Pharmacy Prior Authorization Criteria

Nexletol (bempedoic acid) and Nexlizet (bempedoic acid-ezetimibe)

Indications for Prior Authorization

Nexletol (bempedoic acid)

• For diagnosis of HeFH or primary hyperlipidemia
  Indicated as an adjunct to diet, in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).

• For diagnosis of Established CVD or high risk for a CVD event but without established CVD
  Indicated to reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with: established cardiovascular disease (CVD), or a high risk for a CVD event but without established CVD.

Nexlizet (bempedoic acid-ezetimibe)

• For diagnosis of HeFH or primary hyperlipidemia
  Indicated as an adjunct to diet, in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).

• For diagnosis of Established CVD or high risk for a CVD event but without established CVD
  Indicated to reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with: established cardiovascular disease (CVD), or a high risk for a CVD event but without established CVD.

Criteria

Nexletol, Nexlizet

Prior Authorization (Initial Authorization)

Length of Approval: 6 Months [A]
For diagnosis of Heterozygous familial hypercholesterolemia (HeFH) or primary hyperlipidemia, established cardiovascular disease (CVD) or high risk for a CVD event but without established CVD

• One of the following diagnoses:
• Heterozygous familial hypercholesterolemia (HeFH)
• Primary Hyperlipidemia
• Established cardiovascular disease (CVD) (e.g., coronary artery disease, symptomatic peripheral arterial disease, cerebrovascular atherosclerotic disease)
• At high risk for a CVD event but without established CVD [e.g., diabetes mellitus (type 1 or type 2) in females over 65 years of age or males over 60 years of age]
AND
• One of the following:
• Patient has been receiving at least 12 consecutive weeks of highest tolerable dose of statin therapy
• Patient is statin intolerant as evidenced by an inability to tolerate at least two statins, with at least one started at the lowest starting daily dose, due to intolerable symptoms or clinically significant biomarker changes of liver function or muscle function (e.g., creatine kinase)
• Patient has an FDA labeled contraindication to all statins
AND
• One of the following LDL-C values while on maximally tolerated statin therapy within the last 120 days:
• LDL-C greater than or equal to 55 mg/dL with ASCVD
• LDL-C greater than or equal to 70 mg/dL without ASCVD
AND
• One of the following:
• For Nexletol, ONE of the following:
• Patient has been receiving at least 12 consecutive weeks of generic ezetimibe therapy as adjunct to maximally tolerated statin therapy
• Patient has a history of contraindication or intolerance to ezetimibe
OR
• For Nexlizet, patient has been receiving at least 12 consecutive weeks of generic ezetimibe therapy as adjunct to maximally tolerated statin therapy

Nexletol, Nexlizet

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Heterozygous familial hypercholesterolemia (HeFH) or primary hyperlipidemia, established cardiovascular disease (CVD) or high risk for a CVD event but without established CVD

• Patient demonstrates positive clinical response to therapy (e.g., reduction in LDL-C levels)
AND
• One of the following:
• Patient continues to receive other lipid-lowering therapy (e.g., statins, ezetimibe) at the maximally tolerated dose
• Patient has a documented inability to take other lipid-lowering therapy (e.g., statins, ezetimibe)

P & T Revisions

2024-07-15, 2024-05-02, 2024-02-27, 2023-11-02, 2023-07-06, 2023-05-02, 2022-05-05, 2021-09-28, 2021-05-11, 2020-05-28, 2020-05-05

References

1. Nexletol Prescribing Information. Esperion Therapeutics, Inc. Ann Arbor, MI. March 2024.
2. Nexlizet Prescribing Information. Esperion Therapeutics, Inc. Ann Arbor, MI. March 2024.
3. 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.
4. Alonso R, Cuevas A, Cafferata A. Diagnosis and Management of Statin Intolerance. J Atheroscler Thromb. 2019 Mar 1;26(3):207-215. doi: 10.5551/jat.RV17030. Epub 2019 Jan 19. PMID: 30662020; PMCID: PMC6402887.
5. 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.
6. 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.
7. Harada-Shiba M, Arai H, Ishigaki Y, Ishibashi S, Okamura T, Ogura M, Dobashi K, Nohara A, Bujo H, Miyauchi K, Yamashita S, Yokote K; Working Group by Japan Atherosclerosis Society for Making Guidance of Familial Hypercholesterolemia. Guidelines for Diagnosis and Treatment of Familial Hypercholesterolemia 2017. J Atheroscler Thromb. 2018 Aug 1;25(8):751-770. doi: 10.5551/jat.CR003. Epub 2018 Jun 7. PMID: 29877295; PMCID: PMC6099072.
8. Lloyd-Jones D, Morris P, et al. 2022 ACC Expert Consensus Decision Pathway on the Role of Nonstatin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk. J Am Coll Cardiol. 2022 Oct, 80 (14) 1366–1418. https://doi.org/10.1016/j.jacc.2022.07.006

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Revision History

• 2024-07-15: Updated LDL-C threshold for patients without ASCVD to align with LDL-C thresholds in 2022 ACC recommendations. Consolidated criteria. Updated references.
• 2024-05-02: Updated criteria due to indication updates in prescribing information.
• 2024-02-27: Criteria streamlined
• 2023-11-02: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-07-06: Update to account for 2022 ACC recommendations of a lower LDL threshold of 55mg/dl for patients with ASCVD at very high risk.
• 2023-05-02: Annual Review - criteria update
• 2022-05-05: Annual review, No criteria changes
• 2021-09-28: Annual Review: Updated references and background
• 2021-05-11: Annual Review: Updated references and background
• 2020-05-28: Update to add Nexlizet (bempedoic acid-ezetimibe) to the guideline and updated guideline name; no changes to criteria
• 2020-05-05: New program

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