CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Leqvio (inclisiran) (Subcutaneous)

Medical-benefit coverage and prior authorization criteria for Leqvio (inclisiran) for Medicaid, Commercial, and Medicare-Medicaid Plan members of Neighborhood Health Plan of Rhode Island, including initial and continuation criteria, dosing, and applicable billing codes.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLeqvio (inclisiran) (Subcutaneous)

Policy CodePolicy N/A

Change Typeclarified

Effective DateSep 1, 2022

Next Review Date

Key ActionCoverage will be reviewed prospectively via the prior authorization process; requests must include documentation meeting the initial criteria and a current LDL-C within six months.

SourceLink

POLICY UPDATE CHANGES

Review dates updated through 04/30/2025 and reference to Leqvio package insert (June 2025) included.

2FDA-approved indications covered (ASCVD, HeFH)

6 monthsInitial coverage duration

12 monthsContinuation coverage duration

284 mgPer-dose amount (mg)

Coverage Summary

Scope: Medical-benefit coverage for Leqvio (inclisiran) for Medicaid, Commercial, and Medicare-Medicaid Plan members of Neighborhood Health Plan of Rhode Island. Coverage stance: covered_with_criteria when prior authorization and policy criteria are met.

Indication summary: Leqvio (inclisiran) is indicated as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional LDL-C lowering. Administration and billing: 284 mg subcutaneously initially, at 3 months, then every 6 months (1 mg = 1 billable unit; HCPCS code J1306).

Key thresholds and dosing/coverage

LDL-C documentation windowLDL-C level dated within 6 months prior to authorization request

ASCVD LDL-C target for inadequate responseTarget LDL-C ≤ 70 mg/dL (failure to reach this despite adherence to maximally tolerated statin ± ezetimibe/PCSK9 prior to panel)

HeFH LDL-C thresholds - primary preventionLDL-C ≥ 100 mg/dL

HeFH LDL-C thresholds - secondary preventionLDL-C ≥ 70 mg/dL

Statin-associated rhabdomyolysis CK thresholdAcute CK elevation usually > 5,000 IU/L or 5× ULN to support diagnosis

Per-dose amount284 mg per subcutaneous dose (284 billable units; 1 mg = 1 billable unit)

Initial and continuation coverage durationsInitial coverage: 6 months; Continuation coverage: 12 months

Initial Therapy Criteria

Universal Initial Criteria

Covered when ALL of the following are met:

ALL of the following

Patient is at least 18 years of age
Patient is not on concomitant PCSK9- or ANGPTL3- inhibitors (i.e., alirocumab, evolocumab, evinacumab, etc.)
Must be prescribed by, or in consultation with, a specialist in cardiology, lipidology, or endocrinology
Documentation of current LDL-C level for both initial and continuation requestsLDL-C level dated within 6 months preceding the authorization request

Atherosclerotic Cardiovascular Disease (ASCVD) indication

In addition to universal initial criteria, ALL of the following must be met for ASCVD indication:

ALL of the following

Therapy will be used in conjunction with diet alone or in conjunction with other lipid-lowering therapies unless the patient is unable to tolerate (e.g., statins, ezetimibe)
ONE of
- Myocardial infarction
- Acute coronary syndromes
- Coronary artery disease
- Stable or unstable angina

Heterozygous Familial Hypercholesterolemia (HeFH) indication

In addition to universal initial criteria, ALL of the following must be met for HeFH indication:

ALL of the following

Provider submits diagnosis of HeFH as confirmed by genotyping OR by patient having a first-degree relative similarly affected or with premature coronary vascular disease or with positive genetic testing for an LDL-C raising gene defect (LDL receptor, apoB, or PCSK9)
Therapy will be used in conjunction with diet alone or in conjunction with other lipid-lowering therapies unless the patient is unable to tolerate (e.g., statins, ezetimibe)
Patient has prior treatment history with the highest available age-appropriate dose or maximally tolerated dose of high-intensity statin therapy (examples: atorvastatin 40 or 80 mg daily; rosuvastatin 20 or 40 mg daily; simvastatin 80 mg daily), unless contraindicated
Patient has been adherent to ezetimibe used concomitantly with a statin when LDL-C levels are ≥ 100 mg/dL at maximally tolerated dose for at least three months unless contraindicated

Continuation Therapy Criteria

Continuation of Therapy Criteria

Coverage can be renewed when ALL of the following are met:

ALL of the following

Patient continues to meet initial criteria universal and other indication-specific relevant criteria (not including prerequisite therapy)
Absence of unacceptable toxicity from therapy (examples: severe injection site reactions, serious hypersensitivity reaction)
Documentation that patient has had a reduction in LDL-C when compared to the baseline labs (prior to initiating inclisiran)
Patient continues to adhere to diet and/or lipid lowering therapy established prior to the original approval

Provider Actions / Prior Authorization & Billing

Prior Authorization

Prior authorization required

Coverage will be reviewed prospectively via the prior authorization process. Requests must include documentation that meets the initial criteria and a current LDL-C level dated within six months of the authorization request.

