CurrentUnitedHealthcarePolicy IEXD0101.11

Leqvio (inclisiran) — Individual Exchange Medical Benefit Drug Coverage Criteria

Defines UnitedHealthcare Individual Exchange medical benefit drug coverage criteria for inclisiran (Leqvio) as adjunct therapy for adults with primary hyperlipidemia, HeFH, or clinical ASCVD under Individual Exchange plans (excludes MA, NV, NY). Applies to prescribers and payers making coverage determinations.

Policy Summary

PayerUnitedHealthcare

PolicyLeqvio (inclisiran) — Individual Exchange Medical Benefit Drug Coverage Criteria

Policy CodePolicy IEXD0101.11

Change TypeAdministrative code updatesminor reference and format revisions

Effective DateOct 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, prescriber specialty, prior PCSK9 use (≥12 weeks) or intolerance, and baseline/on-treatment LDL-C values.

SourceLink

POLICY UPDATE CHANGES

Added ICD-10 diagnosis codes E78.010, E78.011, and E78.019 and removed E78.01.

Added a 'Benefit Considerations' section.

Updated FDA and References sections to reflect current information.

J1306HCPCS

3Indication groups

≤12 moInitial auth

≤12 mo

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Coverage Criteria for Inclisiran (Leqvio)

Initial Therapy — Covered when ALL of the following are met for initial therapy

Covered when ALL of the following are met for initial therapy

Initial Coverage Requirements

Prior therapy/response: (A) Despite adherence to PCSK9 therapy for at least 12 consecutive weeks, either: (i) patient has clinical ASCVD AND failed to achieve LDL-C goal of < 55 mg/dL, OR (ii) patient has primary hyperlipidemia (pre-treatment LDL-C ≥ 190 mg/dL) AND failed to achieve LDL-C goal of < 100 mg/dL; OR (B) patient has a history of intolerance or contraindication to PCSK9 therapy.

Continuation Therapy — Covered when ALL of the following are met for continuation of therapy

Covered when ALL of the following are met for continuation of therapy

Continuation Requirements: Documentation of a positive clinical response to Leqvio (inclisiran) therapy; AND Leqvio will not be used in combination with PCSK9 inhibitor therapy; AND dosing follows United States FDA approved labeling; AND reauthorization will be for no more than 12 months.

Instructions for Use

Concomitant therapy and dosing: Patient will continue other traditional LDL-C lowering therapies (e.g., maximally tolerated statins, ezetimibe) in combination with Leqvio; Leqvio will not be used in combination with PCSK9 inhibitor therapy; Leqvio dosing is in accordance with United States FDA approved labeling; initial authorization and reauthorization durations limited to no more than 12 months.

Leqvio (inclisiran) must not be used concomitantly with PCSK9 inhibitor therapy. Requests for continuation or initiation that indicate combined use of Leqvio and a PCSK9 inhibitor will not meet the policy’s instructions for use and are excluded from coverage.

Use of inclisiran (Leqvio) without meeting the policy’s required criteria is not supported. Specifically, requests that do not document an eligible diagnosis (HeFH, clinical ASCVD, or primary hyperlipidemia), are not prescribed by an appropriate lipid specialist (for example, cardiologist, endocrinologist, or lipidologist), lack required prior-therapy documentation (such as ≥ 12 consecutive weeks of PCSK9 inhibitor therapy when applicable or documented intolerance/contraindication), or do not demonstrate the applicable LDL-C thresholds/goals are not consistent with coverage criteria and may be denied.

Coding: HCPCS and Diagnosis Codes

Applicable HCPCSHCPCS

J1306

Injection, inclisiran, 1 mg.

Applicable ICD-10 Diagnosis CodesICD-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.

inv-08: LDL-C treatment thresholds — thresholds for ASCVD and primary hyperlipidemia

ASCVD treatment thresholdFailure to achieve LDL-C goal of < 55 mg/dL for patients with clinical ASCVD after prior PCSK9 therapy

Primary hyperlipidemia thresholdFor primary hyperlipidemia with pre-treatment LDL-C ≥ 190 mg/dL, failure to achieve LDL-C goal of < 100 mg/dL

Context for thresholdsThresholds apply when prior PCSK9 therapy has been used as specified in policy (see prior therapy requirements)

inv-09: PCSK9 prior therapy duration — ≥ 12 consecutive weeks when required

Required durationAt least 12 consecutive weeks of PCSK9 inhibitor use when prior PCSK9 therapy is required

Examples of PCSK9 agents

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial and continuation Leqvio (inclisiran) therapy. Initial authorizations will be for no more than 12 months. Documentation submitted with the prior authorization must clearly demonstrate the diagnosis, prescriber specialty, prior lipid-lowering therapy and responses or intolerances, and the clinical rationale for Leqvio.

