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

CORRESPONDENCE are essential. Increased funding will help but will not be enough. COMPETING FINANCIAL INTERESTS The author declares no competing financial interests. Mark Kessel Mark Kessel is at FIND, Geneva, Switzerland. e-mail: mark.kessel@shearman.com 1. Hwang, T.J., Powers, J.H., Carpenter, D. & Kesselheim, A.S. Nat. Biotechnol. 33, 589–590 (2015). 2. WHO. Global action plan on antimicrobial resistance. (WHO, May 2015). http://www.who.int/drugresistance/ global_action_plan/en/ International Federation of Pharmaceutical Manufacturers & Associations. Rethinking The Way We Fight Bacteria. (IFPMS, April 2015). http://www. ifpma.org/fileadmin/content/Publication/2015/IFPMA_ Rethinking_the_way_we_fight_bacteria_April2015_ FINAL.pdf 4. Davies, S. WISH 2015 policy briefing. Developing an action plan to tackle antimicrobial resistance (AMR): where to start? (World Innovation Summit for Health, 2015). http://dpnfts5nbrdps.cloudfront.net/app/ media/1696 Availability and payer coverage of BRCA1/2 tests and gene panels 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 issue 1 described, despite the increasing use of NGS in clinical practice, regulatory standards remain vague and payers have not adopted clear coding and reimbursement guidelines 1 . 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. For BRCA1/2 testing, the shift toward gene panels has primarily occurred because the US Supreme Court ruled in June 2013 that companies may not patent isolated genes, thus invalidating five patents held by Myriad Genetics (Salt Lake City, UT, USA) and clearing the way for other laboratories to offer tests with the BRCA1/2 genes 2 . Before June 2013, Myriad was the sole provider of BRCA1/2-only tests for clinical use, other than tests limited to single-site analysis, and there were no commercially available BRCA1/2 panels. The analysis of the BRCA1/2 testing landscape presented here is the first since the historic 2013 Supreme Court decision that allowed the entry of new testing providers. We identified commercially available and soon-to-be-available BRCA1/2- only tests and panels and collected data about the price and scope of testing for each. Because access to genetic tests is considerably influenced by insurance coverage 3,4 , we also reviewed publicly available coverage policies from private payers. Although past studies have demonstrated that most payers cover BRCA1/2 testing in indicated populations in accordance with National Comprehensive Cancer Network guidelines 5–7 , coverage policies have not been examined since the launch of new BRCA1/2-only tests and panels to assess whether and how policies have changed. We identified laboratories offering BRCA1/2 tests and panels through test registries and gray literature (the US National Institutes of Health Genetic Testing Registry, http://www.ncbi.nlm.nih.gov/gtr/; Genetests. org, http://genetests.org; the Association for Molecular Pathology Test Directory, http://www.amptestdirectory.org/index.cfm; Myriad’s integrated BRACAnalysis Price ($) npg © 2015 Nature America, Inc. All rights reserved. to collect the data necessary to be certain that appropriate use of antibiotics is included in these programs. It should not be ignored that pharmaceutical companies need to ensure that antibiotic drugs are ethically promoted. Lastly, effective hygiene and infection prevention measures can reduce the incidence of infections 3,4 . If the world health community is to effectively deal with the threat of AMR, then the above proposals should be systematically and seriously addressed. That means that there must be the concurrent political will to implement them. In the absence of effective measures being taken, it has been estimated that a continued rise in resistance would lead by 2050 to 10 million people dying every year and would cost the world up to $100 trillion 3 . Collaboration and commitment BRCA1/2 tests n = 12 Panels n = 26 Figure 1 Pricing for BRCA1/2-only and panel tests. Error bars represent the minimum and maximum values, the boxes show the 25th percentile to 75th percentile and the middle horizontal line shows median value. Two-gene test prices ranged from $500 to $2,895, with a mean price of $1,711 versus $4,040 for Myriad’s standard offering, Integrated BRACAnalysis. Pricing for panels including the BRCA1/2 genes ranged from $1,500 to $6,749 with a mean price of $3,357. Illumina’s TruGenome Predisposition Screen (BRCA gene analysis in a panel of 1,600 genes, $9,500) was excluded as an outlier. VOLUME 33 NUMBER 9 SEPTEMBER 2015 NATURE BIOTECHNOLOGY