Does Not Apply to Commercial Genetic Testing Program effective 6/1/2018
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).
Genetic testing for the presence of variants in the SLCO1B1 gene for the purpose of identifying individuals at risk of statin-induced myopathy is considered not medically necessary.
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, the express terms of the health plan will govern.
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.
Arrigoni, E., Del Re, M., Fidilio, L., Fogli, L., Danesi, R., and 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. 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.
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)
ORIGINAL EFFECTIVE DATE: 12/14/2013
MOST RECENT REVIEW DATE: 12/13/2018
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.
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