CurrentCignaPolicy IP0122

Lupus - Lupkynis

Cigna coverage policy specifying prior authorization criteria, duration of approval, prescribing specialist requirement, and exclusions for Lupkynis (voclosporin) used to treat active lupus nephritis in adults. It describes initial and continuation approval criteria, limitations (e.g., not to combine with cyclophosphamide or biologics), and appendix examples of biologics.

Policy Summary

PayerCigna

PolicyLupus - Lupkynis

Policy CodePolicy IP0122

Change TypeAnnual Revision (no criteria changes)

Effective DateJun 15, 2025

Next Review Date

Key ActionPrior Authorization is recommended; approvals are provided for specified durations (6 months for initial therapy, 1 year for continuation) and require prescribing by or consultation with a nephrologist or rheumatologist.

POLICY UPDATE CHANGES

Updated coverage policy title from Voclosporin to Lupus - Lupkynis

Updated Appendix

2Approval Pathways (Initial, Continuation)

>45eGFR threshold

6mo / 1yrTypical approval durations (initial/continuation)

Coverage Summary

Lupkynis (voclosporin) is covered with criteria for adults with active, biopsy-confirmed lupus nephritis under policy number IP0122. This Cigna coverage policy applies to prescription benefit plans administered by Cigna Companies. The policy effective and last review date is 2025-06-15 (Effective Date/Last Review: 6/15/2025). The coverage stance is covered_with_criteria and approvals are provided for the durations specified in the policy when criteria are met.

FDA-Approved Indication — Initial & Continuation Criteria

FDA-Approved Indication

Approve for the duration noted if the patient meets ONE of the following (A or B):

ANY of the following

A) Initial Therapy
- Patient is ≥ 18 years of age
- Diagnosis of lupus nephritis has been confirmed on biopsy
  For example, World Health Organization class III, IV, or V lupus nephritis.
- The medication is being used concurrently with an immunosuppressive regimen
  For example, mycophenolate mofetil or azathioprine with a systemic corticosteroid.
- Patient has an estimated glomerular filtration rate (eGFR) > 45 mL/min/m2> 45 mL/min/m2
- The medication is prescribed by or in consultation with a nephrologist or rheumatologist
B) Patient is Currently Receiving Lupkynis
- Patient is ≥ 18 years of age
- The medication is being used concurrently with an immunosuppressive regimen
  For example, mycophenolate mofetil or azathioprine with a systemic corticosteroid.
- Patient has responded to Lupkynis, as determined by the prescriber
  Examples of a response include improvement in organ dysfunction, reduction in flares, reduction in corticosteroid dose, decrease of anti-double stranded DNA (anti-dsDNA) titer, and improvement in complement levels (i.e., C3, C4).
- The medication is prescribed by or in consultation with a nephrologist or rheumatologist

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Prescribing & Administration Requirements

Prescribing and Administration Requirements

Operational requirements for approvals:

ALL of the following

Prior Authorization is recommended for prescription benefit coverage of Lupkynis
Approvals are provided for the duration noted; when authorized in months, 1 month = 30 days
Because of specialized skills required, approval requires Lupkynis to be prescribed by a physician who has consulted with or who specializes in the condition (nephrologist or rheumatologist)
Specifically requires prescription by or consultation with a nephrologist or rheumatologist (also listed in indication criteria).
Dosage, frequency, duration of therapy, and site of care should be reasonable, clinically appropriate, and supported by evidence-based literature
Receipt of sample product does not satisfy any criteria requirements for coverage

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Prior Authorization

Prior authorization required

Prior authorization is recommended for Lupkynis. Approvals are provided for the durations specified (6 months for initial therapy; 1 year for continuation). Approval requires that Lupkynis be prescribed by or in consultation with a nephrologist or rheumatologist.

Initial therapy approval: 6 months
Continuation approval: 1 year
Must be prescribed by or in consultation with a nephrologist or rheumatologist

Documentation Required

Documentation of biopsy-confirmed lupus nephritis

For initial therapy, the provider must document that the diagnosis of lupus nephritis was confirmed on kidney biopsy (for example, World Health Organization class III, IV, or V).

Documentation Required

Concurrent immunosuppressive regimen

The provider must document that Lupkynis is being used concurrently with an immunosuppressive regimen.

Examples: mycophenolate mofetil
azathioprine with a systemic corticosteroid

Documentation Required

Evidence of response for continuation

For continuation (patients currently receiving Lupkynis), the provider must document that the patient has responded to therapy as determined by the prescriber. Examples of response include improvement in organ dysfunction, reduction in flares, reduction in corticosteroid dose, decrease of anti-double stranded DNA (anti-dsDNA) titer, and improvement in complement levels (C3, C4).

Denial Risk

Coverage denial for unapproved combinations

Claims for concurrent use of Lupkynis with biologic agents or with cyclophosphamide, or for indications such as plaque psoriasis, may be considered experimental/investigational and denied because safety and efficacy have not been established.

See Appendix for examples of biologics that should not be taken in combination with Lupkynis

Unproven / Exclusions

Conditions Not Covered (Experimental/Unproven)

Any other use is considered experimental, investigational, or unproven, including but not limited to:

ANY of the following

Concurrent use with biologics or with cyclophosphamide
Lupkynis has not been studied in combination with other biologics or cyclophosphamide; safety and efficacy have not been established. See Appendix for examples of biologics that should not be taken in combination with Lupkynis.
Plaque Psoriasis
Voclosporin was inferior to cyclosporine in a Phase III trial; other FDA-approved therapies with established efficacy are available.

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OpenPayer

Lupus - Lupkynis

Coverage Summary

FDA-Approved Indication — Initial & Continuation Criteria

Prescribing & Administration Requirements

Unproven / Exclusions

Applicable Codes

Clinical Evidence & Background

Definitions

Revision History