ModifiedBluecross IdahoPolicy MP 5.01.663

Leqvio (inclisiran)

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Defines medical necessity criteria and coverage conditions for Leqvio (inclisiran) injections as an adjunct to diet and statin therapy for adults with primary hyperlipidemia or established ASCVD under Blue Cross of Idaho benefit plans.

Policy Summary

PayerBluecross Idaho

PolicyLeqvio (inclisiran)

Policy CodePolicy MP 5.01.663

Change TypeIndication addition and criteria revision

Effective DateOct 1, 2026

Last ReviewJun 25, 2026

Next Review DateJun 25, 2026

Key ActionDocument prior trial and titration of a preferred PCSK9 inhibitor (≥90 days compliant therapy) and verify diagnosis/statin use or intolerance when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

Indications added for Homozygous Familial Hypercholesterolemia (HoFH) and hypercholesterolemia.

Updated criteria to align with recent guideline changes.

284 mgdose per administration

initial, 3m, 6mdosing schedule

≥55 mg/dLLDL threshold

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ModifiedBluecross IdahoPolicy MP 5.01.663

Leqvio (inclisiran)

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Policy Summary

PayerBluecross Idaho

PolicyLeqvio (inclisiran)

Policy CodePolicy MP 5.01.663

Change TypeIndication addition and criteria revision

Effective DateOct 1, 2026

Last ReviewJun 25, 2026

Next Review DateJun 25, 2026

Key ActionDocument prior trial and titration of a preferred PCSK9 inhibitor (≥90 days compliant therapy) and verify diagnosis/statin use or intolerance when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

Indications added for Homozygous Familial Hypercholesterolemia (HoFH) and hypercholesterolemia.

Updated criteria to align with recent guideline changes.

284 mgdose per administration

initial, 3m, 6mdosing schedule

≥55 mg/dLLDL threshold

Coverage Criteria for Leqvio (inclisiran)

Initial Therapy

Covered when ALL of the following are met for initial treatment:

Initial authorization core requirements: 1) Patient has had an adequate trial and titration of a preferred PCSK9 inhibitor (e.g., Repatha) per the individual's pharmacy benefit with at least 90 days of compliant therapy; medication samples/coupons/discount cards are excluded. 2) Patient is at high risk for atherosclerotic cardiovascular disease (ASCVD) as defined below. 3) Patient is on high‑intensity statin therapy or statin at the maximum tolerated dose, or has a documented contraindication to statins, or is statin intolerant as defined in policy.

See subsequent nodes for detailed definitions of high ASCVD risk and LDL/genetic thresholds.

High ASCVD risk definitions (any one qualifies): - Homozygous Familial Hypercholesterolemia (HoFH) verified; OR - Heterozygous Familial Hypercholesterolemia (HeFH) confirmed by presence of a pathogenic mutation in LDLR, APOB, PCSK9 or LDLRAP1 OR by WHO/Dutch Lipid Clinic Network score >8; OR - History of clinical ASCVD (acute coronary syndrome, coronary artery disease, myocardial infarction, stable/unstable angina, coronary or other arterial revascularization, stroke, TIA, or peripheral arterial disease); OR - Hypercholesterolemia with additional risk features (see LDL/genetic-specific criteria).

Any one of these pathways satisfies the high ASCVD risk requirement.

LDL/genetic-specific qualifying criteria: - LDL-C >=55 mg/dL AND history of clinical ASCVD; OR - LDL-C >=70 mg/dL AND biallelic pathogenic/likely pathogenic variants on different chromosomes in LDLR, APOB, PCSK9 or LDLRAP1 OR >=2 such variants at different loci; OR - Untreated LDL-C >400 mg/dL plus cutaneous/tendonous xanthoma before age 10 years OR untreated LDL-C levels consistent with HeFH in both parents (>190 mg/dL); OR - LDL-C >=100 mg/dL.LDL thresholds: 55, 70, 100, untreated >400 mg/dL

Specific LDL thresholds apply to different genetic or clinical contexts as listed in policy.

Continuation Therapy

Continuation of therapy is covered when ALL of the following are met:

Continuation criteria: 1) Patient continues Leqvio (inclisiran) in combination with maximally tolerated statin therapy unless there is a documented contraindication or statin intolerance; AND 2) Patient has documented LDL‑C reduction while on therapy.

Maximally tolerated statin therapy is defined in policy (e.g., high‑intensity statin such as atorvastatin ≥40 mg or rosuvastatin ≥20 mg, or the maximum tolerated dose).

