CurrentAvMedPolicy N/A

Prior authorization and step-edit coverage criteria for Nexletol (bempedoic acid) and Nexlizet (bempedoic acid/ezetimibe)

Form and clinical criteria used by AvMed to evaluate prior authorization and step-edit requests for Nexletol (bempedoic acid) and Nexlizet (bempedoic acid/ezetimibe); applies to prescribers requesting pharmacy coverage for eligible members.

Policy Summary

PayerAvMed

PolicyCoverage criteria for Nexletol and Nexlizet prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must sign and complete the AvMed prior authorization/step-edit request form and fax to 1-305-671-0200.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moInitial authorization duration

12 moReauthorization duration

8 wksStatin trial length

90 daysPCSK9 trial

Coverage and Prior Authorization Criteria

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Age: Member is 18 years of age or older (for ASCVD and HeFH indications); age 40-75 years specified for diabetes high-risk subgroup.see chunks 3,6,8

Indication: Member has one of: established ASCVD (documented by specific events/procedures), high risk for CVD event without established CVD (per Reynolds risk score, 10-year ASCVD risk score, coronary artery calcium score, or diabetes age subgroup), or heterozygous familial hypercholesterolemia (per untreated LDL ≥190 mg/dL, genetic confirmation, or diagnostic criteria).see chunks 4,6,8

Submit documentation for the selected indication.

Prior lipid-lowering therapy: Member has tried an adequate statin regimen for at least 8 consecutive weeks (high-, moderate-, or low-intensity as applicable) verified by pharmacy paid claims, OR is statin intolerant per Section II; if applicable, member's LDL-C after an 8-week trial of maximally tolerated statin remains ≥ 70 mg/dL.8 weeks; LDL ≥ 70 mg/dL

Pharmacy paid claims or chart notes must be provided.

PCSK9 requirement: Member has had a 90-day trial of a PCSK9 inhibitor and failed to reach LDL target with documentation of LDL after 90 days, OR has had a life‑threatening adverse reaction to a PCSK9 inhibitor with documentation.90 days

Provide LDL labs after 90 days or documentation of life‑threatening reaction.

inv-02: Statin intolerance (Section II)

Statin intolerance criteria (Section II) — required to qualify as statin intolerant

Attempts: Member must have intolerable and persistent symptoms to TWO different statins (each >2 weeks); provide previously attempted statin name, strength, and therapy initiation date.>=2 statins

Complete medication history required in form fields.

Intolerance manifestations: Documented occurrence of at least one: myalgia (muscle symptoms without CK elevations), myositis (muscle symptoms with CK elevations < 10× upper limit of normal), rhabdomyolysis or muscle symptoms with CK elevations > 10× upper limit of normal, a labeled contraindication to ALL statins, or failed re‑initiation of statin therapy.clinical documentation required

Submit supporting clinical records and CK results where applicable.

inv-03: Reauthorization

Reauthorization requirements

Clinical response: Provider must submit documentation of positive clinical response to therapy (for example, reduction in LDL‑C levels), including LDL baseline and post‑treatment labs, and evidence of medication compliance (verified by pharmacy paid claims).

Reauthorization period: 12 months if criteria met.

Use of medication samples to initiate therapy does not satisfy the plan's step edit or prior authorization requirements. Providers must submit a completed prior authorization/step-edit request with supporting documentation (e.g., prior therapy history verified by pharmacy paid claims or chart notes) rather than rely on samples as evidence of a qualifying trial.

Initial Authorization Criteria (6 months)

inv-17: Initial therapy

Initial authorization criteria (6 months)

Age: Member is 18 years of age or older.

Indication: Member meets one of the covered indications: ASCVD, high‑risk without established CVD, or HeFH (documentation required).

See indication-specific documentation requirements.

Statin requirement: Member has tried an adequate statin regimen for at least 8 consecutive weeks unless statin intolerant per Section II; if LDL after maximally tolerated statin remains ≥ 70 mg/dL approval may be considered.8 weeks; LDL ≥ 70 mg/dL

Prior therapies will be verified via pharmacy paid claims.

