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PGX Tests Determined to be Medicially Necessary for Medicare Coverage

GeneDrugUse Description
CYP2C19ClopidogrelIndividuals who are undergoing treatment with clopidogrel and have not been tested or for whom the use of clopidogrel is being proposed
CYP2D6Tetrabenazine (Xenazine)
& eliglustat (Cerdelga)
Persons who have been prescribed doses of tetrabenazine >50 mg per day
& persons with Gaucher disease type 1, being considered for eliglustat treatment
TPMT6-mercaptopurine or azathioprinePrior to initiation of 6-mercaptopurine or azathioprine
HLA-B*1502 Carbamazepine (Tegretol)Persons of Asian ancestry before commencing treatment with carbamazepine
HLA-B*5701 Abacavir (Ziagen)Persons infected with HIV-1 before commencing treatment with abacavir.
KRASCetuximab (Erbitux®) and panitumumab (Vectibix®) Only prior to initiation of epidermal growth factor receptor (EGFR) inhibitor therapies for the treatment of metastatic colorectal cancer
CFTRIvacaftor (Kalydeco, Orkambi)Persons with cystic fibrosis, being considered for ivacaftor treatment
EGFREGFR tyrosine kinase inhibitors (TKIs) To determine a subset of patients with non-small cell lung cancer (NSCLC) who are likely to have a favorable response to EGFR TKIs
BRAF V600E or V600KVemurafenib (Zelboraf) Persons considering vemurafenib for unresectable or metastatic melanoma treatment
ALKCrizotinib (Xalkori)Persons who are considering crizotinib for the treatment of non-small cell lung cancer 
MGMTTemozolomide (Temodar)Predicting response to temozolomide in persons with glioblastoma
NS3 Q80K Simeprevir (Olysio) Persons with hepatitis C virus genotype 1a infection being considered for simeprevir treatment
BRCA Olaparib (Lynparaza) Women with ovarian cancer who have been treated with three or more prior lines of chemotherapy and are being considered for olaparib