Prior Auth Protocol

FDA Approved Indications:

For use as an adjunct to lipid-lowering medications and diet to reduce low density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B), total cholesterol (TC), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH)

Health Net Approved Indications and Usage Guidelines:

AND

Prescribed by or in consultation with a Cardiologist, Endocrinologist, or lipid specialist

AND

Member must meet prior authorization criteria for and failed or had clinically significant adverse effects to Repatha 420 mg (unless contraindicated)

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:

The safety and effectiveness of Kynamro have not been established in patients with hypercholesterolemia who do not have HoFH.
The effect of Kynamro on cardiovascular morbidity and mortality has not been determined.
The safety and effectiveness of Kynamro have not been established in pediatric patients.
There is a black box warning on the package labeling for Kynamro regarding the risk of hepatotoxicity. In the Kynamro HoFH clinical trial 4 (12%) of the 34 patients treated with Kynamro compared to 0% of the 17 placebo-treated patients had an elevation in alanine transaminase (ALT) at least 3x upper limit of normal (ULN); and, 3 (9%) of those treated with Kynamro compared to 0% treated with placebo had at least one elevation in ALT of at least 5x ULN.
Because of the risk of hepatotoxicity, Kynamro is available only through a Risk Evaluation and Mitigation Strategy (REMS) program.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Vytorin^R (ezetimibe/simvastatin)	10/40 mg PO QD	10/40 mg PO QD (Use of the 10/80 mg dose is restricted to patients who have been taking simvastatin 80 mg for 12 months or more without evidence of muscle toxicity)
atorvastatin (Lipitor^R)	40 mg PO QD	80 mg PO QD
Crestor^R(rosuvastatin)	5 - 40 mg PO QD	40 mg PO QD
Repatha	HoFH 420 mg SC once monthly	420 mg SC once monthly

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Kynamro	200 mg SC once per week	Length of Benefit

Product Availability:

Vial, pre-filled syringe: 1 mL of 200 mg/mL solution

References:

Kynamro [Prescribing Information]. Cambridge, MA: Genzyme Corporation; March 2015.
Raal FJ, Santos RD, Blom DJ, et al. Mipomersen, an apolipoprotein B synthesis inhibitor, for lowering of LDL cholesterol concentrations in patients with homozygous familial hypercholesterolaemia: a randomized, double-blind, placebo-controlled trial. Lancet 2010;375:998-1006.
Micromedex^R Healthcare Series [Internet database]. Greenwood Village, CO: Thomson Healthcare. Updated periodically. Accessed May 27, 2015.