CurrentSecurity Health Plan of Wisconsin, Inc.Policy SHP-0652

Leqvio (inclisiran) Subcutaneous Injection

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This policy governs prior authorization, medical necessity, dosing, renewal, and billing requirements for Leqvio (inclisiran) used to lower LDL-C in members with hypercholesterolemia, heterozygous familial hypercholesterolemia, or homozygous familial hypercholesterolemia.

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyLeqvio (inclisiran) Subcutaneous Injection

Policy CodePolicy SHP-0652

Change TypeNo material changes

Effective DateN/A

Last ReviewMar 3, 2026

Next Review DateN/A

Key ActionBefore initiation, document an inadequate response, contraindication, or intolerance to Praluent or Repatha and obtain baseline LDL-C laboratory results.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization

12 monthsRenewal authorization

284 mgMaximum scheduled dose

12 yearsMinimum age for HeFH and HoFH

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CurrentSecurity Health Plan of Wisconsin, Inc.Policy SHP-0652

Leqvio (inclisiran) Subcutaneous Injection

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Sign up for security_health_plan_of_wisconsin_inc Policy SHP-0652 alerts

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Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyLeqvio (inclisiran) Subcutaneous Injection

Policy CodePolicy SHP-0652

Change TypeNo material changes

Effective DateN/A

Last ReviewMar 3, 2026

Next Review DateN/A

Key ActionBefore initiation, document an inadequate response, contraindication, or intolerance to Praluent or Repatha and obtain baseline LDL-C laboratory results.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization

12 monthsRenewal authorization

284 mgMaximum scheduled dose

12 yearsMinimum age for HeFH and HoFH

Minimum age for hypercholesterolemia

8Covered diagnosis codes

Medical Necessity and Authorization Criteria

Initial Approval and Universal Criteria

Initial approval requires all universal criteria and the applicable indication-specific criteria, along with the prerequisite therapy requirement.

Initial approval and universal criteria: The member must have tried and had an inadequate response, contraindication, or intolerance to an adequate trial of Praluent (alirocumab) or Repatha (evolocumab); baseline LDL-C laboratory results must be obtained before treatment initiation; the member must not receive another PCSK9 inhibitor concurrently; the prescriber must be a specialist in, or consult with, cardiology, lipidology, or endocrinology; and therapy must be used in conjunction with diet and exercise.

All listed requirements apply.

Hypercholesterolemia

Covered for hypercholesterolemia when all applicable criteria are met.

Hypercholesterolemia criteria

ONE of the following ASCVD or risk pathways: The member has ASCVD; or has extremely high-risk ASCVD with LDL-C >70 mg/dL; or very high-risk ASCVD with LDL-C >100 mg/dL; or high-risk ASCVD with LDL-C >130 mg/dL; or has less extensive ASCVD with well-controlled cardiometabolic risk factors; or has severe hypercholesterolemia with untreated LDL-C >220 mg/dL and poorly controlled cardiometabolic risk factors.LDL-C thresholds are >70, >100, >130, or >220 mg/dL, depending on the pathway.
ASCVD includes coronary heart disease, cerebrovascular disease, peripheral arterial disease, or aortic atherosclerosis.

Heterozygous Familial Hypercholesterolemia

Covered for heterozygous familial hypercholesterolemia when all applicable criteria are met.

HeFH criteria: The member is at least 12 years old; has prior treatment with the highest available age-appropriate or maximally tolerated dose of high-intensity statin therapy unless contraindicated; failed to reach the LDL-C target despite physician attestation of adherence to maximally tolerated statin therapy before the lipid panel demonstrating suboptimal reduction; and the diagnosis is confirmed by at least one accepted method.At least 12 years; historical LDL-C greater than 190 mg/dL may confirm the diagnosis.

Accepted confirmation includes positive genetic testing for an LDLR, apoB, or PCSK9 mutation; historical LDL-C greater than 190 mg/dL; clinical manifestations such as cutaneous xanthomas, tendon xanthomas, or corneal arcus; or a probable or definite diagnosis according to Simon Broome or Dutch Lipid Clinic criteria.

Homozygous Familial Hypercholesterolemia

Covered for homozygous familial hypercholesterolemia when all applicable criteria are met, including an accepted diagnostic pathway and required lipid-lowering therapy.

