CurrentColorado Rocky Mountain Health PlansPolicy 2025D0101K

Leqvio (Inclisiran) Medical Benefit Drug Policy

Defines UnitedHealthcare commercial/Medicaid medical benefit coverage criteria for Leqvio (inclisiran) as treatment for primary hyperlipidemia, HeFH, or clinical ASCVD, including initial and continuation authorization requirements, required documentation, dosing conformity to FDA labeling, prescriber specialties, and applicable billing codes.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyLeqvio (Inclisiran) Medical Benefit Drug Policy

Policy CodePolicy 2025D0101K

Change TypeReferences/coverage rationale updates

Effective DateNov 1, 2025

Next Review Date

Key ActionSubmit medical records confirming prior PCSK9 therapy or at least 12 weeks of high-intensity statin therapy (or documented statin intolerance) and LDL-C value for prior authorization and reauthorization.

SourceLink

POLICY UPDATE CHANGES

Added reference link to the Medical Benefit Drug Policy titled Provider Administered Drugs - Site of Care.

Coverage Rationale updated and instruction to refer to the CMS section for Medicare reviews was added.

Updated FDA, CMS, and References sections to reflect most current information.

Archived previous policy version 2025D0101J.

3Covered Indications (HeFH, ASCVD, Primary hyperlipidemia)

12 moAuthorization duration (initial/renewal)

>=55 mg/dLLDL-C coverage threshold

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Coverage Summary

UnitedHealthcare covers Leqvio (inclisiran) under the commercial/Medicaid medical benefit with criteria-based approval (policy number 2025D0101K, effective November 1, 2025). Coverage stance: covered_with_criteria. Indications covered: primary hyperlipidemia, heterozygous familial hypercholesterolemia (HeFH), or clinical atherosclerotic cardiovascular disease (ASCVD). Required documentation includes prior therapies and LDL-C value; the LDL-C coverage threshold is LDL-C >= 55 mg/dL. Initial and reauthorization durations are limited to 12 months, and dosing must follow FDA labeling.

Key thresholds and authorization durations

LDL-C thresholdLDL-C ≥ 55 mg/dL

High-intensity statin duration>= 12 consecutive weeks of high-intensity statin therapy (e.g., atorvastatin 40-80 mg, rosuvastatin 20-40 mg)

Low/moderate-intensity statin duration>= 12 consecutive weeks of low- or moderate-intensity statin therapy (examples listed in policy)

Statin intolerance symptom durationIntolerable and persistent symptoms > 2 weeks (e.g., myalgia or myositis with CK < 10x ULN)

Authorization duration (initial and renewal)Initial authorization and reauthorization: no more than 12 months

Initial Therapy Criteria

Initial Therapy

Leqvio is medically necessary when ALL of the following are met:

Continuation Therapy Criteria

Continuation of Therapy

Reauthorization is permitted when ALL of the following are met:

ALL of the following

Documentation of a positive clinical response to Leqvio therapy
Prescribed by one of the following specialists: Cardiologist; Endocrinologist; Lipid specialist
Leqvio will not be used in combination with PCSK9 inhibitor therapy
Leqvio dosing is in accordance with the FDA approved labeling
Reauthorization will be for no more than 12 months

Unproven Uses and Exclusions

Leqvio is not to be used concomitantly with PCSK9 inhibitor therapy; the policy explicitly states Leqvio will not be used in combination with PCSK9 inhibitor therapy. The criteria allow use when there is documented failure, contraindication, or intolerance to PCSK9 therapy or when prior PCSK9 therapy was given and other statin requirements are met. The policy also permits use when patients have a contraindication to all statins (or documented statin intolerance) per the stated intolerance/contraindication rules. Use outside these criteria or in combination with PCSK9 monoclonal antibodies is not supported.

Applicable Codes

HCPCS/J-code for drugHCPCSCovered

J1306

Injection, inclisiran, 1 mg

Diagnosis codes (examples listed for reference)ICD-10

E75.5	Other lipid storage disorders
E78.00	Pure hypercholesterolemia, unspecified
E78.010	Homozygous familial hypercholesterolemia [HoFH]
E78.011	Heterozygous familial hypercholesterolemia [HeFH]
E78.019	Familial hypercholesterolemia, unspecified
E78.2	Mixed hyperlipidemia
E78.49	Other hyperlipidemia
E78.5	Hyperlipidemia, unspecified
E78.9	Disorder of lipoprotein metabolism, unspecified

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization required for initial and renewal

Initial authorization limited to no more than 12 months; reauthorization limited to no more than 12 months. Providers must submit chart notes and laboratory values confirming the diagnosis, prior therapies, LDL-C value, and — for continuation — documentation of a positive clinical response.

Affected code: J1306
Required documentation: chart notes, laboratory values, diagnosis, prior therapies, LDL-C value, positive response for continuation

Documentation Required

Document prior therapies and intolerance

Submit medical records confirming prior use of PCSK9 therapy or at least 12 consecutive weeks of high-intensity statin therapy, or documentation of statin intolerance. When intolerance is claimed, include symptom documentation (e.g., myalgia, myositis) and relevant CK results to support the intolerance assessment.

Document CK levels when claiming myositis/myalgia and any CK elevations

Clinical Evidence

ORION-10: 52.3%ORION-10 percent LDL-C reduction at day 510 vs placebo (p<0.001)

ORION-11: 49.9%ORION-11 percent LDL-C reduction at day 510 vs placebo (p<0.001)

Inclisiran (Leqvio) is a GalNAc-conjugated double-stranded small interfering RNA (siRNA) that directs catalytic degradation of hepatocyte PCSK9 mRNA, reducing PCSK9 synthesis, increasing LDL receptor recycling and expression, and thereby lowering circulating LDL-C. In the pivotal ORION trials (ORION-9, -10, -11), inclisiran was studied as an add-on to maximally tolerated statin therapy and produced LDL-C reductions of approximately 39%–53% versus placebo.

Background and Definitions

Inclisiran is a small interfering RNA (siRNA), conjugated with triantennary N-acetylgalactosamine (GalNAc) to facilitate hepatocyte uptake, that uses RNA interference to degrade PCSK9 mRNA in hepatocytes resulting in increased LDL receptor recycling and reduced LDL-C. The ORION phase 3 trials evaluated inclisiran added to maximally tolerated statin therapy in patients with HeFH or at high cardiovascular risk; across ORION-9, ORION-10, and ORION-11, inclisiran demonstrated robust, placebo‑corrected LDL‑C reductions (~39.7% in ORION‑9 and ~49.9–52.3% in ORION‑10/11) when administered on the studied schedule.

Term	Definition
High Risk Conditions
Includes age ≥ 65, HeFH, prior CABG or PCI outside major ASCVD events, diabetes, hypertension, chronic kidney disease (eGFR 15-59 mL/min/1.73 m2), current smoking, persistently elevated LDL-C ≥ 100 mg/dL despite maximally tolerated statin therapy and ezetimibe, history of congestive heart failure.

Revision History

2025-11-01added

Added reference link to Provider Administered Drugs - Site of Care (Related Commercial Policy).

2025-11-01revised

Coverage Rationale updated and instruction to refer to the CMS section for Medicare reviews was added.

2025-11-01updated

Updated FDA, CMS, and References sections to reflect the most current information.