Not Medically Necessary

Not covered when any of the following apply:

Not medically necessary situations: - Use in combination with Lerochol, Praluent or Repatha; OR - When the initial or continuation criteria described above are not met; OR - For any indications not listed in this policy.

Requests meeting any of these conditions are considered NOT medically necessary per policy.

Indications (summary)

Covered when ALL of the following are met (policy-level summary):

General indications: Patient is an adult with primary hyperlipidemia (including HeFH), established atherosclerotic cardiovascular disease (ASCVD), or Homozygous Familial Hypercholesterolemia (HoFH) who requires additional LDL‑C lowering; Leqvio is used as an adjunct to diet and statin therapy.

Safety and effectiveness in pediatric patients have not been established; cardiovascular outcomes impact not determined.

This policy may not apply to all lines of business. Examples of plans and arrangements potentially excluded from this medical policy include the Federal Employee Program, Medicare Supplement, Medicare Advantage, Medicaid, and certain self‑insured groups. Verify member-specific benefit plan terms and any applicable program rules before assuming coverage.

The policy states that the safety and effectiveness of Leqvio in pediatric patients have not been established. Coverage is directed to adult patients only (those with primary hyperlipidemia or ASCVD who require additional LDL‑C lowering); pediatric use is excluded from the indicated population.

Requests for Leqvio are considered not medically necessary when any of the listed non‑covered situations apply, including use in combination with Lerochol, Praluent, or Repatha, when the policy’s coverage criteria are not met, or for indications beyond those specifically listed in the policy. Do not authorize combination therapy with the agents named above under this policy.

The codes listed in this policy are provided for reference and administrative convenience only. Inclusion of a code does not guarantee coverage or reimbursement; conversely, absence of a code does not imply non‑coverage. All coverage and payment decisions remain subject to the member’s specific benefit plan, the terms and conditions of that plan, and applicable medical policy requirements — including documentation sufficiency.

Initial Therapy Criteria

Initial Leqvio Therapy

Initial therapy is covered when the patient meets all of the following:

Initial Leqvio Therapy: 1) Prior adequate trial and titration of a preferred PCSK9 inhibitor (e.g., Repatha) with at least 90 days of compliant therapy (samples/coupons/discount cards excluded). 2) Patient meets high ASCVD risk criteria (HoFH; HeFH by mutation or Dutch Lipid Clinic Network score >8; prior clinical ASCVD events; or hypercholesterolemia with qualifying risk features). 3) Patient is on high‑intensity statin therapy or maximally tolerated statin, or has documented statin contraindication or intolerance as specified in policy.

See policy for the detailed LDL and genetic thresholds that further define eligibility.

Initial therapy (summary)

Initial therapy (summary):

Initial therapy (summary): Adults requiring additional LDL‑C reduction despite diet and statin therapy; documentation of diagnosis (e.g., HeFH, HoFH, ASCVD) and prior lipid‑lowering therapy per prior authorization requirements is required.

Policy updates added HoFH and aligned criteria with guidelines; pediatric use not established.

Continuation / Maintenance Criteria

Continuation of Leqvio

Continuation requests may be considered medically necessary if the following are met:

Continuation of Leqvio: 1) Continued use of Leqvio in combination with maximally tolerated statin therapy unless contraindicated or statin intolerant; AND 2) Documented LDL‑C reduction from baseline while on therapy.

Documentation of ongoing statin therapy or a justified statin intolerance should be maintained as part of the prior authorization/reauthorization process.

Continuation therapy (summary)

Continuation therapy (summary):

Continuation therapy: Ongoing therapy is appropriate for patients who met initial criteria and demonstrate continued need for LDL‑C lowering or clinical benefit; maintain documentation of continued statin therapy or documented intolerance and evidence of LDL‑C response.

Specific refill intervals and numeric response thresholds are addressed in the full policy and prior authorization process.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization: document prior PCSK9 inhibitor trial

Initial prior authorization requests must include documentation that the patient completed an adequate trial and titration of a preferred PCSK9 inhibitor (for example, Repatha) consistent with the patient’s pharmacy benefit and had a suboptimal lipid‑lowering response after at least 90 days of compliant therapy; medication samples/coupons/discount cards do not count as a trial.

At least 90 days of compliant therapy with a preferred PCSK9 inhibitor required.
Medication samples, coupons or discount cards are excluded from consideration as a trial.

Prior Authorization

Prior authorization required; indicate diagnosis and prior therapies

Prior authorization is required for Leqvio per this policy; Leqvio is indicated as an adjunct to diet and statin therapy for adults with primary hyperlipidemia, ASCVD, and Homozygous Familial Hypercholesterolemia (HoFH). Ensure documentation of diagnosis and prior therapies with the authorization request.

