Evolocumab (Repatha) prior authorization coverage criteria
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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.
No material clinical or coverage changes in this revision.
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
- HeFH: Member has heterozygous familial hypercholesterolemia (HeFH) with supporting criteria documented such as untreated LDL-C ≥ 190 mg/dL (or ≥160 mg/dL as captured on the form), genetic confirmation of one mutant allele (LDLR, APOB, PCSK9, or LDLRAP1), corneal arcus before age 45, tendon/tuberous xanthoma or xanthelasma, or WHO/Dutch Lipid Clinical Network score > 8 points.
See HeFH checklist on form
- Primary hyperlipidemia: Member has primary hyperlipidemia not associated with ASCVD, HeFH, or HoFH as indicated by the form checkbox and accompanying documentation.
Provider must indicate and provide supporting clinical information
Statin therapy trial and intolerance
Therapy history and tolerance criteria must be documented for coverage determination.
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).
The prior authorization form does not enumerate specific exclusion diagnoses. Instead, it captures indication groupings via checkboxes, including a distinct Primary hyperlipidemia option for members who do not meet ASCVD, HeFH, or HoFH criteria. Providers must check the applicable indication box and supply supporting clinical documentation for the selected category.
Completion of this authorization form is a request for medical review only; authorization does not guarantee payment. Coverage and payment remain subject to the member's eligibility and benefit provisions at the time services are rendered.
Formulary & Clinical Coding Fields
Provider Submission Requirements & Actions
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
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
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
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
Background
Evolocumab (Repatha) is a monoclonal antibody that inhibits PCSK9 to lower low-density lipoprotein cholesterol (LDL-C). The form is used to document indications consistent with Repatha's labeled uses — including members with ASCVD, homozygous or heterozygous familial hypercholesterolemia (HoFH/HeFH), and patients with primary hyperlipidemia or statin intolerance or inadequate LDL-C response on maximally tolerated statin therapy — and captures baseline and on-treatment lipid values and relevant diagnostic criteria to support medical necessity.
Clinical Definitions
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