms of coverage, including 87% for non-small cell lung cancer, 47% for EGFR gene testing and 79% for specific brand-name tests.
Researchers found 28 payers had positive coverage policies, including 22 Blue Cross Blue Shield Association plans. Forty-five payers had negative coverage policies, including 25 Blue Cross Blue Shield Association plans. One-third (33%) of private payers had explicitly positive or negative coverage policies.
Additionally, researchers found eight final, two draft and two future effective final local coverage determinations that cover non-FDA-approved ctDNA-based tests. The draft and future effective determinations were the first policies to cover pan-cancer use.
Four Medicare Administrative Contractors issued final local coverage determination policies for ctDNA-based panel tests for NSCLC — in 2018 for Guardant360 (Guardant Health) and in 2019 for InVisionFirst (Inivata).
The fact that researchers did not include Medicaid policies, as well as Canary Insights Database not including all policies from all private payers in the United States, served as limitations to this study.
“We think that the increased coverage, especially Medicare coverage of pan-cancer use, will expand the use of liquid biopsies in clinical practice in the future,” Douglas said in the press release. “The hope is that results in more targeted care with better treatment and diagnostic options, leading to long-term benefits.”
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