CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Nexletol

Prior authorization criteria for Nexletol and Nexlizet for adults with hypercholesterolemia (including HeFH) or for risk reduction of major adverse cardiovascular events when statin therapy is not possible or tolerated; includes duration of approval and references.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyNexletol

Policy CodePolicy N/A

Change TypeClarified

Effective Date

Next Review Date

Key ActionAuthorization required and may be granted only if the patient meets the specific indication-based criteria (hypercholesterolemia/HeFH or MACE risk reduction) including statin intolerance or contraindication where applicable.

SourceLink

POLICY UPDATE CHANGES

Restates indications and PA criteria for Nexletol and Nexlizet consistent with product labeling and clinical references.

2Covered Indications

36Duration of Approval (months)

CriteriaCoverage Stance

Coverage Summary

Scope: Prior authorization criteria for Nexletol (bempedoic acid) and Nexlizet (bempedoic acid/ezetimibe) for adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH), and for reduction of risk of major adverse cardiovascular events (MACE) in adults at increased risk who are unable to take recommended statin therapy. Coverage stance: Covered with criteria. Approval is subject to indication-based requirements (e.g., adjunct to diet and exercise, use with or when concomitant LDL‑C lowering therapy is not possible, or statin intolerance/contraindication for MACE risk reduction) and duration of approval is 36 months. Product labeling and major lipid guideline documents are referenced for clinical criteria and implementation.

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Initial Therapy Criteria

Hypercholesterolemia including Heterozygous Familial Hypercholesterolemia (HeFH) - Initial Authorization

Authorization may be granted when the requested drug is being prescribed to reduce LDL-C in an adult with hypercholesterolemia, including HeFH, when ALL of the following criteria are met:

ALL of the following

The requested drug is being prescribed as an adjunct to diet and exercise
If the request is for Nexletol, ONE of the following must be met
- The requested drug will be used in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies
- Concomitant use of the requested drug with other low-density lipoprotein cholesterol (LDL-C) lowering therapies is NOT possible

Risk Reduction of Major Adverse Cardiovascular Events - Initial Authorization

Authorization may be granted when the requested drug is being prescribed to reduce the risk of major adverse cardiovascular events (MACE) in an adult at increased risk for these events when the following criteria is met:

ONE of

The patient experienced an intolerance to the recommended statin therapy
The patient has a contraindication that would prohibit use of statin therapy

Continuation Therapy Criteria

Continuation of Therapy

All patients (including new patients) requesting authorization for continuation of therapy must meet ALL requirements in the coverage criteria section.

ALL of the following

Patient continues to meet the applicable initial coverage criteria for the indication being treated
The patient has achieved or maintained a reduction in low-density lipoprotein cholesterol (LDL-C) from baseline

Provider Actions & Documentation

Prior Authorization

Prior authorization required

Authorization is required and will be granted only when the patient meets the indication-based criteria. Covered indications include reduction of LDL-C in adults with hypercholesterolemia (including HeFH) as an adjunct to diet and exercise — either in combination with other LDL-C–lowering therapies or when concomitant use is not possible — and reduction of risk of major adverse cardiovascular events (MACE) in adults at increased risk who are unable to take recommended statin therapy. For the MACE indication, inability to take recommended statin therapy includes documented statin intolerance or a contraindication to statins.

Documentation Required

Document LDL-C response for continuation

For continuation of therapy, documentation must show the patient continues to meet the applicable initial coverage criteria for the treated indication and has achieved or maintained a reduction in LDL-C from baseline.

Background & Definitions

Background: Nexletol and Nexlizet are indicated to reduce LDL‑C in adults with hypercholesterolemia, including HeFH, as an adjunct to diet and exercise (either in combination with other LDL‑C lowering therapies or alone when concomitant therapy is not possible). Bempedoic acid (component of Nexletol and Nexlizet) is also indicated to reduce the risk of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, or coronary revascularization) in adults at increased risk who are unable to take recommended statin therapy. Policy implementation references product labeling and major lipid guideline documents for criteria and clinical guidance.

Definitions:

MACE: Major adverse cardiovascular events — cardiovascular death, myocardial infarction, stroke, or coronary revascularization.

HeFH: Heterozygous familial hypercholesterolemia.