Prior Auth Protocol

FDA Approved Indications:

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.

Vytorin:

To reduce elevated total cholesterol (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.
To reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering.

Health Net Approved Indications and Usage Guidelines:

Failure to achieve National Cholesterol Education Program (NCEP) goals or clinically significant adverse reaction to one generic formulary statin (atorvastatin, lovastatin, pravastatin, simvastatin)

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

General Information:

Vytorin is contraindicated with concomitant administration of:

Strong CYP3A3 inhibitors (e.g., itraconazole, ketocaonazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone, and cobicistat-containing products)
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 provides 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.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
atorvastatin (Lipitor^R)	10 - 80 mg PO QD	80 mg/day (20 mg/day for pediatrics 10 to 17 years)
simvastatin (Zocor^R)	5 - 80 mg PO QD	80 mg/day (40 mg/day for pediatrics 10 to 17 years)
lovastatin (Mevacor^R)	10 - 480 mg PO QD	80 mg/day (40 mg/day for pediatrics 10 to 17 years)
pravastatin (Pravachol^R)	40 - 80 mg PO QD Pediatrics: 10 40 mg PO QD	80 mg/day Pediatrics: 20 mg/day for 8 to 13 years 40 mg/day for 14 to 18 years

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Vytorin	10/10 mg - 10/40 mg PO QD Use of the 10/80 mg dose of Vytorin should be restricted to patients who have been taking Vytorin 10/80 mg for 12 months or more without evidence of muscle toxicity	Length of benefit
Livalo	1 - 4 mg PO QD	Length of Benefit

Vytorin

10/10 mg - 10/40 mg PO QD

Use of the 10/80 mg dose of Vytorin should be restricted
to patients who have been taking Vytorin 10/80 mg for
12 months or more without evidence of muscle toxicity

Length of benefit

Livalo

1 - 4 mg PO QD

Length of Benefit

Product Availability:

Vytorin: 10/10, 10/20, 10/40, 10/80 mg tablet

Livalo: 1, 2, 4 mg tablet

References:

Vytorin [Prescribing Information] Whitehouse Station, NJ: Merck & Co., Inc.; February 2015.
Livalo [Prescribing information] Tokyo, Japan: Kowa Pharmaceuticals; October 2013.
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.
Micromedex^R Healthcare Series [Internet database]. Greenwood Village, CO: Thomson Healthcare. Updated periodically. Accessed June 22, 2015.
Clinical Pharmacology Web site. Available at: http://cpip.gsm.com/. Accessed: June 22, 2015.
Ezetimibe. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/ Accessed: June 22, 2015.
Simvastatin. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 22, 2015.
Livalo. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed: June 22, 2015.