CurrentUnitedHealthcarePolicy 2025 P 1166-12

Praluent (alirocumab) prior authorization

Prior authorization and notification criteria for coverage of Praluent (alirocumab) for UnitedHealthcare members, including indications, initial and reauthorization rules, and combination-use restrictions.

Policy Summary

PayerUnitedHealthcare

PolicyPraluent (alirocumab) prior authorization

Policy CodePolicy 2025 P 1166-12

Key ActionObtain prior authorization; initial approvals are issued for 12 months when diagnosis and combination-use restrictions are met.

Change TypeMaterial revisions and administrative updates

Effective DateAug 1, 2025

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

Effective Date listed as 8/1/2025 and P&T approval entries updated through 5/2025.

Background updated to include pediatric indication for patients aged 8 years and older with HeFH.

Authorization and reauthorization criteria simplified; reauthorization requires documentation of positive clinical response.

Added prohibitions on combination use with Leqvio (inclisiran) and clarified not to be used with other PCSK9 inhibitors.

Removed 'diet' requirement from policy.

12 monthsauthorization duration

2025-08-01effective date

5/2025latest P&T

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Praluent (alirocumab)

Initial Therapy (Primary hyperlipidemia / HeFH / ASCVD)

Initial Authorization — primary hyperlipidemia, HeFH, or ASCVD

Initial Authorization for primary hyperlipidemia, HeFH, or ASCVD: All of the following must be met:

Authorization for 12 months

Diagnosis: Patient has one of: (a) Primary hyperlipidemia OR (b) Heterozygous familial hypercholesterolemia (HeFH) OR (c) Atherosclerotic cardiovascular disease (ASCVD)

Combination restrictions: Not used in combination with another proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor (e.g., Repatha/evolocumab) AND not used in combination with Leqvio (inclisiran)

Initial Therapy (HoFH)

Initial Authorization — Homozygous familial hypercholesterolemia (HoFH)

Initial Authorization for HoFH: All of the following must be met:

Authorization for 12 months

Diagnosis of homozygous familial hypercholesterolemia (HoFH)

Concomitant therapy: Patient is receiving other lipid-lowering therapy (e.g., statin, ezetimibe, LDL apheresis)

Combination exclusions: Not used in combination with another proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor (e.g., Repatha/evolocumab) AND not used in combination with Juxtapid (lomitapide)

Reauthorization

Reauthorization requirements: All of the following must be met:

Authorization for 12 months

Clinical response: Documentation of positive clinical response to Praluent therapy

Combination exclusions: Not used in combination with another proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor AND not used in combination with Leqvio (inclisiran) or Juxtapid (lomitapide) where applicable

Praluent must not be used in combination with another PCSK9 inhibitor. The policy explicitly excludes concurrent use with another proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor (for example, Repatha (evolocumab)), and this prohibition applies across initial authorization and reauthorization criteria. Additionally, combination use with Leqvio (inclisiran) is prohibited; for patients with homozygous familial hypercholesterolemia (HoFH) the policy further prohibits combination use with Juxtapid (lomitapide). These combination-use exclusions are enforced as conditions of approval and will result in denial if present.

Coverage of Praluent is subject to member-specific benefit plan rules. Praluent is typically excluded from coverage on some plans and may be subject to tried/failed or other plan-level requirements; providers must refer to the member’s benefit plan to determine coverage. State mandates, federal requirements, other policies, and additional utilization management programs (for example, step therapy, supply limits, or site-of-care rules) may also affect coverage and authorization decisions.

Initial Authorization Criteria (by indication)

Initial Therapy — Initial authorization criteria by indication

Initial authorization criteria by indication

Indication selection: Patient must have one of the covered diagnoses: primary hyperlipidemia, HeFH, ASCVD, or HoFH (HoFH criteria listed separately).

Continuation / Reauthorization Criteria

Continuation Therapy — Reauthorization requires demonstration of benefit

Reauthorization requires demonstration of benefit

Continuation: Documentation of positive clinical response to Praluent therapy is required for reauthorization.

12-month reauthorizations

Provider Actions and Documentation Requirements

Prior Authorization

Initial Authorization — Prior authorization required

Prior authorization required. Initial approval issued for 12 months when diagnosis and combination-use restrictions are met. Approval criteria include appropriate diagnosis (primary hyperlipidemia, HeFH, ASCVD, or homozygous familial hypercholesterolemia as applicable) and that Praluent is not used in combination with another PCSK9 inhibitor (e.g., Repatha/evolocumab).

Initial approval duration: 12 months
Affected products: Praluent
Combination restriction: Not to be used with other PCSK9 inhibitors (e.g., Repatha/evolocumab)

Step Therapy

Plan-level utilization controls

Plan-level utilization controls may apply, including step therapy, medical necessity reviews, supply limits, automated approval based on claims/medication history, and other utilization management programs. Check member-specific benefit plan coverage and state or federal mandates.

Step Therapy and Benefit Limitations

Step	Requirement / Note
1	Refer to member-specific benefit plan coverage; plan-level utilization management programs (e.g., step therapy, medical necessity rules, supply limits) may apply.
	UnitedHealthcare may approve initial or re-authorization based on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic; automated approval processes vary by program.
	Authorization, when criteria are met, will be issued for 12 months. State mandates and federal requirements may affect coverage; Praluent may be excluded on some plans—refer to plan specifics.

Site of Care and Billing Rules

Note

Site-of-care rules and automated approval processes

Site-of-care rules may apply depending on the program; UnitedHealthcare may use automated approval processes that rely on prior claim/medication history and diagnosis codes.

Definitions and Coding-related Notes

Atherosclerotic cardiovascular disease (ASCVD) — examples of qualifying conditions

Acute coronary syndromesIncluded as an example of ASCVD

Prior myocardial infarction (MI)Listed as an example of ASCVD

Angina and coronary revascularizationAngina and revascularization are cited examples of ASCVD

Stroke and transient ischemic attack (TIA)Stroke and TIA are specified as manifestations of ASCVD

Peripheral arterial disease of atherosclerotic originPAD of atherosclerotic origin is included as ASCVD

Background and Indications

Praluent (alirocumab) is a monoclonal antibody in the PCSK9 inhibitor class. It is indicated to reduce cardiovascular risk and to lower LDL-C in specified populations, including adults with primary hyperlipidemia, heterozygous familial hypercholesterolemia (HeFH), and adults with established atherosclerotic cardiovascular disease (ASCVD). Praluent is also indicated as adjunct LDL-C–lowering therapy in homozygous familial hypercholesterolemia (HoFH) and for pediatric patients aged 8 years and older with HeFH.

Policy Changes and Revision History

2025-08-01Effective dateLatest

Policy effective date updated to 2025-08-01 with program number 2025 P 1166-12 and P&T approvals listed through 5/2025.

2025-05Annual review

Annual review conducted and policy updated to remove the 'diet' requirement.

2025-05Background revision

Background updated to align with new label for pediatric patients aged 8 years and older with HeFH.