CurrentHighmark Blueshield NenyPolicy N/A

Praluent (alirocumab) prior authorization — medication prior authorization form and clinical checklist

This document is a medication prior authorization form and clinical checklist for Praluent (alirocumab) requests, used by providers to document clinical information, prior therapies, and lab values to obtain coverage for members under Highmark BlueShield plans.

Policy Summary

PayerHighmark Blueshield Neny

PolicyPraluent (alirocumab) prior authorization form and coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a separate prior authorization request by fax to 1-866-240-8123 with complete supporting clinical documentation including diagnosis, prior therapies, and baseline lipid panels.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

items 1-18clinical questions on the form

fax 1-866-240-8123submission fax number

Praluent 75/150product options

120 Fifth AveSPECARE mailing

Coverage Criteria for Praluent (alirocumab)

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Information and clinical criteria requested to establish medical necessity

Form requests documentation of one or more of the following clinical situations and supporting labs/history.

Indication: Member meets ONE of: ASCVD OR heterozygous familial hypercholesterolemia (HeFH) OR homozygous familial hypercholesterolemia (HoFH) OR primary hyperlipidemia not associated with ASCVD/HeFH/HoFH

Provider must indicate which applies and specify ASCVD events or familial criteria

Baseline lipid documentation: Provide pretreatment LDL-C, pretreatment non-HDL-C, and pretreatment apolipoprotein B values with dates; provide CAC (Agatston) score if availableLDL-C and other labs as numeric values

Used to assess baseline severity and treatment response

Prior therapy or intolerance

Statin intolerance details: If statin intolerant, document at least two separate trials of different statins with resolution on discontinuation; indicate presence of rhabdomyolysis, CK ≥10x ULN, LFTs ≥3x ULN, or hospitalization for statin-related adverse eventCK ≥10x ULN; LFTs ≥3x ULN
Required when 'intolerant' selected

Current therapy and continuation: If currently on Praluent, provide duration of therapy, current on-therapy LDL-C with date, and whether continued therapy is requiredDates and current LDL-C value required

Supports continuation requests

Additional clinical details: Provide diagnosis/ICD-10, list of prior and concurrent lipid-lowering therapies, any major ASCVD events or high-risk conditions, and provider signature/contact information

Complete clinical documentation required for prior authorization; payment is subject to member eligibility

The prior authorization form asks the provider to indicate whether Praluent is being used for primary prevention of cardiovascular events and to supply supporting clinical details. The form explicitly documents this with question 4 asking “Is Praluent being used for primary prevention of cardiovascular events?” and requests the provider complete the rest of the checklist appropriate to the stated indication so the member’s clinical context (ASCVD, HoFH, HeFH, or primary hyperlipidemia) is clear.

Payment for Praluent is contingent on the member’s eligibility under their Highmark benefit plan; an approved authorization does not assure payment. The instructions emphasize that the completed form and all clinical documentation must be faxed to 1-866-240-8123, and note submission completeness and member eligibility affect coverage decisions.

Requested Products, Codes and Laboratory Thresholds

Requested productsmixed

Praluent Pen 75mg/ml	Requested product option listed on form
Praluent Pen 150mg/ml	Requested product option listed on form

LDL-C thresholds and laboratory values

Untreated LDL-C (HeFH)Greater than or equal to 190 mg/dL (ask for pretreatment LDL-C and date)

Untreated LDL-C (HoFH)Greater than 400 mg/dL (criterion listed for homozygous FH)

Pretreatment non-HDL-CForm requests pretreatment non-HDL-C value with date (provide numeric value and date)

Pretreatment apolipoprotein BForm requests pretreatment apolipoprotein B value with date (provide numeric value and date)

Coronary artery calcium (CAC) scoreProvide CAC score in Agatston units if available (prior to therapy)

Provider Submission and Documentation Requirements

Denial Risk

Submission and payment risk

Fax the completed prior authorization form and all required clinical documentation to 1-866-240-8123. Payment is subject to member eligibility and authorization does not guarantee payment. Incomplete forms or missing documentation may result in denial of the request or delay in processing.

