CurrentmhnPolicy CP.PHAR.504

Voclosporin (Lupkynis)

Defines medical necessity criteria, initial and continued approval requirements, exclusions, dosing limits, prescriber and concomitant therapy requirements, and authorization durations for voclosporin (Lupkynis) across Commercial, ICHRA, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyVoclosporin (Lupkynis)

Policy CodePolicy CP.PHAR.504

Change TypeRevisions and annual reviews

Effective DateJan 22, 2021

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, other clinical information) supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Revised initial approval duration from 6 to 12 months and added Gazyva as an example of a biologic excluded for concurrent use; added ICHRA line of business.

Added exclusion for concurrent treatment with cyclophosphamide or a biologic and revised continued approval duration to 12 months.

Added criteria for member's treatment response and risk of worsening nephrotoxicity for requests exceeding >12 months and revised continued approval duration to 6 months (later changed back).

Template changes applied to other diagnoses/indications and continued therapy section.

3Biopsy classes listed for approval

18+Minimum age (years)

47.4Maximum daily dose (mg)

Coverage Summary

Coverage stance: covered_with_criteria for voclosporin (Lupkynis) for treatment of adult patients with active lupus nephritis. Scope: defines medical necessity, initial and continued approval requirements, exclusions, dosing limits, prescriber and concomitant therapy requirements, and authorization durations across Commercial, ICHRA, and Medicaid lines of business. Effective date: 01.22.21; Last review / most recent update: 05.26 (2Q 2026 annual review).

Initial Therapy Criteria — Lupus Nephritis

I. Initial Approval Criteria - Lupus Nephritis

Covered when ALL of the following are met:

ALL of the following

Diagnosis of lupus nephritis with kidney biopsy
- LN class III (focal)
- LN class IV (diffuse segmental or global)
- LN class V (membranous)
Prescriber requirement: Prescribed by or in consultation with a nephrologist or rheumatologist
Age requirement: Age ≥ 18 yearsAge: ≥ 18 years
SLE diagnosis: Confirmed diagnosis of systemic lupus erythematosus
Evidence of proteinuria (ONE of)
- UPCR threshold A: Urine protein/creatinine ratio (UPCR) ≥ 1.5 mg/mgUPCR ≥ 1.5 mg/mg
- UPCR threshold B: UPCR ≥ 2 mg/mg and LN Class VUPCR ≥ 2 mg/mg if LN Class V
Concomitant therapy requirement
- Background immunosuppressive therapy (e.g., mycophenolate, azathioprine)
- Systemic corticosteroid (e.g., prednisone)
Concurrent excluded therapies: Not prescribed concurrently with cyclophosphamide or a biologic (examples: Benlysta, Gazyva, Saphnelo, rituximab)
Safety and efficacy in combination with cyclophosphamide not established
Dose limit: Dose does not exceed 47.4 mg (6 capsules) per dayMaximum daily dose: 47.4 mg/day (6 capsules)
LN dosing regimen: 23.7 mg PO BID; maximum 47.4 mg/day

Initial Therapy — Other Diagnoses / Off‑Label Routing

I. Initial Approval Criteria - Other diagnoses/indications

If drug label recently changed or requested use not listed:

Routing for other diagnoses/indications

Recent label change: If drug had a label change within last 6 months not yet reflected in this policy, follow applicable formulary/no-coverage or non-formulary policies per line of business (references provided in policy)
See policy for specific referenced policies per line of business
Off-label referral: If requested use is not specifically listed under section III and criterion 1 above does not apply, refer to off-label use policy for the relevant line of business (references provided)
See policy for specific off-label policy references per line of business

Continuation Therapy Criteria — Lupus Nephritis

II. Continued Therapy - Lupus Nephritis

Covered when ALL of the following are met:

ALL of the following

Member eligibility for continued therapy (ONE of)
- Currently receiving via Centene or met initial criteria: Currently receiving medication via Centene benefit or previously met initial approval criteria
- Continuity of care: Currently receiving medication and enrolled in a state/product with continuity of care regulations (refer to state addendums CC.PHARM.03A and CC.PHARM.03B)
Member is responding positively as evidenced by ONE of

Continuation Therapy — Other Diagnoses / Off‑Label Routing

II. Continued Therapy - Other diagnoses/indications

Same routing as initial 'Other diagnoses' section:

Routing for continued therapy - other diagnoses

Recent label change: If drug had a label change within last 6 months not yet reflected, follow applicable formulary/no-coverage or non-formulary policies per line of business (references provided)
See policy for specific referenced policies per line of business
Off-label referral: If requested use is not specifically listed under section III and criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business (references provided)
See policy for specific off-label policy references per line of business

Exclusions & Not Authorized Uses

III. Diagnoses/Indications NOT authorized

Coverage is NOT authorized for:

Non-FDA indications excluded: Non-FDA approved indications unless sufficient documentation of efficacy and safety per off-label use policies or evidence of coverage documents

Refer to off-label policies CP.CPA.09 (commercial), HIM.PA.154 (ICHRA), CP.PMN.53 (Medicaid)

Concurrent-use exclusion: voclosporin is not authorized to be prescribed concurrently with cyclophosphamide or a biologic; examples of excluded biologics listed include Benlysta, Gazyva, Saphnelo, and rituximab. Product availability/strength context: voclosporin is available as a 7.9 mg capsule.

Applicable Codes

Product availability / StrengthNDC

7.9 mg capsule

Voclosporin capsule strength (product availability)

Provider Actions & Authorization Requirements

Prior Authorization

Prescriber specialty requirement

Prescribed by or in consultation with a nephrologist or rheumatologist is required for initial approval.

Documentation Required

Submit supporting documentation

Provider must submit documentation such as office chart notes, lab results, or other clinical information supporting that the member has met all approval criteria.

Clinical Evidence & Guidelines

Evidence summary: the primary randomized controlled trial cited is the AURORA 1 trial (voclosporin vs placebo). The policy references the KDIGO 2024 Lupus Nephritis guideline. The drug is FDA‑approved in combination with background immunosuppressive therapy for active lupus nephritis; safety and efficacy in combination with cyclophosphamide have not been established.

AURORA 1Primary RCT cited in policy (voclosporin vs placebo)

KDIGO 2024Guideline referenced for lupus nephritis management and policy updates

23.7 mg BIDLN dosing regimen (max 47.4 mg/day) from policy label

Background

Voclosporin (Lupkynis) is a calcineurin inhibitor FDA‑approved in combination with background immunosuppressive therapy for treatment of adult patients with active lupus nephritis. The labeling states that safety and efficacy in combination with cyclophosphamide have not been established and use with cyclophosphamide is not recommended.

Revision History

2Q 2026materialLatest

Annual review: revised initial approval duration from 6 to 12 months; added Gazyva as an example of a biologic excluded for concurrent use; added ICHRA line of business; references reviewed and updated; P&T Approval Date = 05.26.

2Q 2024material

Annual review: added exclusion for concurrent treatment with cyclophosphamide or a biologic; revised continued approval duration to 12 months and removed treatment response criterion for requests exceeding 12 months per 2024 KDIGO guideline updates; P&T Approval Date = 05.24.

2Q 2023material