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Clinical Policy: Pitavastatin (Livalo), Ezetimibe/Simvastatin

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Clinical Policy: Pitavastatin (Livalo), Ezetimibe/Simvastatin Clinical Policy: Pitavastatin (Livalo), Ezetimibe/Simvastatin (Vytorin 10/10 mg) Reference Number: CP.CPA.62 Effective Date: 11.16.16 Last Review Date: 11.17 Revision Log Line of Business: Commercial See Important Reminder at the end of this policy for important regulatory and legal information. Description Pitavastatin (Livalo®) is an inhibitor of HMG-CoA reductase (statin) that lowers cholesterol in the blood for prevention of cardiovascular events and for the management of dyslipidemias. Ezetimibe/simvastatin (Vytorin®) is a combination cholesterol absorption inhibitor and HMG- CoA reductase inhibitor (statin). FDA approved indication Livalo: • Primary Hyperlipidemia or Mixed Dyslipidemia: As an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high density lipoprotein cholesterol (HDL-C) in adult patients with primary or mixed dyslipidemia. Vytorin: • Primary Hyperlipidemia: As an adjunctive therapy to diet to reduce elevated total-C, LDL- C, apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. • Homozygous Familial Hypercholesterolemia (HoFH): As an adjunctive therapy to diet to reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments. Limitations of use: • Doses of Livalo greater than 4 mg once daily were associated with an increased risk for severe myopathy in premarketing clinical studies. Do not exceed 4 mg once daily dosing of Livalo. • The effect of Livalo on cardiovascular morbidity and mortality has not been determined. • Livalo has not been studied in Fredrickson Type I, III, and V dyslipidemias. • No incremental benefit of Vytorin on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established. • Vytorin has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias. Page 1 of 6 CLINICAL POLICY Ezetimibe/simvastatin, Pitavastatin Policy/Criteria Provider must submit documentation (which may include office chart notes and lab results) supporting that member has met all approval criteria It is the policy of health plans affiliated with Centene Corporation® that Livalo and Vytorin are medically necessary when the following criteria are met: I. Initial Approval Criteria A. Hyperlipidemia (must meet all): 1. Diagnosis of one of the following: a. Primary Hyperlipidemia; b. Mixed Dyslipidemia; c. Homozygous Familial Hypercholesterolemia (HoFH); 2. One of the following (a or b): a. Failure to achieve National Cholesterol Education Program (NCEP) goals; b. Failure of one generic formulary statin (e.g., atorvastatin, lovastatin, pravastatin, simvastatin) unless contraindicated or clinically significant adverse effects are experienced; 3. Dose does not exceed: Livalo – 4 mg/day; Vytorin – 10/40 mg/day. Approval duration: Length of Benefit B. Other diagnoses/indications 1. Refer to CP.CPA.09 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized). II. Continued Therapy A. Hyperlipidemia (must meet all): 1. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; 2. Member is responding positively to therapy; 3. If request is for a dose increase, new dose does not exceed: Livalo – 4 mg/day; Vytorin – 10/40 mg/day. Approval duration: Length of Benefit B. Other diagnoses/indications (must meet 1 or 2): 1. Currently receiving medication via Centene benefit and documentation supports positive response to therapy. Approval duration: Duration of request or 12 months (whichever is less); or 2. Refer to CP.CPA.09 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized). III. Diagnoses/Indications for which coverage is NOT authorized: A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policy – CP.CPA.09 or evidence of coverage documents. Page 2 of 6 CLINICAL POLICY Ezetimibe/simvastatin, Pitavastatin IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key Apo B: apolipoprotein B HDL-C: high-density lipoprotein-cholesterol HMG-CoA: 3-hydroxy-3-methyl-glutaryl-CoA HoFH: heterozygous familial and nonfamilial hypercholesterolemia LDL-C: low-density lipoprotein-cholesterol Mg: milligram(s) TG: triglyceride Total-C: total cholesterol Appendix B: General Information • Vytorin is contraindicated with concomitant administration of: o Strong CYP3A3 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, o HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone, and cobicistat-containing products) o Gemfibrozil, cyclosporine, or danazol. • Simvastatin is metabolized by the cytochrome P450 isoform 3A4. Certain drugs that inhibit this metabolic pathway can raise the plasma levels of the simvastatin component of Vytorin and may increase the risk of myopathy. • Due to the increased risk of myopathy, including rhabdomyolysis, associated with the 10/80 mg dose of Vytorin, patients unable to achieve their LDL-C goal utilizing the 10/40-mg dose of Vytorin should not be titrated to the 10/80-mg dose, but should be placed on alternative LDL-C-Iowering treatment(s) that provide greater LDL-C lowering. • Livalo is contraindicated with co-administration of cyclosporine. • Doses of Livalo greater than 4 mg once daily were associated with an increased risk for severe myopathy in pre-marketing clinical studies. Do not exceed 4 mg once daily dosing of Livalo. • Liver function tests are recommended before initiating therapy with Vytorin or Livalo, and as clinically indicated thereafter. • Relative LDL-lowering Efficacy of Statin and Statin-based Therapies: http://www.fda.gov/Drugs/DrugSafety/ucm256581.htm • Pravastatin is FDA approved for pediatric patients 8 to 13 years up to 20 mg per day and 14 to 18 years up to 40 mg per day; simvastatin is FDA approved for pediatric patients 10 to 17 years of age up to 40 mg per day; lovastatin is FDA approved for pediatric patients 10 to 17 years of age up to 40 mg per day; atorvastatin is FDA approved for pediatric patients 10 to 17 years of age up to 20 mg per day. Appendix C: Therapeutic Alternatives Drug Dosing Regimen Dose Limit/ Maximum Dose atorvastatin 10 – 80 mg PO QD 80 mg/day (Lipitor®) (20mg/day for pediatrics 10 to 17 years) Page 3 of 6 CLINICAL POLICY Ezetimibe/simvastatin, Pitavastatin Drug Dosing Regimen Dose Limit/ Maximum Dose simvastatin 5 – 80 mg PO QD 80 mg/day (Zocor®) (40 mg/day for pediatrics 10 to 17 years) lovastatin 10 – 80 mg PO QD 80 mg/day (Mevacor®) (40mg/day for pediatrics 10 to 17 years) pravastatin 40 – 80 mg PO QD 80 mg/day (Pravachol®) Pediatrics: 10 – 40 mg PO QD Pediatrics: 20 mg/day for 8 to 13 years 40 mg/day for 14 to 18 years Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. V. Dosage and Administration Drug Name Indication Dosing Regimen Maximum Dose Pitavastatin Primary 1 - 4 mg PO QD 4 mg PO QD (Livalo) Hyperlipidemia; Mixed Dyslipidemia Ezetimibe/ Primary 10/10 mg - 10/40 mg 10/80 mg PO QD simvastatin Hyperlipidemia; PO QD (Vytorin) Homozygous Familial Use of the 10/80 mg Hypercholesterolemi dose of Vytorin a (HoFH) should be restricted to patients who have been taking Vytorin 10/80 mg for 12 months or more without evidence of muscle toxicity VI. Product Availability Drug Availability Livalo Tablets: 1 mg, 2 mg, 4 mg Vytorin Tablets: 10/10 mg, 10/20 mg, 10/40 mg, 10/80 mg VII. References 1. Vytorin Prescribing Information. Whitehouse Station, NJ: Merck & Co., Inc. February 2015. http://www.merck.com/product/usa/pi_circulars/v/vytorin/vytorin_pi.pdf. Accessed January 2017. Page 4 of 6 CLINICAL POLICY Ezetimibe/simvastatin, Pitavastatin 2. Livalo Prescribing Information. Tokyo, Japan: Kowa Pharmaceuticals. October 2013. Accessed January 2017. 3. Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults. Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA. May 16, 2001; 285(19):2486-2497. 4. Micromedex® Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed January 23, 2017 5. Clinical Pharmacology Web site. Available at: http://clinicalpharmacology- ip.com/Forms/drugoptions.aspx?cpnum=2671&n=Livalo&t=0. Accessed January 23, 2017. 6. Clinical Pharmacology Web site. Available at: http://clinicalpharmacology- ip.com/Forms/drugoptions.aspx?cpnum=3268&aprid=4591. Accessed January 17, 2017. 7. Ezetimibe. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed January 18, 2017. 8. Simvastatin. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed January 18, 2017. 9. Livalo. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed January 23, 2017.
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