CurrentViva Health PlanPolicy IC-0652

Leqvio (inclisiran) Subcutaneous Coverage Criteria

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This policy governs prior authorization, dosing, billing, and renewal criteria for Leqvio (inclisiran) used to lower LDL-C in adults with hypercholesterolemia, members with heterozygous familial hypercholesterolemia, and members ages 12 to 17 with homozygous familial hypercholesterolemia.

Policy Summary

PayerViva Health Plan

PolicyLeqvio (inclisiran) Subcutaneous Coverage Criteria

Policy CodePolicy IC-0652

Change TypeNo material change

Effective DateN/A

Last ReviewAug 4, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document contraindication, intolerance, or failure to both Repatha and Praluent before requesting Leqvio.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization

12 monthsRenewal authorization

284 mgMaximum dose

3Covered indication groups

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CurrentViva Health PlanPolicy IC-0652

Leqvio (inclisiran) Subcutaneous Coverage Criteria

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Sign up for vivahealthplan Policy IC-0652 alerts

Get alerted when Policy IC-0652 changes without checking for updates manually.

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Policy Summary

PayerViva Health Plan

PolicyLeqvio (inclisiran) Subcutaneous Coverage Criteria

Policy CodePolicy IC-0652

Change TypeNo material change

Effective DateN/A

Last ReviewAug 4, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document contraindication, intolerance, or failure to both Repatha and Praluent before requesting Leqvio.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization

12 monthsRenewal authorization

284 mgMaximum dose

3Covered indication groups

Diagnosis codes covered

LDL-C reductionRenewal requirement

Coverage Criteria

Universal and prerequisite criteria

Covered when all universal and prerequisite requirements are met.

Prerequisite PCSK9 therapy
- The member has a contraindication to, intolerance of, or failure of Repatha and Praluent.
Baseline LDL-C laboratory results have been obtained before initiating treatment.
Baseline LDL-C is also required for renewal.
The member is not receiving concomitant treatment with another PCSK9 inhibitor.
Leqvio is prescribed by, or in consultation with, a cardiology, lipidology, or endocrinology specialist.
Therapy is used in conjunction with diet and exercise.

Hypercholesterolemia

Covered for hypercholesterolemia when all criteria are met.

The member is at least 18 years of age.
The member has prior treatment with the highest available age-appropriate or maximally tolerated dose of high-intensity statin therapy, unless contraindicated.
Examples include atorvastatin 40 or 80 mg daily or rosuvastatin 20 or 40 mg daily.
The member failed to reach the target LDL-C despite physician attestation of adherence to maximally tolerated statin doses before the lipid panel demonstrating suboptimal reduction.
ASCVD or LDL-C pathway
- The member has clinical ASCVD.

Heterozygous familial hypercholesterolemia

Covered for HeFH when all criteria are met.

The member is at least 12 years of age.
The member has prior treatment with the highest available age-appropriate or maximally tolerated dose of high-intensity statin therapy, unless contraindicated.
Examples include atorvastatin 40 or 80 mg daily or rosuvastatin 20 or 40 mg daily.
The member failed to reach the target LDL-C despite physician attestation of adherence to maximally tolerated statin doses before the lipid panel demonstrating suboptimal reduction.
HeFH confirmation
- Positive genetic testing confirms a mutation in the LDLR, apoB, or PCSK9 gene.

Homozygous familial hypercholesterolemia

Covered for HoFH when all criteria are met.

The member is 12 to 17 years of age.
HoFH diagnostic pathway
- A DNA test confirms functional mutation(s) affecting LDL receptor functionality in LDLR, LDLRAP1, ARH, PCSK9, or apoB gene(s).
- ALL of the following
  - Untreated LDL-C is greater than 400 mg/dL or treated LDL-C is at least 300 mg/dL.Untreated > 400 mg/dL or treated >= 300 mg/dL
  - Additional qualifying finding

Continuation or renewal therapy

Renewal is covered when all renewal criteria are met.

The member continues to meet the universal and applicable indication-specific criteria from initial approval, including relevant concomitant therapy requirements.
Prerequisite therapy is not included in the renewal requirement.
The member has no unacceptable toxicity from therapy.
Examples include severe hypersensitivity reactions.
The member has a reduction in LDL-C compared with baseline before inclisiran initiation.LDL-C reduced from baseline

Concomitant treatment with another PCSK9 inhibitor is not covered. Members must not receive Leqvio together with another PCSK9 inhibitor.

