WHA

LEQVIO (inclisiran)

Office-Administered – subcutaneous injection

Diagnosis considered for coverage:
  • HeFH, ASCVD - a small interfering RNA (siRNA) directed to PCSK9 (proprotein convertase subtilisin kexin type 9) mRNA indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low-density lipoprotein cholesterol (LDL-C).
Coverage Criteria:

For diagnosis of atherosclerotic cardiovascular disease (ASCVD):

  • Dose does not exceed 284 mg administered as a single subcutaneous injection initially, again at 3 months, and then every 6 months thereafter; AND
  • Patient is age 18 years or older; AND
  • Prescribed by or in consultation with a cardiologist, endocrinologist, or lipid specialist; AND
  • Medical record documentation confirms a diagnosis of established ASCVD by history of ONE of the following: acute coronary syndrome (ACS), myocardial infarction (MI), angina, coronary or other arterial revascularization, stroke, transient ischemic attack (TIA), or clinically significant coronary heart disease (CHD) diagnosed by testing (e.g., coronary angiography, treadmill stress test, stress echocardiography, or nuclear imaging); AND
  • ONE of the following is confirmed by medical record documentation:
    • Patient has received a high-intensity statin therapy (see Table 1) for at least 3 months and will continue to receive a high-intensity statin at maximally tolerated dose
    • BOTH of the following:
      • Patient experienced persistent and intolerable side effects to statin therapy (e.g. myalgia or myositis - muscle pain, weakness, or inflammation)
      • ONE of the following:
        • Patient has received a moderate-intensity statin therapy (see Table 1) for at least 3 months and will continue to receive a moderate-intensity statin at maximally tolerated dose
        • Patient has received a low-intensity statin therapy (see Table 1) for at least 3 months and will continue to receive a low-intensity statin at maximally tolerated dose
        • Patient has a contraindication to all statin therapies
        • Patient has rhabdomyolysis or muscle symptoms associated with creatine kinase (CK) level increases greater than ten times the upper limit of normal (ULN); AND
  • ONE of the following is confirmed by medical record documentation:
    • Patient has received ezetimibe (Zetia) in combination with maximally tolerated statin therapy for at least 3 months
    • If intolerant to statins, the patient has tried ezetimibe (without a statin) for at least 3 months
    • Patient experienced intolerable side effects or a contraindication to ezetimibe; AND
  • Patient has a low-density lipoprotein cholesterol (LDL-C) equal to or greater than 70 mg/dL while on maximally tolerated lipid-lowering therapy (e.g., statin therapy with ezetimibe) within the last 120 days; AND
  • A medically appropriate reason is provided why the patient cannot use the following alternative pharmacy benefit agents indicated for their condition: PCSK9-inhibitors (i.e., Praluent, Repatha), ACL-inhibitors (i.e., Nexletol, Nexlizet); AND
  • Medication will not be used in combination with PCSK9 inhibitors (e.g., Praluent, Repatha), microsomal triglyceride transfer protein inhibitors (e.g., Juxtapid), or angiopoietin-like 3 (ANGPTL3) inhibitors (e.g., Evkeeza).

For diagnosis of heterozygous familial hypercholesterolemia (HeFH):

