CurrentMass General Brigham Health PlanPolicy N/A

Lupkynis Effective 09/01/2021

Policy governs prior authorization, specialty dispensing, quantity limits, continuation/reauthorization, and clinical eligibility for Lupkynis for treatment of adult active lupus nephritis for Mass General Brigham Health Plan / MassHealth UPPL plans (Commercial/Exchange and MassHealth).

Policy Summary

PayerMass General Brigham Health Plan

PolicyLupkynis Effective 09/01/2021

Policy CodePolicy N/A

Change Typeclarified (administrative separation)

Effective DateSep 1, 2021

Next Review Date

Key ActionSubmit prior authorization with documentation of active lupus nephritis, age ≥18, concurrent immunosuppressive therapy (or documented contraindication), dosing rationale, and evidence of improvement for reauthorization.

SourceLink

POLICY UPDATE CHANGES

09/21/2022 Reviewed and updated for September P&T. Separated Comm/Exch vs MH. No clinical changes

1Indication (lupus nephritis)

180/30dQuantity limit

12 moApproval duration

Coverage Summary

Lupkynis (voclosporin) is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis. This policy aligns authorization criteria with the labeled indication and requires that patients receive concurrent immunosuppressive therapy unless there is a documented contraindication. The policy explicitly excludes cyclophosphamide and biologic agents from allowed contraindications to concurrent immunosuppressive therapy. The scope of this policy governs prior authorization, specialty dispensing, quantity limits, continuation/reauthorization, and clinical eligibility for Lupkynis for treatment of adult active lupus nephritis for Mass General Brigham Health Plan / MassHealth UPPL plans (Commercial/Exchange and MassHealth).

Policy quick facts

Indication (lupus nephritis)Treatment of adult patients with active lupus nephritis in combination with background immunosuppressive therapy

Quantity limit180 capsules per 30 days (Lupkynis 7.9 mg)

Approval durationInitial approvals and reauthorizations valid for 12 months

Age≥ 18 years

Payer / PlansMass General Brigham Health Plan / MassHealth UPPL (Commercial/Exchange and MassHealth)

Effective / Last reviewEffective: 09/01/2021; Last review: 09/21/2022

Continuation Therapy Criteria

Continuation of Therapy / Reauthorization

Reauthorization may be granted when the following are met:

Indication: Continued treatment is for lupus nephritis
Clinical response: Patient is experiencing an improvement in their condition
Risk/benefit: Benefits of continued treatment outweigh the risk of worsening nephrotoxicity

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for Lupkynis; authorizations are reviewed for members new to the plan who are currently receiving Lupkynis and for new starts when criteria are met and documentation is provided.

Documentation Required

Clinical documentation required

Provide documentation supporting: diagnosis of active lupus nephritis; member age (≥ 18 years); evidence of concurrent immunosuppressive therapy or documentation of a contraindication to immunosuppressive therapy (excluding cyclophosphamide and biologics); and rationale for dosing (policy references package insert for dosing). For reauthorization, provide evidence of clinical improvement and that benefits of continued treatment outweigh the risk of worsening nephrotoxicity.

Diagnosis of active lupus nephritis
Member is ≥ 18 years
Concurrent immunosuppressive therapy OR contraindication to immunosuppressive therapy (excluding cyclophosphamide and biologics)
Rationale for dosing (per package insert)
For reauthorization: evidence of clinical improvement and that benefits outweigh nephrotoxicity risk

Billing Rule

Specialty pharmacy dispensing requirement

Lupkynis has been designated specialty and must be filled at a contracted specialty pharmacy; contact information for specialty and non-specialty medication routing is provided in the policy.

Specialty pharmacy contact: Phone 877-519-1908, Fax 855-540-3693
Non-specialty contact: Phone 800-711-4555, Fax 844-403-1029

Billing Rule

Approval duration

Initial approvals and reauthorizations are valid for 12 months.

Billing Rule

Quantity limit enforcement

Quantity limit: Lupkynis 7.9 mg — 180 capsules per 30 days.

Background & Definitions

Background summary: Lupkynis is indicated in combination with background immunosuppressive therapy for adult patients with active lupus nephritis. The policy aligns prior authorization criteria with this indication and requires concurrent immunosuppressive therapy unless contraindicated (excluding cyclophosphamide and biologics). Scope summary: the policy applies to prior authorization requirements, specialty pharmacy dispensing, quantity limits (including a limit of 180 capsules per 30 days for Lupkynis 7.9 mg), continuation/reauthorization criteria, and clinical eligibility for the specified Mass General Brigham Health Plan / MassHealth UPPL plans (Commercial/Exchange and MassHealth).

Term	Definition
Specialty	Medication designated to be dispensed via contracted specialty pharmacy.

Policy Summary

PayerMass General Brigham Health Plan

PolicyLupkynis Effective 09/01/2021

Policy CodePolicy N/A

Change Typeclarified (administrative separation)

Effective DateSep 1, 2021

Next Review Date

SourceLink

On This Page

OpenPayer

Lupkynis Effective 09/01/2021

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Provider Actions & Requirements

Applicable Codes & Dispensing Details

Clinical Evidence & References

Background & Definitions

Revision History