Coding and Dose Information

Covered HCPCS CodeHCPCSCovered

J1306

Injection, inclisiran, 1 mg; 1 billable unit = 1 mg

Covered NDCNDCCovered

00078-1000-xx

Leqvio 284 mg/1.5 mL single-dose prefilled syringe

Covered Diagnosis CodesICD-10Covered

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, familial combined hyperlipidemia
E78.5	Hyperlipidemia, unspecified

Dosage and Administration

Dose284 mg administered by a healthcare professional as a subcutaneous injection initially, again at 3 months, and then every 6 months.

LDL-C monitoringAssess LDL-C when clinically indicated. The LDL-lowering effect may be measured as early as 30 days after initiation and anytime thereafter, without regard to dose timing.

HCPCS billing units284 billable units per dose (284 mg).

Hypercholesterolemia Without Clinical ASCVD

Baseline requirementsMember is at least 18 years of age; has prior treatment with the highest available age-appropriate or maximally tolerated dose of high-intensity statin therapy (atorvastatin 40 or 80 mg daily, or rosuvastatin 20 or 40 mg daily), unless contraindicated; and has failed to reach the target LDL-C despite physician attestation of adherence before the lipid panel showing suboptimal reduction.

Authorization and Provider Requirements

Prior Authorization

Prior Authorization and Authorization Period

Obtain prior authorization before initiating Leqvio. Initial authorization is valid for 6 months (180 days); renewal authorization may be issued every 12 months (365 days) when renewal criteria continue to be met.

Initial authorization: 6 months (180 days).
Renewal authorization: every 12 months (365 days), subject to renewal criteria.

Step Therapy

Prerequisite PCSK9 Therapy and Specialist Involvement

Before Leqvio is considered, document a contraindication, intolerance, or failure to Repatha and Praluent. Leqvio must be prescribed by, or in consultation with, a cardiology, lipidology, or endocrinology specialist.

Member must not receive another PCSK9 inhibitor concomitantly.
Use in conjunction with diet and exercise.

Policy Background

Leqvio (inclisiran) is used with diet and exercise to reduce LDL-C in patients with hypercholesterolemia and familial hypercholesterolemia. Treatment is subject to the applicable prior lipid-lowering therapy and LDL-C response requirements.

Clinical Definitions

Clinical ASCVD

Acute coronary conditionsAcute coronary syndromes, myocardial infarction, and stable or unstable angina

RevascularizationCoronary or other arterial revascularization

Cerebrovascular diseaseStroke or transient ischemic attack

Peripheral or aortic diseasePeripheral arterial disease presumed to be of atherosclerotic origin, including aortic aneurysm

HeFH

Genetic confirmationPositive genetic testing for a mutation in the LDLR, apoB, or PCSK9 genes

LDL-C history

Initial Therapy Criteria

Universal initial criteria

Initial therapy requires all universal and prerequisite conditions.

The member has a contraindication to, intolerance of, or failure of Repatha and Praluent before Leqvio consideration.
Baseline LDL-C laboratory results were obtained before treatment.
The member is not receiving another PCSK9 inhibitor.
Leqvio is prescribed by, or in consultation with, a cardiology, lipidology, or endocrinology specialist.
Treatment is used in conjunction with diet and exercise.

Continuation and Renewal Criteria

Renewal criteria

Renewal may be authorized when all criteria are met.

The member continues to meet the universal and relevant indication-specific criteria, including applicable concomitant therapy requirements.
The member has no unacceptable toxicity from therapy.
Examples include severe hypersensitivity reactions.
The member demonstrates a reduction in LDL-C compared with baseline before inclisiran initiation.LDL-C reduction from baseline

Step Therapy Requirements

Step	Required therapy	Coverage requirement
1	Repatha and Praluent	Both prerequisite PCSK9 monoclonal antibodies must be tried, or a contraindication, intolerance, or failure to both must be documented, before Leqvio is considered.

