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Medicare to Cover Myriad Genetics' BRACAnalysis for FDA-Approved CDx Indications

NEW YORK – The Centers for Medicare & Medicaid Services will now cover Myriad Genetics' BRACAnalysis CDx when used to identify prostate cancer patients with germline BRCA1 and BRCA2 mutations who may benefit from the PARP inhibitor olaparib (AstraZeneca/Merck's Lynparza), the company said on Friday.

In May, the US Food and Drug Administration approved olaparib for metastatic castration-resistant prostate cancer patients with germline or somatic mutations in homologous recombination repair genes who have progressed on enzalutamide and abiraterone. The agency simultaneously approved two companion diagnostics that may be used to identify best responders to this drug: Myriad's BRACAnalysis CDx to identify patients with germline BRCA1/2 mutations, and Foundation Medicine's FoundationOne CDx to identify patients with HRR-mutated genes in their tumors. 

Medicare contractors partaking in the MolDx program — Palmetto, CGS Administrators, Noridian, and Wisconsin Physicians Service Insurance Corporation — all recently issued local coverage articles that now list the four tumor types for which olaparib is approved alongside BRACAnalysis CDx as a companion diagnostic, including  breast, ovarian, pancreatic, and prostate cancer. The article also notes that the test is a covered companion diagnostic for not just olaparib in these settings, but other FDA-approved PARP inhibitors, such as talazoparib (Pfizer's Talzenna) and Rubraca (Clovis Oncology's rucaparib), in breast and ovarian cancer.  

"BRACAnalysis CDx is only covered for individuals diagnosed with ovarian cancer, breast cancer, pancreatic cancer, or prostate cancer and who have not been previously tested for BRCA mutations," the coverage article said. "MolDX will allow future FDA-approved and amended indications for this test."