CurrentHighmark Blueshield NenyPolicy N/A

Outpatient Leqvio (inclisiran) Injectable Request Form — Coverage Criteria

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Form and requirements to request outpatient medical benefit coverage for Leqvio (inclisiran) for Highmark members; used by ordering providers and facilities to document clinical indications and prior therapies. Affects providers submitting Leqvio requests for Highmark Blueshield NENY members.

Policy Summary

PayerHighmark Blueshield Neny

PolicyOutpatient Leqvio (inclisiran) Injectable Request Form — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the completed Outpatient Medical Injectable Leqvio Request Form by fax to 833-581-1861 with patient, provider, drug, diagnosis, and supporting clinical documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1drug addressed

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CurrentHighmark Blueshield NenyPolicy N/A

Outpatient Leqvio (inclisiran) Injectable Request Form — Coverage Criteria

Customize your policy alerts

Sign up for all Highmark Blueshield Neny policy alerts

Know when Highmark Blueshield Neny releases new policies or updates existing guidance.

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Policy Summary

PayerHighmark Blueshield Neny

PolicyOutpatient Leqvio (inclisiran) Injectable Request Form — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the completed Outpatient Medical Injectable Leqvio Request Form by fax to 833-581-1861 with patient, provider, drug, diagnosis, and supporting clinical documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1drug addressed

Coverage Criteria for Leqvio (inclisiran)

Initial therapy / general authorization criteria

Covered when ALL of the following are met (form collects these elements to support coverage determination):

General requirements: Leqvio prescribed by or in consultation with a cardiologist, endocrinologist, or lipid specialist; used as adjunct to maximally tolerated statin therapy unless the member is statin intolerant; documentation of prior PCSK9 inhibitor failure if applicable (≥3 months).

Elements appear on form for all indications

Statin tolerance/attempts: While receiving at least two (2) separate trials of different statins, member experienced statin-related rhabdomyolysis resolved on discontinuation, skeletal-related muscle symptoms resolved on discontinuation, LFTs increase to 3x ULN, CK increase to 10x ULN, or hospitalization for severe statin adverse event; OR documentation that member is on maximally tolerated statin therapy with intolerance documented.2 separate statin trials referenced

Form queries multiple statin intolerance criteria

ASCVD-specific criteria

For Clinical Atherosclerotic Cardiovascular Disease (ASCVD):

ASCVD manifestations: Presence of at least one ASCVD condition: acute coronary syndrome; history of transient ischemic attack; coronary or other arterial revascularization; peripheral arterial disease presumed to be of atherosclerotic origin; history of myocardial infarction; stable or unstable angina; history of stroke.

Form lists each ASCVD item as yes/no

HeFH-specific criteria

For Heterozygous Familial Hypercholesterolemia (HeFH):

HeFH diagnostic criteria: Clinical documentation of HeFH defined by ONE of: genetic confirmation of pathogenic variant at LDLR, APOB, PCSK9, or LDLRAP1; tendon xanthomas; corneal arcus before age 45; tuberous xanthomas; xanthelasma; WHO/Dutch Lipid Clinical Network criteria (score >8); Simon Broome definite criteria; MEDPED definite diagnosis; or documentation of untreated LDL-C ≥190 mg/dL (or ≥160 mg/dL if <20 years).

Form lists each diagnostic option as yes/no

Primary hyperlipidemia criteria

For Primary Hyperlipidemia (not ASCVD/HeFH/HoFH):

Primary hyperlipidemia criteria: Serum LDL-C greater than or equal to 70 mg/dL AND fasting triglycerides less than 400 mg/dL.LDL-C >=70 mg/dL; TG <400 mg/dL

Form requests these lab thresholds

Continuation/response

Response and continuation criteria:

Response documentation: For new starts or continuation, documentation of LDL-C reduction from baseline or other positive clinical response (e.g., LDL-C reduction) is requested on the form to demonstrate benefit.

Used to assess ongoing benefit

This request form does not include pathways for Homozygous Familial Hypercholesterolemia (HoFH). The form and the coverage criteria focus on Clinical Atherosclerotic Cardiovascular Disease (ASCVD), Heterozygous Familial Hypercholesterolemia (HeFH), and Primary Hyperlipidemia only, and providers should not use this form to document HoFH-specific diagnostic or treatment requirements.

Requests lacking required clinical documentation may be considered not medically necessary. Common missing elements include the indication-specific evidence requested on the form (for example, ASCVD manifestations, HeFH diagnostic criteria, or primary hyperlipidemia lab thresholds), absence of documentation that Leqvio will be used as an adjunct to maximally tolerated statin therapy (unless statin intolerance is documented), missing documentation of prior PCSK9 inhibitor failure when applicable, and absent baseline or follow-up LDL-C response data. The form explicitly queries prior statin trials and statin‑intolerance events (including at least two separate statin trials), specific lab abnormalities, and whether there has been documentation of LDL‑C reduction from baseline.

