CurrentallcareadvantagePolicy 104.1

voclosporin (Lupkynis) — calcineurin‑inhibitor immunosuppressant coverage criteria

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Defines prior authorization and renewal criteria for coverage of the calcineurin‑inhibitor voclosporin (Lupkynis) for adult patients with active lupus nephritis; applies to AllCare Advantage members requiring PA for this agent.

Policy Summary

Payerallcareadvantage

Policyvoclosporin (Lupkynis) — calcineurin‑inhibitor immunosuppressant coverage criteria

Policy CodePolicy 104.1

Change TypeNo material change

Effective DateJun 1, 2021

Last ReviewJun 17, 2021

Next Review DateJun 17, 2023

Key ActionObtain prior authorization and document that the prescriber is a rheumatologist (or consulted with one) plus required biopsy, labs, and trial or contraindication to belimumab.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial/renewal approval length

eGFR >45minimum renal function

≥50% ↓ UPCRrenewal response required

adultFDA population

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CurrentallcareadvantagePolicy 104.1

voclosporin (Lupkynis) — calcineurin‑inhibitor immunosuppressant coverage criteria

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Sign up for allcareadvantage Policy 104.1 alerts

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Policy Summary

Payerallcareadvantage

Policyvoclosporin (Lupkynis) — calcineurin‑inhibitor immunosuppressant coverage criteria

Policy CodePolicy 104.1

Change TypeNo material change

Effective DateJun 1, 2021

Last ReviewJun 17, 2021

Next Review DateJun 17, 2023

Key ActionObtain prior authorization and document that the prescriber is a rheumatologist (or consulted with one) plus required biopsy, labs, and trial or contraindication to belimumab.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial/renewal approval length

eGFR >45minimum renal function

≥50% ↓ UPCRrenewal response required

adultFDA population

Coverage Criteria for Voclosporin (Lupkynis)

Initial Therapy

Covered when ALL of the following initial criteria are met:

Initial approval criteria: 1) Prescription written by or in consultation with a rheumatologist; 2) Documentation of funded diagnosis of active lupus nephritis with renal biopsy performed within the previous 6 months to 2 years; 3) Current laboratory results documenting estimated glomerular filtration rate (eGFR) >45; 4) Documentation that the member will continue receiving standard background immunosuppressive therapy; 5) Documentation of trial of, or contraindication to, belimumab when required; 6) Member is not receiving concurrent treatment with belimumab unless criteria allowing concurrent use are met.eGFR >45

Approval length up to 6 months.

Continuation / Renewal Therapy

Renewal covered when ALL of the following are met:

Renewal criteria: 1) Member has been evaluated by a rheumatologist or nephrologist within the prior 6 months (or is scheduled for evaluation within 3 months); 2) Documentation or physician attestation of response to therapy defined as ≥ 50% decrease in urinary protein:creatinine ratio (UPCR) from baseline.≥50% UPCR decrease

Renewal approval up to 6 months if criteria met.

Concurrent use of belimumab is addressed explicitly in the coverage criteria. Members who are receiving concurrent belimumab may be denied unless documentation meets the policy's conditions (e.g., prior trial or documented contraindication to belimumab where required). Ensure the authorization request clearly describes current biologic therapy and provides the necessary justification to support coverage when belimumab is being given concomitantly.

Coverage is contingent on clinician specialty, diagnostic documentation, and specified laboratory thresholds. The prescription must be written by—or in consultation with—a rheumatologist; requests that do not meet this requirement are deniable. For initial approval, provide documentation of a funded diagnosis of active lupus nephritis supported by a renal biopsy performed within the prior 6 months to 2 years. Current labs must document an estimated glomerular filtration rate of eGFR >45. For renewals, the member must have been evaluated by a rheumatologist or nephrologist within the prior 6 months or be scheduled for evaluation within 3 months, and there must be documentation or physician attestation of treatment response defined as a ≥ 50% decrease in urinary protein:creatinine ratio from baseline. Requests missing these biopsy, specialty, or laboratory requirements should be denied.

Key Clinical Thresholds and Coding

Proteinuria response threshold

Proteinuria response threshold≥ 50% decrease in urinary protein:creatinine ratio from baseline

Measurement metricUrinary protein:creatinine ratio (UPCR)

Used forRenewal decision — documented response to therapy required

Renal function threshold

Renal function thresholdeGFR >45

Assessment timingCurrent labs required at time of initial authorization

Consequence if not metDenial of request

Provider Requirements, Documentation, and Denial Triggers

Prior Authorization

Prior authorization required for voclosporin (Lupkynis)

Prior authorization is required for voclosporin (Lupkynis); coverage is limited to adult patients with active lupus nephritis who meet the policy's criteria.

Step Therapy

Trial of belimumab or documented contraindication required

Document a trial of belimumab or a documented contraindication before approval; members receiving concurrent belimumab may be denied unless the policy criteria permitting concomitant use are met.

Step requires trial of or contraindication to belimumab per policy language.

Background

Voclosporin is a calcineurin-inhibitor immunosuppressant authorized by FDA for treatment of adult patients with active lupus nephritis and is intended for use in combination with background immunosuppressive therapy. The policy requires adherence to the labeled adult indication and notes clinical oversight by a rheumatologist (or consultation) and monitoring of renal function; if therapeutic benefit is not evident by about 24 weeks, discontinuation should be considered.

Definitions

Active lupus nephritis and renal biopsy timing

DefinitionClinical diagnosis of active lupus nephritis (LN) documented and supported by renal biopsy

Biopsy timing requirementRenal biopsy performed within the prior 6 months to 2 years

Prescribing clinicianPrescription must be written by or in consultation with a rheumatologist

Context of useVoclosporin is indicated for adult patients with active LN and used with background immunosuppressive therapy

Initial Authorization Criteria

Initial

Initial authorization criteria for voclosporin (Lupkynis):

Initial: 1) FDA‑approved indication: treatment of adult patients with active lupus nephritis and used in combination with background immunosuppressive therapy; 2) Prescribing clinician is a rheumatologist or the prescription is in consultation with a rheumatologist; 3) Documentation of renal biopsy within the prior 6 months to 2 years confirming active lupus nephritis; 4) Current labs showing eGFR >45; 5) Documentation of trial of, or contraindication to, belimumab when required; 6) Not receiving concurrent belimumab unless criteria permitting concurrent use are met.use in adults; eGFR >45

Consider discontinuation if no therapeutic benefit by 24 weeks. Initial approval up to 6 months.

Renewal / Continuation Criteria

Renewal

Renewal requirements for continued coverage of voclosporin:

Renewal: 1) Member has been evaluated by a rheumatologist or nephrologist within the prior 6 months (or is scheduled for evaluation within 3 months); 2) Documentation or physician attestation demonstrating a response to therapy defined as ≥ 50% decrease in urinary protein:creatinine ratio from baseline.≥50% UPCR decrease

Renewal approval up to 6 months.

Step Therapy Requirements

Requirement	Details
Trial of belimumab or documented contraindication to belimumab	Documentation of a trial of belimumab OR a documented contraindication to belimumab is required prior to approval (member receiving concurrent belimumab may lead to denial unless criteria permitting concurrent use are met).