CurrentHawaii Medical Service Association (HMSA)Policy 4448-A

Lupkynis (voclosporin) Coverage Criteria for Active Lupus Nephritis

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This policy governs HMSA prior authorization and coverage of Lupkynis in combination with background immunosuppressive therapy for adults with active lupus nephritis. It establishes documentation, initial approval, continuation, and exclusion requirements.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyLupkynis (voclosporin) Coverage Criteria for Active Lupus Nephritis

Policy CodePolicy 4448-A

Change TypeNo material change

Effective DateJul 1, 2023

Next Review DateN/A

Key ActionSubmit prior authorization documentation for the applicable lupus nephritis diagnosis and clinical criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsAuthorization period

>45 mL/min/1.73 m²Minimum eGFR

MMF + corticosteroidsBackground therapy

CyclophosphamideExcluded combination

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CurrentHawaii Medical Service Association (HMSA)Policy 4448-A

Lupkynis (voclosporin) Coverage Criteria for Active Lupus Nephritis

Customize your policy alerts

Sign up for Hawaii Medical Service Association (HMSA) Policy 4448-A alerts

Get alerted when Policy 4448-A changes without checking for updates manually.

Monitor payer policy activity

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Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyLupkynis (voclosporin) Coverage Criteria for Active Lupus Nephritis

Policy CodePolicy 4448-A

Change TypeNo material change

Effective DateJul 1, 2023

Next Review DateN/A

Key ActionSubmit prior authorization documentation for the applicable lupus nephritis diagnosis and clinical criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsAuthorization period

>45 mL/min/1.73 m²Minimum eGFR

MMF + corticosteroidsBackground therapy

CyclophosphamideExcluded combination

Coverage Overview

Initial therapy: active lupus nephritis

Authorization of 12 months may be granted for active lupus nephritis when all of the following criteria are met.

Initial therapy for active lupus nephritis

SLE or lupus nephritis confirmation: Prior to initiating therapy, the member is positive for autoantibodies relevant to SLE, such as ANA, anti-dsDNA, anti-Sm, antiphospholipid antibodies, or complement proteins, or lupus nephritis was confirmed on kidney biopsy.
At least one form of diagnostic support is required.
Active renal disease and background therapy: Member has clinically active lupus renal disease and is receiving background therapy with mycophenolate mofetil (MMF) with corticosteroids.
Renal function: Member has an eGFR greater than 45 mL/min per 1.73 m².>45 mL/min per 1.73 m²

Continuation therapy

Authorization of 12 months may be granted for continued treatment for an indication approved under the initial-therapy criteria when the member achieves or maintains a positive clinical response.

Positive clinical response: Member has low disease activity or improvement in signs and symptoms of the condition.
At least one response indicator is required.

Coverage is excluded when Lupkynis is used in combination with cyclophosphamide.

Initial Approval for Active Lupus Nephritis

Initial approval for active lupus nephritis

Authorization of 12 months may be granted for treatment of active lupus nephritis when all criteria are met.

Initial treatment of active lupus nephritis

Diagnostic confirmation: Relevant SLE autoantibodies are present or lupus nephritis is confirmed on kidney biopsy.
Examples include ANA, anti-dsDNA, anti-Sm, antiphospholipid antibodies, or complement proteins.
Clinical disease and regimen: Clinically active lupus renal disease is present and the member is receiving background therapy with mycophenolate mofetil (MMF) and corticosteroids.
Renal function: eGFR is greater than 45 mL/min per 1.73 m².>45 mL/min per 1.73 m²

Reauthorization with Clinical Response

Reauthorization with clinical response

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the initial approval criteria who achieve or maintain a positive clinical response.

Continuation therapy

Response evidence: Low disease activity or improvement in signs and symptoms of the condition.

Clinical Thresholds

Estimated glomerular filtration rate

ThresholdeGFR >45 mL/min per 1.73 m²

Applies toInitial approval for active lupus nephritis

Policy requirementMember must have an eGFR greater than 45 mL/min per 1.73 m² before initiating therapy.

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Lupkynis. Initial requests must include the documentation needed to establish eligibility, and continuation requests must document the member’s response to therapy. Authorization may be granted for 12 months when the applicable criteria are met.

Submit initial and continuation requests for review before coverage is provided.
Initial requests: include diagnostic records and documentation of all applicable clinical criteria.
Continuation requests: include records documenting a positive clinical response, including low disease activity or improvement in signs and symptoms.

Documentation Required

Initial Diagnostic Documentation

For an initial request, submit medical records such as chart notes or laboratory reports documenting autoantibodies relevant to systemic lupus erythematosus (SLE), or a kidney biopsy supporting or confirming the diagnosis.

Lupkynis Clinical Context

Lupkynis (voclosporin) is a calcineurin-inhibitor immunosuppressant indicated for use with a background immunosuppressive regimen in adults with active lupus nephritis. For initial approval, the required background regimen includes mycophenolate mofetil and corticosteroids, and renal function must be above the specified eGFR threshold.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyLupkynis (voclosporin) Coverage Criteria for Active Lupus Nephritis

Policy CodePolicy 4448-A

Change TypeNo material change

Effective DateJul 1, 2023

Next Review DateN/A

Key ActionSubmit prior authorization documentation for the applicable lupus nephritis diagnosis and clinical criteria.

SourceLink

On This Page

Relevant autoantibodies may include ANA, anti-dsDNA, anti-Sm, antiphospholipid antibodies, and complement proteins.
A kidney biopsy supporting or confirming lupus nephritis may be submitted instead of autoantibody documentation.

Documentation Required

Continuation Response Documentation

For a continuation or reauthorization request, submit medical records such as chart notes or laboratory reports documenting disease stability or improvement and a positive clinical response to treatment.

Document low disease activity or improvement in signs and symptoms of the condition.
Continuation authorization may be granted for 12 months when a positive clinical response is achieved or maintained.

Denial Risk

Cyclophosphamide Combination Excluded

Coverage will not be provided for Lupkynis used in combination with cyclophosphamide. Safety and efficacy of the combination have not been established, and use in this situation is not recommended.

Exclude cyclophosphamide combination therapy from the treatment plan and authorization request.

Denial Risk

Initial Clinical Criteria Not Met

An initial request will not meet coverage criteria unless the member has active lupus nephritis and satisfies all required clinical conditions for treatment.

The member must have relevant SLE autoantibodies or lupus nephritis confirmed on kidney biopsy.
The member must have clinically active lupus renal disease and receive background therapy with mycophenolate mofetil (MMF) plus corticosteroids.
The member’s eGFR must be > 45 mL/min per 1.73 m².
Requests missing the diagnosis, required background therapy, or eGFR threshold may be denied.

Denial Risk

Insufficient Response for Reauthorization

Reauthorization may be denied when the member does not achieve or maintain a positive clinical response to Lupkynis.

Document low disease activity or improvement in signs and symptoms to support continuation.
Requests without evidence of disease stability, improvement, or a positive clinical response may be denied.