CurrentHighmark Blueshield NenyPolicy N/A

Evolocumab (Repatha) prior authorization coverage criteria

Defines the information and clinical criteria required for prior authorization of Evolocumab (Repatha) injections for members of Highmark BlueShield regions. Affects prescribing providers (cardiologists, lipid specialists, endocrinologists, PCPs) and pharmacy/benefit reviewers processing Repatha requests.

Policy Summary

PayerHighmark Blueshield Neny

PolicyEvolocumab (Repatha) prior authorization coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed Repatha-specific prior authorization form with required clinical documentation and supporting lipid panels; send one form per medication via fax or mail.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multipleFormulation options

comprehensiveClinical checklist

labsLab data required

fax/mailSubmission method

Coverage Criteria for Evolocumab (Repatha)

Indications (ASCVD, HoFH, HeFH, Primary Hyperlipidemia)

Coverage is assessed when required clinical elements are provided, including diagnosis group and response to prior therapy. The form collects data supporting these distinct indication groups:

Indication groups

ASCVD: Member has ASCVD and provider documents specific ASCVD conditions (history of myocardial infarction, history of stroke, stable or unstable angina, history of transient ischemic attack, acute coronary syndrome, coronary or other arterial revascularization procedure, or peripheral arterial disease of atherosclerotic origin).
See clinical information checklist on form
HoFH: Member has homozygous familial hypercholesterolemia (HoFH) with supporting criteria documented such as untreated LDL-C > 400 mg/dL, untreated total cholesterol > 500 mg/dL, genetic confirmation of two mutant alleles (LDLR, APOB, PCSK9, or LDLRAP1), evidence of heterozygous FH in both parents, cutaneous or tendon xanthoma before age 10, or major ASCVD risk factors (eg, diabetes).
See HoFH checklist on form

Policy Summary

PayerHighmark Blueshield Neny

PolicyEvolocumab (Repatha) prior authorization coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed Repatha-specific prior authorization form with required clinical documentation and supporting lipid panels; send one form per medication via fax or mail.

SourceLink

On This Page

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Statin therapy trial and intolerance

Therapy history and tolerance criteria must be documented for coverage determination.

Prior statin therapy and response: Provider documents whether the member had therapeutic failure to a maximally tolerated statin OR documents statin intolerance, and whether the member had <50% reduction in baseline LDL-C despite use of a maximally tolerated statin therapy.<50% LDL-C reduction

If statin intolerance is claimed, document trials of at least two separate statins with resolution of symptoms upon discontinuation, and record statin-related adverse events (eg, rhabdomyolysis, CK increase to 10× ULN, LFT increase to 3× ULN, or hospitalization for a statin-related adverse event).

Provider Submission Requirements & Actions

Prior Authorization

Prior Authorization Needed

Prior authorization is required for Repatha and must be submitted using the Repatha-specific prior authorization form. Submit a separate form for each medication request. Fax completed form and all clinical documentation to 1-866-240-8123 or mail to 120 Fifth Avenue, SPECARE, Pittsburgh, PA 15222. The prescribing physician (PCP or Specialist) should, in most cases, complete the form. Payment is subject to member eligibility; authorization does not guarantee payment.

Submit separate form per medication
Fax to 1-866-240-8123 or mail to 120 Fifth Avenue, SPECARE, Pittsburgh, PA 15222
Prescribing physician should complete the form
Authorization does not guarantee payment

Documentation Required

Statin Therapy Documentation Required

Provide documentation of statin therapy and response. The form must indicate whether the member experienced therapeutic failure on a maximally tolerated statin and whether there was a < 50% reduction in baseline LDL-C despite maximally tolerated statin therapy. If the member is statin-intolerant, document specifics (e.g., rhabdomyolysis, CK ≥ 10× ULN, LFTs ≥ 3× ULN, hospitalization for a statin-related adverse event) and whether at least two separate trials of different statins were attempted and discontinued due to adverse effects. Include dates and details of statin trials.

Was there therapeutic failure to a maximally tolerated statin? (Yes/No)
Was there < 50% reduction in baseline LDL-C despite maximally tolerated statin therapy? (Yes/No)
If statin-intolerant: document rhabdomyolysis, CK increase to ≥10× ULN, LFT increase to ≥3× ULN, hospitalization, and trials of ≥2 different statins

Documentation Required

Required Clinical Documentation

Provide complete clinical documentation with the prior authorization request. Incomplete or inaccurate submissions may result in denial. Required documentation includes diagnosis with ICD-10 code(s); member's pretreatment LDL-C and date of lipid panel; pretreatment non-HDL-C and date; any current Repatha therapy and duration; current LDL-C and date if on therapy; medication history including other lipid-lowering agents tried and failed (with dates); and relevant clinical history (ASCVD details, familial hypercholesterolemia criteria, coronary artery calcification score if applicable). The submitting provider must certify that information is true, accurate, and complete.

Diagnosis and ICD-10 code(s)
Pretreatment LDL-C (mg/dL) and date of lipid panel
Pretreatment non-HDL-C and date of lipid panel
If currently on Repatha: duration of therapy, current LDL-C (mg/dL) and date
Medication history: other lipid-lowering medications tried and failed (include dates)
Clinical history: ASCVD details (MI, stroke, ACS, revascularization, PAD, etc.), HoFH/HeFH criteria, CAC score if ≥ 1000 Agatston units
Provider certification that information is true, accurate, and complete

Denial Risk

Incomplete Submission May Lead to Denial

Incomplete or missing information may lead to denial of the authorization request. Ensure all required fields on the form are completed, documentation is legible, and supporting clinical records (labs, imaging, genetic testing, prior medication trials) are attached. Note that authorization approval does not guarantee payment and payment remains subject to member eligibility.

Complete all required fields on the form
Attach supporting clinical records (labs, imaging, genetic testing, medication trial records)
Authorization approval does not guarantee payment

Clinical Definitions

ASCVD — included conditions

Atherosclerotic cardiovascular disease (ASCVD) - core conditionsIncludes history of myocardial infarction (MI), history of stroke, stable or unstable angina, and acute coronary syndrome (ACS)

Other ASCVD events/proceduresCoronary or other arterial revascularization procedures

Cerebrovascular eventsHistory of transient ischemic attack (TIA)

Peripheral vascular diseasePeripheral arterial disease presumed to be of atherosclerotic origin (including descending thoracic and abdominal aortic aneurysm)

HoFH / HeFH definitions and thresholds

HoFH diagnostic criteriaForm lists criteria for homozygous familial hypercholesterolemia including untreated LDL‑C > 400 mg/dL, untreated total cholesterol > 500 mg/dL, genetic confirmation of two mutant alleles at LDLR/APOB/PCSK9/LDLRAP1 loci, evidence of heterozygous FH in both parents, childhood xanthomas, or presence of major ASCVD risk factors

HeFH diagnostic promptsForm lists heterozygous familial hypercholesterolemia criteria including untreated LDL‑C ≥ 190 mg/dL (and an alternative threshold ≥160 mg/dL), genetic confirmation of one mutant allele, early corneal arcus or tendon xanthomas, and WHO/Dutch score > 8

Genetic confirmation noteForm explicitly captures whether genetic confirmation of one (HeFH) or two (HoFH) mutant alleles at LDLR, APOB, PCSK9, or LDLRAP1 loci is present

OpenPayer

Evolocumab (Repatha) prior authorization coverage criteria

Coverage Criteria for Evolocumab (Repatha)

Formulary & Clinical Coding Fields

Provider Submission Requirements & Actions

Background

Clinical Definitions