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

J Genet Couns. 2018 Feb;27(1):131-139. doi: 10.1007/s10897-017-0130-7. Epub 2017 Aug 5.

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™.

Keywords: BRCA1; BRCA2; Companion diagnostics; Genetic counseling; Genetic testing; Olaparib; Ovarian cancer; PARP inhibitor.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Attitude of Health Personnel*
  • BRCA1 Protein
  • Female
  • Genetic Counseling / methods*
  • Genetic Testing / methods*
  • Humans
  • Ovarian Neoplasms / drug therapy*
  • Ovarian Neoplasms / genetics
  • Phthalazines / therapeutic use
  • Piperazines / therapeutic use
  • Poly(ADP-ribose) Polymerase Inhibitors / standards*
  • Professional-Patient Relations

Substances

  • BRCA1 Protein
  • BRCA1 protein, human
  • Phthalazines
  • Piperazines
  • Poly(ADP-ribose) Polymerase Inhibitors
  • olaparib