CurrentCignaPolicy CNF410

Hyperlipidemia – Nexletol Prior Authorization Policy - (CNF410)

Cigna coverage policy specifying prior authorization clinical criteria for Nexletol (bempedoic acid tablets) for FDA‑approved indications: reduction of major adverse cardiovascular events in adults with established cardiovascular disease unable to take recommended statin therapy, heterozygous familial hypercholesterolemia (HeFH), and hypercholesterolemia (primary/combined). Defines initial therapy and continuation criteria, statin‑intolerance definitions, diagnostic thresholds, and approval duration.

Policy Summary

PayerCigna

PolicyHyperlipidemia – Nexletol Prior Authorization Policy - (CNF410)

Policy CodePolicy CNF410

Change TypeCriteria revised and continuation pathway added

Effective Date

Next Review Date

Key ActionPrior authorization is recommended for Nexletol; approvals are for 1 year and require meeting the specific initial or continuation criteria depending on indication.

SourceLink

POLICY UPDATE CHANGES

Added statement that patients who previously met initial therapy criteria and are currently receiving Nexletol only need to meet continuation criteria.

Atherosclerotic Cardiovascular Disease requirements were divided to distinguish initial therapy and patient currently receiving Nexletol.

HeFH diagnostic criteria wording changed several times (phenotypic vs genetic confirmation); latest states diagnosis has been confirmed by genetic testing.

Primary Hyperlipidemia (now Hypercholesterolemia) moved into FDA‑Approved Indications and diabetes included as qualifying condition; LDL-C threshold after statin+ezetimibe lowered to ≥70 mg/dL.

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

3FDA‑approved indications covered

1 yearTypical approval duration

≥55Lowest LDL‑C post‑statin threshold (established CVD)

Coverage Summary

Background: Nexletol (bempedoic acid) is an adenosine triphosphate‑citrate lyase inhibitor indicated to reduce major adverse cardiovascular events in adults at increased risk who are unable to take recommended statin therapy, and to reduce LDL‑C as an adjunct to diet and other LDL‑lowering therapies (including for heterozygous familial hypercholesterolemia and hypercholesterolemia).

CLEAR Outcomes trial highlight: In CLEAR Outcomes (13,970 statin‑intolerant adults; median follow‑up 40.6 months) the primary endpoint occurred in 11.7% of Nexletol patients versus 13.3% of placebo (P = 0.004); mean LDL‑C at 6 months was 107 mg/dL with Nexletol versus 136 mg/dL with placebo.

Policy scope summary: This Cigna coverage policy sets prior authorization clinical criteria for Nexletol (bempedoic acid tablets) for FDA‑approved indications — reduction of major adverse cardiovascular events in statin‑intolerant adults with established cardiovascular disease, heterozygous familial hypercholesterolemia (HeFH), and hypercholesterolemia (primary/combined). It defines initial therapy and continuation pathways, statin‑intolerance definitions, diagnostic thresholds (including LDL‑C and coronary artery calcium score), and typical approval duration of 1 year.

Medical Necessity Criteria (Initial and Continuation)

Reduce Major Adverse Cardiovascular Events in Patients at Increased Risk (Established Cardiovascular Disease)

Approve for 1 year if the patient meets ONE of the following (A or B):

B) Patient Currently Receiving Nexletol

Patient is currently receiving Nexletol
According to the prescriber, the patient has experienced a response to therapy (examples: decreasing LDL-C, total cholesterol, non‑HDL‑C, or apolipoprotein B levels)

Heterozygous Familial Hypercholesterolemia (HeFH)

Approve for 1 year if the patient meets ONE of the following (A or B):

B) Patient Currently Receiving Nexletol

Patient is currently receiving Nexletol
According to the prescriber, the patient has experienced a response to therapy (examples: decreasing LDL-C, total cholesterol, non‑HDL‑C, or apolipoprotein B levels)

Hypercholesterolemia (Primary/Combined Hyperlipidemia)

Approve for 1 year if the patient meets ONE of the following (A or B). Note: Not associated with established CVD or HeFH.

B) Patient Currently Receiving Nexletol

Patient is currently receiving Nexletol
According to the prescriber, the patient has experienced a response to therapy (examples: decreasing LDL-C, total cholesterol, non‑HDL‑C, or apolipoprotein B levels)

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is recommended for Nexletol. Approvals are for 1 year and require meeting the specific initial or continuation criteria depending on the indication.

Documentation Required

Evidence of statin trials or statin intolerance required

Documentation must show trials of specified high-intensity statin therapy and/or evidence of statin intolerance. Required trial details and LDL documentation include:

Trial of one high-intensity statin: atorvastatin ≥ 40 mg daily or rosuvastatin ≥ 20 mg daily (single-entity or combination).
Trial of that high-intensity statin plus ezetimibe for ≥ 8 continuous weeks (when claiming inadequate LDL-C lowering).

Coding

Drug productNDCCovered

No codes listed

Background & Evidence

Nexletol is an adenosine triphosphate‑citrate lyase (ACL) inhibitor. The product is indicated to reduce the risk of major adverse cardiovascular events in adults at increased risk who are unable to take recommended statin therapy, and to reduce LDL‑C as an adjunct to diet and other LDL‑lowering therapies (including for HeFH and primary/combined hypercholesterolemia).

