BlueCross BlueShield of Tennessee Medical Policy Manual

Genetic Testing for Statin-Induced Myopathy

Does Not Apply to Commercial Genetic Testing Program effective 6/1/2018

DESCRIPTION

Statin drugs are the primary pharmacologic treatment for hypercholesterolemia. Use of statin drugs are associated with an approximate 30% reduction in cardiovascular events across a wide variety of populations. Statin drugs can cause muscle-related side effects such as myalgia, myositis or rhabdomyolysis. This myopathy may be associated with genetic factors such as variants in the SLCO1B1 gene.

Several commercial labs offer genetic testing for the SLCO1B1 variant used to predict the risk of muscle-related adverse events. Some labs offer panel tests for drug metabolism, which may use next-generation sequencing that includes the SLCO1B1 gene (i.e., ApolloGen).

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION 

Evidence is lacking to determine if a clinical strategy guided by testing for SLCO1B1 or other genetic variants involved in statin metabolism can lead to improved health outcomes.

SOURCES

Arrigoni, E., Del Re, M., Fidilio, L., Fogli, L., Danesi, R., & Di Paolo, A. (2017). Pharmacogenetic foundations of therapeutic efficacy and adverse events of statins. International Journal of Molecular Science, 18 (104), ijms18010104. (Level 2 evidence)

BlueCross BlueShield Association. Evidence Positioning System. (12:2019). Genetic testing for statin-induced myopathy (2.04.96). Retrieved August 19, 2020 from https://www.evidencepositioningsystem.com/. (17 articles and/or guidelines reviewed)

Canestaro, W., Austin, M., & Thummel, K. (2014). Genetic factors affecting statin concentrations and subsequent myopathy: a huGENet systematic review. Genetics in Medicine, 16 (11), 810-819. (Level 2 evidence)

Carr, D., O’Meara, H., Jorgensen, A., Campbell, J., Hobbs, M., McCann, G., et al. (2013). SLCO1B1 genetic variant associated with statin-induced myopathy: a proof-of-concept study using the clinical practice research datalink. Clinical Pharmacology & Therapeutics, 94 (6), 695-701. (Level 1 evidence)

Clinical Pharmacogenetics Implementation Consortium. (October, 2014). Guideline for SLCO1B1 and simvastatin-Induced myopathy: 2014 update. Retrieved August 19, 2020 from https://cpicpgx.org/guidelines/guideline-for-simvastatin-and-slco1b1/.

Ferrari, M., Guasti, L., Maresca, A., Mirabile, M., Contini, S., Grandi, A. M., et al. (2014). Association between statin-induced creatine kinase elevation and genetic polymorphisms in SLCO1B1, ABCB1 and ABCG2. European Journal of Clinical Pharmacology, 70 (5), 539-547. Abstract retrieved January 10, 2017 from PubMed database.

Talameh, J., & Kitzmiller, J. (2014). Pharmacogenetics of statin-induced myopathy: a focused review of the clinical translation of pharmacokinetic genetic variants. Journal of Pharmacogenomics & Pharmacoproteomics, 5 (2). (Level 2 evidence)

Tuteja, S., & Rader, D. (2018). SLCO1B1 and statin therapy - getting the gist of pharmacogenetic testing. Circulation: Genomic and Precision Medicine, 11:e002320. DOI: 10.1161. (Level 2 evidence)

ORIGINAL EFFECTIVE DATE:  12/14/2013

MOST RECENT REVIEW DATE:  10/22/2020

ID_BA

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.