CurrentHealth NetPolicy CP PHAR.504

Clinical Policy: Voclosporin (Lupkynis)

Defines medical necessity criteria, initial and continuation approval criteria, dosing limits, contraindications/boxed warnings, and administrative references for voclosporin (Lupkynis) when used for lupus nephritis across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Voclosporin (Lupkynis)

Policy CodePolicy CP PHAR.504

Change TypeFDA-aligned updates; continued therapy clarifications

Effective Date01.22.21

Next Review Date

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

SourceLink

POLICY UPDATE CHANGES

FDA-aligned updates: eGFR requirement removed; cyclophosphamide removed as concurrent recommended therapy; 'background' immunosuppressive therapy language added; rheumatology specialist added; SLE diagnosis criterion added; max dose clarified as 6 capsules/day.

Added continued therapy response criteria (UPCR reduction, eGFR thresholds) for continuation approvals (historically added then revised per 2024 KDIGO guideline).

References and line-of-business off-label policy citations updated (HIM references changed to HIM.PA.154 etc.)

1Covered Indication (FDA)

6 monthsInitial approval duration

12 months

Continued approval duration

47.4 mg/dayMaximum daily dose

Coverage Summary

Coverage stance: covered with criteria for the FDA-approved indication of voclosporin (Lupkynis) in combination with background immunosuppressive therapy for adult patients with active lupus nephritis. Scope: defines medical necessity criteria (initial and continuation), dosing limits (maximum daily dose 47.4 mg / 6 capsules), contraindications/exclusions (concurrent cyclophosphamide or biologic agents), and administrative references across Commercial, HIM, and Medicaid lines of business. Policy number: CP PHAR.504. Effective date: 01.22.21. Last review date: 05.25.

Key thresholds and approval durations

Covered Indication (FDA)1

Initial approval duration6 months

Continued approval duration12 months

Maximum daily dose47.4 mg/day (6 capsules)

UPCR threshold (initial)>= 1.5 mg/mg (alternate >= 2 mg/mg when LN class V)

Initial Therapy Criteria

Other Diagnoses / Initial Coverage Pathways

Continuation Therapy Criteria

Continuation quick-reference thresholds

UPCR response for continuationUPCR < 0.5 mg/mg (from baseline)

eGFR response for continuationeGFR >= 60 ml/min/1.73 m2 OR no reduction > 20% from baseline

Continued approval duration12 months

Diagnoses / Indications Not Authorized

Applicable Codes

NDC / ProductNDC

Capsule: 7.9 mg

Voclosporin available strength per product availability

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is required for Lupkynis (voclosporin). Approval durations per policy are: initial approval for 6 months; continued therapy approvals for 12 months.

Documentation Required

Submit supporting documentation

Submit documentation such as office chart notes, laboratory results, or other clinical information supporting that the member has met all approval criteria.

Clinical Evidence & Guidelines

AURORA 1Primary trial cited: AURORA 1 (phase 3) demonstrating efficacy vs placebo

KDIGO 2024Guideline referenced: KDIGO 2024 Clinical Practice Guideline for lupus nephritis

Primary evidence cited: the phase 3 AURORA 1 trial demonstrating voclosporin efficacy versus placebo for lupus nephritis. Guideline referenced: KDIGO 2024 Clinical Practice Guideline for lupus nephritis. Safety note: voclosporin is a calcineurin inhibitor and, per labeling/background, safety and efficacy in combination with cyclophosphamide have not been established and use is not recommended.

Background

Background: Voclosporin (Lupkynis) is a calcineurin inhibitor approved by the FDA to be used in combination with a background immunosuppressive therapy regimen for treatment of adult patients with active lupus nephritis. The approved dosing regimen for LN is 23.7 mg twice daily (maximum 47.4 mg/day; 6 capsules). It is intended to be prescribed together with background non-biologic immunosuppressive therapy (examples include mycophenolate or azathioprine) and systemic corticosteroid. Explicit safety information: safety and efficacy with cyclophosphamide have not been established and use with cyclophosphamide is not recommended.

Definitions

UPCRUrine protein/creatinine ratio

eGFREstimated glomerular filtration rate

LNLupus nephritis

Revision History

02.23.21revised

05.21 (P&T Approval Date)revised

P&T approval recorded for FDA-aligned criteria updates (same changes as 02.23.21).

06.15.21revised

Removed requirement for trial of immunosuppressive therapy prior to alignment with FDA labeling.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Voclosporin (Lupkynis)

Policy CodePolicy CP PHAR.504

Change TypeFDA-aligned updates; continued therapy clarifications

Effective Date01.22.21

Next Review Date

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

SourceLink

On This Page

Billing Rule

Dose limit enforcement

Dose limit enforcement: the policy lists a maximum daily dose of 47.4 mg (6 capsules/day). Requests for dose increases that would exceed 47.4 mg/day may be denied.

Denial Risk

Concurrent therapy exclusions

Denial risk — concurrent therapy exclusions: requests will not be approved if Lupkynis is prescribed concurrently with cyclophosphamide or a biologic (examples listed in the policy: belimumab/Benlysta, anifrolumab/Saphnelo, rituximab).

02.05.22administrative

2Q2022 annual review: no significant changes; references reviewed and updated.

10.03.22administrative

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

02.08.23administrative

2Q2023 annual review: no significant changes; references reviewed and updated.

12.14.23revised

Added criteria for treatment response and risk of worsening nephrotoxicity for requests exceeding 12 months and revised continued approval duration to 6 months based on time to complete response with Lupkynis.

02.22.24revised

2Q2024 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 based on updated 2024 KDIGO guideline; references reviewed and updated.

02.26.25administrativeLatest

2Q2025 annual review: no significant changes; references reviewed and updated. Policy status current with approval durations: initial 6 months; continued therapy 12 months; maximum daily dose 47.4 mg (6 capsules); voclosporin indicated in combination with background immunosuppressive therapy and not recommended with cyclophosphamide.