Humana Pharmacogenomics - Cytochrome P450 Polymorphisms and VKORC1 Form

. Pharmacogenomics testing is laboratory testing which has the potential to determine how an individual’s genetic factors may affect the safety and effectiveness of that individual’s response to a specific medication. The goal of pharmacogenomics testing is to reduce the incidence of adverse medication reactions while improving an individual’s positive response to the medication. Additionally, some tests may help provide information on how well a specific treatment may work for an individual. Cytochrome P450 enzymes are a group of enzymes that account for approximately 75 percent of drug metabolism in the human body. Enzymes encoded by the P450 genes (eg, CYP2C9, CYP2C19, CYP2D6, CYP3A4, CYP3A5) are found primarily in the liver. The action of the P450 enzymes affects the blood levels of many drugs. Genotyping for cytochrome P450 has been proposed for possible use in medical Pharmacogenomics - Cytochrome P450 Polymorphisms and VKORC1 Effective Date: 11/02/2023 Revision Date: 11/02/2023 Review Date: 11/02/2022 Policy Number: HUM-0531-021 Page: 2 of 20 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. management of drug therapies including, but may not be limited to, anticoagulants, antiplatelet, barbiturates, opioid analgesics, proton pump inhibitors, psychotropic medications and selective estrogen receptor modulator (SERM). Examples of pharmacogenomic tests include, but may not be limited to, GeneSight Psychotropic, IDGenetix, Neuropsychiatric Panel EffectiveRX, PersonalisedRX, Roche Amplichip CYP450 Test, STA2R SureGene, VerifyNow and Warfarin Response Genotype. (Refer to Coverage Limitations) For information regarding pharmacogenomics for noncancer indications, please refer to Pharmacogenomics - Noncancer Indications Medical Coverage Policy. For information regarding pharmacogenomics for the following, please refer to Genetic Testing Medical Coverage Policy: • Interpretation and reporting for molecular pathology procedures, cytogenetics and molecular cytogenetics • Retrieved archival tissue Humana recognizes that the field of genetic testing is rapidly changing and that other tests may become available. Coverage Determination Services provided by a psychiatrist, psychologist or other behavioral health professionals are subject to the provisions of the applicable behavioral health benefit. Any state mandates for pharmacogenomic/pharmacogenetic testing take precedence over this medical coverage policy. Apply General Criteria for Genetic and Pharmacogenomics Tests when disease- or gene-specific criteria are not available on a medical coverage policy. For information regarding general criteria for genetic and pharmacogenomics tests, please refer to Genetic Testing Medical Coverage Policy. CYP2C9 Genotyping See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Pharmacogenomics - Cytochrome P450 Polymorphisms and VKORC1 Effective Date: 11/02/2023 Revision Date: 11/02/2023 Review Date: 11/02/2022 Policy Number: HUM-0531-021 Page: 3 of 20 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Humana members may be eligible under the Plan for CYP2C9 genotyping when the following criteria are met: • Individual has been diagnosed with multiple sclerosis; AND • Testing performed prior to initiation of treatment with siponimod (Mayzent) For information regarding Mayzent, please refer to Mayzent (siponimod) Pharmacy Coverage Policy. CYP2D6 Genotyping Humana members may be eligible under the Plan for CYP2D6 genotyping (eg, Roche Amplichip CYP450 Test) when the following criteria are met: • Individual has been diagnosed with Gaucher type I disease; AND o Testing performed using a US Food & Drug Administration (FDA)-approved test prior to initiation of treatment with eliglustat (Cerdelga); OR • Individual has been diagnosed with chorea associated with Huntington’s disease; AND o Prior to initiation of treatment with a daily dose of tetrabenazine (Xenazine) over 50 mg to determine dosing regimen For information regarding Cerdelga and Xenazine, please refer to Cerdelga (eliglustat) and Xenazine (tetrabenazine) Pharmacy Coverage Policies. Coverage Limitations Humana members may NOT be eligible under the Plan for pharmacogenomics/ pharmacogenetic testing for any indications other than those listed above including, but may not be limited to, the following: • Assessment of multiple conditions including, but not limited to: o Single gene analysis for any of the following: See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Pharmacogenomics - Cytochrome P450 Polymorphisms and VKORC1 Effective Date: 11/02/2023 Revision Date: 11/02/2023 Review Date: 11/02/2022 Policy Number: HUM-0531-021 Page: 4 of 20 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.  