CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Leqvio (inclisiran) (Subcutaneous)

Clinical coverage policy governing prospective prior authorization and coverage criteria for Leqvio (inclisiran) for Medicaid, Commercial, and Medicare-Medicaid Plan members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLeqvio (inclisiran) (Subcutaneous) — coverage criteria for use as adjunct to maximally tolerated statin therapy in adults with HeFH or ASCVD

Policy CodePolicy N/A

Change TypeNo material change

Effective Date09/01/2022

Next Review DateN/A

Key ActionSubmit prior authorization with current LDL-C within six months and documentation of prior trials or intolerance to maximally tolerated statin therapy and ezetimibe.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

284 mgstandard administered dose per injection

every 6 monthsmaintenance dosing interval

J1306applicable HCPCS code

12 monthscontinuation coverage duration

Coverage Criteria for Leqvio (inclisiran)

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Initial Therapy

Covered when ALL of the following are met for initial therapy (adults ≥18):

Age and provider: Patient is at least 18 years of age and medication is prescribed by or in consultation with a cardiology, lipidology, or endocrinology specialist.

Indication: Diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD) OR heterozygous familial hypercholesterolemia (HeFH) confirmed by genotyping or by family history/positive genetic testing.

Baseline LDL-C documentation: Documentation of current LDL-C level dated within six months preceding the authorization request.

Concomitant therapy: To be used in conjunction with diet and maximally tolerated statin therapy; ezetimibe recommended when tolerated.

Prior therapies: Patient has trialed maximally tolerated high‑intensity statin therapy and ezetimibe (when applicable) and has inadequate response OR has intolerance/contraindication. Patient must have inadequate response, intolerance, or contraindication to PCSK9 inhibitor therapy for at least 3 months unless contraindicated.

MMP members who received medication within past 365 days may be exempt from step therapy per policy note.

LDL-C threshold by prevention goal: For HeFH: primary prevention LDL‑C ≥ 100 mg/dL; for secondary prevention with ASCVD LDL‑C ≥ 70 mg/dL (patient has failed to reach target despite adherence).

Physician attestation of adherence to maximally tolerated therapies required.

Continuation of Therapy

Covered when ALL of the following are met for continuation/renewal:

Ongoing indication: Patient continues to meet initial criteria and indication‑specific relevant requirements (excluding prerequisite therapy).

Toxicity: Absence of unacceptable toxicity from therapy (examples include severe injection site reactions or serious hypersensitivity).

Effectiveness: Documentation of reduction in LDL‑C compared to the baseline labs prior to initiating inclisiran.

Adherence: Patient continues to adhere to diet and/or lipid‑lowering therapy as established at original approval.

Investigational use of inclisiran (Leqvio) is not covered. Therapies used at a dose or for a condition other than recognized, medically accepted indications are considered investigational and are excluded from coverage. Medically accepted indications are those listed in standard reference compendia (e.g., AHFS, DrugDex, Clinical Pharmacology, Lexi-Drugs) or supported by peer-reviewed literature; uses that do not meet those sources' criteria will be treated as investigational and will not be reimbursed.

Leqvio (inclisiran) is covered under the Medical Benefit only when used within the policy guidelines. Use outside the stated guidelines or for investigational indications may be non-covered and result in non-payment unless an exception is approved through the plan’s exception process. Providers seeking coverage for uses outside these criteria must submit an exception request with supporting clinical evidence from recognized compendia or peer-reviewed literature.

Provider Actions and Requirements

Prior Authorization

Prior authorization required for J1306

Coverage of Leqvio (inclisiran) is reviewed prospectively via the prior authorization process; requests billed with HCPCS code J1306 must meet the policy criteria to be considered for coverage.

Step Therapy

Therapy prerequisites before approval

Before initiating inclisiran, the patient must have trialed maximally tolerated high‑intensity statin therapy and ezetimibe (when applicable) with inadequate response or documented intolerance; in addition, the patient must have inadequate response, intolerance, or contraindication to PCSK9 inhibitor therapy for at least 3 months unless contraindicated. MMP members who received the medication within the past 365 days may be exempt from step therapy.

Maximally tolerated high‑intensity statin therapy (e.g., atorvastatin 40–80 mg, rosuvastatin 20–40 mg, simvastatin 80 mg) unless contraindicated.
Ezetimibe used concomitantly with a statin at maximally tolerated dose for ≥3 months unless contraindicated.
Inadequate response/intolerance/contraindication to PCSK9 inhibitor therapy for ≥3 months unless contraindicated.
MMP members with receipt of medication within past 365 days may be exempt from step therapy.

Documentation Required

Required clinical documentation

Submit documentation of the current LDL‑C level dated within six months preceding the authorization request and, for continuation requests, documentation of reduction in LDL‑C compared with baseline; also include documentation of prior therapies and any contraindications or intolerance and specialist involvement.

Current LDL‑C level dated within six months of the authorization request.
For continuation: evidence of LDL‑C reduction from baseline prior to initiating inclisiran.
Documentation of prior lipid‑lowering therapies, contraindications or intolerance (statins, ezetimibe, PCSK9 inhibitors).
Prescriber is or consulted with a cardiology, lipidology, or endocrinology specialist.

Denial Risk

Noncompliant use may be denied

Use of inclisiran outside the stated guidelines or for investigational indications may be non‑covered and result in non‑payment unless an exception is approved through the exception process.

Indication & Definitions

Indication — Adjunct to diet and maximally tolerated statin therapy

Indication (FDA-approved)Adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) requiring additional LDL-C lowering

Use with other lipid-lowering agentsTo be used in conjunction with diet and maximally tolerated statin therapy; ezetimibe recommended when tolerated

Patient populationAdults (≥18 years) with HeFH or clinical ASCVD who have elevated LDL-C despite maximal tolerated therapy

Clinical evidence summaryORION Phase 3 trials showed up to ~52% LDL-C reduction versus placebo and generally favorable tolerability

OpenPayer

Leqvio (inclisiran) (Subcutaneous)

Coverage Criteria for Leqvio (inclisiran)

Coding and Thresholds

Provider Actions and Requirements

Background

Indication & Definitions