JUXTAPID (LOMITAPIDE) Products Affected JUXTAPID PA Criteria Criteria Details Covered Uses *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) Exclusion N/A Criteria Required *Patient has a diagnosis of homozygous familial hypercholesterolemia Medical (HoFH). Information *Patient has a baseline LDL-C greater than 100mg/dl within the last 30 days. *Must be used as an adjunct to a low fat diet and other lipid lowering treatments, including LDL apheresis. *Tried and failed maximum dose of atorvastatin or rosuvastatin or intolerant to either medication. *Must have tried LDL apheresis without complete results. *Tried and failed a statin in combination with other lipid lowering therapies such as ezetimibe, bile acid sequestrants, or niacin. *Patient does not have any of the following contraindications to therapy: Moderate or severe hepatic impairment OR Active liver disease including unexplained persistent abnormal liver function tests. *If female, patient is not pregnant. Age Restrictions *Must be 18 years of age or older Prescriber *Must be prescribed by or in consultation with a cardiologist, Restrictions endocrinologist or lipid specialist Coverage *Initial: 6 months. Renewal: 1 year Duration Other Criteria *Criteria for continuation of therapy: *Patient is tolerating treatment and there continues to be a medical need for the medication. *Patient has disease stabilization or improvement in disease (such as decreased LDL-C levels). The criteria listed above applies to Fallon Health Plan and its subsidiaries. Fallon Health Department of Pharmacy Services Page 1 PA Criteria Criteria Details *Patient must continue to follow a low fat diet *Patient does not have any of the following contraindications to therapy: Moderate or severe hepatic impairment OR Active liver disease including unexplained persistent abnormal liver function tests OR *If female, patient is not pregnant. *Benefit type: Pharmacy *Adopted: 06/12/13 *Reviewed: 12/14/16, 3/8/17: no change; 2/14/18: added contraindications to criteria for use section: Moderate or severe hepatic impairment OR Active liver disease including unexplained persistent abnormal liver function tests OR If female, patient is not pregnant, added age restrictions, prescriber and added contraindications to continuation of therapy criteria. The criteria listed above applies to Fallon Health Plan and its subsidiaries. Fallon Health Department of Pharmacy Services Page 2 .