PCSK9 alternative: Alternatively, member has had a 90‑day PCSK9 inhibitor trial and failed to reach LDL target (provide LDL after 90 days) or has a documented life‑threatening adverse reaction to a PCSK9 inhibitor.90 days

Documentation of PCSK9 failure or adverse reaction must be provided.

Step Therapy Requirements

Step	Requirement	Failure / Exception
1	Trial of a specified statin intensity for at least 8 consecutive weeks (verified by pharmacy paid claims). Acceptable options include: high-intensity atorvastatin ≥ 40 mg daily, high-intensity rosuvastatin ≥ 20 mg daily, or documented inability to tolerate higher intensities allowing moderate- or low-intensity therapy.	If LDL-C after an 8-week trial of maximally tolerated statin remains ≥ 70 mg/dL, criteria for advancement may be met (submit LDL baseline and post-treatment labs).
2	Documented statin intolerance per Section II (intolerable and persistent symptoms to two different statins, >2 weeks each, with documentation of prior statin name, strength, and dates).	Statin intolerance must include at least one: myalgia (no CK elevation), myositis (CK < 10x ULN), rhabdomyolysis or CK > 10x ULN, labeled contraindication to all statins, or failed re‑initiation of statin therapy (submit documentation).
3	Alternatively, a 90-day trial of a PCSK9 inhibitor (e.g., evolocumab/Repatha) with documentation of failure to reach LDL target may be submitted (documentation of LDL after 90 days required).	If member had a life‑threatening adverse reaction to a PCSK9 inhibitor, provide documentation of the reaction in lieu of trial.

Clinical Thresholds and Risk Values

Age for diabetes high-risk subgroup

Age for diabetes high-risk subgroupMember age between 40 and 75 years (Type 1 or 2 diabetes)

General adult age requirementMember is 18 years of age or older (for ASCVD and HeFH indications)

Documentation requiredSubmit documentation confirming diabetes diagnosis and member age

10-year ASCVD risk

10-year ASCVD risk threshold10-year ASCVD risk score ≥ 20%

Documentation requiredSubmit documentation of calculated 10-year ASCVD risk score

Applies toHigh risk for CVD event without established CVD indication

Reynolds risk score

Reynolds risk score thresholdReynolds risk score > 30%

Documentation requiredSubmit documentation of Reynolds risk score calculation

Applies toHigh risk for CVD event without established CVD indication

Coronary artery calcium score

Coronary artery calcium (CAC) thresholdCoronary artery calcium score > 300 Agatston units

Documentation requiredSubmit CAC score report as supporting documentation

Applies toHigh risk for CVD event without established CVD indication

LDL-C threshold after statin trial

LDL-C threshold after statin trialIf applicable, LDL-C after an 8-week trial of maximally tolerated statin therapy remains ≥ 70 mg/dL

When assessedMeasure LDL baseline and LDL post-treatment after the 8-week statin trial (submit labs)

VerificationPharmacy paid claims will be used to verify prior statin therapy

Provider Submission and Documentation Requirements

Prior Authorization

Form and submission

Prescriber must sign and complete the AvMed prior authorization/step-edit request form for Nexletol or Nexlizet and fax to 1-305-671-0200. The prescribing physician must sign and clearly print name (preprinted stamps not valid). All required member and prescriber fields (member name, AvMed #, DOB, prescriber name, signature, NPI, office contact, phone, fax) must be provided. Incomplete, incorrect, or illegible information (including missing phone/fax) can delay or deny the authorization process.

Fax prior authorization form to 1-305-671-0200
Prescriber signature required (no preprinted stamps)
Provide complete member & prescriber contact info (NPI, phone, fax)

Step Therapy

Statin trial or documented intolerance

Members must generally have tried an adequate statin regimen unless statin intolerance is documented. Requirements include an ≥8 consecutive week trial of a specified statin intensity (high-, moderate-, or low-intensity) verified by pharmacy paid claims, or documentation that the member is statin intolerant per Section II. If applicable, submit LDL-C after the 8-week trial; approval considerations include LDL-C ≥ 70 mg/dL after maximally tolerated statin therapy. A 90-day trial of a PCSK9 inhibitor (with LDL labs after 90 days) and documentation of failure is required when applicable, or documentation of a life‑threatening adverse reaction to a PCSK9 inhibitor.

