CurrentCignaPolicy N/A

Hyperlipidemia - Nexlizet Prior Authorization Policy

Cigna prior authorization policy for outpatient prescription coverage of Nexlizet (bempedoic acid + ezetimibe) including FDA-approved indications (established CVD, HeFH, primary hyperlipidemia), initial and continuation criteria, duration of approval, and non-covered uses.

Policy Summary

PayerCigna

PolicyHyperlipidemia - Nexlizet Prior Authorization Policy

Policy CodePolicy N/A

Change TypeCriteria additions and revisions (initial vs continuation pathways; diagnostic wording updates; new indication added)

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization for Nexlizet; approvals are for 1 year when criteria are met, with new starts requiring Initial Therapy criteria and current users requiring only continuation criteria with prescriber attestation of response.

POLICY UPDATE CHANGES

A continuation-of-therapy pathway was added: patients who previously met Initial Therapy criteria and are currently receiving Nexlizet only need to meet continuation criteria (prescriber attests to response).

Established Cardiovascular Disease initial LDL-C threshold after one high-intensity statin was changed from ≥ 70 mg/dL to ≥ 55 mg/dL.

HeFH diagnostic criteria wording was revised multiple times (phenotypic vs genetic confirmation; prescriber confirmation language clarified).

Primary Hyperlipidemia was added as a new indication under FDA-approved indications.

Note added that a patient may have diagnoses that pertain to more than one indication and to consider review under different approval conditions.

3Covered Indications (FDA-approved)

1 year

Coverage Summary

Cigna requires prior authorization for outpatient Nexlizet (bempedoic acid + ezetimibe). Nexlizet is covered with criteria for the FDA‑approved indications: Established Cardiovascular Disease, Heterozygous Familial Hypercholesterolemia (HeFH), and Primary Hyperlipidemia. Approvals are provided for 1 year. Patients previously approved and currently receiving Nexlizet need only meet continuation criteria (prescriber attests to response); new starts or restarts must meet Initial Therapy criteria. Nexlizet is considered not medically necessary for any uses outside these criteria.

Quick Facts and Key Thresholds

Covered Indications (FDA-approved)3 (Established CVD; Heterozygous Familial Hypercholesterolemia; Primary Hyperlipidemia)

Approval duration1 year

Lowest LDL-C threshold (Established CVD after high-intensity statin)>= 55 mg/dL

Coronary artery calcium (CAC) score threshold (Primary Hyperlipidemia)>= 300 Agatston units

Untreated LDL-C threshold for HeFH (phenotypic/genetic baseline)>= 190 mg/dL

High-intensity statin definitionatorvastatin >= 40 mg daily; rosuvastatin >= 20 mg daily

Initial Therapy Criteria

General Policy Statement: Prior authorization is required. Nexlizet (bempedoic acid and ezetimibe) is considered medically necessary only when the following indication-specific criteria are met.

ALL of the following

FDA-Approved Indication 1: Established Cardiovascular Disease
- A) Initial Therapy
  - Patient is an adult with established cardiovascular disease (ASCVD), as defined by acute coronary syndrome, history of myocardial infarction, stable or unstable angina, coronary or other revascularization, stroke, transient ischemic attack, or peripheral arterial disease.
  - Patient has been treated with maximally tolerated statin therapy and adjunctive non-statin therapies as appropriate (e.g., ezetimibe, PCSK9 monoclonal antibody) unless statin-intolerant, and despite therapy remains above LDL-C treatment goal.
    High-intensity statin defined as atorvastatin 40–80 mg or rosuvastatin 20–40 mg (LDL-C lowering ≥50%); if statin intolerance, document intolerance per policy.

Continuation Therapy Criteria

Continuation: Patient Currently Receiving Nexlizet

Continuation pathway for patients previously approved and currently receiving Nexlizet:

If the patient previously met Initial Therapy criteria under the Coverage Review Department and is currently receiving Nexlizet, only continuation criteria are required (no repeat Initial Therapy documentation).

Continuation requirement: According to the prescriber, the patient has experienced a response to therapy.

Examples of response include decreasing LDL-C, total cholesterol, non-HDL-C, or apolipoprotein B levels

Unproven / Exclusions

Conditions Not Covered

Nexlizet is considered not medically necessary for ANY other use(s) outside the criteria listed in this policy; criteria will be updated as new published data are available.

Provider Actions

Prior Authorization

Prior authorization required

Submit prior authorization for Nexlizet; approvals are provided for 1 year when criteria are met. New starts or restarts must meet Initial Therapy criteria; patients previously approved and currently receiving Nexlizet need only meet continuation criteria (prescriber attests to response).

Documentation Required

Statin trial documentation or statin intolerance evidence

Document trials of high-intensity statin therapy (specify agent and dose) for ≥ 8 continuous weeks and provide post-treatment LDL‑C level, OR document statin intolerance defined as either statin-related rhabdomyolysis (CK ≥ 10× ULN with end-organ damage, e.g., ≥ 0.5 mg/dL increase or doubling of serum creatinine and/or myoglobinuria) or skeletal-related muscle symptoms (myopathy or myalgia) that occurred with separate trials of both atorvastatin and rosuvastatin and resolved upon discontinuation of each statin.

Applicable Codes

No specific billing codes listedmixed

No codes listed

Clinical Evidence

13,970CLEAR Outcomes trial population (adults); median follow-up 40.6 months; primary endpoint 11.7% Nexletol vs 13.3% placebo (P=0.004)

40.6Median follow-up (months)

Nexlizet combines bempedoic acid (an ATP‑citrate lyase inhibitor) and ezetimibe (a cholesterol absorption inhibitor). It is indicated as an adjunct to diet for primary hyperlipidemia, HeFH, and to reduce cardiovascular events in statin‑intolerant adults at risk for CVD. Safety and effectiveness have not been established in pediatric patients. The CLEAR Outcomes trial demonstrated LDL‑C reduction and a statistically significant reduction in composite cardiovascular endpoints versus placebo.

Background

Nexlizet is a combination product containing bempedoic acid (an adenosine triphosphate‑citrate lyase inhibitor) and ezetimibe (a cholesterol absorption inhibitor). The FDA‑approved indications include: adjunct to diet for Primary hyperlipidemia (including HeFH), adjunct to diet for HeFH, and use of the bempedoic acid component to reduce risk of cardiovascular events in statin‑intolerant adults with established CVD or at high CVD risk. The safety and effectiveness of Nexlizet have not been established in pediatric patients. Primary Hyperlipidemia was added as a new FDA‑approved indication in the policy updates.

Revision History

05/28/2025policy changeLatest

Continuation-of-therapy pathway added: patients who previously met Initial Therapy criteria and are currently receiving Nexlizet only need to meet continuation criteria (prescriber attests to response to therapy with examples provided).

05/28/2025policy changeLatest

Established Cardiovascular Disease criteria divided into Initial Therapy and Patient Currently Receiving Nexlizet pathways; LDL-C threshold after one high-intensity statin for Initial Therapy was changed from ≥ 70 mg/dL to ≥ 55 mg/dL.