• For use as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH)

• Diagnosis of homozygous familial hypercholesterolemia (HoFH)

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)
  
  

• 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.

• The safety and effectiveness of Juxtapid have not been established in patients with hypercholesterolemia who do not have HoFH.
• The safety and effectiveness of Juxtapid have not been studied in pediatric patients less than 18 years.
• The effect of Juxtapid on cardiovascular morbidity and mortality has not been determined.
• There is a black box warning on the package labeling for Juxtapid regarding the risk of hepatotoxicity. In the Juxtapid clinical trial 10 (34%) of the 29 patients treated with Juxtapid had at least one elevation in alanine transaminase (ALT) or aspartate aminotransferase (AST) that was at least three times the upper limit of normal (ULN). There were no concomitant clinically meaningful elevations of total bilirubin, INR, or alkaline phosphatase. Juxtapid also increases hepatic fat, with or without concomitant increases in transaminases. Hepatic steatosis associated with Juxtapid treatment may be a risk factor for progressive liver disease, including steatohepatitis and cirrhosis. The package labeling for Juxtapid recommends that ALT, AST, alkaline phosphatase, and total bilirubin be measured before treatment, and then ALT and AST regularly as recommended. During treatment, dose adjustments may be needed if ALT or AST are at least 3x ULN. Juxtapid should be discontinued for clinically significant liver toxicity.
• Because of the risk of hepatotoxicity, Juxtapid is available only through a Risk Evaluation and Mitigation Strategy (REMS) program called the Juxtapid REMS Program.
• Juxtapid has not been studied concomitantly with other LDL-lowering agents that can also increase hepatic fat. Therefore, the combined use of such agents is not recommended.
• Juxtapid may cause fetal harm when administered to a pregnant woman. Females of reproductive potential should have a negative pregnancy test before starting Juxtapid and should use effective contraception during therapy with Juxtapid.