Step	Required therapy	Coverage requirement
2	High-intensity atorvastatin or rosuvastatin	Use the highest available age-appropriate or maximally tolerated dose unless contraindicated. Examples include atorvastatin 40 or 80 mg daily or rosuvastatin 20 or 40 mg daily.

Step	Required therapy	Coverage requirement
3	Atorvastatin or rosuvastatin for HoFH	Try and fail at least 3 months of adherent therapy with the highest available or maximally tolerated dose, with or without other lipid-lowering therapy, unless contraindicated.

Quantity and Administration Limits

Leqvio (inclisiran)

Maximum quantity284 billable units, equivalent to 284 mg, per dose

Month 0Administer at the initial dose

Month 3Administer the second dose at month 3

Ongoing scheduleAdminister every 6 months thereafter

Administration Site and Method

Billing Rule

Administer Leqvio in the office

Leqvio must be administered by a healthcare professional as a subcutaneous injection.

Policy Summary

PayerViva Health Plan

PolicyLeqvio (inclisiran) Subcutaneous Coverage Criteria

Policy CodePolicy IC-0652

Change TypeNo material change

Effective DateN/A

Last ReviewAug 4, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document contraindication, intolerance, or failure to both Repatha and Praluent before requesting Leqvio.

SourceLink

On This Page

The member does not have clinical ASCVD and has treated LDL-C at least 100 mg/dL.

The member does not have clinical ASCVD and has treated LDL-C at least 70 mg/dL with subclinical atherosclerosis or additional ASCVD risk factors.>= 70 mg/dL

The member has a history of LDL-C greater than 190 mg/dL.> 190 mg/dL

The member has clinical manifestations of HeFH, such as cutaneous xanthomas, tendon xanthomas, or arcus cornea.

The member has a probable or definite diagnosis of HeFH according to Simon Broome diagnostic criteria.

The member has a probable or definite diagnosis of HeFH according to Dutch Lipid Clinic diagnostic criteria.

Cutaneous or tendon xanthoma occurred before 10 years of age.

Untreated LDL-C levels in both parents are consistent with HeFH.

Therapy is used in conjunction with other LDL-lowering therapies, such as statins, ezetimibe, evinacumab, lomitapide, bempedoic acid, or LDL apheresis.

The member has tried and failed at least a 3-month trial of adherent therapy with the highest available or maximally tolerated dose of atorvastatin or rosuvastatin, with or without other lipid-lowering therapy, unless contraindicated.At least 3 months

The member failed to reach the target LDL-C despite physician attestation of adherence to maximally tolerated statin doses before the lipid panel demonstrating suboptimal reduction.

With clinical ASCVDClinical ASCVD includes acute coronary syndromes, 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, including aortic aneurysm.

Without clinical ASCVDTreated LDL-C ≥ 100 mg/dL; or treated LDL-C ≥ 70 mg/dL with subclinical atherosclerosis or additional ASCVD risk factors.

Homozygous Familial Hypercholesterolemia (HoFH)

AgeMember is 12 to 17 years of age.

Genetic confirmationConfirmed DNA test for functional mutation(s) in LDL receptor alleles or alleles known to affect LDL receptor functionality, including LDLR, LDLRAP1, ARH, PCSK9, or apoB genes.

Untreated LDL-C threshold> 400 mg/dL

Treated LDL-C threshold≥ 300 mg/dL

Additional diagnostic evidenceCutaneous or tendon xanthoma before age 10; or untreated LDL-C levels in both parents consistent with HeFH.

Statin-Associated Rhabdomyolysis and Muscle Symptoms

Statin-associated muscle symptomsEvidence of pain, tenderness, stiffness, cramping, weakness, and/or fatigue; symptoms resolve after statin discontinuation, recur on rechallenge at a lower dose of the same statin, and recur after switching to an alternative statin. Non-statin causes, including hypothyroidism, renal or hepatic dysfunction, rheumatologic disorders, steroid myopathy, vitamin D deficiency, or primary muscle disease, must be ruled out.

Rhabdomyolysis supportDiagnosis associated with statin use should be supported by acute neuromuscular illness or dark urine and an acute creatine kinase elevation, usually > 5,000 IU/L or ≥ 5 times the upper limit of normal (ULN).

