Juxtapid (lomitapide) — United Healthcare
homozygous familial hypercholesterolemia (HoFH)
Preferred products
- Repatha (evolocumab)
- Evkeeza (evinacumab)
Initial criteria
- Diagnosis of homozygous familial hypercholesterolemia (HoFH) confirmed by one of the following: (1) submission of medical records confirming genetic confirmation of bi-allelic pathogenic/likely pathogenic variants on different chromosomes at the LDLR, APOB, PCSK9, or LDLRAP1 genes or ≥ 2 such variants at different loci OR (2) BOTH of the following: (a) untreated LDL-C > 400 mg/dL AND (b) one of the following: xanthoma before 10 years of age OR evidence of familial hypercholesterolemia in at least one parent
- Patient is on a low-fat diet
- Patient is receiving other lipid-lowering therapy (e.g., statin, ezetimibe, LDL apheresis)
- Prescribed by a cardiologist OR endocrinologist OR lipid specialist
- EITHER (1) BOTH of the following: (a) history of intolerance, failure or contraindication to Repatha (evolocumab) AND (b) history of intolerance, failure or contraindication to Evkeeza (evinacumab) OR (2) patient is currently on Juxtapid therapy
- Not used in combination with a PCSK9 inhibitor [e.g., Praluent (alirocumab), Repatha (evolocumab)]
- Not used in combination with Evkeeza (evinacumab-dgnb)
Reauthorization criteria
- Patient is on a low-fat diet
- Patient continues to receive other lipid-lowering therapy (e.g., statin, LDL apheresis)
- Documentation of a positive clinical response to therapy from pre-treatment baseline
- Prescribed by a cardiologist OR endocrinologist OR lipid specialist
- Not used in combination with a PCSK9 inhibitor [e.g., Praluent (alirocumab), Repatha (evolocumab)]
- Not used in combination with Evkeeza (evinacumab-dgnb)
Approval duration
12 months