ModifiedCignaPolicy N/A

Nexletol (bempedoic acid) prior authorization for hyperlipidemia

Cigna prior authorization policy governing medical necessity criteria and coverage for Nexletol (bempedoic acid) for adults with hyperlipidemia, HeFH, or established/at-risk cardiovascular disease under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyNexletol (bempedoic acid) prior authorization for hyperlipidemia

Policy CodePolicy N/A

Change TypeCriteria revised and added (continuation criteriaLDL-C thresholdsindication reclassification)

Effective DateN/A

Next Review DateN/A

Key ActionFor continuation requests, prescriber must attest the patient is currently receiving Nexletol and has experienced a response to therapy.

SourceLink

POLICY UPDATE CHANGES

Continuation-of-therapy criteria were newly developed so patients who previously met initial therapy criteria and are currently receiving Nexletol only need to meet continuation criteria.

Initial therapy requirements for some indications were divided to distinguish between initial therapy and patients currently receiving Nexletol; diagnostic confirmation wording for heterozygous familial hypercholesterolemia and LDL-C thresholds were changed for certain indications.

Primary hyperlipidemia indication was moved from 'Other Uses with Supportive Evidence' to 'FDA-Approved Indications' and initial therapy LDL-C thresholds were lowered (e.g., to ≥70 mg/dL) and expanded to include patients with diabetes when criteria are met.

1 yeartypical approval duration

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Coverage and Medical Necessity Criteria

Statin‑intolerance pathway

Statin‑intolerance pathway (applies to relevant indications above: Established CVD, HeFH, and Primary Hyperlipidemia). Approve when the patient meets ONE of the statin‑intolerance pathways below.

ANY of the following

Statin‑related rhabdomyolysis
- Patient experienced statin‑related rhabdomyolysis (statin‑induced muscle breakdown with markedly elevated creatine kinase ≥ 10× upper limit of normal) with evidence of end‑organ damage (e.g., acute renal injury demonstrated by a ≥ 0.5 mg/dL increase in serum creatinine or doubling of serum creatinine, and/or myoglobinuria).
  Documenting lab results and clinical findings supporting rhabdomyolysis is required.
Skeletal‑muscle adverse effects with resolution on discontinuation
- Patient experienced skeletal‑related muscle symptoms (e.g., myopathy or myalgia) while receiving separate trials of both atorvastatin and rosuvastatin (as single‑entity or combination products).
- The skeletal‑muscle related symptoms resolved upon discontinuation of each respective statin trial (atorvastatin and rosuvastatin).
- Separate trials must be distinct exposures (not a single switch) and prescriber documentation of symptoms, timing, and resolution must be provided.
Unable to tolerate statin intensity required despite alternative management
- Patient has trialed one high‑intensity statin (atorvastatin ≥ 40 mg daily or rosuvastatin ≥ 20 mg daily) and trialed that high‑intensity statin in combination with ezetimibe for ≥ 8 continuous weeks, but the regimen was not tolerated due to muscle‑related adverse effects or other documented statin‑related intolerance preventing adequate dosing.
- Prescriber documents that alternative lipid‑lowering options (e.g., ezetimibe alone, other tolerated statins at lower intensity) are inadequate, contraindicated, or not possible.
- Lab monitoring and documentation of intolerance and attempts at rechallenge or dose adjustment should be included when available.

Product and Clinical Threshold Coding

Referenced productNDC

NDC not specified

Nexletol (bempedoic acid) - product referenced but NDCs not listed in this chunk

inv-12: LDL-C after prior therapy — post-treatment LDL-C thresholds by indication

Established CVD — post-treatment LDL-C thresholdLDL-C ≥ 55 mg/dL after trial of a high-intensity statin (atorvastatin ≥40 mg or rosuvastatin ≥20 mg) plus ezetimibe for ≥8 continuous weeks

HeFH — post-treatment LDL-C thresholdLDL-C ≥ 70 mg/dL after trial of a high-intensity statin plus ezetimibe for ≥8 continuous weeks

Primary hyperlipidemia — post-treatment LDL-C thresholdLDL-C ≥ 70 mg/dL after trial of a high-intensity statin plus ezetimibe for ≥8 continuous weeks

