CurrentNeighborhood Health Plan of Rhode IslandPolicy 3647-A

Nexletol (bempedoic acid) and Nexlizet (bempedoic acid/ezetimibe) prior authorization

Defines medical necessity and authorization criteria for Nexletol and Nexlizet for adults with hypercholesterolemia or at increased cardiovascular risk, including requirements for LDL-C reduction, statin intolerance/contraindication, and adjunct to diet and exercise. Affects prescribers and prior authorization reviewers for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyNexletol (bempedoic acid) and Nexlizet (bempedoic acid/ezetimibe) prior authorization

Policy CodePolicy 3647-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization showing the drug is prescribed as an adjunct to diet and exercise and documentation of statin intolerance or LDL-C response as applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

36 monthsDuration of approval (DOA)

2 productsDrugs referenced

LDL-C & MACEPrimary indications summarized

Coverage Criteria

Initial therapy for Hypercholesterolemia (including HeFH)

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Hypercholesterolemia initial authorization: The requested drug is being prescribed as an adjunct to diet and exercise.

From hypercholesterolemia criteria

Nexletol-specific usage

ONE of: The requested drug will be used in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies.
Combination therapy option
ONE of: Concomitant use of the requested drug with other low-density lipoprotein cholesterol (LDL-C) lowering therapies is NOT possible.
When concomitant use is not possible

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Risk reduction of Major Adverse Cardiovascular Events (MACE)

Covered when ONE of the following is met for risk reduction of major adverse cardiovascular events (MACE):

MACE risk reduction: The patient experienced an intolerance to the recommended statin therapy.

Statin intolerance required for MACE indication

MACE risk reduction: The patient has a contraindication that would prohibit use of statin therapy.

Statin contraindication option

Continuation of therapy

Continuation/maintenance coverage requirements:

Continuation: All patients requesting authorization for continuation must meet ALL requirements in the coverage criteria; AND the patient has achieved or maintained a reduction in low-density lipoprotein cholesterol (LDL-C) from baseline.

Continuation requires documented LDL-C response

This policy applies only to adults. Authorization criteria address use of Nexletol (bempedoic acid) and Nexlizet (bempedoic acid/ezetimibe) for adult patients with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). For hypercholesterolemia indications, the request must document that the drug is being prescribed as an adjunct to diet and exercise and, for continuation requests, that the patient has achieved or maintained a reduction in LDL-C from baseline.

Use is limited to the adult indications and clinical scenarios described in the criteria. The drug must be prescribed as an adjunct to diet and exercise for hypercholesterolemia; Nexletol requests must either be for combination use with other LDL-C lowering therapies or demonstrate that concomitant use is not possible. For the MACE risk‑reduction indication, the patient must have documented statin intolerance or a contraindication to statin therapy.

Scenarios that do NOT meet criteria and therefore are not covered include requests for pediatric patients, use not prescribed as an adjunct to lifestyle measures, absence of documented statin intolerance/contraindication when seeking MACE risk‑reduction, or lack of documented LDL‑C reduction/maintenance when requesting continuation of therapy.

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for these agents. Approvals are issued for a duration of 36 months.

Policy number: 3647-A
Duration of Approval (DOA): 36 months

Step Therapy

Step/Therapeutic Positioning

Policy positions these therapies as adjuncts to diet and exercise and permits use either in combination with other LDL‑C lowering therapies or when concomitant use of other LDL‑C lowering therapies is not possible. For Nexletol specifically, the request must meet one of the combination or inability-to-use conditions.

Documentation Required

Required Documentation

Clinical documentation must demonstrate the drug is being prescribed as an adjunct to diet and exercise. For continuation requests, documentation must show the patient has achieved or maintained a reduction in LDL‑C from baseline. If claiming statin intolerance or contraindication for cardiovascular risk reduction indications, include clinical details supporting intolerance/contraindication.

Documentation that diet and exercise adjunctive therapy is being used
For continuation: evidence of maintained LDL‑C reduction from baseline
If claiming statin intolerance/contraindication: clinical notes detailing intolerance or contraindication

Denial Risk

Triggers for Denial

Authorization will be denied if all required criteria are not met. Examples of triggers for denial include: lack of documentation that the drug is adjunctive to diet/exercise, failure to document combination therapy or inability to use other LDL‑C lowering therapies when required (including Nexletol-specific requirements), missing evidence of LDL‑C reduction for continuation requests, or absence of documentation supporting statin intolerance/contraindication when that is the basis for therapy.

Missing documentation that therapy is adjunct to diet and exercise
No documentation of concomitant LDL‑C lowering therapy or reason why it is not possible (when required)
For continuation: no evidence of maintained LDL‑C reduction from baseline
No clinical evidence of statin intolerance or contraindication when used to justify non-statin therapy

Definitions

Major adverse cardiovascular events (MACE) — definition

DefinitionMajor adverse cardiovascular events (MACE) are defined as cardiovascular death, myocardial infarction, stroke, or coronary revascularization.

Context of indicationNexletol and bempedoic acid (component of Nexlizet) are indicated to reduce the risk of MACE in adults at increased risk who are unable to take recommended statin therapy (including those not taking a statin).

PopulationApplies to adults at increased risk for cardiovascular events who have statin intolerance or a contraindication to recommended statin therapy.

ExamplesEvents included under MACE: cardiovascular death; myocardial infarction; stroke; coronary revascularization.

Adjunct to diet and exercise — definition and requirement

DefinitionAdjunct to diet and exercise means the therapy is prescribed in addition to lifestyle measures (diet and exercise).

Policy requirementThe requested drug must be prescribed as an adjunct to diet and exercise for hypercholesterolemia indications; this is required for authorization.

Nexlizet specific wordingNexlizet is indicated as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia, including HeFH.

Nexletol positioningNexletol is indicated as an adjunct to diet and exercise to reduce LDL-C in adults and may be used in combination with other LDL-C–lowering therapies or alone when concomitant therapy is not possible.

Background

Bempedoic acid (Nexletol) and the fixed‑dose combination bempedoic acid/ezetimibe (Nexlizet) are oral lipid‑lowering agents indicated in adults to reduce LDL‑C as an adjunct to diet and exercise. In addition, bempedoic acid (the component in Nexletol and in Nexlizet) is indicated to reduce the risk of major adverse cardiovascular events — defined as cardiovascular death, myocardial infarction, stroke, or coronary revascularization — in adults at increased cardiovascular risk who are unable to take the recommended statin therapy.

Mechanistically, bempedoic acid works upstream of HMG‑CoA reductase in the cholesterol biosynthesis pathway and is used either alone or combined with ezetimibe to achieve further LDL‑C lowering when statins are insufficient, contraindicated, or not tolerated.