CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Nexletol Nexlizet Pa Policy 3647 A Udr 12 2023 V2 1

Defines prior authorization coverage criteria for Nexletol and Nexlizet when prescribed to reduce LDL-C or to reduce risk of myocardial infarction and coronary revascularization in adults unable to take recommended statin therapy; includes initial and continuation criteria and duration of approval.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyNexletol Nexlizet Pa Policy 3647 A Udr 12 2023 V2 1

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization is required for coverage; the requested drug will be covered only when the policy criteria (initial or continuation) are met.

SourceLink

POLICY UPDATE CHANGES

No material changes to clinical coverage criteria or policy content.

36 monthsDuration of Approval (DOA)

Coverage Summary

Coverage stance: covered with criteria for Nexletol (bempedoic acid) and Nexlizet (bempedoic acid/ezetimibe). The policy defines initial and continuation prior authorization criteria that must be met for coverage and requires prior authorization for approval.

Duration of approval: 36 months.

High-level indications: both products are indicated to reduce LDL-C in adults with primary hyperlipidemia including HeFH. In addition, the bempedoic acid component (Nexletol and the bempedoic acid component of Nexlizet) is indicated to reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy.

Initial Therapy Criteria

Initial Prior Authorization - Coverage Criteria

Covered when ALL of the following are met:

ALL of the following

ALL of the following
- The requested drug is being prescribed to reduce low-density lipoprotein cholesterol (LDL-C) in an adult with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH)
- AND
  - The requested drug is being prescribed as an adjunct to diet
  - The request is NOT for continuation of therapy
  - The requested drug will be used in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies

OR alternative pathway

ALL of the following
- The requested drug is being prescribed to reduce the risk of myocardial infarction and coronary revascularization in an adult
- The patient has ANY of the following: A) established cardiovascular disease (CVD), B) a high risk for a cardiovascular disease (CVD) event but without established CVD
- 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 - Coverage Criteria

Covered when ALL of the following are met:

ALL of the following

The request is for continuation of therapy
The patient has achieved or maintained a reduction in low-density lipoprotein cholesterol (LDL-C) from baseline
Concomitant use of the requested drug with other low-density lipoprotein cholesterol (LDL-C) lowering therapies is not possible
This enables continuation when combination therapy is not possible

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for coverage; the requested drug will be covered only when the policy criteria (initial or continuation) are met.

Documentation Required

Document statin intolerance or contraindication

For the risk-reduction pathway, provider must document either intolerance to recommended statin therapy or a contraindication that would prohibit statin use.

Documentation Required

Document LDL-C response for continuation

For continuation requests, provider must document that the patient has achieved or maintained a reduction in LDL-C from baseline and that concomitant use with other LDL-C lowering therapies is not possible.

Clinical Evidence

Primary evidence sources cited by the policy are the Nexletol and Nexlizet package inserts (March 2024) and clinical guideline/expert consensus documents (including AHA/ACC guideline references and the 2022 ACC expert consensus decision pathway). These sources are listed in the policy references and form the basis for the coverage criteria.

Background

Indications: Nexletol (bempedoic acid) is indicated to reduce the risk of myocardial infarction and coronary revascularization in adults unable to take recommended statin therapy (including those not taking a statin) who have established CVD or are at high risk for a CVD event; it is also indicated as an adjunct to diet, alone or in combination with other LDL-C lowering therapies (or alone when concomitant therapy is not possible) to reduce LDL‑C in adults with primary hyperlipidemia including HeFH.

Nexlizet (bempedoic acid/ezetimibe) is indicated as an adjunct to diet, alone or in combination with other LDL‑C lowering therapies, to reduce LDL‑C in adults with primary hyperlipidemia including HeFH; the bempedoic acid component of Nexlizet carries the same risk‑reduction indication described above for Nexletol.

The policy references the package inserts and clinical guideline documents when defining coverage criteria and pathways for LDL‑C reduction and for risk‑reduction in patients unable to take statins.

Definitions / Glossary: HeFH = heterozygous familial hypercholesterolemia; LDL‑C = low‑density lipoprotein cholesterol; CVD = cardiovascular disease.