BlueCross BlueShield of Tennessee Medical Policy Manual

Genetic Testing for Statin-Induced Myopathy

DESCRIPTION

Statin drugs are the primary pharmacologic treatment for hypercholesterolemia.  Use of statin drugs are associated with an approximately 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 SLCO1B1 variant (i.e., Boston Heart Diagnostics™, Arup Laboratories) 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., and Di Paolo, A. (2017, January) Pharmacogenetic foundations of therapeutic efficacy and adverse events of statins. International Journal of Molecular Science, 18 (104) ijms18010104. (Level 2 evidence)

BlueCross BlueShield Association. Medical Policy Reference Manual. (11:2017). Genetic testing for statin-induced myopathy (2.04.96). Retrieved December 29, 2017 from BlueWeb. (26 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. Clinical Pharmacology & Therapeutics, 92 (1), 112-118.

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.

Notarangelo, F. M., Marziliano, N., Demola, A. M., Pigazzani, F., Guidorossi, A., Merlini, A. P., et al. (2012). Genetic predisposition to atorvastatin-induced myopathy: a case report. Journal of Clinical Pharmacy and Therapeutics, 37 (5), 604-606. 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)

Wilke, R and Fanciullo, J. (2017, March) SLCO1B1 genotyping for statins (point-counterpoint). South Dakota Medicine, 70 (3), 102-104. (Level 5 evidence)

Winifred S. Hayes, Inc. Genetic Test Evaluation (GTE) Indication. (2016, August). SLCO1B1 pharmacogenomic genotyping for statin dosing or selection. Retrieved January 10, 2017 from www.Hayesinc.com/subscribers. (30 articles and/or guidelines reviewed)

ORIGINAL EFFECTIVE DATE:  12/14/2013

MOST RECENT REVIEW DATE:  1/25/2018

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