HoFH core criteria

ONE accepted diagnostic pathway: Confirmed DNA testing demonstrates functional mutation(s) in LDLR or alleles known to affect LDL receptor function, including LDLRAP1, PCSK9, or apoB; or untreated LDL-C is >500 mg/dL or treated LDL-C is ≥300 mg/dL together with cutaneous or tendon xanthoma before 10 years of age; or untreated LDL-C levels in both parents are consistent with HeFH.Untreated LDL-C >500 mg/dL; treated LDL-C ≥300 mg/dL; xanthoma before 10 years of age where applicable.
Statin intolerance or rhabdomyolysis pathway when maximum statin dosing cannot be used: The member has muscle symptoms that resolve after statin discontinuation, recur when rechallenged at a lower dose of the same statin, recur after switching to an alternative statin, and have non-statin causes ruled out; or the member has statin-associated rhabdomyolysis supported by acute neuromuscular illness or dark urine and an acute creatine kinase elevation.For rhabdomyolysis, creatine kinase is usually >5,000 IU/L or 5 times the upper limit of normal.

Renewal Criteria

Renewal requires all renewal criteria and continued satisfaction of the applicable initial and indication-specific criteria.

Renewal criteria: The member continues to meet the universal and other applicable indication-specific criteria identified in the initial approval section, including applicable concomitant therapy requirements; has no unacceptable toxicity from therapy; and demonstrates a reduction in LDL-C compared with laboratory results obtained before inclisiran initiation.LDL-C must be reduced from the pre-inclisiran baseline.

Examples of unacceptable toxicity include severe hypersensitivity reactions.

Leqvio must not be administered concurrently with another PCSK9 inhibitor.

Billing Codes, Dose, and Clinical Thresholds

Covered HCPCS CodesHCPCSCovered

J1306

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

Covered NDC CodesNDCCovered

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

Inclisiran Dose

Dose284 mg (284 billable units) per administration

Initial administrationAdminister initially and again at 3 months

Maintenance scheduleAdminister every 6 months thereafter

Extremely High-Risk ASCVD

LDL-C threshold>70 mg/dL

Risk categoryExtremely high-risk ASCVD

Pathway

Authorization, Documentation, and Billing Requirements

Prior Authorization

Authorization Duration

Initial authorization is valid for 6 months (180 days). Renewal authorization may be issued every 12 months (365 days) thereafter.

Initial authorization: 6 months (180 days).
Renewal authorization: every 12 months (365 days).

Documentation Required

Prerequisite Therapy and Baseline Testing

Before initiating Leqvio, document an adequate trial of the required prerequisite therapy and obtain baseline LDL-C laboratory results. Baseline LDL-C is required for renewal review.

Document inadequate response, contraindication, or intolerance to an adequate trial of Praluent or Repatha.
Obtain LDL-C laboratory testing before initiating treatment.

Therapy Overview

Leqvio (inclisiran) is administered subcutaneously to reduce LDL-C in adults with hypercholesterolemia and in patients with heterozygous or homozygous familial hypercholesterolemia. Use is expected to occur with diet and exercise and, when applicable, prior maximally tolerated high-intensity statin therapy and an adequate trial of another PCSK9 inhibitor.

Clinical Terms and Treatment Definitions

Atherosclerotic Cardiovascular Disease (ASCVD)

Coronary heart diseaseIncludes myocardial infarction and angina pectoris

Cerebrovascular diseaseIncludes nonhemorrhagic stroke and transient ischemic attack

Other included conditionsPeripheral arterial disease and aortic atherosclerosis

High-Intensity Statin Therapy

Atorvastatin40 mg or 80 mg daily

Rosuvastatin20 mg or 40 mg daily

Therapy classificationHigh-intensity statin therapy

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyLeqvio (inclisiran) Subcutaneous Injection

Policy CodePolicy SHP-0652

Change TypeNo material changes

Effective DateN/A

Last ReviewMar 3, 2026

Next Review DateN/A

Key ActionBefore initiation, document an inadequate response, contraindication, or intolerance to Praluent or Repatha and obtain baseline LDL-C laboratory results.

SourceLink

On This Page

This pathway supports the maximally tolerated statin exception.