Prior Authorization

Prior Authorization Applies

Prior authorization applies to Leqvio for covered indications under the plan’s utilization-management process. The NQTL assessment identifies the indication and cost of the drug as factors considered for prior authorization; safety and efficacy and misuse/abuse were not identified as PA priorities.

PA applies to covered indications.
Drug cost was considered in applying PA.
The utilization-management NQTL is intended to apply comparably to MH/SUD and medical/surgical medical-benefit prescription drugs.

Step Therapy

Required Prior Lipid-Lowering Therapy

Document prior treatment with the highest available age-appropriate or maximally tolerated high-intensity statin dose, unless contraindicated, and document the required Repatha and Praluent prerequisite. For HoFH, document at least a 3-month adherent trial of the highest available or maximally tolerated atorvastatin or rosuvastatin dose, with or without other lipid-lowering therapy, unless contraindicated.

High-intensity statin examples: atorvastatin 40 or 80 mg daily, or rosuvastatin 20 or 40 mg daily.
Leqvio must be used with other LDL-lowering therapies for HoFH, such as statins, ezetimibe, evinacumab, lomitapide, bempedoic acid, or LDL apheresis.
Do not use Leqvio with another PCSK9 inhibitor.

Documentation Required

Clinical Documentation Required

Submit complete clinical documentation supporting the requested indication and the member’s response to prior therapy. Documentation must establish diagnosis, applicable age, baseline and treated LDL-C values, adherence to maximally tolerated therapy, suboptimal LDL-C reduction, and relevant concomitant treatment.

Include baseline LDL-C before initiating Leqvio; baseline labs are required for renewal.
Document physician attestation that the member was adherent to maximally tolerated statin therapy before the lipid panel showing suboptimal reduction.
Document clinical ASCVD or applicable LDL-C thresholds and risk factors for hypercholesterolemia.
For renewal, document continued applicable criteria, absence of unacceptable toxicity, and LDL-C reduction from baseline.

Documentation Required

FH and Statin-Intolerance Evidence

For FH requests, submit evidence supporting the specific diagnosis and any statin-intolerance exception. Documentation may include genetic testing, LDL-C history, physical findings, clinical or family history, formal diagnostic criteria, and the required evidence that symptoms are causally related to statin therapy.

HeFH confirmation: pathogenic LDLR, apoB, or PCSK9 mutation; LDL-C greater than 190 mg/dL; clinical manifestations such as cutaneous or tendon xanthomas or arcus cornea; or probable/definite Simon Broome or Dutch Lipid Clinic diagnosis.
Dutch Lipid Clinic interpretation: definite FH >8 points; probable FH 6–8 points; possible FH 3–5 points.
HoFH confirmation: functional mutation affecting LDL-receptor function; or untreated LDL-C >400 mg/dL or treated LDL-C ≥300 mg/dL plus cutaneous/tendon xanthoma before age 10 or untreated LDL-C consistent with HeFH in both parents.
For statin-associated muscle symptoms, document resolution after discontinuation, recurrence on lower-dose rechallenge and an alternative statin, and exclusion of non-statin causes; rhabdomyolysis requires supporting illness or dark urine and acute CK elevation, usually >5,000 IU/L or 5 times ULN.

Denial Risk

Failure to Meet Clinical Criteria

A request may be denied when required clinical criteria are not met or cannot be substantiated. Do not submit Leqvio for a member receiving another PCSK9 inhibitor, without the required prerequisite therapy or specialist involvement, or without indication-specific evidence and documentation.

Failure, contraindication, or intolerance to both Repatha and Praluent must be documented before consideration of Leqvio.
Required age, diagnosis, LDL-C thresholds, statin history, adherence, and suboptimal response must be met for the applicable indication.
HoFH requires concurrent other LDL-lowering therapy and the specified statin trial unless contraindicated.
Renewal requires continued applicable criteria, no unacceptable toxicity, and reduced LDL-C compared with baseline.

Billing Rule

Dose and Administration Limits

Administer Leqvio only according to the approved schedule and bill no more than the authorized dose. Leqvio must be administered by a healthcare professional.

