FDA Approval of PARP Inhibitors and the Impact on Genetic Counseling and Genetic Testing Practices

In December 2014, the FDA approved olaparib, a poly(ADP-ribose) polymerase inhibitor (PARPi) for ovarian cancer patients who have failed three or more lines of chemotherapy and have a germline BRCA1/2 mutation identified through a companion diagnostic test (BRACAnalysis CDx (TM) (CDx (TM))) offered exclusively by Myriad Genetic Laboratories. This study explored the impact of PARPi/CDx (TM) on genetic counselors' (GCs) counseling and testing practices. One hundred twenty three GCs responded to an online survey regarding pre- and post-FDA approval referral patterns, testing strategies/influences, and anecdotal experiences with insurance coverage of PARPi for BRCA1/2 positive patients through a non-CDx (TM) platform. Following PARPi approval, 40% of respondents reported an increase in overall referrals of ovarian cancer patients and 20% had an increase in post-test counseling only referrals. The majority (61.9%) of respondents reported no change in genetic testing strategy, and there was no change in factors influencing choice of testing laboratory. Nearly all (98.1%) respondents who had experience with insurance covering PARPi indicated approval with mutations identified via non-CDx (TM) testing. Respondents indicated an increase in referral volume following FDA approval of PARPi/CDx (TM), but did not report changes in testing practices. Respondents were not aware of PARPi insurance coverage denial in the absence of CDx (TM).