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    PCSK9 inhibitors

    Drug Class - Proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors 
    Drugs     - Praluent™ (alirocumab) [Sanofi-Aventis U.S.]; Repatha™ (evolocumab) [Amgen Inc]

    March 2016

    Therapeutic area - Hyperlipidemia

    Approval criteria

    • Prescriber must be a cardiologist, endocrinologist, or mid-level practitioner specializes in cardiology or endocrinology or documentation of consultation with a cardiologist, endocrinologist, or mid-level practitioner specializes in cardiology or endocrinology is provided at time of request AND
    • Patient has been compliant for 3 months with high dose statin therapy (at minimum atorvastatin 40mg to 80mg daily or rosuvastatin 20mg to 40mg daily) OR at maximally tolerated statin therapy OR failure to tolerate at least two statins as documented in chart notes provided at time of request AND
    • If patient is tolerant to statins, confirmation is provided that statin therapy will continue along with PCSK9 therapy AND

    Diagnosis of one of the following (documentation of diagnosis and LDL values must be provided at time of request):

    • Heterozygous or homozygous familial hypercholesterolemia with LDL >190mg/dL in adults or LDL >155mg/dL in children under age 16 OR
    • Clinical atherosclerotic cardiovascular disease with LDL >130mg/dL and one of the following risk factors:
      • Acute coronary syndromes
      • Myocardial infarction
      • Stable or unstable angina
      • Coronary or other arterial revascularization
      • Stroke
      • Peripheral artery disease presumed to be of atherosclerotic origin
      • Transient ischemic attack
      • Clinically significant coronary artery disease
      • Carotid artery occlusion >50%
      • Renal artery stenosis or renal artery stent procedure

    Initial approvals will be limited to 3 months in duration.

    Renewal criteria

    • Confirmation of continued maximally-tolerated statin therapy AND
    • Documentation is provided of at least a 45% LDL reduction from baseline while on PCSK9 therapy OR LDL ≤ 100 mg/dL 

    Denial criteria

    • Concurrent use of Praluent ,Repatha, Kynamro, or Juxtapid
    • Doses exceeding FDA approved limits

    Quantity limits

    • Praluent is limited to 2 ml per month
    • Repatha is limited to 3 ml per month

    Questions?

    MHCP Provider Call Center 651-431-2700 or 800-366-5411

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