CurrentUnitedHealthcarePolicy 2025 P 1359-5

Lupkynis (voclosporin) prior authorization criteria

UnitedHealthcare prior authorization policy for Lupkynis (voclosporin) for treatment of adult patients with active lupus nephritis, covering initial and reauthorization requirements and authorization duration.

Policy Summary

PayerUnitedHealthcare

PolicyLupkynis (voclosporin) prior authorization criteria

Policy CodePolicy 2025 P 1359-5

Change TypeAdministrative updatesreference update

Effective DateSep 1, 2025

Next Review Date

Key ActionSubmit prior authorization requests and required documentation; approvals are granted when initial or reauthorization criteria are met and authorizations are issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

Authorization lengths were updated to 12 months (6/2024).

Reference list updated (6/2025).

12 monthsInitial authorization length

12 monthsReauthorization length

1Drug covered by this program

adultPopulation specified

Medical Necessity Criteria for Lupkynis (voclosporin)

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Initial Authorization 6 Medically Necessary

Lupkynis will be approved based on ALL of the following criteria:

ALL of the following

Diagnosis of active lupus nephritis
Prescribed in combination with a background immunosuppressive therapy regimen (e.g., mycophenolate mofetil and corticosteroids)
Patient is not receiving Lupkynis in combination with cyclophosphamide
Use of Lupkynis in combination with cyclophosphamide is not recommended; safety and efficacy not established.

Reauthorization 6 Continued Therapy

Lupkynis will be approved for reauthorization based on ALL of the following criteria:

ALL of the following

Documentation of positive clinical response to Lupkynis therapy
Prescribed in combination with a background immunosuppressive therapy regimen (e.g., mycophenolate mofetil and corticosteroids)
Patient is not receiving Lupkynis in combination with cyclophosphamide
Reauthorization requires continued absence of combination with cyclophosphamide.

Prior Authorization, Documentation, and Denial Risk

Prior Authorization

Prior authorization required

Prior authorization/notification program applies for Lupkynis; approvals are granted when initial or reauthorization criteria are met. Authorization length is 12 months.

Authorization length = 12 months

Documentation Required

Document clinical response for reauthorization

For reauthorization, providers must supply documentation of positive clinical response to Lupkynis therapy as part of the reauthorization criteria.

Denial Risk

Denial risk if combined with cyclophosphamide

Use of Lupkynis in combination with cyclophosphamide is not recommended and safety and efficacy have not been established; requests for such combination therapy do not meet criteria and may be denied.

Prior Authorization

Automated approvals may occur

UnitedHealthcare may approve initial and reauthorization requests based solely on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic where applicable; automated approval processes vary by program.

Clinical and Administrative Background

Lupkynis (voclosporin) is a calcineurin-inhibitor immunosuppressant indicated, in combination with a background immunosuppressive therapy regimen, for adult patients with active lupus nephritis. Authorization under this program follows UnitedHealthcare prior authorization requirements and is issued for 12 months for both initial and reauthorization requests.

Safety and efficacy have not been established when Lupkynis is used in combination with cyclophosphamide; use in this setting is not recommended and such combinations do not meet criteria for approval.

This policy references the Lupkynis package insert (Aurinia Pharma U.S., Inc.; April 2024) and reflects administrative updates to authorization length and reference citations in the change control history.

Policy Scope and Status

Policy metadata and notes

Policy number2025 P 1359-5

Coverage stanceCovered with criteria (prior authorization/notification required)

SubjectLupkynis (voclosporin) prior authorization criteria

Scope summaryUnitedHealthcare prior authorization policy for Lupkynis (voclosporin) for treatment of adult patients with active lupus nephritis, covering initial and reauthorization requirements and authorization duration.

Status and effective dateCURRENT; Effective date: 2025-09-01; Last review: 2025-06

NotesState mandates and member-specific benefit plan coverage may impact coverage; supply limitations may apply. Policy references Lupkynis package insert (Aurinia Pharma U.S., Inc.; April 2024).

Policy Update Changes

2024-06clarified

Authorization lengths were updated to 12 months; administrative update reflected in change control history; clinical criteria remained unchanged.

2025-06revisedLatest

Reference list updated (citation to package insert updated to April 2024 edition); administrative update reflected in change control history; clinical criteria remained unchanged.