COMT (eg, Mayo Clinic Catechol-O-Methyltransferase [COMT] Genotype [0032U])  Mayo Clinic CYP2D6 Common Variants and Copy Number (0070U)  Mayo Clinic CYP2D6 Full Gene Sequencing (0071U)  Mayo Clinic CYP2D6-2D7 Hybrid Gene Targeted Sequence Analysis (0072U)  Mayo Clinic CYP2D7-2D6 Hybrid Gene Targeted Sequence Analysis (0073U)  Mayo Clinic CYP2D7-2D6 trans-duplication/multiplication non-duplicated gene targeted sequence analysis (0074U)  Mayo Clinic CYP2D6 5’ gene duplication/multiplication targeted sequence analysis (0075U)  Mayo Clinic CYP2D6 3’ gene duplication/multiplication targeted sequence analysis (0076U) o Multigene panel analysis including, but may not be limited to:  Drug metabolism (eg, pharmacogenomic testing of at least 6 genes, including CYP2C19, CYP2D6, and CYP2D6 duplication/deletion analysis [81418])  Focused Pharmacogenomics Panel (0029U)  PersonalisedRX (0380U)  RightMed Comprehensive Test (0349U)  RightMed Comprehensive Test exclude F2 and F5 (0348U)  RightMed Gene Report (0350U)  RightMed PGx16 (0347U) See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Pharmacogenomics - Cytochrome P450 Polymorphisms and VKORC1 Effective Date: 11/02/2023 Revision Date: 11/02/2023 Review Date: 11/02/2022 Policy Number: HUM-0531-021 Page: 5 of 20 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. • Cardiovascular conditions including, but not limited to: o Single gene analysis for any of the following:  CYP2C19  CYP2C9  CYP4F2  P2Y12 (eg, VerifyNow)  SLCO1B1  VKORC1 (81355) o Multigene panel analysis including, but may not be limited to, Warfarin Drug Response (0030U) • Psychiatric conditions including, but not limited to: o Single gene analysis for any of the following:  CYP1A2 (eg, Cytochrome P450 1A2 Genotype [0031U])  CYP2C19  CYP2C9  CYP2D6  CYP2D7  CYP3A4  CYP3A5  CYP4F2  HTR2A  HTR2C o Multigene panel analysis including, but may not be limited to:  EffectiveRX Neuropsychiatric Panel (0392U)  GeneSight Psychotropic (0345U)  Genomind Professional PGx Express CORE (0175U)  IDGenetix (0411U)  Psych HealthPGx Panel (0173U)  Serotonin Receptor Genotype (0033U)  SureGene STA2R See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Pharmacogenomics - Cytochrome P450 Polymorphisms and VKORC1 Effective Date: 11/02/2023 Revision Date: 11/02/2023 Review Date: 11/02/2022 Policy Number: HUM-0531-021 Page: 6 of 20 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.  Tempus nP (0419U) These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language. Background Additional information about pharmacogenomics/pharmacogenetics may be found from the following websites: • American College of Medical Genetics and Genomics • American Heart Association • Huntington's Disease Society of America • National Comprehensive Cancer Network • National Gaucher Foundation • National Multiple Sclerosis Society • US Food & Drug Administration Medical Alternatives Physician consultation is advised to make an informed decision based on an individual’s health needs. Humana may offer a disease management program for this condition. The patient may call the number on his/her member identification card to ask about our programs to help manage his/her care. Provider Claims Codes Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure. CPT® Code(s) 81225 Description CYP2C19 (cytochrome P450, family 2, subfamily C, polypeptide 19) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *4, *8, *17) Comments Not Covered See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Pharmacogenomics - Cytochrome P450 Polymorphisms and VKORC1 Effective Date: 11/02/2023 Revision Date: 11/02/2023 Review Date: 11/02/2022 Policy Number: HUM-0531-021 Page: 7 of 20 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *4, *5, *6, *9, *10, *17, *19, *29, *35, *41, *1XN, *2XN, *4XN) Not Covered if used