Initial authorization duration: ≤ 12 months
Prescriber specialty required: lipid specialist (e.g., cardiologist, endocrinologist, lipidologist)
Do not use Leqvio concurrently with PCSK9 inhibitor therapy

Step Therapy

Step Therapy Expectations

Step therapy expectations: patients should be on maximally tolerated statin therapy (with or without ezetimibe) prior to Leqvio unless there is a documented contraindication or intolerance. When the policy requires prior PCSK9 inhibitor therapy, documentation must show at least 12 consecutive weeks of use or a history of intolerance/contraindication to PCSK9 inhibitors.

Background and Clinical Context

Atherosclerosis results from lipid accumulation in arterial walls, with LDL-C playing a central role in plaque formation and progression leading to events such as myocardial infarction and stroke. PCSK9 is a hepatic protein that promotes degradation of LDL receptors, raising circulating LDL-C; inhibiting PCSK9 reduces LDL-C by preserving LDL receptor recycling. Inclisiran (Leqvio) is a small interfering RNA that lowers hepatic PCSK9 production, thereby increasing LDL receptor availability and reducing circulating LDL-C. Per the policy, inclisiran is intended as an adjunct to other LDL-C–lowering therapies (for example, maximally tolerated statins ± ezetimibe) and is not to be used together with PCSK9 inhibitor monoclonal antibodies.

Risk Definitions and Related Terms

inv-15: Very High Risk (cardiovascular) — definition and related items

DefinitionVery High Risk is defined as a history of multiple Major ASCVD Events OR one Major ASCVD Event plus multiple High Risk Conditions

Major ASCVD Events examplesHistory of ischemic stroke; history of myocardial infarction; recent acute coronary syndrome (within 12 months); symptomatic peripheral arterial disease

ImplicationPatients meeting Very High Risk definition are candidates for more intensive LDL-C lowering strategies per policy criteria

inv-16: High Risk Conditions — list of high risk conditions

Age criterionAge ≥ 65 years

Renal dysfunctionChronic kidney disease with eGFR 15–59 mL/min/1.73 m2

Policy Summary

PayerUnitedHealthcare

PolicyLeqvio (inclisiran) — Individual Exchange Medical Benefit Drug Coverage Criteria

Policy CodePolicy IEXD0101.11

Change TypeAdministrative code updatesminor reference and format revisions

Effective DateOct 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, prescriber specialty, prior PCSK9 use (≥12 weeks) or intolerance, and baseline/on-treatment LDL-C values.

SourceLink

On This Page

Includes agents such as alirocumab (Praluent) and evolocumab (Repatha) as noted in policy

Alternative to trialA documented history of intolerance or contraindication to PCSK9 therapy is an alternative to meeting the duration requirement

Optimize statin ± ezetimibe before Leqvio
If required, trial of PCSK9 inhibitor (e.g., alirocumab, evolocumab) for ≥ 12 consecutive weeks OR documented intolerance/contraindication

Documentation Required

Documentation Requirements

Required documentation should include: the specific qualifying diagnosis (e.g., HeFH, ASCVD, primary hyperlipidemia), pretreatment LDL-C values and on-treatment LDL-C goals, documentation of prior therapies tried and duration (including statins, ezetimibe, and PCSK9 inhibitors when applicable), prescriber specialty, and evidence of clinical response for reauthorization requests.

Document diagnosis with appropriate ICD-10 code (e.g., E78.011 for HeFH, E78.00 for pure hypercholesterolemia)
Provide pretreatment LDL-C and most recent LDL-C values and stated LDL-C goal
List prior therapies, durations, and reasons for discontinuation or intolerance
Include prescriber specialty and clinical rationale for Leqvio use

Denial Risk

Potential Denial Triggers

Potential denial triggers include missing or insufficient documentation of the diagnosis, lack of prescriber specialty information, absence of prior therapy documentation or failure/intolerance evidence (including lack of required PCSK9 trial when specified), or use of Leqvio in combination with PCSK9 inhibitor therapy.

No documentation of qualifying diagnosis or supporting ICD-10 code
Prescriber not a lipid specialist and no documented specialist involvement
No evidence of prior maximally tolerated statin ± ezetimibe or required PCSK9 trial (≥12 weeks) or documented intolerance
Concurrent use of Leqvio with a PCSK9 inhibitor

Tobacco useCurrent smoking

DiabetesDiabetes mellitus

Familial hypercholesterolemiaHeterozygous familial hypercholesterolemia (HeFH)

Cardiac historyHistory of congestive heart failure or prior CABG/PCI outside Major ASCVD Events

Persistent LDL-CPersistently elevated LDL-C (≥ 100 mg/dL) despite maximally tolerated statin therapy and ezetimibe