ModifiedUnitedHealthcarePolicy N/A

Praluent (alirocumab) prior authorization and medical necessity

Defines UnitedHealthcare pharmacy prior authorization and medical necessity criteria for coverage of Praluent (alirocumab) for adults and pediatric patients meeting specified diagnoses and treatment history; applies to members whose benefit plans incorporate this program.

Policy Summary

PayerUnitedHealthcare

PolicyPraluent (alirocumab) prior authorization and medical necessity

Policy CodePolicy N/A

Change TypeClinical criteria and operational revisions (material)

Effective DateMay 1, 2025

Next Review DateFeb 1, 2025

Key ActionSubmit prior authorization with documentation of diagnosis, prior statin/ezetimibe therapy or intolerance, LDL-C values, and genetic test results when applicable; approvals issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

Simplified diagnosis requirements for HeFH, ASCVD, and primary hyperlipidemia; removed diet requirement and revised HoFH criteria to account for genetic test interpretation and digenic mutations.

Added criterion for pediatric patients aged less than 10 to align with new label for pediatric patients 8 years and older with HeFH.

Lowered LDL-C threshold requirement for initiation of Praluent therapy per American College of Cardiology guidance.

Added criterion that Praluent is not to be used in combination with inclisiran (Leqvio).

Changed initial authorization duration to 12 months to align all PCSK9 programs and removed reauthorization criteria.

12 monthsauthorization period

>=12 wks

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Coverage Criteria for Praluent (alirocumab)

Initial Therapy - Primary hyperlipidemia/HeFH/ASCVD

Covered when ALL of the following are met

Diagnosis: Member has one of: heterozygous familial hypercholesterolemia (HeFH), atherosclerotic cardiovascular disease (ASCVD), or primary hyperlipidemia.

Statin therapy requirement: One of: (a) Patient has been receiving ≥12 consecutive weeks of high-intensity statin therapy and will continue high-intensity statin at maximally tolerated dose; OR (b) patient is unable to tolerate high-intensity statin as shown by intolerable persistent symptoms (eg, myalgia or myositis with CK ≥10× ULN) and has been receiving ≥12 consecutive weeks of low- or moderate-intensity statin and will continue statin at maximally tolerated dose; OR (c) patient is unable to tolerate low-, moderate-, and high-intensity statins due to intolerable persistent symptoms or has a contraindication to all statins or experienced rhabdomyolysis (CK ≥10× ULN).≥12 weeks where applicable

Intolerance examples: myalgia, myositis with CK elevations ≥10× ULN.

LDL-C and ezetimibe: Patient has LDL-C ≥55 mg/dL AND either has had ≥12 consecutive weeks of ezetimibe as adjunct to maximally tolerated statin OR has history of contraindication/intolerance to ezetimibe.LDL-C ≥55 mg/dL; ezetimibe trial ≥12 weeks

Document dates and reasons for therapeutic failure, contraindication, or intolerance.

Therapy exclusions: Not used in combination with another PCSK9 inhibitor (eg, evolocumab/Repatha) or with inclisiran (Leqvio).

Initial Therapy - Homozygous familial hypercholesterolemia (HoFH)

Covered when ALL of the following are met

Diagnostic confirmation: Either genetic confirmation of bi-allelic pathogenic/likely pathogenic variants in LDLR, APOB, PCSK9, or LDLRAP1 genes (or ≥2 such variants at different loci) OR both: untreated LDL-C >400 mg/dL AND one of: xanthoma before age 10, or evidence of familial hypercholesterolemia in at least one parent.Untreated LDL-C >400 mg/dL where used

Submit medical records, chart notes, laboratory values to confirm.

Concurrent therapy: Patient is receiving other lipid-lowering therapy (eg, statin, ezetimibe, LDL apheresis).

Prior failure to other PCSK9: History of failure, contraindication, or intolerance to evolocumab (Repatha) must be documented (date and reason).

Not used in combination with Repatha or Juxtapid (lomitapide).

Revised coverage criteria (summary)

Policy revisions noted that initiation, diagnostic, and prior-therapy requirements were simplified and updated across HeFH, ASCVD, primary hyperlipidemia, and HoFH.

General: Requires diagnosis of HeFH, ASCVD, primary hyperlipidemia, or HoFH per updated diagnostic criteria; prior statin therapy/failure/intolerance and ezetimibe trial requirements have been revised and simplified; not to be used with inclisiran (Leqvio); pediatric criteria added for certain ages.see policy

Exact numeric LDL-C thresholds and stepwise logic are in other policy sections.

