PCSK9 Inhibitors

Drug
Praluent™ (alirocumab) [Regeneron Pharmaceuticals, Inc.] 
Repatha™ (evolocumab) [Amgen Inc]

August 2026

Therapeutic area - Lipotropics, Other

Initial approval criteria

  • Patient must meet an age-appropriate medically accepted indication, as defined in Section 1927 of the Social Security Act, for the requested agent; 

AND

  • Patient has ONE of the following diagnoses that is aligned with the FDA-approved label of the requested agent:
    • Established Atherosclerotic Cardiovascular Disease (ASCVD) (e.g., acute coronary syndromes, history of myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease presumed to be of atherosclerotic origin); OR
    • Homozygous Familial Hypercholesterolemia (HoFH) as evidenced by one of the following:
      • Genetic confirmation of two mutant alleles at the LDL receptor, ApoB, PCSK9, or LDLRAP1 gene locus or ARH adaptor protein gene locus; OR
      • An untreated LDL-C > 500 mg/dL with either: 
        • Cutaneous or tendon xanthoma before age 10 years; OR 
        • Untreated LDL-C levels consistent with heterozygous familial hypercholesterolemia in both parents (≥190 mg/dL); OR
    • Heterozygous Familial Hypercholesterolemia as evidenced by one of the following: 
      • Functional mutation in the LDLR, ApoB, PCSK9 or ARH adaptor protein (LDLRAP1) gene; OR
      • Corneal arcus (seen in ages < 45 years), xanthelasma (seen in ages < 25 years), or tendon xanthomas; OR 
      • Clinical diagnosis based on the World Health Organization Dutch Lipid Clinical Network criteria with a “probable familial hypercholesterolemia” score of ≥ 6 points or definite diagnosis by Simon Broom criteria; OR
    • Primary hypercholesterolemia with ONE of the following:
      • Untreated LDL-C ≥ 190 mg/dL; OR
      • At high risk for ASCVD defined as a 10-year ASCVD risk ≥ 20% with LDL-C 70-189 mg/dL; OR
      • 40-75 years of age with diabetes and 10-year ASCVD risk > 7.5%

AND

  • Documentation of recent (within the last 30 days) LDL-C of one of the following despite maximally tolerated lipid-lowering therapy:  
    • LDL-C ≥ 55 mg/dL AND Very High Risk ASCVD (defined as a history of multiple major ASCVD events or 1 major ASCVD event and multiple high-risk conditions); OR
    • LDL-C ≥ 70 mg/dL for patients with clinical ASCVD AND not at very high risk; OR 
    • LDL-C ≥ 100 mg/dL (or LDL ≥ 70 mg/dL for patients 40 to 75 years of age with diabetes) for severe primary hypercholesteremia (including HeFH) without ASCVD but with multiple risk factors that increase subsequent risk of ASCVD

AND

  • Adherence (defined as 85% by consistent pharmacy claims) to a high intensity statin regimen for at least 12 weeks or to a moderate-intensity statin for at least 12 weeks if unable to tolerate a high-intensity statin, unless one of the following applies: 
    • Statin therapy is contraindicated; OR
    • Documented statin risk factors; OR
    • Rhabdomyolysis or muscle symptoms with statin treatment with CK elevations; OR
    • Statin intolerance due to one of the following: 
      • Myopathy: Unexplained muscle pain or weakness accompanied by CK elevations; OR 
      • Myalgia: Muscle symptoms without CK elevations and meets both of the following: 
        • Intolerable statin associated muscle symptoms (SAMS) persisted for at least two weeks which disappeared with discontinuation of the statin therapy and recurred with a statin re-challenge; AND
        • Intolerant despite re-challenge with titration from the lowest possible dose and/or intermittent dosing frequency (e.g., 1 to 3 times weekly)

AND

  • Adherence (defined as 85% by consistent pharmacy claims) to Zetia (ezetimibe) therapy used concomitantly with a statin at the maximally tolerated dose over the past 12 weeks, unless one of the following applies:
    • Zetia therapy is contraindicated; or
    • History of Zetia intolerance (e.g. associated diarrhea or upper respiratory tract infection); or
    • If ≥ 15% LDL-C reduction is required despite adherence with statin therapy, use of Zetia is not required.

AND

  • Requested agent will be used concomitantly with a maximally tolerated statin and Zetia unless contraindications, intolerance, or the use of Zetia is not required. 

AND

  • Requested agent will not be used in combination with Juxtapid (lomitapide), Leqvio (inclisiran), or another PCSK9 inhibitor.

Renewal criteria

  • Evidence of adherence (defined as 85% consistent pharmacy claims) to ongoing concomitant lipid lowering therapy as applicable; AND
  • Lab results obtained within the last 12 weeks show an LDL-C reduction since the initiation of PCSK9 inhibitor therapy.

Quantity limits

  • Quantity limits pursuant to the FDA-approved label will apply

Questions?

Provider Call Center: (844) 575-7887