Description

Pharmacogenomic tests are laboratory studies that use an individual's unique genetic makeup to help determine response to a specific medication. These tests are used to guide management for a variety of noncancer indications to detect genetic variants that may be associated with an increased risk of developing a potentially life-threatening condition, severe adverse reaction or drug-related toxicity that may occur when using certain medications.

Multigene (or expanded) panels analyze a broad set of genes simultaneously (as opposed to single gene testing that searches for variants in one specific gene) and have been proposed to evaluate the DNA of an individual with a personal and/or family history of more than 1 hereditary condition or syndrome. Panels often include medically actionable genes but may also include those with unclear medical management. (Refer to Coverage Limitations section)

Pharmacogenomics – Noncancer Indications

Effective Date: 04/27/2023

Revision Date: 04/27/2023

Review Date: 04/27/2023

Policy Number: HUM-0466-069

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.

Targeted (or focused) multigene panels analyze a limited number of genes targeted to a specific condition. (Refer to Coverage Limitations section)

For information regarding pharmacogenomics testing for the following, please refer to Genetic Testing Medical Coverage Policy:

• Cryopreservation, thawing and expansion of biological materials
• Interpretation and reporting for molecular pathology procedures, cytogenetics and molecular cytogenetics
• Repeat somatic testing
• Retrieved archival tissue

Humana recognizes that the field of genetic testing is rapidly changing and that other tests may become available.

Coverage Determination

Any state mandates for pharmacogenomic 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.

Human Leukocyte Antigens (HLA) Allele Testing

Humana members may be eligible under the Plan for HLA-B*1502 genotyping when testing is performed prior to the initiation of carbamazepine, oxcarbazepine or phenytoin for an individual of Asian ancestry.

Humana members may be eligible under the Plan for HLA-B*5701 genotyping when testing is performed prior to the initiation of abacavir.

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 HLA-B*5801 genotyping when testing is performed prior to the initiation of allopurinol for an individual of African American, Han-Chinese, Korean or Thai ancestry.

Nudix Hydroxylase 15 (NUDT15) Gene Testing and/or Thiopurine S- Methyltransferase (TPMT) Gene Mutation Assay/TPMT Phenotypic Assays

Humana members may be eligible under the Plan for NUDT15 (81306) and/or TPMT gene testing (81335, 84433) or NUDT15 and TPMT testing (0034U, 0169U) when performed prior to the initiation of thiopurine medication therapy (eg, azathioprine, mercaptopurine).

RPE65 Gene Testing

Humana members may be eligible under the Plan for RPE65 gene testing for an individual diagnosed with hereditary, early-onset retinal dystrophy prior to initiation of treatment with voretigene neparvovec-rzyl.

For information regarding CYP2D6 genotyping including, but not limited to, CYP2C9, CYP2C19, CYP2D6, CYP3A4 and VKORC1, please refer to Pharmacogenomics - Cytochrome P450 Polymorphisms and VKORC1 Medical Coverage Policy.

Coverage Limitations

Humana members may NOT be eligible under the Plan for pharmacogenomics testing for any indications or tests other than those listed above including, but not limited to:

• Diagnosis for which pharmacologic therapy is not indicated and the drug(s) under consideration are not indicated for the treatment of the individual’s diagnosis; OR
• Diseases for which the individual is not currently seeking treatment; OR
• KIF6 (kinesin family member 6) testing; OR
• Multigene panels unless ALL genes in the panel meets disease- or gene-specific criteria including, but may not be limited to:

Pharmacogenomics – Noncancer Indications Effective Date: 04/27/2023 Revision Date: 04/27/2023 Review Date: 04/27/2023 Policy Number: HUM-0466-069 Page: 4 of 11

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.

o CNT (centrosomal protein 72-KDa [CEP72], NUDT15 and TPMT) genotyping panel (0286U); OR

• SLCO1B1 gene analysis (81328)

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.

Additional information about pharmacogenomics may be found from the following websites:

• American Heart Association
• Centers for Disease Control and Prevention
• National Library of Medicine
• 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 member may call the number on his/her identification card to ask about our programs to help manage his/her care.

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.