Requests for Praluent (alirocumab) that would result in concurrent use with another PCSK9 inhibitor (for example, Repatha/evolocumab) or with inclisiran (Leqvio) are excluded and will not meet coverage criteria. The policy explicitly states Praluent is not used in combination with another PCSK9 inhibitor and documents combination exclusions for HoFH (e.g., Juxtapid) where applicable.

When submitting an authorization request, ensure the member is not currently receiving another PCSK9 inhibitor or inclisiran; combination therapy with these agents is a disqualifying condition for approval per the coverage criteria.

The policy includes a specific operational exclusion that Praluent is not to be used in combination with inclisiran (Leqvio); requests for concomitant therapy will be denied. This criterion was added to the policy and is enforced at authorization.

Providers should not request coverage for simultaneous administration of Praluent and Leqvio; if a member has received or is planned to receive inclisiran, Praluent will not meet the program's coverage requirements.

Plan-specific exclusions may apply: Praluent is identified in the policy as a product that is typically excluded from coverage for some plans. Federal or state mandates and the member’s specific benefit plan may affect whether Praluent is covered, and some plans may maintain separate tried/failed or exclusion rules.

Before pursuing prior authorization, consult the member’s benefit plan details to confirm whether Praluent is subject to a plan-level exclusion or additional plan-specific requirements that would preclude coverage.

Use of Praluent outside the updated diagnostic groups or without meeting the revised LDL-C thresholds and prior therapy requirements is considered not medically necessary. The policy revisions simplified diagnostic and prior-therapy requirements and lowered initiation LDL-C thresholds; requests that do not meet these updated criteria will not satisfy medical necessity.

Authorization decisions require that the member’s diagnosis and documented prior therapies align with the revised policy language; absence of required LDL-C values, documentation of prior statin/ezetimibe trials, or use for unlisted diagnoses will result in non-coverage.

LDL-C Thresholds and Coding Notes

LDL-C thresholds — Key numeric criteria

Primary hyperlipidemia/HeFH/ASCVD LDL-C thresholdLDL-C ≥ 55 mg/dL

HoFH diagnostic LDL-C criterion (untreated)Untreated LDL-C > 400 mg/dL

Required ezetimibe trialIf applicable, ≥12 consecutive weeks of ezetimibe as adjunct to maximally tolerated statin (documented)

LDL-C threshold for initiation

Initiation LDL-C threshold statusLDL-C threshold for initiation has been lowered per American College of Cardiology guidance

Reference to numeric changePolicy notes the LDL-C threshold was lowered (exact numeric value is specified in ACC guidance and adopted by policy)

Initial Therapy Coverage Rules

Initial Therapy — Initial approval criteria (primary initial therapy group)

Initial approval criteria

See coverage.criteria_sets: Initial therapy criteria for primary hyperlipidemia/HeFH/ASCVD as detailed in coverage criteria including diagnosis, statin/ezetimibe trials, LDL thresholds, and exclusions.

Initial therapy — Initial therapy criteria updated and simplified; pediatric indication added

Initial therapy criteria updated and simplified; pediatric indication added

Initial Therapy: Patient meets diagnostic criteria (HeFH, ASCVD, primary hyperlipidemia, or HoFH), prior therapy requirements addressed per simplified criteria, LDL-C meets revised threshold, and not receiving excluded combinations (eg, Leqvio).revised LDL-C threshold per ACC guidance

Pediatric patients criteria added to align with updated label for certain ages.

Continuation and Reauthorization

Continuation Therapy — Re-authorization criteria (historical and current rules)

Re-authorization

Re-authorization duration: Authorization will be issued for 12 months when criteria remain met.12 months

Continuation/Reauthorization — Continuation and reauthorization rules were removed or simplified in recent updates

Continuation and reauthorization rules were removed or simplified in recent updates

Continuation: Reauthorization criteria removed; initial authorization set to 12 months to align PCSK9 programs.12 months

Provider Actions, Documentation, and Denials

Prior Authorization

Prior Authorization Required

Prior authorization is required for Praluent (alirocumab). Approval will be issued for an initial duration of 12 months when criteria are met.

Prior authorization required for Praluent (alirocumab).
Initial authorization duration: 12 months.

Note

Initial Authorization Duration

Initial prior authorization for PCSK9 inhibitor therapy (Praluent) will be issued for 12 months.

Initial authorization duration: 12 months for Praluent/PCSK9 inhibitor therapy.