  • Dose does not exceed 284 mg administered as a single subcutaneous injection initially, again at 3 months, and then every 6 months thereafter; AND
  • Patient is age 18 years or older; AND
  • Prescribed by or in consultation with a cardiologist, endocrinologist, or lipid specialist; AND
  • Patient has a diagnosis of HeFH that is confirmed by medical record documentation by BOTH of the following:
    • Untreated/pre-treatment LDL-cholesterol (LDL-C) is greater than 190 mg/dL (greater than 155 mg/dL if less than 16 years of age)
    • One of the following:
      • Family history of myocardial infarction (heart attack) in first-degree relative less than 60 years of age
      • Family history of myocardial infarction (heart attack) in second-degree relative less than 50 years of age
      • Family history of LDL-C greater than 190 mg/dL in first- or second-degree relative
      • Family history of familial hypercholesterolemia (HeFH or HoFH) in first- or second-degree relative
      • Family history of tendinous xanthoma (lipid deposits in tendons) or arcus cornealis (lipid deposits in the outer part of the cornea) in first- or second-degree relative
      • Patient has genetic mutation in the LDL receptor, ApoB, or PCSK9 gene
      • Patient has physical signs of HeFH (i.e., tendon xanthomas, corneal arcus and age less than 45 years)
      • Dutch Lipid Clinic Network diagnostic criteria for familial hypercholesterolemia score is greater than 8 (i.e., definite familial hypercholesterolemia)
      • Simon Broome diagnostic criteria for familial hypercholesterolemia corresponds to definite familial hypercholesterolemia; AND
  • ONE of the following is confirmed by medical record documentation:
    • Patient has received a high-intensity statin therapy (see Table 1) for at least 3 months and will continue to receive a high-intensity statin at maximally tolerated dose
    • BOTH of the following:
      • Patient experienced persistent and intolerable side effects to statin therapy (e.g. myalgia or myositis - muscle pain, weakness, or inflammation)
      • ONE of the following:
        • Patient has received a moderate-intensity statin therapy (see Table 1) for at least 3 months and will continue to receive a moderate-intensity statin at maximally tolerated dose
        • Patient has received a low-intensity statin therapy (see Table 1) for at least 3 months and will continue to receive a low-intensity statin at maximally tolerated dose
        • Patient has a contraindication to all statin therapies
        • Patient has rhabdomyolysis or muscle symptoms associated with creatine kinase (CK) level increases greater than ten times the upper limit of normal (ULN); AND
  • ONE of the following is confirmed by medical record documentation:
    • Patient has received ezetimibe (Zetia) in combination with maximally tolerated statin therapy for at least 3 months
    • If intolerant to statins, the patient has tried ezetimibe (without a statin) for at least 3 months
    • Patient experienced intolerable side effects or a contraindication to ezetimibe; AND
  • A medically appropriate reason is provided why the patient cannot use the following alternative pharmacy benefit agents indicated for their condition: PCSK9-inhibitors (i.e., Praluent, Repatha), ACL-inhibitors (i.e., Nexletol, Nexlizet); AND
  • Medication will not be used in combination with PCSK9 inhibitors (e.g., Praluent, Repatha), microsomal triglyceride transfer protein inhibitors (e.g., Juxtapid), or angiopoietin-like 3 (ANGPTL3) inhibitors (e.g., Evkeeza).
Reauthorization Criteria:

For a diagnosis of ASCVD or HeFH:

  • Dose does not exceed the FDA-labeled maximum for the patient’s condition; AND
  • Medical records (e.g. chart notes, laboratory results) document an LDL-C reduction of 10% or more after starting therapy; AND
  • One of the following:
    • Will continue to use in combination with a statin and/or ezetimibe at maximally tolerated dose
    • Patient experienced persistent and intolerable side effects or a contraindication to ezetimibe and statins; AND
  • Medication will not be used in combination with PCSK9 inhibitors (e.g., Praluent, Repatha), microsomal triglyceride transfer protein inhibitors (e.g., Juxtapid), or angiopoietin-like 3 (ANGPTL3) inhibitors (e.g., Evkeeza).
Coverage Duration:
  • Initial: 6 months
  • Reauthorization: 1 year
Authorization is not covered for the following:
  • The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
Additional Information:
  • LEQVIO 284 mg/1.5 mL (189 mg/mL) in a single-dose prefilled syringe should be administered by a healthcare professional injected subcutaneously into the abdomen, upper arm, or thigh.
Policy Updates:
  • 05/17/2022 – New policy approved by P&T.
References:
  1. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 2019; 73:e285-e350.
  2. Leqvio prescribing information. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021.
  3. Ray KK, Wright RS, Kallend D, et al. Two phase 3 trials of inclisiran in patients with elevated LDL cholesterol. N Engl J Med. 2020;382(16):1507-1519.
  4. Raal FJ, Kallend D, Ray KK, et al. Inclisiran for the Treatment of Heterozygous Familial Hypercholesterolemia. N Engl J Med. 2020;382(16):1520-1530.
  5. Scientific Steering Committee on behalf of the Simon Broome Register Group. Risk of fatal coronary heart disease in familial hypercholesterolaemia. BMJ. 1991;303:893-6.

Last review date: May 17, 2022