Genetic Testing for Pharmacogenetics

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Genetic Testing for Pharmacogenetics MP9479 Covered Service: Yes when meets criteria below Prior Authorization Required: Yes-as shown below (1.0 and 3.

1 Genetic Testing for Pharmacogenetics MP9479 Covered Service: Yes when meets criteria below Prior Authorization Required: Yes-as shown below (1.0 and 3.0) Additional Information: None Prevea360 Health Plan Medical Policy: 1.0 Pharmacogenetic testing requires prior authorization through the Quality and Care and is medically necessary when EITHER of the following criteria have been met: 1.1 The individual is a candidate for a targeted drug therapy associated with a specific genotype, AND The results of the pharmacogenetics test will directly impact clinical decision-making and clinical outcome for the individual, AND Published, peer-reviewed studies have proven that identifying the specific genetic variant improves clinical outcomes. 1.2 Identification of the genetic variant is required prior to initiating therapy with the target drug as noted by the U.S. Food and Drug Administration (FDA) approved prescribing label. 2.0 Multi-gene pharmacogenetics genotyping assays that do not meet the above criteria are considered experimental and investigational and therefore are not medically necessary. 3.0 The following pharmacogenomic tests require prior authorization and are considered medically necessary when the criteria in either 1.1 or 1.2 have been met: 3.1 One genotyping for CYP2C19 polymorphisms for persons who have been prescribed PLAVIX (clopidogrel). Repeat CYP2C19 genotyping has no proven value; 3.2 One genotyping for CYP2D6 polymorphisms for persons who have been prescribed doses of XENAZINE (tetrabenazine) greater than 50 mg per day. Repeat CYP2D6 genotyping has unproven value. 3.3 One genotyping for CYP2D6 polymorphisms for persons with Gaucher disease type 1 who are being considered for treatment with CERDELGA (eliglustat). Repeat CYP2D6 genotyping has no proven value. Genetic Testing for Pharmacogenetics 1 of 6 Underwritten by Dean Health Plan, Inc.

2 3.4 Genotyping for HLA-B 1502 for persons with Asian ancestry before starting treatment with TEGRETOL (carbamazepine), DILANTIN (phenytoin), or CEREBYX (fosphenytoin). 3.5 HLA-B for persons who are infected with HIV-1 before starting treatment with ZIAGEN (abacavir). 3.6 BRAF V600E mutation (the cobas 4800 BRAF mutation test) for person who are considering ZELBORAF (vemurafenib) for the treatment of unresectable or metastatic melanoma. 3.7 CFTR gene testing for persons with cystic fibrosis who are being considered for treatment with KALYDECO (ivacaftor). 3.8 CFTR gene testing for persons with cystic fibrosis who are being considered for treatment with ORKAMBI (lumacaftor/ivacaftor). 3.9 Anaplastic lymphoma kinase (ALK) fusion gene (e.g. the Vysis ALK Break Apart FISH Probe Kit) for persons who are considering XALKORI (crizotinib) or ZYKADIA (ceritinib) for the treatment of non-small cell lung cancer (NSCLC) MGMT (O(6)-methylguanine-DNA methyltransferase) gene mutation assay for predicting response to TEMODAR (temozolomide) in persons with glioblastoma The THxID BRAF test for detecting mutation of the BRAF gene (V600E or V600K) in persons with unresectable or metastatic melanoma who are being considered for treatment with TAFINLAR (dabrafenib), or MEKINIST (trametinib) Testing for the presence of virus with the NS3 Q80K polymorphism for persons with hepatitis C virus (HCV) genotype 1a infection being considered for treatment with OLYSIO (simeprevir) Genotyping for HLA-B 58:01 prior to starting allopurinol therapy Warfarin Pharmacogenetics - CYP2C9, CYP4F2, and VKORC1 Genes testing may be indicated when ALL of the following are present Age 18 years and older; AND Venous thromboembolism prophylaxis with warfarin planned for elective hip or knee arthroplasty; AND No known bleeding disorder or thrombophilia. 4.0 The following tests are considered experimental and investigational and therefore are not medically necessary: 4.1 CYP2D6 genotyping for predicting response to beta blockers 4.2 CYP2D6 genotyping for individual s with Alzheimer s disease 4.3 UGT1A1 molecular assay Genetic Testing for Pharmacogenetics 2 of 6 Underwritten by Dean Health Plan, Inc.

3 4.4 Apolipoprotein E (ApoE) 4.5 MTHFR genotyping 4.6 Measurement of thromboxane metabolites in urine (e.g. AspirinWorks) 4.7 rs allele 4.8 Area under the curve (AUC)-targeted 5-fluorouracil dosing (e.g. Myriad Genetics OnDose) 4.9 IL28B gentotyping 4.10 Psychotropic Medication Pharmacogenetics Gene Panel (e.g. GeneSight Rx) 4.11 Platelet reactivity/function testing (VerifyNow P2Y12 Assay, Ultegra System Rapid Platelet Function Assay-ASA) 4.12 Genecept Assay (Genomind) 4.13 Methotrexate polyglutamates (Avise PG test) 4.14 Beta adrenergic receptor genotyping 4.15 Millenium PGT (Millennium Laboratories) 4.16 PersonaGene Genetic Panels (AlBioTech) 4.17 A1555G genotyping 4.18 Proove Narcotic Risk Panel and the Proove Drug Metabolism Panel 4.19 DPYD genes 4.20 TYMS genes 4.21 ADRA2A, COMT, CYP2B6 genes 4.22 GRIK4 gene CITALOPRAM pharmacogenetics 4.23 OPRM1 gene NALTREXONE pharmacogenetics CPT/HCPCS Codes Related to MP9479 * The list of codes (and their descriptors, if any) is provided for informational purposes only and may not be all inclusive or current. Listing of a code in this medical policy does not imply that the service described by the code is a covered or non-covered service. Benefit coverage for any service is determined by the member s policy of health coverage with Prevea360 Health Plan. Inclusion of a code above does not imply any right to reimbursement or guarantee claim payment. Other medical policies may also apply. Genetic Testing for Pharmacogenetics 3 of 6 Underwritten by Dean Health Plan, Inc.