Step Therapy and Prior Treatment Requirements

Requirement	Documentation needed	Notes
Statin therapy trial or documented intolerance	Medical record or prescription claims showing ≥12 consecutive weeks of high‑intensity statin therapy OR documentation of intolerance with ≥12 consecutive weeks of low‑ or moderate‑intensity statin when high‑intensity is not tolerated (include dates, dose, symptoms, CK results if applicable)	Policy requires documentation of trials/failures or intolerance; automated approvals may use claims/diagnosis history when applicable
Ezetimibe adjunctive trial or intolerance	Medical record or prescription claims showing ≥12 consecutive weeks of ezetimibe used as adjunct to maximally tolerated statin OR documentation of contraindication/intolerance to ezetimibe (include dates and reasons)	LDL‑C threshold and ezetimibe trial requirement apply together for primary hyperlipidemia/HeFH/ASCVD initial therapy
Prior lipid‑lowering therapies (other PCSK9 agents)	Documentation of prior use, failure, contraindication, or intolerance to other PCSK9 inhibitor (e.g., evolocumab) when applicable (include date and reason)	Policy excludes concurrent use with another PCSK9 inhibitor; prior failure to other PCSK9 agents is documented for some indications (e.g., HoFH)
Supply limits / step therapy rules	Claims history or prior authorization records demonstrating prior approvals, fills, or program‑specific step requirements as applicable	UnitedHealthcare may apply supply limits and step therapy; automated approvals may rely on claims/diagnosis history

Simplified prior therapy item	Acceptable documentation	Minimum expectation
Statin intolerance or maximally tolerated statin	Chart note describing intolerance (symptoms, CK if measured), statement of maximally tolerated dose, and related dates or prescription history	When high‑intensity statin not tolerated, documentation of ≥12 weeks on low/moderate intensity with intent to continue at maximally tolerated dose is expected
Ezetimibe trial or intolerance	Prescription claims or chart documentation of ≥12 consecutive weeks of ezetimibe as adjunct OR documentation of contraindication/intolerance with dates and reason	Document dates and reasons for therapeutic failure, contraindication, or intolerance
Prior use of other lipid‑lowering agents (including PCSK9) when relevant	Records of prior agent use with dates and reason for discontinuation or failure (e.g., lack of LDL‑C response, adverse event)	For some indications (e.g., HoFH) history of failure/contraindication to evolocumab should be documented
Use of claims/automated approval evidence	Previous claim/medication history and diagnosis codes may be used to support prior therapy when available	UnitedHealthcare may approve based solely on prior claims/diagnosis history per program or therapeutic class

Supply Limits and Site-of-Care

Billing Rule

Site‑of‑care and supply limits may apply

Supply limits and site‑of‑care rules may apply for administration settings (e.g., infusion center); UnitedHealthcare may use previous claim history for automated approvals related to site‑of‑care and supply limits.

Supply limits and site‑of‑care rules may be in place depending on program.
Automated approvals may consider prior claims/medication history and diagnosis codes.

Background

Praluent (alirocumab) is a monoclonal antibody PCSK9 inhibitor indicated to reduce low-density lipoprotein cholesterol (LDL-C) and, in adults with established cardiovascular disease, to reduce the risk of myocardial infarction, stroke, and unstable angina. It is also indicated to lower LDL-C in adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) and as adjunctive therapy in homozygous familial hypercholesterolemia; pediatric indications include patients ≥8 years with HeFH.

Within this policy, Praluent is positioned as a specialty lipid‑lowering therapy with defined diagnostic, prior‑therapy, and LDL‑C threshold requirements; the policy also notes changes to initiation thresholds and authorization processes to align with contemporary guideline and labeling updates.

Definitions and Key Terms

PCSK9 inhibitor — Praluent (alirocumab)

Mechanism of actionPraluent (alirocumab) is a monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), lowering LDL‑C.

Therapeutic roleUsed to reduce risk of myocardial infarction, stroke, and unstable angina in adults with established cardiovascular disease and to lower LDL‑C in primary hyperlipidemia including HeFH.

Adjunct usesAlso indicated as adjunctive therapy in HoFH and in pediatric patients ≥8 years with HeFH to reduce LDL‑C.

ASCVD — components and policy relevance

ASCVD componentsIncludes acute coronary syndromes; history of myocardial infarction; stable or unstable angina; coronary or other arterial revascularization; stroke; transient ischemic attack (TIA); and peripheral arterial disease of atherosclerotic origin.

Role in coverage criteria

Policy Revision History and Key Changes

Revised coverage criteria (summary)

Policy revisions noted that initiation, diagnostic, and prior-therapy requirements were simplified and updated across HeFH, ASCVD, primary hyperlipidemia, and HoFH.

