CMS releases pharmacogenetic marker report

The Centers for Medicare & Medicaid Services released a technology assessment that reviewed published literature to assess the benefits and harms of three pharmacogenetic tests that predict response to cancer therapy. The report evaluated cytochrome P450 2D6 (CYP2D6) to predict response to tamoxifen to treat breast cancer, K-Ras (KRAS) to predict response to Erbitux cetuximab and Vectibix panitumumab to treat colorectal cancer, and BCR- ABL1 to predict response to Gleevec imatinib, Sprycel dasatinib, and Tasigna nilotinib for chronic myelogenous leukemia (CML). CMS said the report may be used as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies.

CMS said there were no consistent associations between CYP2D6 polymorphism status and outcomes in tamoxifen-treated women with breast cancer across the 16 studies included in its review. For K-Ras, the researchers found wild-type K-Ras was associated with positive treatment outcomes. Additionally, the report noted that while any BCR-ABL1 mutation did not predict differential response to tyrosine kinase inhibitors, the rare T315I mutation was predictive of treatment failure, mainly in terms of hematologic and cytogenetic response. CMS requested the report from the Agency for Health Care Research and Quality (AHRQ). ...