CurrentHighmark Blueshield NenyPolicy N/A

Praluent (alirocumab) prior authorization / coverage request form

This document is a prior authorization/coverage request form for Praluent (alirocumab) for members of Highmark BlueShield regions; it governs provider submission requirements and clinical information needed to evaluate medical necessity for Praluent therapy.

Policy Summary

PayerHighmark Blueshield Neny

PolicyPraluent (alirocumab) prior authorization / coverage request form

Policy CodePolicy N/A

Change TypeNo material changes noted

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form (one form per medication) with supporting clinical documentation and lipid labs to the provided fax or mailing address.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

one medication per formForms

28 or 84 daysDay supply

pretreatment LDL-C requiredLabs requested

statin tolerance questionsStatin history

Repatha failure queriedPrior biologic

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Coverage Criteria for Praluent (alirocumab)

General medical necessity data elements

Coverage consideration requires documented diagnosis and prior therapy/status information.

Provider and diagnosis: Prescribing provider identified (cardiologist, lipid specialist, endocrinologist, or other) and member diagnosis documented (ASCVD, HoFH, HeFH, or primary hyperlipidemia)

Provider specialty selection and diagnosis/ICD-10 codes required on form

ASCVD specifics: If ASCVD is present, specific ASCVD conditions should be checked (history of MI, stroke, stable or unstable angina, TIA, acute coronary syndrome, coronary or other arterial revascularization, or peripheral arterial disease of atherosclerotic origin)

List of ASCVD conditions provided on form

Familial hypercholesterolemia criteria: For HoFH or HeFH, one or more listed diagnostic criteria should be documented (LDL thresholds, total cholesterol thresholds, genetic confirmation, early xanthomas or parental FH, WHO/Dutch/MEDPED/Simon Broome scoring as applicable)HoFH: untreated LDL-C >400 mg/dL; HeFH: untreated LDL-C ≥190 mg/dL (or ≥160 mg/dL before age 20)

Multiple checkbox criteria available for each FH type

Statin therapy requirement: Documentation of maximal statin therapy trial and whether member experienced therapeutic failure or intolerance to statins; if intolerant, documentation of adverse events and at least two separate statin trials is requestedAt least two statin trials if intolerance assessed

Questions 6-8 capture statin failure/intolerance details including rhabdomyolysis, CK or LFT elevations, and hospitalization for statin-related adverse event

Lipid values: Provide pretreatment LDL-C (required) and date; pretreatment non-HDL-C and date; if currently on Praluent provide duration of therapy and current LDL-C with dateNumeric LDL-C and dates requested

Fields present for lipid panel dates and values (pretreatment and on-therapy)

Additional high-risk features and imaging: Document coronary artery calcification (CAC) score ≥1000 Agatston units and any major ASCVD events or high-risk conditions with supporting documentationCAC ≥1000 Agatston units

Form requests CAC score and free-text for major ASCVD events/high-risk conditions; include supporting documentation

Prior biologic/PCSK9 therapy: Document therapeutic failure or intolerance to Repatha and list other prior lipid-lowering medications tried and failed

Medication history section asks about Repatha failure and other medications

The form does not list any explicit unconditional exclusions for Praluent; there are no items on the form that state therapies, diagnoses, or patient groups that are categorically excluded from consideration.

The form does not enumerate specific conditions that are "not medically necessary." Providers should note that payment remains subject to the member's eligibility and benefit coverage, and completion of the form and submission of required documentation does not guarantee payment or authorization.

Clinical Thresholds and Coding-related Values

inv-04: LDL-C thresholds — HoFH and HeFH

HoFH untreated LDL-C thresholdUntreated LDL-C > 400 mg/dL (checkbox on form for HoFH)

HoFH additional criteriaUntreated total cholesterol > 500 mg/dL; genetic confirmation of two mutant alleles at LDLR, APOB, PCSK9, or LDLRAP1; evidence of parental heterozygous FH; cutaneous or tendon xanthoma before age 10; major ASCVD risk factors may be present.

HeFH untreated LDL-C thresholdUntreated LDL-C ≥ 190 mg/dL (checkbox on form for HeFH)

HeFH alternative/early-age thresholdUntreated LDL-C ≥ 160 mg/dL before 20 years of age (checkbox on form)

HeFH additional diagnostic indicatorsGenetic confirmation of one mutant allele (LDLR, APOB, PCSK9, LDLRAP1); physical findings such as corneal arcus prior to age 45, tendon xanthoma, tuberous xanthoma, xanthelasma; WHO/Dutch Lipid Network score > 8; Simon Broome or MEDPED 'definite' categories.

Provider Submission Requirements and Actions

Prior Authorization

Praluent prior authorization submission — one form per medication

Submit the completed prior authorization form for Praluent — one separate form per medication — along with all supporting clinical documentation and laboratory results to the fax or mailing address provided on the form.

Fax to 1-866-240-8123 or mail to 120 Fifth Avenue, SPECARE, Pittsburgh, PA 15222
Complete all requested clinical fields (diagnosis, requested product/dose, day supply, directions, ICD-10 codes)

Step Therapy

Step therapy / prior biologic failure — document Repatha failure

Document whether the member experienced therapeutic failure or intolerance to Repatha and list any other lipid-lowering medications the member has tried and failed on the medication history section of the form.

Answer the Repatha failure/intolerance question (Yes/No)
Provide details of other failed medications in the free-text medication history fields

Background on Medication

Praluent (alirocumab) is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor used to lower low-density lipoprotein cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease, familial hypercholesterolemia, or primary hyperlipidemia. The prior authorization form collects clinical indication details including ASCVD history, familial hypercholesterolemia diagnostic criteria, statin tolerance or failure, prior biologic/PCSK9 therapy history, and required lipid values such as pretreatment LDL-C, current LDL-C if already on therapy, and pretreatment non-HDL-C. Submit the completed form with supporting clinical documentation via the specified fax or mailing address for prior authorization review.

Definitions and Diagnostic Criteria

inv-12: ASCVD — definition

ASCVD definitionAtherosclerotic cardiovascular disease including history of myocardial infarction (MI), history of stroke, stable or unstable angina, history of transient ischemic attack (TIA), acute coronary syndrome (ACS), coronary or other arterial revascularization procedures, or peripheral arterial disease presumed to be of atherosclerotic origin.

ASCVD examples listed on formHistory of MI; history of stroke; stable or unstable angina; history of TIA; ACS; coronary or other arterial revascularization; peripheral arterial disease (including descending thoracic and abdominal aortic aneurysm).

Form instructionIf ASCVD is present, provider is asked to check all applicable specific ASCVD conditions on the form to document member history.

inv-13: HoFH / HeFH criteria

HoFH core criteriaUntreated LDL-C > 400 mg/dL; untreated total cholesterol > 500 mg/dL; genetic confirmation of two mutant alleles at LDLR, APOB, PCSK9, or LDLRAP1; evidence of heterozygous FH in both parents; cutaneous or tendon xanthoma before age 10; presence of major ASCVD risk factors.