4 81210 BRAF (B-Raf proto-oncogene, serine/threonine kinase) (eg, colon cancer, melanoma), gene analysis, V600 variant(s) CFTR (cystic fibrosis transmembrane conductance regulator) (eg, cystic fibrosis) gene analysis; common variants (eg, ACMG/ACOG guidelines) CYP2C19 (cytochrome P450, family 2, subfamily C, polypeptide 19) (eg, drug metabolism), gene analysis, common variants CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism), gene analysis, common variants CYP2C9 (cytochrome P450, family 2, subfamily C, polypeptide 9) (eg, drug metabolism), gene analysis, common variants F2 (prothrombin, coagulation factor II) (eg, hereditary hypercoagulability) gene analysis, 20210G>A variant F5 (coagulation factor V) (eg, hereditary hypercoagulability) gene analysis, Leiden variant MGMT (O-6-methylguanine-DNA methyltransferase) (eg, glioblastoma multiforme), methylation analysis MTHFR (5,10-methylenetetrahydrofolate reductase) (eg, hereditary hypercoagulability) gene analysis, common variants UGT1A1 (UDP glucuronosyltransferase 1 family, polypeptide A1) (eg, irinotecan metabolism), gene analysis, common variants VKORC1 (vitamin K epoxide reductase complex, subunit 1) (eg, warfarin metabolism), gene analysis, common variant(s) HLA Class I and II typing, low resolution (eg, antigen equivalents); HLA-A, -B, -C, -DRB1/3/4/5, and -DQB HLA Class I and II typing, low resolution (eg, antigen equivalents); HLA-A, -B, and -DRB1 (eg, verification typing) HLA Class I typing, low resolution (eg, antigen equivalents); complete HLA Class I typing, low resolution (eg, antigen equivalents); one locus, each HLA Class I typing, low resolution (eg, antigen equivalents); one antigen equivalent (eg, B*27), each HLA Class II typing, low resolution (eg, antigen equivalents); HLA- DRB1/3/4/5 and -DQB1 Genetic Testing for Pharmacogenetics 4 of 6 Underwritten by Dean Health Plan, Inc.

5 81376 HLA Class II typing, low resolution (eg, antigen equivalents); one locus (eg, HLA-DRB1, -DRB3/4/5, -DQB1, -DQA1, -DPB1, or - DPA1), each HLA Class II typing, low resolution (eg, antigen equivalents); one antigen equivalent, each HLA Class I and II typing, high resolution (ie, alleles or allele groups), HLA-A, -B, -C, and -DRB HLA Class I typing, high resolution (ie, alleles or allele groups); complete (ie, HLA-A, -B, and -C) HLA Class I typing, high resolution (ie, alleles or allele groups); one allele or allele group (eg, B*57:01P), each Molecular Pathology Procedure Level Molecular Pathology Procedure Level Unlisted molecular pathology procedure Thromboxane metabolite(s), including thromboxane if performed, urine Infectious agent drug susceptibility phenotype prediction using regularly updated genotypic bioinformatics Infectious agent genotype analysis by nucleic acid (DNA or RNA); Hepatitis C virus Molecular cytogenetics; DNA probe, each (eg, FISH) Molecular cytogenetics; interphase in situ hybridization, analyze cells Molecular cytogenetics; interphase in situ hybridization, analyze cells Morphometric analysis, in situ hybridization (quantitative or semiquantitative), using computer-assisted technology, per specimen; each multiplex probe stain procedure Morphometric analysis, in situ hybridization (quantitative or semiquantitative), manual, per specimen; each multiplex probe stain procedure S U DNA analysis for APOE epsilon 4 allele for susceptibility to Alzheimer's disease Drug metabolism (warfarin drug response), targeted sequence analysis (ie, CYP2C9, CYP4F2, VKORC1, rs ) Genetic Testing for Pharmacogenetics 5 of 6 Underwritten by Dean Health Plan, Inc.

6 Originated: Revised: Reviewed: Committee/Source Date(s) April 3, 2017 June 21, 2017 May 16, 2018 June 21, 2017 May 16, 2018 Published/Effective: 06/01/2018 Genetic Testing for Pharmacogenetics 6 of 6 Underwritten by Dean Health Plan, Inc.

Yes if indicated below. (4.0 TMPT does not require prior authorization)

Yes if indicated below. (4.0 TMPT does not require prior authorization) Genetic Testing for Pharmacogenetics MP9479 Covered Service: Prior Authorization Required: Additional Information: Medicare Policy: BadgerCare Plus Policy: Yes when meets criteria below Yes if indicated