Summary of revisions: Initiation, diagnostic, and prior-therapy requirements were simplified; LDL-C numeric threshold for initiation was lowered per ACC guidance; HoFH genetic testing language was revised to account for interpretation complexity and digenic mutations; pediatric criteria were added for certain ages; exclusion added for combination with inclisiran (Leqvio).see policy

These revisions are operational and material changes to the prior policy.

Policy Summary

PayerUnitedHealthcare

PolicyPraluent (alirocumab) prior authorization and medical necessity

Policy CodePolicy N/A

Change TypeClinical criteria and operational revisions (material)

Effective DateMay 1, 2025

Next Review DateFeb 1, 2025

SourceLink

On This Page

ASCVD — definition and relevance

DefinitionAtherosclerotic cardiovascular disease (ASCVD) — includes acute coronary syndromes, history of myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack (TIA), or peripheral arterial disease presumed to be of atherosclerotic origin.

Context for eligibilityASCVD is an approved diagnosis for Praluent initial therapy criteria (alongside HeFH and primary hyperlipidemia)

DocumentationASCVD diagnosis should be documented in medical records as part of prior authorization submission

HoFH diagnostic criteria (revised)

Primary diagnostic pathways for HoFHEither genetic confirmation of bi‑allelic pathogenic/likely pathogenic variants in LDLR, APOB, PCSK9, or LDLRAP1 (or ≥2 such variants at different loci) OR both: untreated LDL‑C > 400 mg/dL AND one of: xanthoma before age 10, or evidence of familial hypercholesterolemia in at least one parent.

Genetic interpretation noteHoFH criteria were revised to account for genetic test interpretation complexity and possibility of digenic mutations; submit genetic test reports and supporting records when available.

Supporting documentationIf genetic confirmation is not available, provide untreated LDL‑C >400 mg/dL and clinical features (e.g., childhood xanthomas or parental FH) with medical records and labs.

Documentation Required

Submission of Medical Records Confirming Genetic Testing

Submit medical records (chart notes, laboratory values, genetic test reports as applicable) to document diagnosis and confirmatory testing where required. For HoFH, submit records confirming genetic confirmation of bi-allelic pathogenic/likely pathogenic variants on different chromosomes or equivalent genetic documentation.

Submit medical records (chart notes, labs, genetic test reports) to support the request.
For HoFH: medical records confirming genetic confirmation of bi-allelic pathogenic/likely pathogenic variants (LDLR, APOB, PCSK9, LDLRAP1 or digenic variants) are required.

Documentation Required

Medical Record and Prior Therapy Documentation

Documentation and prescription/claim history must support prior therapy requirements, trials, failures, contraindications, or intolerances (e.g., statins and ezetimibe). UnitedHealthcare may review prescription claims history, diagnosis codes, and prior claims to approve initial or re-authorization.

Provide medical record documentation of prior therapies, dates of trials, and reasons for therapeutic failure, contraindication, or intolerance.
UnitedHealthcare may approve based on previous claim/medication history, ICD-10 diagnosis codes, and/or claim logic (automated processes may be used).
Documentation should include prescription claims history when available.

Documentation Required

Prior Statin and Ezetimibe Requirements

Prior statin and ezetimibe requirements: Patients generally must have documented trial and failure, contraindication, or intolerance to maximally tolerated statin therapy (commonly ≥12 weeks of high‑intensity statin when tolerated) and to ezetimibe (≥12 weeks) unless contraindicated or intolerant; document dates and reasons for failure/intolerance.

Document at least 12 consecutive weeks of high‑intensity statin therapy or documentation of intolerance/contraindication to statins at maximally tolerated doses.
Document at least 12 consecutive weeks of ezetimibe adjunct to maximally tolerated statin therapy or documentation of ezetimibe intolerance/contraindication.

HoFH criteria — updated diagnostic considerations

Revised diagnostic optionsHoFH may be confirmed by genetic testing showing bi‑allelic pathogenic/likely pathogenic variants OR by clinical criteria: untreated LDL‑C >400 mg/dL plus early xanthomas or parental FH.

Genetic complexity acknowledgedPolicy revisions explicitly note complexities in genetic test interpretation and digenic mutations; genetic reports should be interpreted in context and submitted when available.

When genetic proof is lackingClinical and laboratory evidence (untreated LDL‑C >400 mg/dL and documented clinical features) can support a HoFH diagnosis for coverage considerations.