Verify 8-week statin trial via pharmacy paid claims
If statin-intolerant, complete Section II documentation
If applicable, submit LDL baseline and post-treatment labs
If claiming PCSK9 failure, submit 90-day PCSK9 therapy documentation and LDL labs

Documentation Required

Required supporting documentation

Submit supporting documentation for every clinical criterion checked on the form. Required documentation includes current and prior LDL-C lab results (baseline and post-treatment), diagnostic evidence confirming ASCVD (e.g., records of acute coronary syndrome, MI, angina, PAD, coronary artery disease, PCI/CABG, stroke, TIA), pharmacy paid claims or chart notes verifying prior therapies, and detailed clinical notes for statin intolerance (drug names, strengths, start dates, symptoms, CK values if relevant). For reauthorization, submit LDL labs showing positive clinical response and evidence of medication adherence (pharmacy paid claims). Use of samples to initiate therapy does not meet criteria.

Provide LDL baseline and LDL post-treatment labs with initial request and reauthorization
Provide documentation confirming ASCVD diagnosis (e.g., procedure reports, discharge summaries)
Attach pharmacy paid claims or chart notes verifying prior statin or PCSK9 use
For statin intolerance: submit documentation of intolerable/persistent symptoms to TWO different statins with dates, CK results when applicable
For PCSK9 failure or adverse reaction: submit 90-day therapy/lab results or documentation of life‑threatening reaction

Denial Risk

Incomplete or illegible submission

Authorization can be delayed or denied if information is incomplete, incorrect, or illegible. Missing required documentation — including signed prescriber form, LDL labs, diagnostics confirming ASCVD, prior-therapy verification, or clear statin‑intolerance evidence — may result in denial. Use of samples to initiate therapy is not acceptable evidence of prior therapy.

Incomplete or illegible forms may delay or deny the request
Missing labs or diagnostic documentation may result in denial
Samples do not satisfy step-edit/prior authorization requirements

Continuation / Reauthorization Rules

inv-18: Continuation therapy / Reauthorization

Reauthorization

Reauthorization evidence: Provider must document LDL reduction and member compliance; submit LDL baseline and post‑treatment labs.

Reauthorization granted for 12 months if criteria met.

Key Definitions

ASCVD (definition)

ASCVD definitionEstablished Atherosclerotic Cardiovascular Disease confirmed by events/procedures such as acute coronary syndrome, history of myocardial infarction, stable or unstable angina, peripheral arterial disease presumed atherosclerotic, coronary artery disease, coronary or other arterial revascularization (e.g., PCI, angioplasty, coronary stent, CABG), history of stroke, or history of transient ischemic attack

Documentation requiredSubmit documentation confirming one of the listed events or procedures

Applies toCovered indication: Established ASCVD for Nexletol/Nexlizet authorization

Heterozygous Familial Hypercholesterolemia (HeFH)

HeFH diagnostic criteriaHeterozygous Familial Hypercholesterolemia (HeFH) confirmed by one of: untreated LDL‑C ≥ 190 mg/dL, genetic confirmation of FH mutation (LDL receptor, APOB, PCSK9, or LDLRAP1), or diagnostic criteria thresholds (e.g., Dutch Lipid Network score >5 or Simon Broome 'definite'/'possible')

Documentation requiredSubmit LDL prior to treatment, genetic test results, or diagnostic criteria scoring documentation

Age requirementMember is 18 years of age or older for HeFH indication

Background

Bempedoic acid (Nexletol) and the fixed-dose combination bempedoic acid/ezetimibe (Nexlizet) are oral lipid-lowering therapies used to reduce LDL-C in adults with indications such as established atherosclerotic cardiovascular disease, high cardiovascular risk without established CVD, or heterozygous familial hypercholesterolemia. For reauthorization, AvMed requires submission of documentation demonstrating a positive clinical response (for example, reduction in LDL-C), the member’s LDL baseline and post-treatment labs, and evidence of medication compliance (verified by pharmacy paid claims). Reauthorizations are granted for 12 months when all criteria and supporting documentation are provided.

Policy Summary

PayerAvMed

PolicyCoverage criteria for Nexletol and Nexlizet prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must sign and complete the AvMed prior authorization/step-edit request form and fax to 1-305-671-0200.

SourceLink

On This Page