Extensive or active ASCVD, or ASCVD with an extremely high burden of poorly controlled cardiometabolic risk factors

Very High-Risk ASCVD

LDL-C threshold>100 mg/dL

Risk categoryVery high-risk ASCVD

PathwayLess extensive ASCVD with poorly controlled cardiometabolic risk factors

High-Risk ASCVD

LDL-C threshold>130 mg/dL

Risk categoryHigh-risk ASCVD

PathwayHigh-risk ASCVD pathway

Severe Hypercholesterolemia

Untreated LDL-C threshold>220 mg/dL

ConditionSevere hypercholesterolemia

Additional pathway requirementPoorly controlled cardiometabolic risk factors

HeFH Historical LDL-C

Historical LDL-C threshold>190 mg/dL

ConditionHeterozygous familial hypercholesterolemia

UseAccepted as one method to confirm the diagnosis

HoFH Untreated LDL-C

Untreated LDL-C threshold>500 mg/dL

ConditionHomozygous familial hypercholesterolemia

Diagnostic contextQualifying HoFH diagnostic pathway

HoFH Treated LDL-C

Treated LDL-C threshold≥300 mg/dL

ConditionHomozygous familial hypercholesterolemia

Diagnostic contextQualifying HoFH diagnostic pathway

Rhabdomyolysis

Creatine kinase thresholdUsually >5,000 IU/L

Alternative threshold5 times the upper limit of normal (ULN)

Supporting findingsAcute neuromuscular illness or dark urine with acute creatine kinase elevation

Simon Broome Adult Total Cholesterol

Adult total cholesterol threshold>7.5 mmol/L (290 mg/dL)

Diagnostic frameworkSimon Broome criteria

PopulationAdults

Simon Broome Adult LDL-C

Adult LDL-C threshold>4.9 mmol/L (189 mg/dL)

Diagnostic frameworkSimon Broome criteria

PopulationAdults

Simon Broome Pediatric Total Cholesterol

Pediatric total cholesterol threshold>6.7 mmol/L (260 mg/dL)

Diagnostic frameworkSimon Broome criteria

PopulationPediatrics

Simon Broome Pediatric LDL-C

Pediatric LDL-C threshold>4.0 mmol/L (155 mg/dL)

Diagnostic frameworkSimon Broome criteria

PopulationPediatrics

Dutch Lipid Clinic Definite FH

Score>8 points

Diagnostic frameworkDutch Lipid Clinic criteria

DiagnosisDefinite familial hypercholesterolemia

Dutch Lipid Clinic Probable FH

Score6 to 8 points

Diagnostic frameworkDutch Lipid Clinic criteria

DiagnosisProbable familial hypercholesterolemia

Dutch Lipid Clinic Possible FH

Score3 to 5 points

Diagnostic frameworkDutch Lipid Clinic criteria

DiagnosisPossible familial hypercholesterolemia

Include baseline LDL-C results with renewal documentation.

Step Therapy

PCSK9 Inhibitor Prerequisite

Leqvio requires a trial of one PCSK9 inhibitor before approval unless the member has a documented contraindication or intolerance.

Required options: Praluent (alirocumab) or Repatha (evolocumab).
Document an inadequate response, contraindication, or intolerance to the selected agent.

Step Therapy

High-Intensity Statin Therapy

Document prior treatment with the highest available age-appropriate dose or maximally tolerated dose of high-intensity statin therapy, unless contraindicated.

Atorvastatin: 40 mg or 80 mg daily.
Rosuvastatin: 20 mg or 40 mg daily.
Document adherence and failure to reach the target LDL-C despite maximally tolerated statin therapy.
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.

Documentation Required

Initial and Renewal Clinical Documentation

Initial and renewal requests must include the clinical information supporting the applicable indication and demonstrate treatment response or the reason maximally tolerated therapy cannot be used.

Identify the indication and member's age.
Document prior therapy, dose, adherence, inadequate response, and any contraindication or intolerance.
Provide relevant LDL-C results, including baseline results and follow-up response for renewal.
Document required concomitant lipid-lowering therapy and supporting clinical records.

Documentation Required

Familial Hypercholesterolemia Diagnosis

For familial hypercholesterolemia, submit documentation establishing the diagnosis through an accepted genetic, laboratory, physical-examination, family-history, or formal diagnostic-criteria pathway.

