Praluent (alirocumab) prior authorization
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Prior authorization and coverage criteria for Praluent (alirocumab) for UnitedHealthcare members, including indications, initial and reauthorization requirements, and combination therapy restrictions.
No material clinical or coverage changes in this revision.
Coverage Criteria for Praluent (alirocumab)
Initial Therapy (Primary Hyperlipidemia/HeFH/ASCVD)
Covered when ALL of the following are met:
Authorization issued for 12 months
Reauthorization (Primary Hyperlipidemia/HeFH/ASCVD)
Covered when ALL of the following are met:
Authorization issued for 12 months
Initial Therapy (HoFH)
Covered when ALL of the following are met:
Authorization issued for 12 months
Reauthorization (HoFH)
Covered when ALL of the following are met:
Authorization issued for 12 months
Coverage of Praluent (alirocumab) may vary by member benefit. Praluent is typically excluded from coverage for some plans; tried/failed criteria or other utilization management requirements may be in place. Providers should refer to the member-specific benefit plan to determine whether Praluent is excluded for a particular member and to identify any plan-level restrictions or requirements.
Initial Authorization Requirements
Initial therapy
Initial authorization rules by indication
Authorization issued for 12 months
Reauthorization / Continuation Requirements
Continuation therapy
Reauthorization requirements
Authorization issued for 12 months
Provider Requirements and Operational Notes
Prior authorization required; initial approval prerequisites
Prior authorization is required for Praluent. Initial approvals are granted only when the member has a covered diagnosis (primary hyperlipidemia, heterozygous familial hypercholesterolemia [HeFH], or atherosclerotic cardiovascular disease [ASCVD]) and all other listed coverage criteria are met; authorizations are issued for 12 months.
- Initial authorization requires one of: primary hyperlipidemia, HeFH, or ASCVD
- Requests must meet all coverage criteria to be approved
- Authorization duration: 12 months
Step therapy, supply limits, and medical necessity may apply
Medical necessity reviews, supply limits, and step therapy requirements may apply based on the member's benefit plan; confirm member-specific plan rules before prescribing.
- Check the member-specific benefit plan for any step therapy requirements
- Supply limits or other utilization management programs may apply
Reauthorization requires documentation of positive clinical response
For reauthorization, submit documentation demonstrating a positive clinical response to Praluent therapy; reauthorizations are contingent on meeting the continuation criteria and are issued for 12 months.
- Provide objective documentation of positive clinical response to therapy
- Reauthorization also requires the medication not be used in prohibited combinations
Do not combine Praluent with other PCSK9 inhibitors, inclisiran, or lomitapide
Requests will be denied if Praluent is prescribed in combination with another PCSK9 inhibitor or with inclisiran (Leqvio); for HoFH, combination with lomitapide (Juxtapid) is also prohibited.
- Do not prescribe Praluent with another PCSK9 inhibitor (e.g., Repatha/evolocumab)
- Do not prescribe Praluent with inclisiran (Leqvio)
- For HoFH patients, do not combine Praluent with lomitapide (Juxtapid)
Step Therapy and Supply Limits
| Plan-level requirement | Notes / member-specific guidance |
|---|---|
| Medical necessity, supply limits, and step therapy may be in place per member benefit plan. | |
| Refer to the member-specific benefit plan and any applicable state mandates or federal regulatory requirements to determine applicable step therapy, quantity/supply limits, or exclusions. Praluent is typically excluded from coverage for some plans; tried/failed criteria may apply. |
Key Definitions
Background
Praluent (alirocumab) is a PCSK9 inhibitor used to reduce low-density lipoprotein cholesterol (LDL-C) and to lower the risk of major adverse cardiovascular events in indicated populations. The policy aligns coverage with labeled indications, including use for primary hypercholesterolemia, heterozygous familial hypercholesterolemia (HeFH) (pediatric patients aged ≥ 8 years noted in labeling), and homozygous familial hypercholesterolemia (HoFH), as well as reduction of cardiovascular risk in adults with atherosclerotic cardiovascular disease (ASCVD). Authorization decisions follow these indications and include requirements for documented clinical response on reauthorization and restrictions on combination use with other PCSK9 inhibitors, lomitapide (for HoFH), and inclisiran (Leqvio).
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