J1306

Documentation Required

Specialist prescribing / consultation requirement

Must be prescribed by, or in consultation with, a specialist in cardiology, lipidology, or endocrinology.

Documentation Required

Physician attestation of adherence

Physician must attest that the patient is adherent to maximally tolerated doses of statins and ezetimibe and/or PCSK9 inhibitor therapy prior to the lipid panel used to demonstrate inadequate response.

Billing Rule

Dose and billing units

Dose: administer 284 mg subcutaneously as a single injection initially, again at 3 months, then every 6 months. Billing: 1 mg = 1 billable unit; maximum billable units = 284 units (284 mg) per dose. Leqvio should be administered by a healthcare professional.

J1306

Documentation Required

LDL-C measurement timing

Assess LDL-C when clinically indicated. The LDL-lowering effect may be measured as early as 30 days after initiation and at any time thereafter regardless of dosing schedule.

Clinical Evidence

over 3,400ORION phase 3 program size (patients)

up to 52%LDL-C reduction at Month 17 vs placebo (P<0.0001)

Evidence basis: FDA approval was granted based on the ORION clinical research program (Phase 3 trials) enrolling over 3,400 patients with ASCVD or HeFH on maximally tolerated statin therapy.

Efficacy outcome: The ORION trials demonstrated an LDL-C reduction of up to 52% at Month 17 versus placebo (P<0.0001).

Reference inclusion: The policy references the Leqvio package insert (Novartis; cited June 2025) as part of the supporting documentation for indications and dosing.

Background & Definitions

Background: Leqvio (inclisiran) is indicated as an adjunct to diet and maximally tolerated statin therapy for adults with HeFH or clinical ASCVD who require additional LDL-C lowering. The mechanism and clinical development supporting approval come from the ORION clinical program, which included Phase 3 trials demonstrating substantial and sustained LDL-C lowering.

Scope context: This policy applies to Neighborhood Health Plan of Rhode Island members across Medicaid, Commercial, and Medicare-Medicaid Plan lines and defines prior authorization, dosing, and applicable billing codes for Leqvio.

Maximally tolerated dose: The highest statin dose the patient can tolerate. If statin intolerance is due to muscle symptoms, a causal relationship between the statin and symptoms must be established and documented (symptom resolution after discontinuation, recurrence on re-challenge at a lower dose, and occurrence after switching to an alternative statin).

Operational note — documenting intolerance: For muscle-symptom–related intolerance, document evidence of pain, tenderness, stiffness, cramping, weakness, and/or fatigue; symptom resolution after stopping the statin; symptoms on re-challenge and with an alternative statin; and exclusion of non-statin causes (e.g., hypothyroidism, renal or hepatic dysfunction, rheumatologic disorders, steroid myopathy, vitamin D deficiency, or primary muscle disease). Rhabdomyolysis diagnosis should be supported by acute neuromuscular illness or dark urine and an acute CK elevation (usually > 5,000 IU/L or 5x ULN).

Definition entry: 'Maximally tolerated dose' as used in this policy refers to the highest statin dose the patient can tolerate, with required documentation when intolerance limits dosing.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLeqvio (inclisiran) (Subcutaneous)

Policy CodePolicy N/A

Change Typeclarified

Effective DateSep 1, 2022

Next Review Date

Key ActionCoverage will be reviewed prospectively via the prior authorization process; requests must include documentation meeting the initial criteria and a current LDL-C within six months.

SourceLink

On This Page

ONE of

Patient has failed to reach a target LDL-C level ≤ 70 mg/dL despite physician attestation that the patient is adherent to maximally tolerated doses of statins and ezetimibe and/or PCSK9 inhibitor therapy prior to the lipid panel demonstrating suboptimal reduction≤ 70 mg/dL
Physician attestation of adherence required
Patient meets other inadequate response/intolerance criteria as described above

OpenPayer

Leqvio (inclisiran) (Subcutaneous)

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Provider Actions / Prior Authorization & Billing

Applicable Codes

Clinical Evidence

Background & Definitions

Revision History