HeFH — untreated LDL-C qualifying valueUntreated LDL-C ≥ 190 mg/dL may satisfy initial HeFH criteria

inv-13: Coronary artery calcium score — threshold for primary hyperlipidemia/high risk

Coronary artery calcium score threshold

Prior Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is recommended for prescription benefit coverage of Nexletol. All approvals are provided for the duration noted in the policy. A patient who previously met Initial Therapy criteria for Nexletol for the requested indication under the Coverage Review Department and is currently receiving Nexletol only needs to meet the Continuation Therapy criteria (i.e., prescriber attests patient is currently receiving therapy and has experienced a response). If past criteria were not met under the Coverage Review Department and the patient is currently receiving Nexletol, or is restarting Nexletol, Initial Therapy criteria must be met. Typical approvals are provided for up to 1 year where noted.

Prior authorization recommended for prescription benefit; approvals provided for the duration noted in policy (typically 1 year for approved indications)
If patient previously met Initial Therapy criteria under Coverage Review Department and is currently receiving Nexletol → only Continuation Therapy criteria required
If patient did not previously meet Initial Therapy criteria under Coverage Review Department, or is restarting therapy → Initial Therapy criteria must be met

Therapeutic Background and Evidence

Nexletol (bempedoic acid) is an adenosine triphosphate‑citrate lyase (ACL) inhibitor indicated to reduce LDL‑C and to reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy. It is also indicated for primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), as an adjunct to diet and other LDL‑C–lowering therapies or alone when concomitant therapy is not possible.

Key Definitions and Diagnostic Criteria

inv-24: Statin intolerance — definitions including rhabdomyolysis and skeletal-related muscle symptoms

Definition — statin intolerance (overall)Statin intolerance is either statin-related rhabdomyolysis or skeletal muscle symptoms with separate trials of atorvastatin and rosuvastatin that resolved upon discontinuation

Rhabdomyolysis definition (policy context)Rhabdomyolysis: statin-induced muscle breakdown associated with markedly elevated creatine kinase (≥10× upper limit of normal) with evidence of end-organ damage (e.g., acute renal injury or myoglobinuria)

Requirement for statin-intolerance pathwayDocumentation must show trials of atorvastatin and rosuvastatin with symptom resolution on discontinuation to meet statin-intolerant criteria for some indications

inv-25: Skeletal-related muscle symptoms — examples for statin intolerance assessment

Examples of skeletal-related muscle symptomsMyopathy (muscle weakness) and myalgia (muscle aches, soreness, stiffness, or tenderness)

Policy Summary

PayerCigna

PolicyNexletol (bempedoic acid) prior authorization for hyperlipidemia

Policy CodePolicy N/A

Change TypeCriteria revised and added (continuation criteriaLDL-C thresholdsindication reclassification)

Effective DateN/A

Next Review DateN/A

Key ActionFor continuation requests, prescriber must attest the patient is currently receiving Nexletol and has experienced a response to therapy.

SourceLink

On This Page

inv-14: LDL-C post-treatment thresholds — examples and changed thresholds noted in revisions

Example change — established CVD thresholdPost-treatment LDL-C threshold for established cardiovascular disease was revised from ≥70 mg/dL to ≥55 mg/dL

Example change — primary hyperlipidemia thresholdInitial therapy LDL-C after statin + ezetimibe for primary hyperlipidemia was lowered from ≥100 mg/dL to ≥70 mg/dL

Operational effect of revisionsCriteria were divided to distinguish initial therapy vs. patients currently receiving Nexletol; continuation pathway added for current recipients

Denial Risk

Requests Billed Without Covered Codes May Be Denied

Requests for services billed without covered diagnosis or procedure code(s) that correspond to the coverage criteria may be denied as not covered. When billing, providers must use the most appropriate codes as of the date of submission.

Claims submitted without covered diagnosis/procedure codes under this coverage policy will be denied as not covered
Use most appropriate codes as of the service date

Documentation Required

Initial Therapy Documentation Requirements

For Initial Therapy, prescribers should document the patient’s age and diagnosis, baseline and on-treatment lipid values with dates, and prior lipid-lowering therapy trials (drug, dose, start/stop dates, and response or reasons for discontinuation). If the patient is restarting Nexletol, Initial Therapy criteria must be met.

