New TRANSPERS Publication in Nature Biotechnology Finds Dropping Prices and Lack of Payer Coverage for Multi-Gene Panels that include BRCA1/2

In recent years, genetic testing for heritable cancer syndromes - such as BRCA1/2 testing for hereditary breast and ovarian cancer - has been shifting from single-gene analysis to multi-gene panels, typically using next-generation sequencing technologies. TRANSPERS collaborators conducted the first review of the BRCA1/2 testing landscape since the historic 2013 Supreme Court decision that allowed the entry of new testing providers, published in the. The manuscript was published in the 9/8/2015 issue of Nature Biotechnology.

We found that the number of BRCA1/2-only tests and panels including BRCA1/2 has increased since June 2013, and average prices have decreased. Although payers cover single gene BRCA1/2 single-gene testing for high risk individuals, many payers consider panels investigational or experimental. 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 panels including BRCA1/2 may be instructive in understanding the evolution of payer coverage policies as other multi-gene panels become more commonly used. TRANSPERS is currently developing a Payer Coverage Policy Registry© that systematically synthesizes payer coverage policies on multi-gene panels in order to be able to assess when payers cover panels, how panels are included in payer policies, and how this is changing over time. Our Registry is unique in its focus on coverage policies, inclusion of a wide range of key factors that influence coverage, and objective analyses by a non-profit academic institution, funded by NIH.

Authors are Elizabeth Clain1, Julia R. Trosman, PhD2,3,4, Michael P. Douglas2, Christine B. Weldon, MBA2,3,4, and Kathryn A. Phillips, PhD1,6

1 Albert Einstein School of Medicine, New York

2UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), the Department of Clinical Pharmacy, University of California, San Francisco (UCSF)

3Center for Business Models in Healthcare, Chicago IL

4Feinberg School of Medicine, Northwestern University

5Department of Medicine, Division of Hematology/Oncology, UCSF

6Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco