Does Not Apply to Commercial Genetic Testing Program effective 6/1/2018
DESCRIPTION
While multiple pharmacologic therapies are available for the management of acute and chronic pain, there is a high degree of heterogeneity in pain response, particularly in the management of chronic pain. Testing for genetic variants that are relevant to pharmacokinetics or pharmacodynamics of analgesics is proposed to assist in selecting and dosing drugs affected by these genetic variants.
Pharmacogenetic testing combines pharmacology and genomics with the intent of discovering effective and safe medications and doses tailored to a person’s genetic makeup. Commercially available panel tests (e.g., GeneSight® Analgesic, Proove® Opioid Risk Panel, Pain Medication DNA Insight™, Millennium PGT™, IDgenetix®) have been proposed as an aid in pain management.
Individual or panel tests relevant to pharmacogenetics could include testing of the following genes:
5HT2C (serotonin receptor gene)
5HT2A (serotonin receptor gene)
SLC6A4 (serotonin transporter gene)
DRD1 (dopamine receptor gene)
DRD2 (dopamine receptor gene)
DRD4 (dopamine receptor gene)
DAT1 or SLC6A3 (dopamine transporter gene)
DBH (dopamine beta-hydroxylase gene)
COMT (catechol O-methyltransferase gene)
MTHFR (methylenetetrahydrofolate reductase gene)
γ-aminobutyric acid (GABA) A receptor gene
OPRM1 (μ-opioid receptor gene)
OPRK1 (κ-opioid receptor gene)
UGT2B15 (uridine diphosphate glycosyltransferase 2 family, member 15)
Cytochrome p450 genes: CYP2D6, CYP2C19, CYP2C9, CYP3A4, CYP2B6, CYP1A2
POLICY
Pharmacogenetic testing for the treatment of pain is considered investigational.
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
No high-quality studies were found in the published literature that validates the use of pharmacogenetic testing for pain management. At present, the clinical utility of pharmacogenetic testing in pain management is poorly defined.
SOURCES
American Academy of Neurology. (2014). Opioids for chronic noncancer pain. Retrieved January 22, 2019 from www.AAN.com.
Bell, G. C., Donovan, K. A., & McLeod, H. L. (2015). Clinical implications of opioid pharmacogenomics in patients with cancer. Cancer Control, 22 (4), 426-432. (Level 4 evidence)
BlueCross BlueShield Association. Evidence Positioning System. (12: 2023). Pharmacogenetic testing for pain management. (2.04.131). Retrieved December 4, 2023 from https://www.bcbsaoca.com/eps/. (16 articles and/or guidelines reviewed)
CMS.gov: Centers for Medicare & Medicaid Services. Palmetto GBA. (2023, August). LCD MolDX: Pharmacogenomics Testing. (LCD ID L382942). Retrieved December 4, 2023 from https://www.cms.gov.
Crews, K. R., Gaedigk, A., Dunnenberger, H. M., Leeder, J. S., Klein, T. E., Caudle, K. E., et al. (2014). Clinical pharmacogenetics implementation consortium guidelines for cytochrome P450 2D6 genotype and codeine therapy: 2014 update. Clinical Pharmacology & Therapeutics, 95 (4). (Level 1 evidence)
Hamilton, W. G., Gargiulo, J. M., Reynolds, T. R., & Parks, N. L. (2022). Prospective randomized study using pharmacogenetics to customize postoperative pain medication following hip and knee arthroplasty. The Journal of Arthroplasty, 37 (6S), S76–S81. (Level 2 evidence)
Kapur, B. M., Lala, P. K., & Shaw, J. L. (2014). Pharmacogenetics of chronic pain management. Clinical Biochemistry, 47, 1169-1187. (Level 2 evidence)
Owusu, A., Hamadeh, I., & Smith, M. (2017). Review of opioid pharmacogenetics and considerations for pain management. Pharmacotherapy, 37 (9), 1105-1121. Abstract retrieved January 22, 2019 from PubMed database.
Scarpi, E., Calistri, D., Klepstad, P., Kaasa, S., Skorpen, F., Habberstad, R., et al. (2014). Clinical and genetic factors related to cancer-induced bone pain and bone pain relief. Oncologist, 19 (12), 1276-1283. (Level 3 evidence)
Smith, D.M., Weitzel, K.W., Elsey, A.R., Langaee, T., Gong, Y., Wake, D.T., et al. (2019). CYP2D6-guided opioid therapy improves pain control in CYP2D6 intermediate and poor metabolizers: a pragmatic clinical trial. Genetics in Medicine, 21 (8), 1842-1850. (Level 4 evidence)
Theken, K.N., Lee, C.R., Gong, L., Caudle, K.E., Formea, C.M., Gaedigk, A. et al. (2020). Clinical Pharmacogenetics Implementation Consortium guideline (CPIC) for CYP2C9 and nonsteroidal anti-Inflammatory drugs. Clinical Pharmacology & Therapeutics, 108 (2), 191-200. (Level 1 evidence)
ORIGINAL EFFECTIVE DATE: 9/13/2015
MOST RECENT REVIEW DATE: 2/8/2024
ID_BA
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