to report any test outlined in Coverage Limitations section CYP2C9 (cytochrome P450, family 2, subfamily C, polypeptide 9) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *5, *6) Not Covered if used to report any test outlined in Coverage Limitations section CYP3A4 (cytochrome P450 family 3 subfamily A member 4) (eg, drug metabolism), gene analysis, common variant(s) (eg, *2, *22) CYP3A5 (cytochrome P450 family 3 subfamily A member 5) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *4, *5, *6, *7) SLCO1B1 (solute carrier organic anion transporter family, member 1B1) (eg, adverse drug reaction), gene analysis, common variant(s) (eg, *5) VKORC1 (vitamin K epoxide reductase complex, subunit 1) (eg, warfarin metabolism), gene analysis, common variant(s) (eg, - 1639G>A, c.173+1000C>T) Drug metabolism (eg, pharmacogenomics) genomic sequence analysis panel, must include testing of at least 6 genes, including CYP2C19, CYP2D6, and CYP2D6 duplication/deletion analysis 81479 Unlisted molecular pathology procedure 85576 Platelet, aggregation (in vitro), each agent Not Covered Not Covered Not Covered Not Covered Not Covered New Code Effective 01/01/2023 Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section 81226 81227 81230 81231 81328 81355 81418 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Pharmacogenomics - Cytochrome P450 Polymorphisms and VKORC1 Effective Date: 11/02/2023 Revision Date: 11/02/2023 Review Date: 11/02/2022 Policy Number: HUM-0531-021 Page: 8 of 20 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 0029U 0030U 0031U 0032U 0033U 0070U 0071U 0072U 0073U Drug metabolism (adverse drug reactions and drug response), targeted sequence analysis (ie, CYP1A2, CYP2C19, CYP2C9, CYP2D6, CYP3A4, CYP3A5, CYP4F2, SLCO1B1, VKORC1 and rs12777823) Drug metabolism (warfarin drug response), targeted sequence analysis (ie, CYP2C9, CYP4F2, VKORC1, rs12777823) CYP1A2 (cytochrome P450 family 1, subfamily A, member 2)(eg, drug metabolism) gene analysis, common variants (ie, *1F, *1K, *6, *7) COMT (catechol-O-methyltransferase)(drug metabolism) gene analysis, c.472G>A (rs4680) variant HTR2A (5-hydroxytryptamine receptor 2A), HTR2C (5- hydroxytryptamine receptor 2C) (eg, citalopram metabolism) gene analysis, common variants (ie, HTR2A rs7997012 [c.614- 2211T>C], HTR2C rs3813929 [c.-759C>T] and rs1414334 [c.551- 3008C>G]) CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, common and select rare variants (ie, *2, *3, *4, *4N, *5, *6, *7, *8, *9, *10, *11, *12, *13, *14A, *14B, *15, *17, *29, *35, *36, *41, *57, *61, *63, *68, *83, *xN) CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, full gene sequence (List separately in addition to code for primary procedure) CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, CYP2D6-2D7 hybrid gene) (List separately in addition to code for primary procedure) CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, CYP2D7-2D6 hybrid gene) (List separately in addition to code for primary procedure) Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Pharmacogenomics - Cytochrome P450 Polymorphisms and VKORC1 Effective Date: 11/02/2023 Revision Date: 11/02/2023 Review Date: 11/02/2022 Policy Number: HUM-0531-021 Page: 9 of 20 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 0074U 0075U 0076U 0173U 0175U 0345U 0347U 0348U 0349U 0350U CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, non-duplicated gene when duplication/multiplication is trans) (List separately in addition to code for primary procedure) CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, 5' gene duplication/multiplication) (List separately in addition to code for primary procedure) CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, 3' gene duplication/multiplication) (List separately in addition to code for primary procedure) Psychiatry (ie, depression, anxiety), genomic analysis panel, includes variant analysis of 14 genes Psychiatry (eg, depression, anxiety), genomic analysis panel, variant analysis of 15 genes Psychiatry (eg, depression, anxiety, attention deficit hyperactivity disorder [ADHD]), genomic analysis panel, variant analysis of 15 genes, including deletion/duplication analysis of CYP2D6 Drug metabolism or processing (multiple conditions), whole blood or buccal specimen, DNA analysis, 