lomitapide — CareFirst (Caremark)

Initial criteria

• Member has a documented diagnosis of homozygous familial hypercholesterolemia confirmed by any of the following: variant in two low-density lipoprotein receptor (LDLR) alleles OR presence of homozygous or compound heterozygous variants in apolipoprotein B (APOB) or proprotein convertase subtilisin-kexin type 9 (PCSK9) gene OR compound heterozygosity or homozygosity for variants in the gene encoding low-density lipoprotein receptor adaptor protein 1 (LDLRAP1).
• Member has an untreated LDL-C > 400 mg/dL AND either presence of cutaneous or tendinous xanthomas before age < 10 years OR an untreated LDL-C level ≥ 190 mg/dL in both parents.
• Prior to initiation, member meets one of the following: treated LDL-C level ≥ 70 mg/dL OR treated LDL-C level ≥ 55 mg/dL AND member has history of a clinical ASCVD event OR major ASCVD risk factors (age ≥ 65 years, familial hypercholesterolemia, diabetes, chronic kidney disease, history of congestive heart failure).
• Prior to initiation, member is/was receiving stable treatment with at least three lipid-lowering therapies (e.g., statins, ezetimibe, PCSK9 directed therapy) at maximally tolerated dose.
• Member will continue to receive concomitant lipid-lowering therapy.
• Submission of genetic testing or medical records confirming diagnosis of HoFH, LDL-C level within six months, chart notes confirming ASCVD if applicable, and documentation of current lipid-lowering therapy.

Reauthorization criteria

• Member meets all initial coverage criteria.
• Member has had at least 20% reduction of LDL-C from baseline.
• Member is currently receiving concomitant lipid-lowering therapy.

Approval duration

Initial: 6 months; Reauthorization: 12 months