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Corporate Medical Policy Pharmacogenetics Testing AHS – M2021 “Notification”

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Corporate Medical Policy Pharmacogenetics Testing AHS – M2021 “Notification” Corporate Medical Policy Pharmacogenetics Testing AHS – M2021 “Notification” File Name: pharmacogenetics_testing Origination: 01/01/2019 Last CAP Review: n/a Next CAP Review: 01/01/2020 Last Review: 01/01/2019 Policy Effective April 1, 2019 Description of Procedure or Service Definitions Pharmacogenetics is defined as the study of variability in drug response due to heredity (Nebert, 1999). Cytochrome P450 enzymes are a class of enzymes essential in the synthesis and breakdown metabolism of various molecules and chemicals. Found primarily in the liver, these enzymes are also essential for the metabolism of many medications. Cytochrome P450 are essential for the production of many molecules including steroid hormones and certain fats, including cholesterol, fatty acids, and bile acids. Additional cytochrome P450 are involved in the metabolism of drugs, carcinogens, and internal substances, such as toxins formed within cells. Mutations in cytochrome P450 genes can result in the inability to properly metabolize medications and other substances, leading to increased possibility of toxic substance levels in the body. There are approximately 57 CYP genes in humans (Bains, 2013; National Institutes of Health, 2017). Thiopurine methyltransferase (TPMT) is an enzyme that methylates azathioprine, mercaptopurine and thioguanine into active thioguanine nucleotide metabolites. The azathioprine and mercaptopurine is used for treatment of nonmalignant immunologic disorders, mercaptopurine is used for treatment of lymphoid malignancies and thioguanine is used for treatment of myeloid leukemias (Relling et al., 2011) . Dihydropyrimidine dehydrogenase (DPYD) gene is encoding for dihydropyrimidine dehydrogenase (DPD) enzyme responsible for fluoropyrimidine catabolism. It is a rate-limiting enzyme. The fluoropyrimidines (5-fluorouracil and capecitabine) are drugs used in the treatment of solid tumors such as colorectal, breast and aerodigestive tract tumors (Amstutz et al., 2018). Human Leukocyte antigens (HLAs) Human Leukocyte antigens is a group of genes that encode a variety of cell surface proteins such as antigen-presenting molecules and other proteins. HLAs are also known as major histocompatibility complex. ***Note: This Medical Policy is complex and technical. For questions concerning the technical language and/or specific clinical indications for its use, please consult your physician. Policy BCBSNC will provide coverage for pharmacogenetics testing when it is determined to be medically necessary because the medical criteria and guidelines shown below are met. Page 1 of 25 An Independent Licensee of the Blue Cross and Blue Shield Association Pharmacogenetics Testing AHS – M2021 “Notification” Benefits Application This medical policy relates only to the services or supplies described herein. Please refer to the Member's Benefit Booklet for availability of benefits. Member's benefits may vary according to benefit design; therefore member benefit language should be reviewed before applying the terms of this medical policy. When Pharmacogenetics Testing is covered 1. Testing for the CYP2D6 genotype once per lifetime (please see policy guideline below) * is considered medically necessary for individuals being considered for therapy with any of the medication listed below, or who are in their course of therapy with a medication listed below, to aid in therapy selection and/or dosing. • Eliglustat • Tetrabenazine (for doses over 50 mg) 2. Testing for the TPMT genotype once per lifetime (please see policy guideline below) * is considered medically necessary for individuals being considered for therapy with the below medication, or who are in their course of therapy with these medications, to aid in therapy selection and/or dosing. • Azathioprine • Mercaptopurine • Thioguanine 3. Testing for the following Human Leukocyte Antigens (HLAs) genotypes once per lifetime is considered medically necessary for individuals being considered for therapy with the below medication, or who are in their course of therapy with these medications, to aid in therapy selection and/or dosing: • HLA-B*57:01 before treatment with Abacavir • HLA-B*15:02 for treatment with Carbamazepine limited to patients of Asian descent 4. Testing for the following genotypes once per lifetime is considered medically necessaary for individuals being considered for therapy with the below medication, or who are in their course of therapy with a medication listed below, to aid in therapy selection and/or dosing. • CFTR for treatment with Ivacaftor • G6PD for treatment with Rasburicase, Primaquine, Chloroquine and Dapsone When Pharmacogenetics Testing is not covered 1. Genetic testing for the presence of variants in the SLCO1B1 gene for the purpose of identifying patients at risk of statin-induced myopathy is considered not medically necessary. 