Leqvio is indicated as adjunct to diet and statin therapy for adults who require additional LDL‑C lowering.

Coding and Diagnosis Codes

Codingmixed

No codes listed

Covered CPT CodesCPTCovered

96372

Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular

Covered HCPCS CodesHCPCSCovered

J1306

Injection, inclisiran, 1 mg

Relevant ICD-10-CM Diagnosis CodesICD-10

E78.01

Familial hypercholesterolemia

Additional ICD-10-CM Codes (documented ranges)ICD-10

I25.10 - I25.119	Atherosclerotic heart disease of native coronary artery
I25.700 -
I25.799 I25.810 -	Atherosclerosis of coronary artery bypass graft(s) and coronary artery of transplanted heart with angina pectoris; Atherosclerosis of other coronary vessels without angina pectoris
I25.812

LDL-C and related thresholds

LDL-C ≥55 mg/dLQualifies when present with history of clinical ASCVD

LDL-C ≥70 mg/dLQualifies when biallelic pathogenic/likely pathogenic variants in LDLR, APOB, PCSK9 or LDLRAP1 on different chromosomes or ≥2 such variants at different loci are documented

Untreated LDL-C >400 mg/dLQualifies when accompanied by cutaneous/tendonous xanthoma before age 10 years or untreated LDL-C consistent with HeFH in both parents

Baseline LDL ≥190 mg/dLCounts as severe hypercholesterolemia when present with HeFH plus additional ASCVD risk factors or coronary calcification

Population

Step Therapy Requirements

Step	Requirement	Notes
1	Prior trial and titration of a preferred PCSK9 inhibitor (e.g., Repatha) with at least 90 days of compliant therapy	Medication samples, coupons, or discount cards are excluded and do not count as a trial; required evidence of suboptimal lipid‑lowering response after the trial

Step	Requirement	Notes
1	Leqvio is indicated as an adjunct to diet and statin therapy — documentation of prior statin use or documentation of statin intolerance/contraindication is required	Provider must document maximally tolerated or high‑intensity statin therapy per policy definition, or a documented contraindication/intolerance to statins; prior authorization will verify statin status in addition to PCSK9 step

Quantity Limits and Dosing

Leqvio (inclisiran) — Dose and schedule

Per‑administration dose284 mg per administration (subcutaneous)

Dosing scheduleInitial dose, repeat at 3 months, then every 6 months

Administration settingShould be administered by a healthcare professional

Site of Care and Administration

Note

Office administration by healthcare professional

Leqvio (inclisiran) must be administered by a healthcare professional as a subcutaneous injection (284 mg per administration per dosing schedule) in the office or appropriate clinical setting.

Administered as subcutaneous injection by a healthcare professional
Dose: 284 mg initially, at 3 months, then every 6 months

Billing Rule

Administration coding — use CPT 96372

Report the injection administration using CPT 96372 (therapeutic, prophylactic, or diagnostic injection; subcutaneous or intramuscular) when billing for Leqvio administration.

CPT 96372 — code for subcutaneous injection administration of Leqvio

Definitions

Maximally tolerated statin therapy (policy definition)

High‑intensity statin definitionAtorvastatin ≥40 mg or rosuvastatin ≥20 mg

Maximally tolerated statin therapyHigh‑intensity statin or statin at the maximum tolerated dose, or documented contraindication to statins

Statin intolerance definitionInability to tolerate ≥2 statins (one started at lowest dose) with adverse effects that improve with dose reduction/discontinuation, or statin‑associated rhabdomyolysis or IMNM after trial of one statin

Inclisiran (Leqvio) — Mechanism

Mechanism of actionDouble‑stranded small interfering RNA (siRNA) that targets PCSK9 mRNA leading to catalytic mRNA breakdown

Physiologic effectIncreases LDL‑receptor recycling and expression on hepatocytes, increasing LDL‑C uptake and lowering circulating LDL‑C

Background

Leqvio (inclisiran) is a double‑stranded small interfering RNA that uses RNA interference to direct catalytic degradation of PCSK9 mRNA, increasing LDL receptor recycling and reducing circulating LDL‑C. It is indicated as an adjunct to diet and maximally tolerated statin therapy for adults with primary hyperlipidemia (including familial forms) or established atherosclerotic cardiovascular disease who require additional LDL‑C lowering. The recommended administered dose is 284 mg per administration, given subcutaneously initially, at 3 months, and then every 6 months, and should be administered by a healthcare professional.

