CurrentCareSourcePolicy N/A

Lupkynis (voclosporin) — Pharmacy coverage criteria for biopsy‑confirmed lupus nephritis

Rules for prior authorization and coverage of oral voclosporin (Lupkynis) for adults with biopsy‑confirmed lupus nephritis as part of a combination immunosuppressive regimen; applies to pharmacy benefit and allows home dispensing.

Policy Summary

PayerCareSource

PolicyLupkynis (voclosporin) — Pharmacy coverage criteria for biopsy‑confirmed lupus nephritis

Policy CodePolicy N/A

Change TypeNew policyadministrative revision

Effective DateJan 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization and document baseline eGFR and UPCR; prescribe Lupkynis only in adults with biopsy‑confirmed class III/IV/V lupus nephritis as part of a background immunosuppressive regimen.

SourceLink

POLICY UPDATE CHANGES

New policy for Lupkynis created.

Removed prescriber specialty requirement and member is not on dialysis or had kidney transplant requirement.

>=18minimum age

6 monthsinitial approval

12 monthsreauthorization

23.7 mg bdmax dosing

>=45initial eGFR threshold

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met for initial authorization

Initial authorization criteria: Member is at least 18 years of age; Member has a diagnosis of lupus nephritis class III, IV, and/or V as confirmed by kidney biopsy; Medication must be prescribed in combination with an immunosuppressant regimen such as mycophenolate mofetil (MMF) and corticosteroid; Chart notes must document baseline eGFR and urine protein‑to‑creatinine ratio (UPCR); eGFR is at least 45 mL/min/1.73m2 OR it has been determined that the benefit exceeds the risk; Lupkynis will not be used in combination with cyclophosphamide; Dosage limit up to 23.7 mg (3 capsules) twice daily with dosing based on eGFR per prescribing information.

If all requirements are met the medication will be approved for 6 months.

Continuation Therapy / Reauthorization

Reauthorization criteria — Covered when ALL of the following are met

Reauthorization criteria: Member has a reduced UPCR (goal is 0.5 mg/mg or less); eGFR is at least 60 mL/min/1.73m2 OR has stabilized.

Policy Summary

PayerCareSource

PolicyLupkynis (voclosporin) — Pharmacy coverage criteria for biopsy‑confirmed lupus nephritis

Policy CodePolicy N/A

Change TypeNew policyadministrative revision

Effective DateJan 1, 2022

Next Review DateN/A

SourceLink

On This Page

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If met, medication will be approved for an additional 12 months.

CareSource considers use of Lupkynis (voclosporin) for any indication not explicitly listed in this policy to be not medically necessary. For requests for indications outside those in this document, adjudication should follow the plan's Off‑Label policy.

Use of Lupkynis (voclosporin) for clinical conditions other than biopsy‑confirmed lupus nephritis (classes III, IV, and/or V) is considered not medically necessary under this policy. Providers should submit requests for non‑listed indications only in accordance with the Off‑Label policy.

Initial Therapy Requirements

Initial Therapy

Initial authorization requirements

Initial: Age >= 18 years; Biopsy‑confirmed lupus nephritis (class III, IV, and/or V); Prescribed in combination with a background immunosuppressant regimen (e.g., mycophenolate mofetil and corticosteroid); Baseline eGFR and urine protein‑to‑creatinine ratio (UPCR) documented in chart notes; Baseline eGFR >= 45 mL/min/1.73m2 OR treating clinician documents that expected benefit outweighs risk; Not to be used concurrently with cyclophosphamide; Dosage limited to up to 23.7 mg (3 capsules) twice daily, with dosing adjustments based on eGFR per prescribing information.

Approve for 6 months if all criteria are met.

Continuation / Reauthorization Requirements

Reauthorization

Reauthorization criteria

Reauthorization: Reduction in UPCR with a goal of 0.5 mg/mg or less; AND eGFR >= 60 mL/min/1.73m2 OR eGFR has stabilized compared with baseline.

Approve for an additional 12 months if met.