The CLEAR Outcomes randomized, double‑blind, placebo‑controlled trial enrolled 13,970 adults who were unable or unwilling to take statins due to unacceptable adverse events; the median follow‑up was 40.6 months. The primary composite endpoint (CV death, nonfatal MI, nonfatal stroke, or coronary revascularization) occurred in 11.7% of patients assigned to Nexletol versus 13.3% assigned to placebo (P = 0.004).

CLEAR Outcomes also demonstrated LDL‑C lowering: mean LDL‑C at 6 months was 107 mg/dL with Nexletol versus 136 mg/dL with placebo. Trial patients had or were at high risk for cardiovascular disease; ~70% had prior CV events (secondary prevention) and ~30% were primary prevention.

Measure	Value
CLEAR Outcomes trial population
13,970 adults; median follow-up 40.6 months; primary endpoint 11.7% Nexletol vs 13.3% placebo (P=0.004)
LDL-C reduction at 6 months
Mean LDL-C 107 mg/dL Nexletol vs 136 mg/dL placebo

High‑intensity statin: Atorvastatin ≥ 40 mg daily or rosuvastatin ≥ 20 mg daily (single‑entity or combination product).

Statin‑related rhabdomyolysis: Statin‑induced muscle breakdown with creatine kinase ≥ 10× ULN and evidence of end‑organ damage (examples include substantial increases in serum creatinine [a ≥ 0.5 mg/dL increase or doubling] and/or myoglobinuria).

Continuation of therapy: A patient currently receiving Nexletol who previously met initial therapy criteria under the Coverage Review Department only needs to meet continuation criteria — specifically, prescriber attestation that the patient has experienced a response to therapy (examples: decreasing LDL‑C, total cholesterol, non‑HDL‑C, or apolipoprotein B).

Revision History

Annual Revision (unspecified) / history entryadded

Policy statement clarified that patients who previously met initial therapy criteria and are currently receiving Nexletol only need to meet newly developed continuation of therapy criteria; continuation requires prescriber attestation of response to therapy (examples provided).

Annual Revision, 05/08/2024revised

For Established Cardiovascular Disease (initial therapy) the post‑statin+ezetimibe LDL‑C threshold was lowered from ≥ 70 mg/dL to ≥ 55 mg/dL (material change).

Annual Revision / Selected Revision (various prior updates through 2023–2025)revised

Policy Summary

PayerCigna

PolicyHyperlipidemia – Nexletol Prior Authorization Policy - (CNF410)

Policy CodePolicy CNF410

Change TypeCriteria revised and continuation pathway added

Effective Date

Next Review Date

Key ActionPrior authorization is recommended for Nexletol; approvals are for 1 year and require meeting the specific initial or continuation criteria depending on indication.

SourceLink

On This Page

Post-treatment LDL-C level threshold: ≥ 55 mg/dL for Established CVD; ≥ 70 mg/dL for HeFH and Hypercholesterolemia.

If statin intolerant: documentation of statin-related rhabdomyolysis (CK ≥ 10× ULN with evidence of end‑organ damage, e.g., substantial ↑ serum creatinine [≥ 0.5 mg/dL increase or doubling] and/or myoglobinuria), OR separate trials of atorvastatin and rosuvastatin with resolution of muscle symptoms upon discontinuation.

Documentation Required

Diagnosis confirmation for HeFH

For HeFH, provide confirmation of diagnosis by one of the accepted methods:

Genetic testing confirming FH (pathogenic variant in LDLR, APOB, PCSK9, or LDLRAP1).
Or prescriber confirmation that the Dutch Lipid Network criteria score was > 5.
Or prescriber confirmation that Simon Broome criteria meet the threshold for 'definite' or 'possible (or probable)' familial hypercholesterolemia.

Documentation Required

Response documentation for continuation

For patients currently receiving Nexletol, prescriber must attest the patient has experienced a response to therapy. Examples of acceptable response documentation are provided.

Decreasing LDL-C levels.
Decreasing total cholesterol.
Decreasing non-HDL-C.
Decreasing apolipoprotein B (apoB).

Heterozygous familial hypercholesterolemia (HeFH) diagnostic language was revised multiple times; most recent language requires that the diagnosis has been confirmed by genetic testing or, alternatively, prescriber confirmation of Dutch Lipid Network or Simon Broome criteria (material change).

Annual Revision, 05/08/2024 and subsequent updatesrevised

Primary Hyperlipidemia (now labeled Hypercholesterolemia / Primary/Combined) was moved into FDA‑Approved Indications; diabetes was added as a qualifying condition and the LDL‑C threshold after statin+ezetimibe was lowered to ≥ 70 mg/dL (material change).

Selected Revision / Annual Revision (various)revised

A coronary artery calcium score threshold was specified for Hypercholesterolemia: coronary artery calcium or calcification score ≥ 300 Agatston units (material change).

Annual Revision / Selected Revision (notes)clarified

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

Current policy (last reviewed 2026-03-04)summaryLatest

Has material changes: criteria now distinguish initial therapy vs continuation; continuation requires prescriber attestation of response to therapy; LDL‑C thresholds and HeFH diagnostic language were updated; coronary calcium score and diabetes included in Hypercholesterolemia criteria.