2. The following pharmacogenetics testing is considered is considered investigational A. Genotyping for any medication therapy more than once per lifetime (please see policy guideline below)* Page 2 of 25 An Independent Licensee of the Blue Cross and Blue Shield Association Pharmacogenetics Testing AHS – M2021 “Notification” B. Testing for the specific genotype for individuals on medications not listed as meeting coverage criteria for testing. C. Testing for all other genotypes including, but not limited to, use of other medication therapy not listed as meeting coverage criteria. D. Genotyping the general population. 3. Genetic testing to aid in therapy selection and/or dosing medication and/or monitoring either as individual single nucleotide polymorphism (SNP) testing or as a panel of SNPs is considered investigational for all indications. The list of SNPs includes, but is not limited to the following: • 5HT2C (serotonin receptor) • 5HT2A (serotonin receptor) • SLC6A4 (serotonin transporter) • DRD1 (dopamine receptor) • DRD2 (dopamine receptor) • DRD4 (dopamine receptor) • DAT1 or SLC6A3 (dopamine transporter) • DBH (dopamine beta-hydroxylase) • COMT (catechol-O-methyl-transferase) • MTHFR (methylenetetrahydrofolate reductase) • γ-Aminobutyric acid (GABA) A receptor • OPRM1 (µ-opioid receptor) • OPRK1 (κ-opioid receptor) • UGT2B15 (uridine diphosphate glycosyltransferase 2 family, member 15) • Cytochrome P450 genes: CYP3A4, CYP2B6, CYP1A2 *Policy Guideline: Genotypic once per lifetime Any gene should be tested once per lifetime regardless the indication (except would be for HLA where a specific variant is tested for the medication). For example, if CYP2C19 was tested for therapy with citalopram, additional testing for CYP2C19 for treatment with clopidogrel is not needed and is considered investigational. Policy Guidelines Background Genetic variations play a role in an individual’s response to medications. Drug metabolism and responses are affected by many factors including age, sex, interactions with other drugs, and disease states with genetic variations offering only a partial explanation of an individual's response (Stamer & Stuber, 2007). However, inherited differences in the metabolism and disposition of drugs and genetic polymorphisms in the targets of drug therapy can have a significant influence on the efficacy and toxicity of medications (Kapur, Lala, & Shaw, 2014) potentially even more so than clinical variables such as age and organ function (Ting & Schug, 2016). Genetic variation can influence pharmacodynamics factors, through variations affecting drug target receptors and downstream signal transduction, or pharmacokinetic factors, affecting drug metabolism and/or elimination, ultimately altering the relationship between drug dose and steady state serum drug concentrations. Development of tolerance, which may occur through both dynamic and kinetic mechanisms, can also play a significant role in this response variation (Nielsen et al., 2015). Page 3 of 25 An Independent Licensee of the Blue Cross and Blue Shield Association Pharmacogenetics Testing AHS – M2021 “Notification” The Cytochrome P450 (CYP 450) system is a group of enzymes responsible for the metabolism of many endogenous and exogenous substances, including many pharmaceutical agents. They may serve to “activate” an inactive form of a drug, and they may serve a role in the inactivation and/or clearance of a drug from circulation. The CYP 450 enzymes are responsible for the clearance of over half of all drugs, and their activity can be affected by diet, age, and other medications. The genes encoding for the CYP 450 enzymes are highly variable, with multiple alleles that confer various levels of metabolic activity for specific substrates. Nomenclature for CYP 450 enzymes reflects the gene family (which is a number), the subfamily (which is a letter), the isoenzyme (which is a number), and the allele (which is noted by a * preceding a number). In some cases, alleles can be highly correlated with ethnic background. The most common alleles are sometimes referred to as “wild type,” while other alleles are said to confer lower or higher activity than normal. Individuals with these allelic types are sometimes referred to as “poor metabolizers” or “ultra-rapid metabolizers,” although standard nomenclature relative to the activity of variant alleles is lacking. Due to the variations in enzyme activity conferred by allelic differences, some CYP 450 alleles are associated with increased risk for certain conditions or adverse outcomes with certain drugs. Knowledge of the allele type may assist in the selection of a drug, or in drug dosing. Three CYP 450 enzymes are most often considered
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