CurrentColorado Rocky Mountain Health PlansPolicy CS2026D00101P

Leqvio (inclisiran) — Coverage Criteria and Prior Authorization

This policy governs medical benefit coverage and prior authorization criteria for Leqvio (inclisiran) as adjunct therapy for adults with primary hyperlipidemia, heterozygous familial hypercholesterolemia (HeFH), or clinical ASCVD when specified criteria are met; it applies to UnitedHealthcare Community Plan standard benefits (state exceptions noted).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyLeqvio (inclisiran) — Coverage Criteria and Prior Authorization

Policy CodePolicy CS2026D00101P

Change TypeTemplate updateremoval of state-specific language

Key ActionObtain prior authorization for initial treatment (up to 12 months) when diagnostic, treatment, and documentation criteria are met.

Effective DateApr 1, 2026

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

Template update and removal of content/language pertaining to the state of Louisiana.

12 monthsinitial authorization maximum duration

J1306billing code for inclisiran (1 mg)

~50%approx. LDL-C reduction (ORION-10/11)

AZ, FL, IN, KS, NC, OH, PAstates with alternative guidance

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Coverage Criteria for Leqvio (inclisiran)

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

Covered when ALL of the following are met for initial therapy

Diagnosis: Patient has one of the following diagnoses: heterozygous familial hypercholesterolemia (HeFH), clinical atherosclerotic cardiovascular disease (ASCVD), or primary hyperlipidemia.

Supported by chunk 2.

Prior PCSK9 therapy or intolerance: Either: (a) documented adherence to PCSK9 inhibitor therapy for at least 12 consecutive weeks with inadequate LDL-C response, OR (b) documented history of intolerance or contraindication to PCSK9 therapy.12 weeks

Supported by chunks 3 and 5.

LDL-C thresholds (when applicable): For patients with ASCVD who meet the prior-therapy requirement, failure to achieve LDL-C goal of <55 mg/dL. For primary hyperlipidemia with pre-treatment LDL-C ≥190 mg/dL, failure to achieve LDL-C <100 mg/dL (per policy thresholds).<55 mg/dL or <100 mg/dL depending on diagnosis

Supported by chunks 3 and 7.

Concomitant LDL-C lowering therapy: Patient will continue other traditional LDL-C lowering therapies (e.g., maximally tolerated statins, ezetimibe) in combination with Leqvio.

Supported by chunk 5.

Prescriber specialty: Leqvio is prescribed by a cardiologist, endocrinologist, or lipid specialist.

Supported by chunk 5.

No concurrent PCSK9 inhibitor therapy: Leqvio will not be used concurrently with PCSK9 inhibitor therapy.

Supported by chunk 5.

Dosing and authorization period: Dosing must follow FDA-approved labeling; initial authorization will be for no more than 12 months.12 months

Supported by chunk 5.

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

Clinical response: Documentation of a positive clinical response to Leqvio therapy.

Supported by chunk 5.

No concurrent PCSK9 inhibitor therapy: Leqvio will not be used in combination with PCSK9 inhibitor therapy.

Supported by chunk 5.

Dosing and reauthorization period: Dosing must follow FDA-approved labeling; reauthorization will be for no more than 12 months.12 months

Supported by chunk 5.

Leqvio (inclisiran) must not be prescribed concurrently with a PCSK9 inhibitor. The policy explicitly prohibits combined use of Leqvio and any PCSK9 inhibitor therapy; requests that propose simultaneous treatment with both agents are not medically necessary and may be denied.

Leqvio is covered only when the patient meets the policy diagnostic and treatment prerequisites. Coverage requires an eligible diagnosis (heterozygous familial hypercholesterolemia, clinical ASCVD, or primary hyperlipidemia) and either documented prior adequate trial of a PCSK9 monoclonal antibody for at least 12 consecutive weeks with inadequate LDL-C response or a documented history of intolerance or contraindication to PCSK9 therapy. For patients with ASCVD, coverage also requires failure to achieve an LDL-C goal of 55 mg/dL. In all cases the patient must continue other LDL-C–lowering therapies (for example, maximally tolerated statin ± ezetimibe) while receiving Leqvio, dosing must follow the FDA label, and Leqvio must not be used in combination with PCSK9 inhibitor therapy.

Coding and Diagnosis Codes

Covered HCPCS CodesHCPCSCovered

J1306

Injection, inclisiran, 1 mg

Relevant 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
E78.9	Disorder of lipoprotein metabolism, unspecified

LDL-C goals for coverage

ASCVD thresholdFailure to achieve LDL-C goal < 55 mg/dL for patients with clinical ASCVD.

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

Required concomitant therapyPatient must continue other LDL‑C lowering therapies (e.g., maximally tolerated statins ± ezetimibe) in combination with Leqvio.

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required for Leqvio (inclisiran). Initial authorization is granted for up to 12 months when the patient meets diagnostic and treatment criteria (see coverage criteria). Continuation/reauthorization may be approved for up to 12 months with documentation of a positive clinical response and continued adherence to labeling.

Initial authorization: up to 12 months when diagnostic and treatment criteria are met
Reauthorization/continuation: up to 12 months with documented positive clinical response

Step Therapy

Step Therapy Expectations

Step therapy expectations require documentation of use of maximally tolerated statin therapy and ezetimibe as applicable. Patients must either have inadequate LDL-C control despite these therapies or have a history of intolerance or contraindication to PCSK9 monoclonal antibody therapy. Leqvio must not be used in combination with PCSK9 inhibitor therapy.

Documented use of maximally tolerated statins ± ezetimibe prior to Leqvio unless contraindicated or not tolerated

Risk and Event Definitions

High Risk Conditions

AgeAge ≥ 65 years.

Heterozygous familial hypercholesterolemia (HeFH)Diagnosis of HeFH.

Prior CABG/PCIHistory of prior coronary artery bypass surgery or percutaneous coronary intervention (PCI) outside of Major ASCVD event(s).

DiabetesHistory of diabetes mellitus.

HypertensionHistory of hypertension.

Chronic kidney diseaseChronic kidney disease with eGFR 15–59 mL/min/1.73 m2.

SmokingCurrent smoking.

Background and Rationale

Atherosclerotic risk is driven by accumulation of low-density lipoprotein cholesterol (LDL-C) in the arterial wall. The protein PCSK9 (proprotein convertase subtilisin/kexin type 9) binds hepatic LDL receptors and promotes their degradation, reducing receptor availability for LDL-C clearance and thereby increasing circulating LDL-C. Inclisiran is a small interfering RNA (siRNA) that targets hepatic PCSK9 messenger RNA to reduce PCSK9 production; lower hepatic PCSK9 increases LDL receptor recycling and results in substantial reductions in LDL-C when administered according to the approved dosing regimen.

Policy Revision History

2026-04-01Template update & jurisdictional language removalLatest

Template update and removal of content/language pertaining to the state of Louisiana; prior policy version CS2025D00101O archived.