Alirocumab (Praluent)

FDA-Approved Indications for prior authorization:

Alirocumab (Praluent): Adjunct to diet and maximally tolerated statin therapy for the treatment of adults with 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:

Heterozygous Familial Hypercholesterolemia

  • The member is ≥ 18 years of age AND
  • Alirocumab (Praluent) 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 Repatha® [evolocumab], Kynamro® [mipomersen], or Juxtapid® [lomitapide] [documentation required] AND
    • Treatment with at least two 8-week trials of different high-intensity statins used concomitantly with 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

  • Alirocumab (Praluent) 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. [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 Period:

  • Patient must have tried/failed preferred Repatha.
  • Initial approval is for 4 months.
  • Renewal for 12 months if documented LDL reduction of ≥ 10%

Quantity Level Limitation:

  • Members who meet the above clinical criteria will be eligible for approval of 2 syringes/autoinjectors per 28 days. 

 

Last review date: July 24, 2016