CurrentCentenePolicy CP PMN.237

Bempedoic Acid (Nexletol), Bempedoic Acid/Ezetimibe (Nexlizet) Clinical Policy

Defines Centene's medical necessity guidance, review history, and prescribing/reference sources for use of bempedoic acid and the fixed-dose combination in adults with hyperlipidemia and cardiovascular risk; affects providers seeking coverage for these products under Centene plans in North Carolina.

Policy Summary

PayerCentene

PolicyBempedoic Acid (Nexletol), Bempedoic Acid/Ezetimibe (Nexlizet) Clinical Policy

Policy CodePolicy CP PMN.237

Change TypeCriteria revised (RT4) and administrative updates

Effective DateSep 1, 2020

Next Review DateN/A

Key ActionObtain and submit documentation of indication and prior statin trial/failure per revised labeling when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

Criteria updated to reflect revised indications expanding primary hyperlipidemia beyond HeFH and a new indication for reducing cardiovascular risk in adults unable to take recommended statin therapy; statin adherence duration reduced and trial/failure criteria simplified.

Removed restriction on coadministration with PCSK9 inhibitors Repatha or Praluent in response to prescribing information changes.

Pravastatin and fluvastatin were added as hydrophilic statin therapeutic alternatives in Appendix B and dosing regimens for Nexletol and Nexlizet are listed separately.

Continuation criteria now require that treatment plans do not include coadministration with Repatha or Praluent (later removed per RT4 updates).

RT4Recent major criteria revision round referenced

multipleGuideline & trial citations

hydrophilic statinsAppendix B updated

Coverage Criteria and Policy Updates

Updated coverage criteria (summary)

Policy criteria were updated (RT4) to align with revised prescribing information and guideline guidance.

Indication alignment: Indication expanded beyond HeFH to other forms of primary hyperlipidemia and includes reduction of cardiovascular risk in adults unable to take recommended statin therapy (including those not taking a statin) with established CVD or at high risk for a CVD event without established CVD.

Per RT4 updates reflecting revised prescribing information.

Statin trial/failure: Prior statin exposure requirements were reduced and simplified: statin adherence duration reduced from 4 months to 8 weeks for a high‑intensity statin; simplified trial/failure criteria for moderate‑ and low‑intensity regimens to require either an insufficient therapeutic response to one high‑intensity statin for 8 weeks or reversible muscle‑related symptoms associated with both rosuvastatin and atorvastatin.8 weeks for high-intensity statin

Per RT4 criteria revision.

Policy Summary

PayerCentene

PolicyBempedoic Acid (Nexletol), Bempedoic Acid/Ezetimibe (Nexlizet) Clinical Policy

Policy CodePolicy CP PMN.237

Change TypeCriteria revised (RT4) and administrative updates

Effective DateSep 1, 2020

Next Review DateN/A

Key ActionObtain and submit documentation of indication and prior statin trial/failure per revised labeling when requesting prior authorization.

SourceLink

On This Page

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Prior Authorization, Step Therapy, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for bempedoic acid products per the revised FDA labeling. Submit prior authorization with clinical documentation demonstrating the member’s diagnosis and indication (primary hyperlipidemia, including non‑HeFH, or cardiovascular risk reduction for adults unable to take recommended statin therapy).

Prior authorization required for Nexletol (bempedoic acid) and Nexlizet (bempedoic acid/ezetimibe).
Updated indications include primary hyperlipidemia (not limited to HeFH) and reduction of cardiovascular risk for adults unable to take recommended statin therapy.

Documentation Required

Document Prior Statin Therapy and Indication

Document prior statin therapy, statin intolerance, or inability to take statins as part of the authorization. Include dates, doses, duration, and clinical response or adverse events. For members without statin use, document the clinical rationale for why statin therapy is not appropriate or tolerated.

Record specific statin trials (agent, dose, start/stop dates) and objective LDL response where available.
If statin intolerance is claimed, document reversible muscle‑related symptoms associated with both rosuvastatin and atorvastatin when applicable, or other documented adverse effects.
Be aware: requests lacking supporting documentation of the required statin trial/failure or of the indicated diagnosis are at risk for denial.

Step Therapy

Step Therapy and Therapeutic Alternatives

Step therapy requires documented trial of appropriate statin therapy per the policy’s simplified criteria before approval, unless the member is unable to take recommended statin therapy. Hydrophilic statin alternatives are acceptable therapeutic options when clinically appropriate.

Step requirement: insufficient therapeutic response to one high‑intensity statin for ≥8 weeks OR documented reversible muscle‑related symptoms associated with both rosuvastatin and atorvastatin, OR documentation that the member is unable to take recommended statin therapy.
Therapeutic alternatives: consider hydrophilic statins such as pravastatin or fluvastatin where appropriate (added to Appendix B 11.07.24).
If clinical documentation does not support the required statin trial/failure or the stated indication, the request may be denied.

Clinical Background and Product Overview

Bempedoic acid (Nexletol) and the fixed‑dose combination bempedoic acid/ezetimibe (Nexlizet) are nonstatin lipid‑lowering therapies developed to reduce LDL‑C in patients with hypercholesterolemia, including those who are statin‑intolerant or unable to take recommended statin therapy. Their clinical development included randomized trials in the CLEAR program and outcomes evaluation (for example, CLEAR Wisdom and CLEAR Outcomes), and their FDA labeling and guideline positioning have been summarized in the policy. The RT4 policy update reflects changes in approved indications (expanding primary hyperlipidemia beyond HeFH and adding an indication for cardiovascular risk reduction in adults unable to take recommended statins) and aligns coverage criteria with the trials, guideline guidance, and revised prescribing information.

Trials and Guideline References

CLEAR trials — randomized clinical trial citations and focus

Key CLEAR trialsCLEAR Wisdom and CLEAR Outcomes randomized clinical trials evaluated bempedoic acid's effect on LDL-C and cardiovascular outcomes; CLEAR Wisdom reported LDL-C lowering when added to maximally tolerated statins and CLEAR Outcomes assessed cardiovascular outcomes including in statin‑intolerant patients.

Major publicationsCLEAR Wisdom: Goldberg et al., JAMA 2019 (effect on LDL‑C); CLEAR Outcomes: Nissen et al., N Engl J Med 2023 (cardiovascular outcomes in statin‑intolerant patients).

Regulatory / evidence synthesisInstitute for Clinical and Economic Review (ICER) assessed bempedoic acid for heterozygous familial hypercholesterolemia and secondary prevention of ASCVD (Final evidence report, March 2021).

Context of trialsCLEAR program includes randomized trials and prespecified analyses reporting efficacy and safety of bempedoic acid ± ezetimibe on LDL‑C and CVD risk markers in patients with and without diabetes.

Nonstatin therapies guidance — ACC expert consensus decision pathway

Authoritative guidance2022 ACC Expert Consensus Decision Pathway on the Role of Nonstatin Therapies for LDL‑C Lowering (J Am Coll Cardiol. 2022;80(14):1366–1418) provides recommendations on use of nonstatin agents in ASCVD risk management.

Scope of guidanceAddresses when to consider nonstatin LDL‑C lowering agents (including for patients unable to tolerate recommended statin therapy) and integrates these options into overall ASCVD risk management.

Relation to bempedoic acidACC pathway informs positioning of nonstatin options such as bempedoic acid and fixed‑dose combinations for patients who require additional LDL‑C lowering or who are statin‑intolerant.

Use in practiceGuidance supports individualized selection of nonstatin therapies guided by residual LDL‑C, ASCVD risk, and tolerability of statins.