CurrentCignaPolicy IP0122

Lupkynis (voclosporin) for lupus nephritis

This Cigna coverage policy governs prior authorization and coverage criteria for Lupkynis (voclosporin) used to treat active lupus nephritis in adults under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyLupkynis (voclosporin) for lupus nephritis

Policy CodePolicy IP0122

Change TypeNo material changes

Effective DateJun 15, 2025

Next Review Date

Key ActionObtain prior authorization; initial approvals are for 6 months and renewals for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18minimum age for coverage

6 moinitial approval

1 yrrenewal approval

>45eGFR threshold

2025-06-15effective date

Coverage Criteria for Lupkynis (voclosporin)

Policy Summary

PayerCigna

PolicyLupkynis (voclosporin) for lupus nephritis

Policy CodePolicy IP0122

Change TypeNo material changes

Effective DateJun 15, 2025

Next Review Date

Key ActionObtain prior authorization; initial approvals are for 6 months and renewals for 1 year when criteria are met.

SourceLink

On This Page

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FDA-Approved Indication Criteria

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

A) Initial Therapy

Initial criteria: i. Patient is ≥ 18 years of age; ii. Diagnosis of lupus nephritis confirmed on biopsy (for example, WHO class III, IV, or V); iii. Medication used concurrently with an immunosuppressive regimen (for example, mycophenolate mofetil or azathioprine with a systemic corticosteroid); iv. Estimated glomerular filtration rate (eGFR) > 45 mL/min/1.73 m2; v. Prescribed by or in consultation with a nephrologist or rheumatologist.
See prescribing context for examples of concurrent regimens.

B) Currently Receiving Lupkynis

Continuation criteria: i. Patient is ≥ 18 years of age; ii. Medication used concurrently with an immunosuppressive regimen (for example, mycophenolate mofetil or azathioprine with a systemic corticosteroid); iii. Patient has responded to Lupkynis as determined by the prescriber (examples: improvement in organ dysfunction, reduction in flares, reduction in corticosteroid dose, decrease in anti-dsDNA titer, improvement in complement C3/C4); iv. Prescribed by or in consultation with a nephrologist or rheumatologist.
Response determination is per prescriber assessment.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required — initial approvals are for 6 months; continuation approvals are for 1 year. Because of the specialized skills required for evaluation and monitoring of patients treated with Lupkynis, approvals require the medication to be prescribed by or in consultation with a nephrologist or rheumatologist.

Initial approvals: 6 months (1 month = 30 days)
Continuation approvals: 1 year

Step Therapy

Step-Therapy / Prescribing Context

No explicit step-therapy sequencing is required by this policy. KDIGO (2024) guidelines recommend Lupkynis or Benlysta as one of the initial treatment options for biopsy-confirmed Class III or IV (± V) lupus nephritis and do not express a required order of therapies; prescribers should consider individual patient factors when selecting treatment.

No step-therapy required; prescriber clinical judgment per KDIGO guidance

Documentation Required

Authorization Prescriber and Documentation Requirements

Approvals require that Lupkynis be prescribed by a physician who has consulted with or who specializes in the condition (nephrologist or rheumatologist). Supporting documentation should be provided demonstrating biopsy-confirmed lupus nephritis for initial therapy, concurrent use of an immunosuppressive regimen, relevant baseline renal function (eGFR), and evidence of treatment response for continuation requests where applicable.

Prescriber requirement: nephrologist or rheumatologist (prescribed by or in consultation with)
Documentation for initial approval: biopsy confirmation of lupus nephritis, patient ≥18 years, eGFR >45 mL/min/1.73 m2, documentation of concurrent immunosuppressive regimen
Documentation for continuation approval: evidence of response to Lupkynis, patient ≥18 years, documentation of concurrent immunosuppressive regimen

Denial Risk

Claims/Billing Denial Risk

Claims for services that are not accompanied by covered code(s) under the applicable Coverage Policy will be denied as not covered. When billing, providers must use the most appropriate diagnosis and procedure codes as of the date of service.

Claims not billed with covered/appropriate codes per the Coverage Policy will be denied as not covered
Use the most appropriate diagnosis/procedure codes as of the date of service

Background

Lupkynis (voclosporin) is a calcineurin inhibitor immunosuppressant indicated for the treatment of active lupus nephritis in adults when used in combination with a background immunosuppressive regimen and systemic corticosteroids. Clinical guidance (KDIGO 2024) recognizes Lupkynis as an initial treatment option alongside other therapies for biopsy‑confirmed Class III or IV (±V) lupus nephritis. Per the policy, FDA‑approved coverage is limited to adults meeting the listed criteria (for example, biopsy‑confirmed disease, use with an immunosuppressive regimen, and eGFR thresholds), and approvals are issued for defined durations when criteria are met.

OpenPayer

Lupkynis (voclosporin) for lupus nephritis

Coverage Criteria for Lupkynis (voclosporin)

Coding and Laboratory Thresholds

Provider Actions and Authorization Requirements

Background

Definitions