16 gene report, with variant analysis and reported phenotypes Drug metabolism or processing (multiple conditions), whole blood or buccal specimen, DNA analysis, 25 gene report, with variant analysis and reported phenotypes Drug metabolism or processing (multiple conditions), whole blood or buccal specimen, DNA analysis, 27 gene report, with variant analysis, including reported phenotypes and impacted gene-drug interactions Drug metabolism or processing (multiple conditions), whole blood or buccal specimen, DNA analysis, 27 gene report, with variant analysis and reported phenotypes Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Pharmacogenomics - Cytochrome P450 Polymorphisms and VKORC1 Effective Date: 11/02/2023 Revision Date: 11/02/2023 Review Date: 11/02/2022 Policy Number: HUM-0531-021 Page: 10 of 20 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 0380U 0392U 0411U Drug metabolism (adverse drug reactions and drug response), targeted sequence analysis, 20 gene variants and CYP2D6 deletion or duplication analysis with reported genotype and phenotype Drug metabolism (depression, anxiety, attention deficit hyperactivity disorder [ADHD]), gene-drug interactions, variant analysis of 16 genes, including deletion/duplication analysis of CYP2D6, reported as impact of gene-drug interaction for each drug Psychiatry (eg, depression, anxiety, attention deficit hyperactivity disorder [ADHD]), genomic analysis panel, variant analysis of 15 genes, including deletion/duplication analysis of CYP2D6 (For additional PLA code with identical clinical descriptor, see 0345U. See Appendix O to determine appropriate code assignment) 0419U Neuropsychiatry (eg, depression, anxiety), genomic sequence analysis panel, variant analysis of 13 genes, saliva or buccal swab, report of each gene phenotype Not Covered New Code Effective 04/01/2023 Not Covered New Code Effective 07/01/2023 Not Covered New Code Effective 10/01/2023 Not Covered New Code Effective 10/01/2023 CPT® Category III Code(s) No code(s) identified Description Comments HCPCS Code(s) G9143 Description Warfarin responsiveness testing by genetic technique using any method, any number of specimen(s) Comments Not Covered References 1. Agency for Healthcare Research and Quality (AHRQ). Comparative Effectiveness Review (ARCHIVED). Testing of CYP2C19 variants and platelet reactivity for guiding antiplatelet treatments. https://www.ahrq.gov. Published November 22, 2011. Accessed October 4, 2023. 2. American College of Cardiology (ACC). 2014 AHA/ACC guideline for the management of patients with non-ST elevation acute coronary syndromes: a See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Pharmacogenomics - Cytochrome P450 Polymorphisms and VKORC1 Effective Date: 11/02/2023 Revision Date: 11/02/2023 Review Date: 11/02/2022 Policy Number: HUM-0531-021 Page: 11 of 20 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. https://www.acc.org. Published 2014. Accessed October 4, 2023. American College of Medical Genetics and Genomics (ACMG). ACMG standards and guidelines. Laboratory testing of CYP2D6 alleles in relation to tamoxifen therapy. https://www.acmg.net. Published December 2012. Accessed October 4, 2023. Association for Molecular Pathology (AMP). CYP3A4 and CYP3A5 genotyping recommendations. A joint consensus recommendation of the Association for Molecular Pathology, Clinical Pharmacogenetics Implementation Consortium, College of American Pathologists, Dutch Pharmacogenetics Working Group of the Royal Dutch Pharmacists Association, European Society for Pharmacogenomics and Personalized Therapy, and Pharmacogenomics Knowledgebase. https://www.amp.org. Published July 5, 2023. Accessed October 3, 2023. Association for Molecular Pathology (AMP). Recommendations for clinical CYP2C9 genotyping allele selection. A joint recommendation of the Association for Molecular Pathology and College of American Pathologists. https://www.amp.org. Published May 7, 2019. Accessed October 4, 2023. Association for Molecular Pathology (AMP). Recommendations for clinical CYP2D6 genotyping allele selection. A joint consensus recommendation of the Association for Molecular Pathology, College of American Pathologists, Dutch Pharmacogenetics Working Group of the Royal Dutch Pharmacists Association, and the European Society for Pharmacogenomics and Personalized Therapy. https://www.amp.org. Published June 9, 2021. Accessed October 4, 2023. Association for Molecular Pathology (AMP). Recommendations for clinical warfarin genotyping allele selection. A report of the Association for Molecular Pathology and the College of American Pathologists. https://www.amp.org. Published May 4, 2020. Accessed October 4, 2023. 