Praluent — Highmark

Preferred products

• Repatha

Initial criteria

• If the request is for Praluent, the member is age ≥ 8 years; if the request is for Repatha, the member is age ≥ 10 years
• Prescribed by or in consultation with a cardiologist, lipid specialist, or endocrinologist
• Diagnosis of HeFH supported by one of the following: (a) genetic confirmation of a mutant allele at the LDLR, ApoB, PCSK9, or LDLRAP1 gene locus OR (b) untreated LDL-C ≥ 190 mg/dL, or untreated LDL-C ≥ 160 mg/dL before 20 years of age, AND physical signs of familial hypercholesterolemia (corneal arcus prior to 45 years, tendon xanthoma, tuberous xanthoma, or xanthelasma) OR (c) WHO/Dutch Lipid Clinical Network score > 8, or 'definite' familial hypercholesterolemia under Simon Broome or MEDPED criteria
• Member has experienced therapeutic failure to a maximally tolerated statin OR is statin intolerant as defined by: (i) at least two separate trials of different statins with statin-related rhabdomyolysis or muscle symptoms resolving on discontinuation OR (ii) CK increase to 10× ULN, LFTs increase to 3× ULN, or hospitalization due to severe statin-related adverse event
• Member meets one of: LDL-C ≥ 70 mg/dL, non-HDL-C ≥ 100 mg/dL, meets very high-risk criteria with LDL-C ≥ 55 mg/dL or non‑HDL‑C ≥ 85 mg/dL, or < 50% reduction in baseline LDL-C despite maximally tolerated statin
• If request is for Praluent and member is age ≥ 10 years, member has experienced therapeutic failure or intolerance to plan-preferred Repatha
• If member is age ≤ 17 years, member will continue to receive concurrent lipid-lowering therapies

Reauthorization criteria

• If the request is for Praluent, the member is age ≥ 8 years; if the request is for Repatha, the member is age ≥ 10 years
• Member has continued diagnosis of HeFH supported by genetic, biochemical, or clinical criteria as defined for initiation
• Prior to therapy member met one of: LDL-C ≥ 70 mg/dL, non-HDL-C ≥ 100 mg/dL, very high-risk criteria with LDL-C ≥ 55 mg/dL or non‑HDL‑C ≥ 85 mg/dL, or < 50% reduction in baseline LDL-C despite maximally tolerated statin therapy
• If member is age ≤ 17 years, member continues concurrent lipid-lowering therapies
• Member has demonstrated a reduction in LDL-C from baseline

Approval duration

initial 6 months (12 months for Delaware Commercial fully-insured/ACA); reauthorization 12 months