Juxtapid — Medical Mutual
Homozygous Familial Hypercholesterolemia (HoFH)
Initial criteria
- Patient age ≥ 18 years
- Patient meets one of the following (i, ii, or iii):
- i. Phenotypic confirmation of homozygous familial hypercholesterolemia OR
- ii. Untreated LDL-C > 400 mg/dL AND (a. Clinical manifestation of HoFH before age 10 years OR b. At least one parent had untreated LDL-C or total cholesterol consistent with HeFH) OR
- iii. Treated LDL-C ≥ 300 mg/dL AND (a. Clinical manifestations of HoFH before age 10 years OR b. At least one parent had untreated LDL-C or total cholesterol consistent with HeFH)
- Patient meets one of the following (i or ii):
- i. Tried at least one PCSK9 inhibitor for ≥ 8 continuous weeks AND LDL-C remains ≥ 70 mg/dL OR
- ii. Patient is known to have two LDL-receptor negative alleles
- Patient meets one of the following (i or ii):
- i. Tried one high-intensity statin (atorvastatin ≥ 40 mg daily OR rosuvastatin ≥ 20 mg daily) AND tried high-intensity statin + ezetimibe for ≥ 8 continuous weeks AND LDL-C remains ≥ 70 mg/dL OR
- ii. Patient determined to be statin intolerant by either:
- a. Experienced statin-related rhabdomyolysis OR
- b. Experienced skeletal-related muscle symptoms that occurred while receiving separate trials of both atorvastatin and rosuvastatin AND resolved upon discontinuation of each respective therapy
Reauthorization criteria
- Initial criteria are still met
- Provider has checked ALT and AST since initiation (monthly within the first year OR every 3 months after the first year) and adjusted dose if ALT or AST ≥ 3x ULN
- Patient is having a beneficial response (as determined by the prescriber) AND reduction in LDL levels
Approval duration
initial 90 days; renewal 180 days