Document patient age (≥ 18 years for Initial Therapy) and qualifying diagnosis (e.g., HeFH, primary hyperlipidemia, ASCVD as applicable)
Provide baseline LDL‑C (pre-treatment) when required and most recent LDL‑C after qualifying statin + ezetimibe trial with dates
List prior lipid‑lowering therapies tried: statin name and dose, ezetimibe, duration (see statin/ezetimibe trial requirements), and outcomes

Documentation Required

Continuation Therapy — Prescriber Attestation

Prescriber must attest that the patient is currently receiving Nexletol and has experienced a response to therapy (e.g., reduction in LDL‑C, non‑HDL‑C, total cholesterol, or apolipoprotein B) when requesting continuation of therapy. If the patient previously met Initial Therapy criteria under the Coverage Review Department, only this attestation is required for continuation approvals.

Attestation: patient currently receiving Nexletol
Attestation: patient has experienced clinical response (examples: decreased LDL‑C, non‑HDL‑C, total cholesterol, or apolipoprotein B)
If prior Initial Therapy approval was granted by Coverage Review Department, only continuation attestation needed

Step Therapy

Required Prior Lipid‑Lowering Trials

Required prior lipid‑lowering trials must be documented before Initial Therapy approval: a trial of one high‑intensity statin (atorvastatin ≥ 40 mg or rosuvastatin ≥ 20 mg daily) and a trial of that high‑intensity statin in combination with ezetimibe for ≥ 8 continuous weeks, with LDL‑C measured after this regimen meeting the policy threshold for the indication (e.g., ≥ 55 mg/dL for ASCVD, ≥ 70 mg/dL for HeFH/primary hyperlipidemia where specified). Alternatively, documented statin intolerance per policy meets this requirement.

High‑intensity statin trial: atorvastatin ≥ 40 mg daily or rosuvastatin ≥ 20 mg daily
High‑intensity statin + ezetimibe combination trial duration: ≥ 8 continuous weeks
Post‑treatment LDL‑C thresholds vary by indication (e.g., ≥ 55 mg/dL for ASCVD; ≥ 70 mg/dL for HeFH/primary hyperlipidemia)
If statin intolerance is documented per policy criteria, prior trials may be waived

Documentation Required

Statin Trial and Intolerance Documentation

Statin trial requirements and documentation of statin intolerance: document adverse events and resolution. Statin intolerance may be met by (1) statin‑related rhabdomyolysis (CK ≥ 10× ULN with end‑organ injury) or (2) documented skeletal‑related muscle symptoms (myalgia/myopathy) that occurred with separate trials of both atorvastatin and rosuvastatin and that resolved upon discontinuation of each agent. Include dates, symptoms, CK and creatinine data if applicable, and trial/resolution details.

Statin‑related rhabdomyolysis: provide CK levels (≥ 10× ULN) and evidence of end‑organ damage (e.g., acute renal injury with Scr increase)
Skeletal‑related muscle symptoms: document trials of both atorvastatin and rosuvastatin (separate trials), symptoms experienced, and resolution upon discontinuation of each statin
Include dates for each statin trial, onset of symptoms, laboratory data, and clinical resolution

inv-26: Dutch Lipid Network Criteria — points-based diagnostic scoring system reference

DescriptionDutch Lipid Network Criteria are a points-based diagnostic scoring system for familial hypercholesterolemia including family history, clinical history, physical findings, LDL-C levels, and DNA analysis with stratified total score cutoffs (definite >8; probable 6–8; possible 3–5; unlikely <3)

Key score elementsElements include family history of premature vascular disease or high LDL-C, clinical history of premature CAD or vascular disease, physical signs (tendon xanthomas, arcus cornealis), LDL-C thresholds by mg/dL ranges, and DNA analysis for functional mutations

Score stratificationTotal score determines classification: Definite (>8), Probable (6–8), Possible (3–5), Unlikely (<3)

inv-27: Simon Broome criteria — familial hypercholesterolemia diagnostic criteria reference

ReferenceSimon Broome Register diagnostic criteria are cited in the policy as an accepted method for confirming familial hypercholesterolemia

Context of useSimon Broome criteria may be used alongside Dutch Lipid Network or genetic testing to confirm HeFH depending on policy wording and version

Policy notePolicy history indicates diagnostic confirmation wording was revised across updates; prescriber confirmation language was adjusted