EVOLOCUMAB (REPATHA) 

FDA-Approved Indications for prior authorization:

  • Adjunct to diet and maximally tolerated statin therapy for the treatment of adults with homozygous familial hypercholesterolemia, heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL-cholesterol (LDL-C)

Patients must meet the following criteria for the indications above:

Homozygous Familial Hypercholesterolemia

  • The member is ≥ 13 years of age AND

  • Prescribed by or in consultation with a cardiologist or lipid specialist AND the patient meets one of the following:

    • There is clinical documentation of one of the following (a or b): a. Genetic confirmation of two mutant alleles at the low-density lipoprotein receptor (LDLR), apolipoprotein B (APOB), proprotein convertase subtilisin kexin type 9 (PCSK9), or low-density lipoprotein receptor adaptor protein 1 (LDLRAP1) gene locus [documentation required] OR

    • The patient has an untreated LDL-C of > 500 mg/dL (prior to treatment with antihyperlipidemic agents) [documentation required]; OR

    • The patient has a treated LDL-C of ≥ 300 mg/dL) (after treatment with antihyperlipidemic agents but prior to agents such as Praluent® [alirocumab], Kynamro® [mipomersen], or Juxtapid® [lomitapide] [documentation required] OR

    • The patient has clinical manifestations of HoFH (e.g., cutaneous or tendon xanthomas, arcus cornea, tuberous xanthomas or xanthelasma [documentation required] AND

    • Evolocumab (Repatha) will be used concomitantly with a maximally-tolerated statin unless all statins are contraindicated or not tolerated AND

    • Evolocumab (Repatha) is not being used concomitantly with lomitapide (Juxtapid), mipomersen (Kynamro), or another PCSK9 inhibitor

?Heterozygous Familial Hypercholesterolemia:

  • The member is ≥ 18 years of age AND

  • Evolocumab (Repatha) must be prescribed by or in consultation with a cardiologist or lipid specialist and there is clinical documentation of one of the following:

    • Presence of causal mutation for familial hypercholesterolemia by genetic testing OR

    • Physical signs of FH, such as presence of tendon xanthomas, corneal arcus in a member < 45 years of age, tuberous xanthomas, or xanthelasma OR

    • Clinical diagnosis based on the WHO criteria/Dutch Lipid Clinical Network criteria with a score > 8 points or the Simon Broome register diagnostic criteria with a criterion for definite familial hypercholesterolemia AND

    • Documentation of LDL-C ≥ 160 mg/dL (after treatment with antihyperlipidemic agents but prior to PCSK9 inhibitor therapy such as Praluent® [alirocumab], Kynamro® [mipomersen], or Juxtapid® [lomitapide] [documentation required] AND

    • Treatment with at least two 8-week trials of different high-intensity statins AND ezetimibe (Zetia) has been ineffective*. Adherence to the current statin regimen must be evidenced by consistent pharmacy claims over the past 8 weeks, unless new to the plan AND

    • The member will be using the PCSK9 inhibitor concomitantly with a maximally-tolerated statin

*Treatment is considered ineffective if it results in a < 50% reduction in LDL-C or an LDL-C ≥ 160 mg/dL. In higher risk patients, treatment is considered ineffective if it results in an LDL-C ≥ 100 mg/dL

  • High risk is defined as: clinically evident coronary heart disease (CHD) or other atherosclerotic cardiovascular disease, diabetes, a family history of very early CHD (men < 45 years of age and women <55 years of age), current smoking, or high lipoprotein (a) ≥ mg/dL

Hypercholesterolemia, ASCVD

  • Evolocumab (Repatha) must be prescribed by or in consultation with a cardiologist or lipid specialist AND

  • The member (≥ 18 years of age) has a documented diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD), defined as one of the following: acute coronary syndrome, or a 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. [Documentation required] AND

  • The patient has tried two high-intensity statin therapies (i.e., atorvastatin ≥ 40mg daily; Crestor [rosuvastatin tablets] ≥ 20mg daily [as a single-entity or as a combination product] AND Zetia (ezetimibe tablets) [as a single-entity or as a combination product] concomitantly for ≥ 8 continuous weeks; AND the LDL-C level remains LDL-C ≥ 130 mg/dL. Adherence to the current statin regimen must be evidenced by consistent pharmacy claims over the past 8 weeks, unless new to the plan. [Documentation required] OR

  • The patient has been determined to be statin intolerant by meeting one of the following criteria:

    • The patient experienced statin-related rhabdomyolysis (statin-induced muscle breakdown with signs and symptoms such as muscle pain, weakness, tenderness, acute renal failure and/or elevated creatine kinase [CK] levels [e.g., greater or equal to 10 times the upper limit of normal]) [documentation required]; OR

    • The patient experienced skeletal-related muscle symptoms (e.g., myopathy [muscle weakness] or myalgia [muscle aches, soreness, stiffness, or tenderness]) and meets both of the following criteria [(i.) AND (ii.]:

      • The skeletal-related muscle symptoms (e.g., myopathy or myalgia) occurred while receiving separate trials of both atorvastatin and Crestor (as single-entity or as combination products) [documentation required]; AND

      • When receiving separate trials of both atorvastatin and Crestor (as single-entity or as combination products) the skeletal-related muscle symptoms (e.g., myopathy, myalgia) resolved upon discontinuation of each respective statin therapy (atorvastatin and Crestor); AND

      • The member will be using the PCSK9 inhibitor concomitantly with a maximally-tolerated statin

Approval:

  • Initial approval is for 4 months

  • Renewal for 12 months if documented LDL reduction of ≥ 10%


 

Last review date: July 24, 2016

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