NEXLETOL (bempedoic acid)

NEXLETOL (bempedoic acid)

SELF ADMINISTRATION-ORAL

Indication for Prior Authorization:

• Indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C
• Limitations of Use:
  • The effect of Nexletol™ on cardiovascular morbidity and mortality has not been determined

Coverage Criteria:

For a diagnosis of Atherosclerotic cardiovascular disease (ASCVD):

• Patient is 18 years of age or older, AND
• Prescribed by a specialist (e.g. cardiologist, endocrinologist, or lipid specialist), AND
• Patient has established Atherosclerotic cardiovascular disease (ASCVD) as confirmed by chart note documentation and one of the following:
  • Acute coronary syndromes 
  • History of myocardial infarction 
  • Stable or unstable angina 
  • Coronary or other arterial revascularization 
  • Stroke 
  • Transient ischemic attack 
  • Peripheral arterial disease presumed to be of atherosclerotic origin
  • Clinically significant coronary heart disease diagnosed by invasive or noninvasive testing (e.g., coronary angiography, stress test using treadmill, stress echocardiography or nuclear imaging), AND
• Patient meets one of the following (as documented in medical records):
  • Patient has received at least 12 consecutive weeks of one high intensity statin therapy (e.g. Atorvastatin 40-80 mg, Rosuvastatin 20-40 mg) 
    • Must also be evidenced by consistent pharmacy claims over the past 12 weeks (unless new to the plan)
  • Patient experienced intolerable and persistent (e.g. more than 2 weeks) side effects to statin therapy (e.g. myalgia or myositis)
  • Patient has a labeled contraindication to all statins
  • Patient has rhabdomyolysis or muscle symptoms with statin treatment with CK elevations greater than 10 times ULN, AND
• Patient meets one of the following:
  • Patient has received at least 12 consecutive weeks of Ezetimibe (Zetia) therapy as adjunct to maximally tolerated statin therapy
    • Must also be evidenced by consistent pharmacy claims over the past 12 weeks (unless new to the plan)
  • Patient has a contraindication or intolerance to Ezetimibe (as documented in medical records), AND
• Patient has an  LDL-C ≥70 mg/dL while on maximally tolerated lipid lowering therapy (e.g. statin and Ezetimibe therapy) within the last 120 days, AND
• Nexletol™ will be used in combination with maximally tolerated statin and/or ezetimibe therapy

For a diagnosis of Heterozygous Familial Hypercholesterolemia (HeFH):

• Patient is 18 years of age or older, AND
• Prescribed by a specialist (e.g. cardiologist, endocrinologist, or lipid specialist), AND
• Patient has a diagnosis of Heterozygous Familial Hypercholesterolemia as confirmed by chart note documentation, AND
• Patient has an untreated/pre-treatment LDL-cholesterol (LDL-C) greater than 190 mg/dL (greater than 155 mg/dL if less than 16 years of age), AND
• Patient meets one of the following (documentation required):
  • Patient has a functional mutation in the LDL receptor, ApoB, or PCSK9 gene
  • Physical signs of FH, such as presence of tendon xanthomas, corneal arcus in a member < 45 years of age, tuberous xanthomas, or xanthelasma 
  • A score of >8 using The Dutch Lipid Clinic Network criteria
  • Definite Familial Hypercholesterolemia using The Simon Broome Criteria, AND
• Patient meets one of the following (as documented in medical records):
  • Patient has received at least 12 consecutive weeks of one high intensity statin therapy (e.g. Atorvastatin 40-80 mg, Rosuvastatin 20-40 mg) 
    • Must also be evidenced by consistent pharmacy claims over the past 12 weeks (unless new to the plan)
  • Patient experienced intolerable and persistent (e.g. more than 2 weeks) side effects to statin therapy (e.g. myalgia or myositis)
  • Patient has a labeled contraindication to all statins
  • Patient has rhabdomyolysis or muscle symptoms with statin treatment with CK elevations greater than 10 times ULN, AND
• Patient meets one of the following:
  • Patient has received at least 12 consecutive weeks of Ezetimibe (Zetia®) therapy as adjunct to maximally tolerated statin therapy
    • Must also be evidenced by consistent pharmacy claims over the past 12 weeks (unless new to the plan)
  • Patient has a contraindication or intolerance to Ezetimibe (as documented in medical records), AND
• Nexletol™ will be used in combination with maximally tolerated statin and/or ezetimibe therapy

Reauthorization Criteria:

• Patient had a positive clinical response to therapy (e.g., reduction in LDL-C levels) as evidenced by chart notes and/or lab results, AND
• Patient will continue therapy with other lipid-lowering therapy (e.g., statins, ezetimibe) at maximally tolerated doses or has a documented inability to take other lipid-lowering therapy

Dosing:

• 180 mg orally once daily
• Avoid concomitant use of Nexletol™ with simvastatin greater than 20 mg or pravastatin greater than 40 mg

Coverage Duration:

• Initial: 4 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 Committee.

Additional Information:

• Hyperuricemia: Nexletol™ inhibits renal tubular OAT2 and may increase blood uric acid levels. Advise patients to contact their healthcare provider if symptoms of hyperuricemia occur. Assess serum uric acid when clinically indicated. Monitor patients for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate
• Tendon Rupture: Nexletol™ is associated with an increased risk of tendon rupture or injury
• Pregnancy: Based on mechanism of action, may cause fetal harm
• Lactation: Breastfeeding is not recommended with Nexletol™

Review History:

11/17/20- Original review

References:

• Nexletol Prescribing Information. Esperion Therapeutics, Inc. Ann Arbor, MI. February 2020. 
• WHO Familial Hypercholesterolemia Consultation Group. Familial Hypercholesterolemia (FH): report of a second WHO consultation. Geneva: World Health Organization; 1999. 
• 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. 
• 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. 
• ATP III Final Report PDF. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) Final Report. Circulation. 2002;106:3143-3421. 
• Per clinical drug consult with cardiologist. August 3, 2015. 
• Lloyd-Jones DM, Morris PB, Ballantyne CM, et al. 2017 Focused Update of the 2016 ACC expert consensus decision pathway on the role of non-statin therapies for LDL-cholesterol lowering in the management of atherosclerotic cardiovascular disease risk. J Am Coll Cardiol. 2017;70:1785-1822. 
• Goldberg AC, Hopkins PN, Toth PP, et al. Familial hypercholesterolemia: screening, diagnosis, and management of pediatric and adult patients: clinical guidance from the National Lipid Association Expert Panel on Familial Hypercholesterolemia. J Clin Lipidol. 2011;5:S1-51. 
• Cannon CP, Blazing MA, Giugliano RP, et al. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med. 2015;372:2387-97. 
• Per clinical drug consult with cardiologist. November 17, 2017.