Policy Summary

PayerBluecross Idaho

PolicyLeqvio (inclisiran)

Policy CodePolicy MP 5.01.663

Change TypeIndication addition and criteria revision

Effective DateOct 1, 2026

Last ReviewJun 25, 2026

Next Review DateJun 25, 2026

Key ActionDocument prior trial and titration of a preferred PCSK9 inhibitor (≥90 days compliant therapy) and verify diagnosis/statin use or intolerance when requesting prior authorization.

SourceLink

On This Page

HoFH and expanded hypercholesterolemia indications were added/updated in the policy.

Step Therapy

Step requirement: trial of preferred PCSK9 inhibitor before Leqvio

Prior to initiating Leqvio, the policy requires a step trial: the member must have had trial and titration of a preferred PCSK9 inhibitor (e.g., Repatha) with documentation of suboptimal response before Leqvio is authorized.

Failure or inadequate LDL‑C lowering after the PCSK9 inhibitor trial is the step/failure criterion.
Samples/coupons/discount cards are excluded when counting prior trials.

Step Therapy

Document statin use or documented statin intolerance

Authorization and continuation require documentation that the patient is using Leqvio in combination with maximally tolerated statin therapy unless there is a documented contraindication or statin intolerance per policy definitions.

Maximally tolerated statin is defined in policy (e.g., atorvastatin ≥40 mg or rosuvastatin ≥20 mg) or statin at the maximum tolerated dose.
If statins are contraindicated or the patient is statin intolerant, document the specific intolerance or contraindication as described in policy.

Documentation Required

Required documentation for initial authorization

For initial authorization, provide documentation of the prior adequate trial and titration of a preferred PCSK9 inhibitor (including dates and duration of therapy), evidence of suboptimal lipid lowering after ≥90 days of compliant therapy, and documentation of high ASCVD risk and statin use or documented statin contraindication/intolerance as specified in the policy.

Specify dates and duration (≥90 days) of the PCSK9 inhibitor trial; note that samples/coupons/discount cards are excluded.
Include documentation of ASCVD risk classification (e.g., HoFH, HeFH, prior clinical ASCVD events, or qualifying LDL thresholds) and statin therapy status or intolerance.

Billing Rule

Coding and documentation: J1306, CPT 96372, include ICD‑10‑CM codes

Use HCPCS code J1306 to report inclisiran (Leqvio) dosing and CPT code 96372 for the therapeutic/prophylactic subcutaneous injection administration; include applicable ICD‑10‑CM diagnosis codes such as E78.01 (familial hypercholesterolemia) and relevant I25.* codes when submitting claims and prior authorization documentation.

HCPCS J1306 — Injection, inclisiran, 1 mg.
CPT 96372 — Therapeutic, prophylactic, or diagnostic injection; subcutaneous or intramuscular.
Include relevant ICD‑10‑CM codes (e.g., E78.01; I25.10–I25.119 and related ranges) as applicable to the diagnosis.

Denial Risk

Not medically necessary triggers: prohibited combinations and unmet criteria

Requests will be considered NOT medically necessary if Leqvio is used in combination with Lerochol, Praluent, or Repatha, or when the policy’s coverage criteria are not met.

Combination therapy with Lerochol, Praluent, or Repatha is an explicit non‑covered scenario.
Any request that does not meet the policy’s stated initial or continuation criteria may be denied as not medically necessary.

Note

Coverage conditional on member benefit plan and documentation

Coverage and reimbursement for Leqvio are subject to the member‑specific benefit plan, plan terms and conditions, and the presence of required documentation; inclusion of codes in the policy does not guarantee payment.

All determinations are subject to the member’s benefit plan and additional terms/conditions.
Presence of a code in the policy does not imply coverage or reimbursement; submit complete documentation with the authorization/claim.

Indicated populationAdults with primary hyperlipidemia (including HeFH) or established ASCVD who require additional LDL‑C lowering

Pediatric useSafety and effectiveness in pediatric patients have not been established (pediatric use excluded)

Adjunct therapyIntended as an adjunct to diet and maximally tolerated statin therapy

Indication contextUsed as adjunct to diet and statin therapy for adults needing additional LDL‑C reduction

Homozygous Familial Hypercholesterolemia (HoFH) — Policy note

HoFH added as indicationHomozygous Familial Hypercholesterolemia (HoFH) is included in policy indications as a qualifying high‑risk condition

HoFH vs HeFHHoFH is listed separately from heterozygous familial hypercholesterolemia (HeFH) criteria and qualifies patients for therapy

DocumentationPolicy updates effective 10/01/2026 include HoFH among diagnosis pathways for eligibility