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Availability and payer coverage of BRCA1/2 tests and gene panels

Nature Biotechnology volume 33, pages 900–902 (2015)Cite this article

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To the Editor:

In recent years, genetic testing for heritable cancer syndromes has been shifting from single-gene analysis to multigene panels, typically using next-generation sequencing (NGS) technologies. As a correspondence in your October issue1 described, despite the increasing use of NGS in clinical practice, regulatory standards remain vague and payers have not adopted clear coding and reimbursement guidelines1. To help clarify the impact of these issues on the availability of testing, we review pricing and payer coverage of BRCA1/2 tests (providing determination of the entire nucleotide sequence for the BRCA1 and BRCA2 genes) and panels containing BRCA1/2 ('panels'). We find that the number of BRCA1/2-only tests and panels has increased since June 2013, and average price has decreased. Even so, many payers consider panels investigational or experimental, although they have positive coverage policies for BRCA1/2 testing. Although 76% of payers have coverage policies about panels, none of these policies provides positive coverage. Of payers with policies on panels, most (77%) consider panels investigational or experimental, and the remainder limits coverage to those panels on which all the genes are considered medically necessary. The experience with BRCA1/2 may be instructive in understanding the evolution of testing and payer coverage toward multigene panels in other indications as well, particularly those with a substantial patient population eligible for testing.

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Figure 1: Pricing for BRCA1/2-only and panel tests.

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Acknowledgements

This study was partially funded by a National Human Genome Research Institute grant to K.A.P. (R01HG007063), a National Cancer Institute grant to the University of California at San Francisco (UCSF), Helen Diller Family Comprehensive Cancer Center (5P30CA082013-15) and the UCSF Mount Zion Health Fund. E.C. received Summer Research Fellowship funds from the Albert Einstein College of Medicine in support of this study.

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Authors and Affiliations

  1. Albert Einstein College of Medicine, Bronx, New York, USA

    Elizabeth Clain

  2. Center for Business Models in Healthcare, Chicago, Illinois, USA

    Julia R Trosman & Christine B Weldon

  3. Department of Clinical Pharmacy, University of California at San Francisco, Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), San Francisco, California, USA

    Julia R Trosman, Michael P Douglas, Christine B Weldon & Kathryn A Phillips

  4. UCSF Philip R. Lee Institute for Health Policy and UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, USA

    Kathryn A Phillips

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  1. Elizabeth Clain
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  2. Julia R Trosman
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  4. Christine B Weldon
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  5. Kathryn A Phillips
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Corresponding author

Correspondence to Kathryn A Phillips.

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Competing interests

K.A.P. has received honoraria for speaking at a professional conference session sponsored by Invitae. Disclosures have been reviewed by the University of California, San Francisco. J.T. and C.W. both received funding from an unrestricted grant from Myriad Genetics.

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Clain, E., Trosman, J., Douglas, M. et al. Availability and payer coverage of BRCA1/2 tests and gene panels. Nat Biotechnol 33, 900–902 (2015). https://doi.org/10.1038/nbt.3322

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