Coding and Clinical Thresholds

Billing codesNDC

NDC	Must use valid NDC for billing Lupkynis

inv-06: UPCR goal — target urine protein‑to‑creatinine ratio

UPCR target0.5 mg/mg or less

MeasurementUrine protein‑to‑creatinine ratio (UPCR)

Use at reauthorizationMember must have a reduced UPCR meeting the goal for continuation

inv-07: Initial eGFR threshold — baseline renal function threshold for initial approval

Initial eGFR threshold>= 45 mL/min/1.73m2 (or benefit outweighs risk)

Required documentationBaseline eGFR must be documented in chart notes

Approval duration if metApproved for 6 months for initial authorization

inv-08: Reauthorization eGFR threshold — eGFR requirement for continuation

Reauthorization eGFR requirement>= 60 mL/min/1.73m2 or has stabilized

Associated requirementAND reduced UPCR meeting goal (0.5 mg/mg or less)

Approval duration if metApproved for an additional 12 months on reauthorization

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Lupkynis (voclosporin) requires prior authorization before coverage.

Benefit type: Pharmacy; Site of service allowed: Home.
Coverage limited to adults (>= 18 years).
Approval duration: up to 6 months for initial authorization.

Note

Combination Therapy Requirement

Combination therapy must be used. Lupkynis must be prescribed in combination with a background immunosuppressive regimen (e.g., mycophenolate mofetil [MMF] plus corticosteroid).

Lupkynis will not be used in combination with cyclophosphamide.

Documentation Required

Required Documentation

Required clinical documentation must be provided with the request. Chart notes should document baseline renal function and proteinuria measures.

Document baseline eGFR and UPCR in the chart.
If eGFR < 45 mL/min/1.73 m2, provide justification that benefit exceeds risk per prescriber documentation.

Billing Rule

Billing and Dispensing Requirements

Billing and dispensing rules: use a valid NDC and bill under the pharmacy benefit. Observe dosing and quantity limits per prescribing information and policy.

Use valid NDC when billing.
Dosage/Quantity limit: Up to 23.7 mg (3 capsules) twice daily (total 6 capsules per day); supply up to 3 wallets per 30 days.
Dosing adjustments per eGFR per prescribing information.

Denial Risk

Triggers for Denial

Denial triggers and exclusions. Requests will be denied when membership, diagnosis, or documentation requirements are not met.

Age < 18 years.
Diagnosis not biopsy‑confirmed as class III, IV, or V lupus nephritis.
Lack of documented baseline eGFR and UPCR.
Lupkynis prescribed without concurrent MMF + corticosteroid or used with cyclophosphamide.

Step Therapy and Regimen Requirements

Step	Requirement
1	Must be prescribed in combination with a background immunosuppressant regimen (e.g., mycophenolate mofetil [MMF] and corticosteroid) as part of initial therapy

Quantity Limits and Dosing

inv-18: Lupkynis (voclosporin) quantity limit — up to 23.7 mg (3 capsules) twice daily

Quantity limitUp to 23.7 mg (3 capsules) twice daily (total 6 capsules per day)

Dosing basisDosing is based on eGFR as directed in prescribing information

Supply cadence3 wallets per 30 days (as noted for total monthly quantity)

Site of Care

Note

Home administration allowed

Home administration is an allowed site of service for Lupkynis when billed under the pharmacy benefit.

Lupkynis is covered as a pharmacy benefit and may be dispensed for home administration.

Definitions

inv-14: Biopsy‑confirmed lupus nephritis — defines lupus nephritis classes III, IV, and/or V

Defined classesBiopsy‑confirmed lupus nephritis classes III, IV, and/or V

Confirmation methodDiagnosis must be confirmed by kidney biopsy

Clinical roleBiopsy class guides treatment and is required for initial coverage

Background

Lupkynis (voclosporin) is an oral immunosuppressant in the calcineurin inhibitor class approved for treatment of active lupus nephritis in adults in combination with background immunosuppressive therapy. The policy notes the drug's approval context and establishes coverage rules specific to lupus nephritis, including requirements for biopsy confirmation, combination therapy, and monitoring parameters.