Coding and Clinical Thresholds

Diagnosis codes (ICD-10) — requested on formICD-10

ICD10

Diagnosis code(s) — ICD-10 (member/claim specific)

Drug — requested on formNDC | mixed

LEQVIO (inclisiran)

Drug name requested on form

LDL-C thresholds (examples requested on form)

ASCVD / HeFH example cutoffLDL-C ≥100 mg/dL referenced on the form as an example threshold for use despite maximally tolerated statin therapy

Primary hyperlipidemia thresholdSerum LDL-C ≥70 mg/dL required for primary hyperlipidemia pathway

Untreated HeFH threshold (adult)Documentation of untreated LDL-C ≥190 mg/dL qualifies as a HeFH diagnostic option on the form

Untreated HeFH threshold (pediatric)Documentation of untreated LDL-C ≥160 mg/dL if <20 years of age qualifies as a HeFH diagnostic option on the form

Fasting triglyceride limit for primary hyperlipidemiaFasting triglycerides <400 mg/dL required in addition to LDL-C ≥70 mg/dL

Provider Actions, Submission, and Requirements

Prior Authorization

How to submit the form and prior authorization

Submit the completed Leqvio (inclisiran) outpatient medical injectable request form and all supporting clinical documentation to the Medical Benefit prior authorization team. Fax the completed form to 833-581-1861. Ensure the form is fully completed to avoid delays.

Fax: 833-581-1861
Include member eligibility verification prior to submission

Step Therapy

Statin trials and PCSK9 step requirements

Document that the member has been prescribed Leqvio as an adjunct to maximally tolerated statin therapy unless statin intolerant. If a PCSK9 inhibitor step is required, include documentation of failure of an FDA‑approved PCSK9 inhibitor (e.g., alirocumab or evolocumab) for at least three (3) months when applicable.

Must indicate use as adjunct to maximally tolerated statin therapy or state specific statin intolerance reason(s)
If applicable, document ≥3 months trial and failure of PCSK9 inhibitor (alirocumab or evolocumab)

Background

Leqvio (inclisiran) is a lipid‑lowering injectable intended to reduce LDL‑C as an adjunct to other lipid‑lowering therapies. The Outpatient Medical Injectable Leqvio Request Form collects clinical information for all indications, including whether the drug is prescribed by or in consultation with a cardiologist, endocrinologist, or lipid specialist, and whether it will be used as adjunct to maximally tolerated statin therapy. The form also requests baseline and response LDL‑C data and other indication‑specific items to support medical benefit authorization.

Definitions

Heterozygous Familial Hypercholesterolemia (HeFH) — acceptable documentation

Genetic confirmationPathogenic variant at LDLR, APOB, PCSK9, or LDLRAP1 gene locus documented

Tendon xanthomas or other physical findingsPresence of tendon xanthomas, tuberous xanthomas, xanthelasma, or corneal arcus by age 45 documented

Diagnostic scoring systemsDiagnosis based on WHO/Dutch criteria (score >8), Simon Broome definite criteria, or MEDPED definite diagnosis documented

Untreated LDL-C numeric criteriaDocumentation of untreated LDL-C ≥190 mg/dL (or ≥160 mg/dL if <20 years) as an acceptable HeFH documentation option

Documentation Required

Required documentation to submit

Attach complete clinical documentation with the request form. Required fields on the form include: member demographics (member name, date of birth, member ID), ordering/attending provider name and NPI, provider contact phone/fax, servicing facility/vendor name and NPI, requested start date of service, ICD‑10 diagnosis code(s) and description, drug name (LEQVIO), strength/dose, date of service, directions, quantity (# doses/visits), and indication details. For clinical justification include: whether prescribed by or in consultation with a cardiologist/endocrinologist/lipid specialist, documentation of maximally tolerated statin therapy or statin intolerance details, results of prior statin trials (including LFTs, CK, hospitalizations), baseline and follow-up LDL‑C values showing response, and copies of any prior PCSK9 inhibitor therapy records.

Member demographics: name, DOB, member ID
Provider: ordering/attending name, NPI, address, phone, fax
Facility: servicing facility/vendor name and NPI
Drug: LEQVIO, strength/dose, directions, quantity, date of service
Diagnosis: ICD‑10 code(s) and description
Clinical: consultation specialty (cardiology/endocrinology/lipid specialist), documentation of maximally tolerated statin therapy or detailed statin intolerance, results of LFTs and CK if relevant, hospitalization records for severe statin adverse events, baseline and post‑treatment LDL‑C values
Attach all pertinent clinical records and lab results