CurrentUnitedHealthcarePolicy 2024 P 3146-5

Step therapy for bempedoic acid products (Nexletol, Nexlizet)

Defines UnitedHealthcare's step therapy requirements for coverage of Nexletol (bempedoic acid) and Nexlizet (bempedoic acid/ezetimibe), including required prior statin and ezetimibe trials and documentation; applies to members whose benefits include the pharmacy clinical programs.

Policy Summary

PayerUnitedHealthcare

PolicyStep therapy for bempedoic acid products (Nexletol, Nexlizet)

Policy CodePolicy 2024 P 3146-5

Change TypeProgram revision (administrative and content updates)

Effective Date2/1/2025

Next Review Date

Key ActionObtain prior authorization documenting ≥12 consecutive weeks of required-intensity statin therapy and ≥12 weeks of ezetimibe (or documented intolerance/contraindication) to support coverage.

SourceLink

POLICY UPDATE CHANGES

Condensed low intensity and moderate-intensity statin therapy sections and added footnote that statin requirement is supported by FDA labeling.

Updated references and annual review entries through 11/2024.

Effective date set to 2/1/2025 for this program iteration.

12 monthsAuthorization duration

>=12 wksStatin trial

DefinedHigh-intensity statin

2024 P 3146-5Program Number

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Coverage Criteria

inv-01: Initial Authorization

Approval will be granted when BOTH of the following overarching conditions are met:

Overall: Both of the following must be satisfied

Statin requirement (one of the following): (1) Patient has been receiving at least 12 consecutive weeks of high-intensity statin therapy and will continue to receive high-intensity statin at maximally tolerated dose>=12 weeks

High-intensity defined as atorvastatin 40-80 mg or rosuvastatin 20-40 mg

Alternative statin pathway: (2) BOTH of the following: patient is unable to tolerate high-intensity statin as evidenced by persistent/intolerable symptoms (>2 weeks) (myositis with CK elevations >=10x ULN or myalgia) AND patient has been receiving at least 12 consecutive weeks of low- or moderate-intensity statin therapy and will continue at maximally tolerated dose>=12 weeks

Examples of low/moderate intensities listed in policy

Complete statin intolerance or contraindication: (3) Patient is unable to tolerate low-, moderate-, and high-intensity statins as evidenced by persistent/intolerable symptoms (myositis with CK elevations >=10x ULN or myalgia) OR has a labeled contraindication to all statins OR has experienced rhabdomyolysis or muscle symptoms with CK elevations >10x ULN

Labeled contraindication to all statins qualifies

Ezetimibe requirement: AND documentation of one of the following: (1) Patient has been receiving at least 12 consecutive weeks of ezetimibe as adjunct to maximally tolerated statin therapy OR (2) Patient has a history of contraindication or intolerance to ezetimibe>=12 weeks

Authorization will be issued for 12 months

If the member has no documentation of a prior statin trial and there is no documented statin intolerance or contraindication (including a labeled contraindication to all statins), the policy provides no coverage pathway to Nexletol or Nexlizet. In other words, absence of a recorded trial of maximally tolerated statin therapy or an established contraindication/intolerance will preclude approval under this step therapy program.

Use of Nexletol (bempedoic acid) or Nexlizet (bempedoic acid/ezetimibe) without meeting the program's step therapy requirements — specifically a documented trial of maximally tolerated statin therapy and either a documented trial of ezetimibe or documented ezetimibe intolerance/contraindication — is considered outside the coverage criteria and may be denied. Prior authorization is required and approvals are based on meeting those statin and ezetimibe trial or intolerance/contraindication conditions; authorizations are typically issued for 12 months.

Coding / Required Durations

inv-04: Required statin trial duration

Required duration>= 12 consecutive weeks

ContextApplies to required statin trial prior to Nexletol or Nexlizet approval

Documentation noteProvider must document intensity and continuous duration of statin therapy

inv-05: Required ezetimibe trial duration

Required duration>= 12 consecutive weeks

ContextApplies to ezetimibe (Zetia) as adjunct to maximally tolerated statin therapy for Nexletol/Nexlizet approval

Documentation note

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Nexletol or Nexlizet. Approval is contingent on documented trials of statin therapy and ezetimibe (or documented intolerance/contraindication) meeting the policy's intensity and duration requirements.

Affected products: Nexletol, Nexlizet
Authorization duration: 12 months
Statin requirement: ≥12 consecutive weeks at maximally tolerated dose (see documentation details)
Ezetimibe requirement: ≥12 consecutive weeks as adjunct to maximally tolerated statin, OR documented intolerance/contraindication

Step Therapy

Step Therapy Requirement

Step therapy must be met before coverage. Member must have either completed a ≥12-week trial of high‑intensity statin therapy (and continue on it at maximally tolerated dose) or have documented inability to tolerate high‑intensity statin plus a ≥12‑week trial of low‑ or moderate‑intensity statin at maximally tolerated dose. In addition, a trial of ezetimibe for ≥12 weeks (as adjunct) is required unless ezetimibe is contraindicated or not tolerated.

Background

Bempedoic acid (Nexletol) and the fixed-dose combination bempedoic acid/ezetimibe (Nexlizet) are non-statin LDL-lowering therapies intended for patients who require additional LDL reduction or who cannot tolerate statins. UnitedHealthcare's step therapy approach encourages use of a maximally tolerated statin (or documented statin intolerance/contraindication) and trial of ezetimibe prior to coverage of these agents to ensure lower-cost or guideline-preferred therapies are attempted first.

Definitions

inv-11: High-intensity statin

DefinitionHigh-intensity statin is defined as atorvastatin 40-80 mg or rosuvastatin 20-40 mg

UsageRequired pathway includes at least 12 consecutive weeks of high-intensity statin when applicable

DocumentationIntensity of statin therapy must be recorded in prior authorization documentation

inv-12: Low- or moderate-intensity statin

ExamplesAtorvastatin 10-20 mg; rosuvastatin 5-10 mg; simvastatin 2-10 mg; pravastatin 2-10 mg; lovastatin 20-40 mg; fluvastatin ER 80 mg or fluvastatin 20-40 mg up to twice daily; pitavastatin 1 mg

ContextThese are listed as examples of low- or moderate-intensity statin therapy used in the alternative statin pathway

Initial Therapy

inv-13: Initial Therapy

Initial authorization criteria

Initial: Statin pathway AND ezetimibe trial or documented intolerance/contraindication must be met as described in coverage criteria

See statin intensity definitions and trial durations

Continuation / Re-authorization

inv-14: Continuation Therapy

Re-authorization and continuation

Re-authorization: Authorization will be issued for 12 months; UnitedHealthcare may approve initial and re-authorization based on previous claim/medication history, diagnosis codes, and/or claim logic12 months

Automated processes may be used per program

Step Therapy Table

Step	Requirement	Notes / Duration
1
Documented trial of statin therapy at required intensity (high-intensity: atorvastatin 40-80 mg or rosuvastatin 20-40 mg) OR documentation of inability to tolerate required intensity statin therapy (intolerance, persistent symptoms, or contraindication)
>= 12 consecutive weeks for applicable intensity; member must continue on maximally tolerated dose

Site of Care

Note

Site-of-care — no specific restrictions

The policy specifies no site‑of‑care restrictions for Nexletol or Nexlizet.