Fax number: 1-866-240-8123
Mailing address for provider notification: 120 Fifth Avenue, SPECARE, Pittsburgh, PA 15222
Payment is subject to member eligibility; authorization is not a guarantee of payment
Incomplete or missing information may result in denial or processing delays

Step Therapy

Prior medication trials

Document all prior medication trials, therapeutic failures, and intolerances. Specifically indicate whether the member experienced failure or intolerance to Repatha and list any other lipid-lowering therapies tried (with dates, doses, and reason for discontinuation).

Has the member experienced therapeutic failure or intolerance to Repatha? (Yes/No) — if yes, provide details
List other medications tried and failed, including dates, doses, and reason for failure/intolerance
Include current and concurrent lipid-lowering therapies and duration of use

Documentation Required

Required clinical documentation

Ensure required clinical documentation is included with the submission: diagnosis and ICD-10 code(s); documentation of prior therapies and medication history; baseline (pretreatment) and most recent lipid panels (including LDL-C and apolipoprotein B) with dates; and any major ASCVD events or high-risk conditions.

Diagnosis and ICD-10 code(s)
Pretreatment LDL-C and date
Pretreatment apolipoprotein B and date
Current or most recent LDL-C and date (if already on therapy)
Documentation of prior therapies, failures, and intolerances (including Repatha)
History of major ASCVD events or high-risk conditions

Prior Authorization

Prior authorization submission — fax number and submission instructions

Follow the form instructions: submit a separate form per medication, complete all fields legibly, provide the physician's address, and fax the form with all clinical documentation to 1-866-240-8123. The prescribing physician should generally complete the form. The submitting provider certifies the information is true and complete.

Submit a separate form for each medication
Complete ALL information on the form and print/type legibly
Provide physician address as required for notification
Fax the completed form and all clinical documentation to 1-866-240-8123

Background

Praluent (alirocumab) is a PCSK9 inhibitor listed on the form as the requested product in two pen strengths: Praluent Pen 75mg/ml and Praluent Pen 150mg/ml. The form collects indication-specific information consistent with Praluent’s clinical uses — presence of ASCVD (with specific event types to check), documentation of homozygous familial hypercholesterolemia (HoFH) or heterozygous familial hypercholesterolemia (HeFH) (including LDL-C thresholds and genetic criteria), and whether the drug is intended for primary prevention. Required supportive data include diagnosis/ICD-10, requested day supply/number of pens, and relevant lipid values to establish medical necessity.

Key Definitions

ASCVD definition — history and procedures

ASCVD componentsHistory of myocardial infarction (MI), history of stroke, stable or unstable angina, or history of transient ischemic attack

Acute coronary conditionsAcute coronary syndrome (ACS) and coronary or other arterial revascularization procedures

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

HoFH / HeFH — familial hypercholesterolemia definitions and diagnostic criteria

HoFH diagnostic criteriaAny of: untreated LDL-C >400 mg/dL; untreated total cholesterol >500 mg/dL; genetic confirmation of two mutant alleles (LDLR, ApoB, PCSK9, LDLRAP1); evidence of HeFH in both parents; cutaneous or tendon xanthoma before age 10; aortic valve disease or xanthomata <20 years; parental HoFH or positive genetic testing indicating autosomal-recessive FH.

HeFH diagnostic thresholdsUntreated LDL-C ≥190 mg/dL (or ≥160 mg/dL before age 20); genetic confirmation of one mutant allele at LDLR, ApoB, PCSK9, or LDLRAP1

Clinical and scoring criteriaClinical features and validated scores accepted: corneal arcus prior to age 45, tendon xanthoma, tuberous xanthoma, xanthelasma; WHO/Dutch Lipid Clinical Network score >8; Simon Broome 'definite'; MEDPED 'definite'