3. 4. 5. 6. 7. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Pharmacogenomics - Cytochrome P450 Polymorphisms and VKORC1 Effective Date: 11/02/2023 Revision Date: 11/02/2023 Review Date: 11/02/2022 Policy Number: HUM-0531-021 Page: 12 of 20 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 8. 9. Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). Pharmacogenomic testing for warfarin response (90.1). https://www.cms.gov. Published August 3, 2009. Accessed September 20, 2023. Clinical Pharmacogenetics Implementation Consortium (CPIC). CPIC guidelines for CYP2C19 genotype and clopidogrel therapy: 2022 update. https://www.CPIC.com. Published June 29, 2011. Updated January 2022. Accessed October 4, 2023. 10. Clinical Pharmacogenetics Implementation Consortium (CPIC). Gene-Drugs. https://www.CPIC.com. Updated 2023. Accessed October 4, 2023. 11. ClinicalKey. Clinical Overview. Chorea. https://www.clinicalkey.com. Updated January 1, 2023. Accessed September 26, 2023. 12. ClinicalKey. Clinical Overview. Long term anticoagulation. https://www.clinicalkey.com. Updated May 12, 2022. Accessed September 26, 2023. 13. ClinicalKey. Clinical Overview. Multiple sclerosis. https://www.clinicalkey.com. Updated March 14, 2022. Accessed September 26, 2023. 14. ClinicalKey. Clinical Overview. Schizophrenia. https://www.clinicalkey.com. Updated October 31, 2022. Accessed September 26, 2023. 15. ECRI Institute. ECRIgene. CYP2D6 testing to inform medication selection for treating mental health disorders. https://www.ecri.org. Published August 1, 2022. Accessed September 22, 2023. 16. ECRI Institute. ECRIgene. Cytochrome P450 2C9 genotyping (LabCorp) for guiding medication selection and dosing of drugs metabolized by CYP2C9. https://www.ecri.org. Published July 16, 2019. Accessed September 22, 2023. 17. ECRI Institute. ECRIgene. eSensor warfarin sensitivity test (GenMark Diagnostics, Inc.) to assess risk for warfarin related adverse events. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Pharmacogenomics - Cytochrome P450 Polymorphisms and VKORC1 Effective Date: 11/02/2023 Revision Date: 11/02/2023 Review Date: 11/02/2022 Policy Number: HUM-0531-021 Page: 13 of 20 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. https://www.ecri.org. Published October 27, 2020. Accessed September 22, 2023. 18. ECRI Institute. ECRIgene. GeneSight psychotropic (Myriad Genetics, Inc.) to inform medication selection for treating major depressive disorder. https://www.ecri.org. Published August 24, 2020. Accessed September 22, 2023. 19. ECRI Institute. ECRIgene. Genomind professional PGx express (Genomind, Inc.) to inform medication selection for treating psychiatric disorders. https://www.ecri.org. Published June 22, 2020. Accessed September 22, 2023. 20. ECRI Institute. ECRIgene. IDgenetix (Castle Biosciences, Inc.) for guiding medication selection for patients with mental health disorders. https://www.ecri.org. Updated June 26, 2023. Accessed September 22, 2023. 21. ECRI Institute. ECRIgene. Pharmacogenomics Panel (Quest Diagnostics) for guiding selection and dosage of common prescription medications. https://www.ecri.org. Updated February 4, 2022. Accessed September 22, 2023. 22. ECRI Institute. ECRIgene. Roche amplichip CYP450 (Roche Molecular Diagnostics) for guiding treatment and dosing of drugs metabolized by CYP2C19 and CYP2D6. https://www.ecri.org. Published July 18, 2018. Accessed September 22, 2023. 23. ECRI Institute. ECRIgene. Warfarin (P450 2C9 and VKORC1) (LabCorp) for assessing risk for warfarin-related adverse events. https://www.ecri.org. Published July 16, 2019. Accessed September 22, 2023. 24. Greden J, Parikh S, Rothschild A, et al. Impact of pharmacogenomics on clinical outcomes in major depressive disorder in the guided trial: a large, patient-and rater-blinded, randomized, controlled study. Journal of Psychiatric Research. 