FDA Approval of PARP Inhibitors and the Impact on Genetic Counseling and Genetic Testing Practices. Issue 1 (5th August 2017)

• Record Type: Journal Article
• Authors: Buchtel, Kathryn M.; Vogel Postula, Kristen J.; Weiss, Shelly; Williams, Carmen; Pineda, Mario; Weissman, Scott M.
• Is Part Of: Journal of genetic counseling. Volume 27:Issue 1(2018)
• Page Start: 131
• Page End: 139
• Publication Date: 2017-08-05
• Subjects: PARP inhibitor -- Olaparib -- Companion diagnostics -- Genetic counseling -- Genetic testing -- Ovarian cancer -- BRCA1 -- BRCA2; Genetic counseling -- Periodicals; 616.042
• DOI: 10.1007/s10897-017-0130-7
• Languages: English
• ISSNs: 1059-7700

Abstract

Abstract: 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™ (CDx™)) offered exclusively by Myriad Genetic Laboratories. This study explored the impact of PARPi/CDx™ 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™ 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™ testing. Respondents indicated an increase in referral volume following FDA approval of PARPi/CDx™, but did not report changes in testing practices. Respondents were not aware of PARPi insurance coverage denial in the absence of CDx™.