CurrentUnitedHealthcarePolicy CSOH2026D0101.E

Leqvio (Inclisiran) (for Ohio Only)

Ohio-only UnitedHealthcare Medical Benefit Drug Policy that defines coverage criteria, continuation criteria, applicable codes, and dosing/administration constraints for Leqvio (inclisiran). Applies to medical-benefit requests evaluated under Ohio Administrative Code when unproven or limited services are requested.

Policy Summary

PayerUnitedHealthcare

PolicyLeqvio (Inclisiran) (for Ohio Only)

Policy CodePolicy CSOH2026D0101.E

Change TypeCoverage criteria update; ICD-10 code additions; supporting info updated

Effective DateJan 1, 2026

Next Review Date

Key ActionInitial authorization limited to no more than 12 months and requires documentation of diagnosis, prior therapy/adherence and LDL-C levels per policy criteria; prescriber must be a cardiologist, endocrinologist, or lipid specialist.

POLICY UPDATE CHANGES

Updated coverage criteria to replace 'prescribed by a lipid specialist (e.g., cardiologist, endocrinologist, lipid specialist/lipidologist)' with 'prescribed by one of the following: cardiologist, endocrinologist, or lipid specialist'.

Added ICD-10 diagnosis codes E78.010, E78.011, and E78.019 to Applicable Codes.

Updated FDA and References sections to reflect most current information; no changes to core coverage logic beyond prescriber wording.

1State-specific policy (Ohio)

J1306Primary drug HCPCS code

10ICD-10 diagnosis codes listed

12 months

Coverage Summary & Scope

This policy covers Leqvio (inclisiran) for adults with primary hyperlipidemia (including HeFH) or clinical ASCVD under an Ohio-only UnitedHealthcare Medical Benefit Drug Policy. Coverage stance: covered_with_criteria; state scope: Ohio-only (medical-benefit requests evaluated under Ohio Administrative Code).

Key thresholds and limits

Initial/reauthorization maximum12 months

PCSK9 adherence definitionAt least 12 consecutive weeks of use

LDL-C goal — clinical ASCVD< 55 mg/dL

Pre-treatment LDL-C — primary hyperlipidemia≥ 190 mg/dL

LDL-C goal — primary hyperlipidemia< 100 mg/dL

Dosing frequency noted in trialsEvery 6 months after initial dose schedule (trials: days 1, 90, then q6 months)

Prescriber requirementPrescribed by cardiologist, endocrinologist, or lipid specialist

Initial Therapy Criteria (Medical Necessity)

Continuation of Therapy (Reauthorization) Criteria

Definitions & Risk Stratification

Clinical ASCVD: Includes acute coronary syndromes, history of myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease presumed to be of atherosclerotic origin.

High Risk Conditions: Age ≥ 65 years; heterozygous familial hypercholesterolemia (HeFH); prior CABG or PCI outside Major ASCVD Event(s); diabetes mellitus; 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.

Major ASCVD Events: Recent acute coronary syndrome (within past 12 months); history of myocardial infarction; history of ischemic stroke; symptomatic peripheral arterial disease (claudication with ABI < 0.85, or prior revascularization or amputation).

PCSK9 therapy adherence: Defined by the policy as at least 12 consecutive weeks of use.

Provider Actions & Documentation Requirements

Prior Authorization

Initial prior authorization required

Initial authorization limited to no more than 12 months. Requires documentation of diagnosis, prior therapy/adherence and LDL-C levels per policy criteria. Prescriber must be one of: cardiologist, endocrinologist, or lipid specialist.

J1306

Documentation Required

Document prior PCSK9 therapy adherence when applicable

For the PCSK9 adherence pathway, document at least 12 consecutive weeks of PCSK9 inhibitor use and include LDL-C results demonstrating failure to meet the specified LDL-C goals.

At least 12 consecutive weeks of use

Applicable Codes

Drug HCPCSHCPCSCovered

J1306

Injection, inclisiran, 1 mg

Applicable ICD-10 diagnosis codes (listed for reference)ICD-10

E75.5	Other lipid storage disorders
E78.00	Pure hypercholesterolemia, unspecified
E78.01	Familial hypercholesterolemia
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

Clinical Evidence

39.7% vs +8.2%ORION-9 LDL-C reduction at day 510 — between-group difference 47.9 percentage points (p<0.001)

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

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

-68.9 mg/dLORION-9 absolute LDL-C change at day 510 (95% CI -77.1 to -60.7; p<0.001)

Inclisiran (Leqvio) is a double-stranded siRNA that reduces hepatic PCSK9 synthesis via RNA interference, increasing LDL‑receptor recycling and lowering circulating LDL‑C. It is indicated as an adjunct to diet and exercise to reduce LDL‑C in adults with hypercholesterolemia, including HeFH.

Clinical trials (ORION‑9, ORION‑10, ORION‑11) demonstrated LDL‑C reductions versus placebo of approximately ~40–53% at day 510, with absolute reductions reported (e.g., between‑group difference −68.9 mg/dL in ORION‑9).

Dosing in the pivotal trials and labeling is administered every 6 months after the initial dosing schedule (trials used dosing on days 1, 90, 270, and 450 with continued 6‑monthly dosing thereafter).

Policy Background & Scope Details

Scope: Ohio-only UnitedHealthcare Medical Benefit Drug Policy that defines coverage and continuation criteria, applicable codes, and dosing/administration constraints for Leqvio (inclisiran).

Policy number: CSOH2026D0101.E; Effective date / Last review: January 1, 2026.

This policy applies only in Ohio and states that medical‑benefit requests for services designated as unproven or limited will be evaluated under the Ohio Administrative Code.

Note: Dosing and administration must follow the FDA‑approved labeling; initial authorization and reauthorization are each limited to no more than 12 months. Medical‑benefit requests are subject to Ohio administrative rules for evaluation.

Revision History

01/01/2026revisedLatest

Clarified prescriber requirement language — Updated coverage criteria to replace 'prescribed by a lipid specialist (e.g., cardiologist, endocrinologist, lipid specialist/lipidologist)' with 'prescribed by one of the following: cardiologist, endocrinologist, or lipid specialist'.

01/01/2026added

Expanded list of referenced diagnosis codes — Added ICD-10 diagnosis codes E78.010, E78.011, and E78.019 to Applicable Codes.

01/01/2026revised