CurrentBlue Cross Blue Shield - IowaPolicy 05.04.34

Lupkynis_Medical_Policy

Defines medical necessity criteria, documentation requirements, quantity limits, dosing guidance, and billing notes for use of Lupkynis (voclosporin) in adult patients with active lupus nephritis for members of Wellmark Blue Cross and Blue Shield.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyLupkynis_Medical_Policy

Policy CodePolicy 05.04.34

Change TypeAdministrative review (no material change)

Effective DateMay 17, 2023

Next Review Date

Key ActionSubmit medical records (chart notes, lab reports) for initial requests documenting autoantibodies or kidney biopsy and for continuation requests documenting disease stability or improvement to initiate prior authorization review.

POLICY UPDATE CHANGES

Policy reviewed April 2025; last revision April 2023; current effective date May 17, 2023.

12 monthsApproval duration

180/30dQuantity limit (7.9 mg)

Adults with active LNCovered population

Coverage Summary

Coverage stance: covered_with_criteria. Scope: Defines medical necessity criteria, documentation requirements, quantity limits, dosing guidance, and billing notes for use of Lupkynis (voclosporin) in adult patients with active lupus nephritis. Subject: Lupkynis (voclosporin) for lupus nephritis. Status: CURRENT. Key thresholds: approval duration 12 months; quantity limit 180 capsules per 30 days (Lupkynis 7.9 mg).

Initial Therapy Criteria

Initial Approval Criteria

Lupkynis (voclosporin) may be considered medically necessary when ALL of the following are met:

ALL of the following

Autoantibodies or biopsy: Member is positive for autoantibodies relevant to SLE (e.g., ANA, anti-ds DNA, anti-Sm, antiphospholipid antibodies, complement proteins) OR lupus nephritis was confirmed on kidney biopsy
Initial request requires medical records (chart notes, lab reports) documenting presence of autoantibodies or kidney biopsy supporting diagnosis
Clinically active disease and background therapy: Member has clinically active lupus renal disease and is receiving background therapy with mycophenolate mofetil (MMF) with corticosteroids
Specialist involvement: Medication is being prescribed by, or in consultation with, a nephrologist or rheumatologist
Include consultation notes when applicable

Policy and indication: Lupkynis is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis

Approvals may be subject to dosing limits per FDA labeling and evidence-based guidelines

Prior Authorization

Prior authorization — initial request

Submission of initial medical records is required for prior authorization review. Provide chart notes and laboratory reports documenting presence of autoantibodies relevant to SLE (e.g., ANA, anti-dsDNA, anti-Sm, antiphospholipid antibodies, complement proteins) or a kidney biopsy supporting the diagnosis.

Continuation Therapy Criteria

Continuation of Therapy

Continued treatment may be considered medically necessary when ALL of the following are met:

Clinical response: Member achieved or maintains a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition

Continuation requests require medical records (chart notes, lab reports) documenting disease stability or improvement

Prior Authorization

Prior authorization — continuation requests

For continuation prior authorization requests, submit medical records demonstrating disease stability or improvement, including chart notes and relevant laboratory reports.

Chart notes
Laboratory reports

Unproven / Not Medically Necessary

Not Medically Necessary

Conditions regarded as not medically necessary:

Not medically necessary uses: Use of Lupkynis in combination with cyclophosphamide

Safety and efficacy have not been established; coverage will not be provided for members using Lupkynis with cyclophosphamide

Failure to meet criteria: Members who do not meet the initial or continuation criteria above

Lupkynis is considered not medically necessary for members who do not meet the criteria set forth in the policy

Denial Risk

Contraindicated combination

Claims will be denied for members using Lupkynis in combination with cyclophosphamide.

Applicable Codes

Procedures and Billing Codesmixed

No codes listed

Billing Rule

Quantity limit enforcement

Quantity limit for Lupkynis 7.9 mg is enforced at 180 capsules per 30 days. Approvals may also be subject to dosing limits in accordance with FDA-approved labeling and evidence-based guidelines.

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is required. Submission of initial or continuation medical records (chart notes, lab reports) documenting autoantibodies or kidney biopsy for initial requests, and documentation of disease stability or improvement for continuation requests, is necessary to initiate prior authorization review.

Initial: chart notes
Initial: laboratory reports
Initial: documentation of autoantibodies or kidney biopsy
Continuation: chart notes demonstrating disease stability or improvement
Continuation: laboratory reports demonstrating disease stability or improvement

Documentation Required

Specialist prescribing/consult requirement

Medication must be prescribed by, or in consultation with, a nephrologist or rheumatologist. Include consultation notes when applicable.

Include consultation notes when applicable

Billing Rule

Quantity limit enforcement

Quantity limit applied: 180 capsules per 30 days for Lupkynis 7.9 mg. Approvals may be subject to dosing limits per FDA-approved labeling and evidence-based guidelines.

Background

Background: Lupkynis (voclosporin) is FDA-approved in combination with background immunosuppressive therapy for the treatment of adult patients with active lupus nephritis. Documentation requirements for prior authorization include medical records (chart notes, lab reports) showing relevant autoantibodies or kidney biopsy for initial requests and evidence of disease stability or improvement for continuation requests. Safety and efficacy of Lupkynis in combination with cyclophosphamide have not been established and use in combination with cyclophosphamide is not recommended and will not be covered.

Key thresholds and population

Approval duration12 months

Quantity limit (Lupkynis 7.9 mg)180 capsules per 30 days

Covered populationAdults with active lupus nephritis

Revision History

April 2025revisedLatest

Policy reviewed April 2025; last revision April 2023; current effective date May 17, 2023.

April 2023revised

Policy reviewed April 2025; last revision April 2023; current effective date May 17, 2023.

May 17, 2023revised

Policy reviewed April 2025; last revision April 2023; current effective date May 17, 2023.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyLupkynis_Medical_Policy

Policy CodePolicy 05.04.34

Change TypeAdministrative review (no material change)

Effective DateMay 17, 2023

Next Review Date

On This Page

OpenPayer

Lupkynis_Medical_Policy

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Unproven / Not Medically Necessary

Applicable Codes

Provider Actions

Clinical Evidence

Background

Revision History