CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Lupkynis

Defines coverage criteria, exclusions, quantity limits, and continuation criteria for Lupkynis (voclosporin) when used to treat adult patients with active lupus nephritis, including required baseline and follow-up monitoring and specialist prescribing requirements.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLupkynis

Policy CodePolicy N/A

Change TypeRevised (package insert update)

Effective DateJul 1, 2021

Next Review Date

Key ActionInitial authorization may be granted for 6 months only when all initial criteria are met, including specialist prescribing/consultation, age, serology/biopsy documentation, background MMF and corticosteroid use, baseline eGFR and UPCR, and failure of belimumab with standard therapy.

SourceLink

POLICY UPDATE CHANGES

Date Effective listed as 7/1/21 and package insert reference updated to April 2024.

1Covered Indication (Lupus Nephritis)

2Required Background Therapies

6Quantity Limit (capsules/day)

Coverage Summary

Coverage stance: covered_with_criteria. Scope: Defines coverage criteria, exclusions, quantity limits, and continuation criteria for Lupkynis (voclosporin) when used to treat adult patients with active lupus nephritis, including required baseline and follow-up monitoring and specialist prescribing requirements. Summary: Lupkynis (voclosporin) is covered for the treatment of active lupus nephritis in adults when used in combination with background immunosuppression (e.g., mycophenolate mofetil and corticosteroids) and all authorization criteria are met (specialist prescribing/consultation, age ≥ 18 years, serologic positivity or biopsy confirmation, baseline eGFR > 45 mL/min/1.73 m2, baseline UPCR provided, and prior inadequate response to belimumab with standard therapy). Safety and efficacy have not been established in combination with cyclophosphamide and use with cyclophosphamide is not recommended; other non‑lupus nephritis indications are considered experimental/not medically necessary. Quantity limit: 7.9 mg capsules — 6 capsules per day.

Initial Authorization - Active Lupus Nephritis

Authorization of 6 months may be granted when ALL of the following criteria are met:

ALL of the following

Medication is prescribed by or in consultation with a nephrologist or rheumatologist
Member is at least 18 years of age>= 18 years
Prior to initiating therapy, documentation that the member is positive for autoantibodies relevant to SLE (e.g., ANA, anti-dsDNA, anti-Sm, antiphospholipid antibodies, complement proteins) OR lupus nephritis was confirmed on kidney biopsy
Either serologic positivity OR biopsy confirmation is acceptable
Member is receiving background therapy with mycophenolate mofetil (MMF) AND corticosteroids
Baseline eGFR > 45 mL/min/1.73 m2 AND baseline urine protein-creatinine ratio (UPCR) has been provided; both eGFR and UPCR will be assessed at regular intervals thereaftereGFR > 45 mL/min/1.73 m2
Documentation that the member has failed to respond adequately to Benlysta (belimumab) with standard immunosuppressive therapy (e.g., corticosteroids and MMF or cyclophosphamide)

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Prior Authorization

Initial prior authorization required

Initial prior authorization required for up to 6 months when all initial criteria are met. Required documentation includes: specialist prescribing or documentation of consultation with a nephrologist or rheumatologist; member age ≥ 18 years; either serologic positivity for SLE autoantibodies (e.g., ANA, anti-dsDNA, anti-Sm, antiphospholipid antibodies, complement proteins) OR kidney biopsy confirming lupus nephritis; evidence the member is receiving background therapy with mycophenolate mofetil (MMF) plus corticosteroids; baseline eGFR > 45 mL/min/1.73 m2 and baseline urine protein-creatinine ratio (UPCR) provided; and documentation that the member has failed to respond adequately to belimumab (Benlysta) with standard immunosuppressive therapy.

Prescribed by or in consultation with a nephrologist or rheumatologist
Member ≥ 18 years
Serologic positivity for SLE autoantibodies OR kidney biopsy confirming lupus nephritis
Background therapy with MMF and corticosteroids
Baseline eGFR > 45 mL/min/1.73 m2 and baseline UPCR provided
Failed to respond adequately to belimumab with standard immunosuppressive therapy

Documentation Required

Baseline and ongoing lab monitoring

Document baseline eGFR and baseline UPCR prior to initiation and include interval eGFR and UPCR results with authorization requests; both will be assessed at regular intervals during therapy.

Continuation / Reauthorization Criteria

Authorization of 6 months may be granted for continued treatment when ALL of the following are met:

ALL of the following

Member is receiving Lupkynis for an indication listed in initial criteria (active lupus nephritis)
clinical response
- Improvement in UPCR to ≤0.5 mg/mgUPCR ≤ 0.5 mg/mg
- eGFR ≥ 60 mL/min/1.73 m2 OR no confirmed decrease from baseline in eGFR of >20%eGFR ≥ 60 mL/min/1.73 m2 or decline ≤20% from baseline

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Prior Authorization

Reauthorization / continuation

Reauthorization/continuation may be granted for 6 months when documentation demonstrates clinical response: improvement in UPCR to ≤ 0.5 mg/mg and eGFR ≥ 60 mL/min/1.73 m2 OR no confirmed decrease from baseline in eGFR of >20%.

UPCR improvement to ≤ 0.5 mg/mg
eGFR ≥ 60 mL/min/1.73 m2 or no confirmed decline >20% from baseline

Exclusions / Not Covered

Lupkynis will not be provided in the following situations:

ANY of the following

Use of Lupkynis in combination with cyclophosphamide
Safety and efficacy not established; use not recommended
Use of Lupkynis in combination with Benlysta (belimumab)
All other indications beyond active lupus nephritis (including non-FDA and non-compendial uses)
Considered experimental/investigational and not medically necessary

Denial Risk

Excluded uses — denial risk

Use of Lupkynis in combination with cyclophosphamide or for indications beyond active lupus nephritis is considered not recommended, experimental/investigational, or not medically necessary and will be denied.

Provider Actions

Prior Authorization

Initial prior authorization required

Initial authorization may be granted for 6 months only when all initial criteria are met, including specialist prescribing/consultation, age ≥ 18 years, serology or biopsy confirmation, background MMF and corticosteroid use, baseline eGFR and UPCR, and failure of belimumab with standard therapy.

Prior Authorization

Reauthorization / continuation

Reauthorization may be granted for 6 months when documentation demonstrates clinical response (UPCR ≤ 0.5 mg/mg and eGFR ≥ 60 mL/min/1.73 m2 or no confirmed eGFR decrease >20% from baseline).

Documentation Required

Baseline and ongoing lab monitoring

Document baseline eGFR and baseline UPCR prior to initiation; assess eGFR and UPCR at regular intervals thereafter and include results with authorization requests.

Billing Rule

Quantity limit

Lupkynis (voclosporin) 7.9 mg limited to 6 capsules per day.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLupkynis

Policy CodePolicy N/A

Change TypeRevised (package insert update)

Effective DateJul 1, 2021

Next Review Date

SourceLink

On This Page

OpenPayer

Lupkynis

Coverage Summary

Initial Authorization - Active Lupus Nephritis

Continuation / Reauthorization Criteria

Exclusions / Not Covered

Applicable Codes

Provider Actions

Clinical Evidence & References

Background

Revision History