OBJECTIVES : The US Supreme Court ruled in 2013 that isolated human genes cannot be patented. The US BRCA 1/2 testing landscape changed with more test companies entering the market and competing with Myriad, the sole BRCA-testing company over previous 17 years. The objective of this study was to estimate BRCA test utilization rates and costs from 2007-2016 and update previously published estimates.

METHODS : We conducted a retrospective descriptive analysis using the Truven Health Analytics Marketscan Databases. We identified women, 18 -64 years old, who had any BRCA1/2 testing claim between January 1, 2007 to December 31, 2016. We utilized both the inpatient and outpatient databases and restricted our study sample to full-year enrollees only. We collected the demographics and total allowable charges (health plan payments, expected out-of-pocket payment) and estimated annual BRCA utilization rates and reimbursements by type of genetic test and age categories.

RESULTS : We identified 221,867 women (out of 119,540,566 women aged 18-64 years) who underwent BRCA testing between 2007 and 2016. Approximately, 95% of BRCA tests were full gene sequencing and the annual rates of BRCA testing were 61.5 and 299.0 per 100,000 person-years in 2007 and 2016, respectively. Each year the BRCA testing rates were lowest among the 18-34-year women and highest among 45-54-year category. Median test costs were $2964 and $2195 in 2007 and 2016, respectively and 28% and 15% women paid any out-of-pocket cost in 2007 and 2016, respectively.

CONCLUSIONS : BRCA testing rates were higher and testing costs were lower post-2013. These findings are consistent with hypothesized changes due to the Supreme Court ruling. However, we caution that these are descriptive results and should not be interpreted as causal. Other factors including celebrity endorsement (i.e. the Angelina Jolie effect) happened at the same time and may have contributed to increased uptake of BRCA post-2013.