Dose: 284 mg (284 billable HCPCS units) subcutaneously at month 0, month 3, and every 6 months thereafter.
Exceeding 284 billable units per dose or administering outside the approved schedule creates denial risk.
LDL-C may be assessed when clinically indicated; the LDL-lowering effect may be measured as early as 30 days after initiation.

History of LDL-C greater than 190 mg/dL

Clinical manifestationsCutaneous xanthomas, tendon xanthomas, or arcus cornea

Diagnostic criteriaProbable or definite diagnosis under Simon Broome or Dutch Lipid Clinic criteria

HoFH

Genetic pathwayConfirmed DNA test for functional mutations affecting LDL receptor functionality, including LDLR, LDLRAP1, ARH, PCSK9, or apoB

LDL-C pathwayUntreated LDL-C greater than 400 mg/dL or treated LDL-C at least 300 mg/dL

Required accompanying findingFor the LDL-C pathway, cutaneous or tendon xanthoma before age 10 or untreated LDL-C levels in both parents consistent with HeFH is also required

Maximally tolerated dose

DefinitionThe highest dose of statin therapy the member can take

Applicable statinsAtorvastatin or rosuvastatin

When usedApplies when the maximum dose is not tolerated because of established statin-related muscle symptoms

Non-quantitative treatment limitations (NQTLs)

DefinitionMethods, guidelines, standards of evidence, or other conditions that can restrict how long or to what extent benefits are provided under a health plan

ExamplesUtilization review and prior authorization

Policy applicationThe utilization management limitation applies comparably, and not more stringently, to mental health/substance use disorder and medical/surgical medical benefit prescription drugs

Hypercholesterolemia

Hypercholesterolemia criteria.

Hypercholesterolemia initial therapy

The member is at least 18 years of age.
The member has used the highest available age-appropriate or maximally tolerated high-intensity statin dose, unless contraindicated.
Examples include atorvastatin 40 or 80 mg daily or rosuvastatin 20 or 40 mg daily.
The member has not reached the target LDL-C despite physician-attested adherence to maximally tolerated statin therapy.
ASCVD or LDL-C pathway
- The member has clinical ASCVD.
- The member does not have clinical ASCVD and has treated LDL-C at least 100 mg/dL.>= 100 mg/dL
- The member does not have clinical ASCVD and has treated LDL-C at least 70 mg/dL with subclinical atherosclerosis or additional ASCVD risk factors.>= 70 mg/dL

Heterozygous familial hypercholesterolemia

HeFH criteria.

HeFH initial therapy

The member is at least 12 years of age.
The member has used the highest available age-appropriate or maximally tolerated high-intensity statin dose, unless contraindicated.
Examples include atorvastatin 40 or 80 mg daily or rosuvastatin 20 or 40 mg daily.
The member has not reached the target LDL-C despite physician-attested adherence to maximally tolerated statin therapy.
HeFH confirmation
- Positive genetic testing confirms a mutation in the LDLR, apoB, or PCSK9 gene.
- The member has a history of LDL-C greater than 190 mg/dL.> 190 mg/dL
- The member has clinical manifestations of HeFH, such as cutaneous xanthomas, tendon xanthomas, or arcus cornea.
- The member has a probable or definite diagnosis according to Simon Broome diagnostic criteria.
- The member has a probable or definite diagnosis according to Dutch Lipid Clinic diagnostic criteria.

Homozygous familial hypercholesterolemia

HoFH criteria.

HoFH initial therapy

The member is 12 to 17 years of age.
HoFH diagnostic pathway
- A DNA test confirms functional mutation(s) affecting LDL receptor functionality in LDLR, LDLRAP1, ARH, PCSK9, or apoB gene(s).
- ALL of the following
  - Untreated LDL-C is greater than 400 mg/dL or treated LDL-C is at least 300 mg/dL.Untreated > 400 mg/dL or treated >= 300 mg/dL
  - Additional qualifying finding
    Cutaneous or tendon xanthoma occurred before 10 years of age.
    Untreated LDL-C levels in both parents are consistent with HeFH.
Therapy is used with other LDL-lowering therapy.
The member has failed at least a 3-month trial of adherent atorvastatin or rosuvastatin at the highest available or maximally tolerated dose, unless contraindicated.At least 3 months
The member has not reached the target LDL-C despite physician-attested adherence to maximally tolerated statin therapy.