Genetic confirmation may involve functional mutations in LDLR, LDLRAP1, PCSK9, or APOB/apoB, as applicable.
Provide relevant untreated or treated LDL-C history, including LDL-C greater than 190 mg/dL for HeFH and the HoFH thresholds specified in the policy.
Document cutaneous or tendon xanthomas, arcus cornealis, or other clinical findings and relevant family history.
HeFH may be established by probable or definite Simon Broome or Dutch Lipid Clinic criteria; for Dutch criteria, document the supporting score and classification (definite >8, probable 6-8, possible 3-5 points).

Documentation Required

HoFH Statin Intolerance or Rhabdomyolysis

For HoFH, if the member cannot use a maximum statin dose because of muscle symptoms, establish a causal relationship between statin use and the symptoms. Alternatively, document statin-associated rhabdomyolysis with the required clinical and laboratory support.

For statin-associated muscle symptoms, document pain, tenderness, stiffness, cramping, weakness, and/or fatigue.
Show that symptoms resolved after statin discontinuation, recurred on rechallenge at a lower dose of the same statin, and recurred after switching to an alternative statin.
Rule out non-statin causes, including hypothyroidism, reduced renal or hepatic function, rheumatologic disorders, steroid myopathy, vitamin D deficiency, and primary muscle disease.
For rhabdomyolysis, document acute neuromuscular illness or dark urine and an acute creatine kinase elevation, usually greater than 5,000 IU/L or 5 times the upper limit of normal.

Prior Authorization

Renewal Evidence

Renewal requires continued eligibility under the universal and applicable indication-specific criteria, no unacceptable toxicity, and documented LDL-C reduction from baseline before inclisiran.

Confirm continued qualification and required concomitant therapy.
Document absence of unacceptable toxicity, including severe hypersensitivity reactions.
Compare follow-up LDL-C with baseline LDL-C and document reduction.

Unsupported block type: denial_riskาοول?

Denial Risk

Indication-Specific Criteria Not Met

Approval may be denied when the member does not meet the applicable clinical indication criteria for hypercholesterolemia, HeFH, or HoFH.

Hypercholesterolemia: missing age, high-intensity statin history, adherence, target-LDL failure, ASCVD or qualifying ASCVD-risk category, or required LDL-C threshold.
HeFH: missing age, maximally tolerated high-intensity statin history, adherence, target-LDL failure, or an accepted diagnostic confirmation.
HoFH: missing required age, diagnostic confirmation, qualifying LDL-C or genetic findings, xanthoma or parental LDL-C evidence, adjunctive therapy, statin trial, or target-LDL failure.

Unsupported block type: denial_riskા

Billing Rule

Dose and Frequency Limit

Do not bill beyond the policy's maximum of 284 HCPCS billable units (284 mg) or outside the permitted administration schedule.

Administer 284 mg subcutaneously initially, again at month 3, and then every 6 months.
Maximum: 284 billable units (284 mg) at months 0 and 3, then every 6 months.
Assess LDL-C when clinically indicated; the LDL-lowering effect may be measured as early as 30 days after initiation.

Denial Risk

Renewal Response or Safety Requirement Not Met

Renewal may be denied when the member no longer meets applicable eligibility criteria, has unacceptable toxicity, or lacks documented LDL-C improvement from baseline.

Continued universal and indication-specific eligibility is required.
Unacceptable toxicity, such as a severe hypersensitivity reaction, must be absent.
Document a reduction in LDL-C compared with the pre-treatment baseline.
No demonstrated LDL-C reduction or missing response documentation may result in renewal denial.

Heterozygous Familial Hypercholesterolemia

Genetic confirmationPositive testing for mutations in LDLR, apoB, or PCSK9 genes

Historical LDL-C definitionLDL-C greater than 190 mg/dL

Clinical manifestationsCutaneous xanthomas, tendon xanthomas, or corneal arcus

Accepted diagnostic criteriaProbable or definite Simon Broome or Dutch Lipid Clinic criteria

Maximally Tolerated Statin Dose

Statin-associated muscle symptomsA causal relationship must be established when the member cannot use the maximum atorvastatin or rosuvastatin dose because of muscle symptoms

Rechallenge evidenceSymptoms resolve after discontinuation, recur at a lower dose of the same statin, and recur after switching to an alternative statin

Alternative causesNon-statin causes of muscle symptoms must be ruled out