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| Medical Policy: | L-148-006 |
| Topic: | CYP2D6 Variant Analysis for Drug Response |
| Section: | Laboratory |
| Effective Date: | July 1, 2018 |
| Issue Date: | July 2, 2018 |
| Last Reviewed: | March 2018 |
The cytochrome P450 2D6 (CYP2D6) enzyme is involved in metabolizing many medications including tamoxifen, tetrabenazine, deutetrabenazine, and eliglustat. CYP2D6 gene result in reduced or absent enzyme function, which may lead to lower levels of active tamoxifen metabolites and reduced treatment efficacy. Testing is not indicated for perimenopausal and premenopausal women with hormone-positive breast cancer. Tamoxifen is the current standard of care for these patients, and no alternative treatment plans have been approved. |
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
| Policy Position Coverage is subject to the specific terms of the member’s benefit plan. |
Testing for Tetrabenazine Response
CYP2D6 testing for tetrabenazine response may be considered medically necessary when the following criteria are met:
- No previous CYP2D6 testing performed; and
- Member has a diagnosis of Huntington’s disease; and
- Treatment with tetrabenazine is being considered in a dosage greater than 50mg per day.
Testing for Deutetrabenazine Response
CYP2D6 testing for Deutetrabenazine response may be considered medically necessary when the following criteria are met:
- No previous CYP2D6 testing performed; and
- Member has a diagnosis of Huntington’s disease; and
- Treatment with deutetrabenazine is being considered in a dosage greater than 36mg per day.
Testing for Eliglustat Response
CYP2D6 testing for eliglustat response may be considered medically necessary when the following criteria are met:
- No previous CYP2D6 testing performed; and
- Member has a diagnosis of Gaucher disease; and
- Treatment with eliglustat is being considered.
Testing for Tamoxifen Response
CYP2D6 testing for tamoxifen response is considered experimental/investigational and therefore, non-covered due to lack of scientific-based evidence published in the peer reviewed literature.
Testing for All Other Indications
CYP2D6 testing for any other indication is considered experimental/investigational and, therefore, non-covered due to lack of scientific-based evidence published in the peer reviewed literature.
CYP2D6 Genotype Cascade from Mayo Clinic is considered experimental/investigational and, therefore, not non-covered due to lack of scientific-based evidence published in the peer reviewed literature.
| Professional Statements and Societal Positions |
Tetrabenazine, deutetrabenazine and eliglustat:
Tamoxifen
|
| Place of Service: Outpatient |
Experimental/Investigational (E/I) services are not covered regardless of place of service.
CYP2D6 variant analysis for drug response is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
| The policy position applies to all commercial lines of business |
| Denial Statements |
Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
| Links |
- Link to Provider Resource Center for the Medical Policy Update
05/2018, REMINDER: Molecular and Genomic Testing
 |
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
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U.S. Department of Health and Human Services
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Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
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