2019;111:59-67. https://www.sciencedirect.com. Accessed September 26, 2023. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Pharmacogenomics - Cytochrome P450 Polymorphisms and VKORC1 Effective Date: 11/02/2023 Revision Date: 11/02/2023 Review Date: 11/02/2022 Policy Number: HUM-0531-021 Page: 14 of 20 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 25. Hayes, Inc. Clinical Utility Evaluation. Pharmacogenetic and pharmacogenomic testing for opioid treatment for pain in adults – selected single-gene variants and pharmacogenomic panels. https://evidence.hayesinc.com. Published December 11, 2019. Updated October 26, 2022. Accessed September 22, 2023. 26. Hayes, Inc. Clinical Utility Evaluation. Pharmacogenetic and pharmacogenomic testing to improve outcomes related to opioid use disorder. https://evidence.hayesinc.com. Published April 27, 2020. Updated June 30, 2023. Accessed September 22, 2023. 27. Hayes, Inc. Clinical Utility Evaluation. Pharmacogenomic testing of selected mental health conditions. https://evidence.hayesinc.com. Published December 6, 2021. Accessed September 22, 2023. 28. Hayes, Inc. Clinical Utility Evaluation. Pharmacogenetic testing to guide codeine or tramadol prescribing for pain in pediatric patients. https://evidence.hayesinc.com. Published February 19, 2020. Updated March 30, 2023. Accessed September 22, 2023. 29. Hayes, Inc. Clinical Utility Evaluation (ARCHIVED). SLCO1B1 pharmacogenomic genotyping for statin dosing or selection. https://evidence.hayesinc.com. Published August 4, 2016. Updated September 4, 2021. Accessed September 22, 2023. 30. Hayes, Inc. Genetic Testing Evaluation (GTE) Indication. CYP2C19 pharmacogenomic genotyping to direct clopidogrel therapy for secondary prevention in patients with a history of stroke and/or transient ischemic attack (TIA). https://evidence.hayesinc.com. Published November 12, 2010. Updated September 30, 2021. Accessed September 22, 2023. 31. Hayes, Inc. Genetic Testing Evaluation (GTE) Indication. CYP2C19 pharmacogenomic genotyping to direct clopidogrel therapy in adult patients undergoing percutaneous coronary intervention (PCI). https://evidence.hayesinc.com. Published November 20, 2017. Updated September 30, 2021. Accessed September 25, 2023. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Pharmacogenomics - Cytochrome P450 Polymorphisms and VKORC1 Effective Date: 11/02/2023 Revision Date: 11/02/2023 Review Date: 11/02/2022 Policy Number: HUM-0531-021 Page: 15 of 20 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 32. Hayes, Inc. Genetic Testing Evaluation (GTE) Report (ARCHIVED). CYP2D6 genotyping for dose management of tamoxifen. https://evidence.hayesinc.com. Published September 5, 2008. Updated August 29, 2012. Accessed September 25, 2023. 33. Hayes, Inc. Genetic Testing Evaluation (GTE) Synopsis (ARCHIVED). Comprehensive personalized medicine panel. https://evidence.hayesinc.com. Published March 12, 2015. Updated September 12, 2018. Accessed September 25, 2023. 34. Hayes, Inc. Genetic Testing Evaluation (GTE) Synopsis (ARCHIVED). STA2R SureGene test for antipsychotic and antidepressant response. https://evidence.hayesinc.com. Published January 15, 2015. Updated September 12, 2018. Accessed September 25, 2023. 35. Hayes, Inc. Molecular Test Assessment. GeneSight psychotropic (Assurex Health Inc/Myriad Neuroscience). https://evidence.hayesinc.com. Published September 10, 2021. Accessed September 25, 2023. 36. Hayes, Inc. Precision Therapy Assessment (ARCHIVED). Eliglustat (Cerdelga) for gaucher disease type 1. https://evidence.hayesinc.com. Published December 4, 2017. Updated January 15, 2019. Accessed September 25, 2023. 37. Holmes R, Dehmer G, Kaul S, Leifer D, O’Gara P, Stein C. ACCF/AHA Clopidogrel clinical alert: approaches to the FDA “boxed warning”: a report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents and the American Heart Association endorsed by the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic. JACC. 2010;56(4):321-341. https://www.sciencedirect.com. Accessed September 26, 2023. 38. MCG Health. Attention-deficit hyperactivity disorder medication pharmacogenetics - ADRA2A, COMT, CYP2B6 and CYP2D6 genes. 27th edition. https://www.mcg.com. Accessed September 26, 2023. 39. MCG Health. 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