CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Saphnelo (anifrolumab-fnia) (Intravenous)

Defines prior authorization, coverage criteria, and continuation requirements for intravenous Saphnelo for Medicaid, Commercial, and Medicare members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySaphnelo (anifrolumab-fnia) (Intravenous)

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date12/15/2021

Next Review Date06/25/2025

Key ActionSubmit prior authorization for Saphnelo; initial approvals cover 6 months and continuation approvals cover 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

300 mgapproved Saphnelo dose for SLE

6 moinitial coverage duration

12 mocontinuation coverage duration

J0491HCPCS code

18+minimum age

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Initial Therapy

Covered when ALL of the following are met:

Initial criteria: Patient is 18 years or older; AND documented diagnosis of active moderate to severe Systemic Lupus Erythematosus (SLE); AND moderate to severe disease as evidenced by all of the following: Physician's Global Assessment (PGA) score of ≥ 1; AND SLEDAI-2K score of ≥ 6; AND BILAG-2004 B organ domain score of ≥ 2; AND failed to respond adequately to at least two (2) standard therapies (e.g., antimalarials, corticosteroids, NSAIDs, or immunosuppressives) excluding intravenous cyclophosphamide; AND used in combination with standard therapy (e.g., prednisone, hydroxychloroquine, azathioprine, mycophenolate mofetil, methotrexate); AND tried and failed Benlysta or has a documented contraindication to Benlysta; AND no active infection; AND has not received a live vaccine within 30 days before starting or concurrently with Saphnelo; AND medication is not being used concurrently with Benlysta, Lupkynis, or another biologic agent; AND does not have severe active central nervous system (CNS) lupus and/or active lupus nephritis

Initial coverage duration 6 months

Use of Saphnelo (anifrolumab-fnia) for indications, dosing, or administration schedules other than the FDA‑approved regimen for systemic lupus erythematosus (SLE) is considered investigational and is not covered. The approved SLE intravenous dose is 300 mg every 4 weeks (maximum billing: 300 units every 28 days, 1 unit = 1 mg). Coverage is limited to uses recognized as medically accepted in standard reference compendia (e.g., AHFS‑DI, Micromedex DrugDex, Clinical Pharmacology, Lexi‑Drugs) or supported by peer‑reviewed literature; uses outside these compendia‑recognized indications are investigational and not provided by Neighborhood Health Plan of Rhode Island.

Saphnelo is not medically necessary and is excluded from coverage when the patient does not meet the policy’s disease activity thresholds or prior therapy requirements. Specifically, coverage is not provided if the patient is younger than 18 years, does not have documented active moderate to severe SLE defined by PGA ≥ 1, SLEDAI‑2K ≥ 6, and BILAG‑2004 B organ domain ≥ 2, or has not failed at least two standard therapies (excluding IV cyclophosphamide).

Saphnelo will not be covered when the patient has active contraindicating conditions or treatment conflicts, including active infection, receipt of a live vaccine within 30 days before or concurrently with therapy, concurrent use with Benlysta, Lupkynis, or another biologic agent, or presence of severe active central nervous system lupus and/or active lupus nephritis.

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required and coverage will be reviewed prospectively. Initial authorizations are granted for 6 months; continuation authorizations may be granted for up to 12 months.

Prior authorization required prior to initiation of Saphnelo (anifrolumab-fnia).
Initial authorization duration: 6 months.
Continuation authorization duration: 12 months.

Step Therapy

Step Therapy / Prior Biologic Requirement

Member must have failed at least two standard therapies (e.g., antimalarials, corticosteroids, NSAIDs, immunosuppressives excluding IV cyclophosphamide) and must have tried and failed Benlysta (belimumab) or have a documented contraindication to Benlysta before Saphnelo will be approved.

Failure of ≥2 standard therapies required prior to approval.
Prior biologic requirement: trial and failure of Benlysta or documented contraindication to Benlysta.
Saphnelo must be used in combination with standard background therapy (e.g., prednisone, hydroxychloroquine, azathioprine, mycophenolate mofetil, methotrexate).

Documentation Required

Required Documentation

Provide documentation demonstrating patient eligibility and disease activity. Submit all of the following with the prior authorization request.

Patient age (≥ 18 years).
Documented diagnosis of active moderate to severe Systemic Lupus Erythematosus (SLE).
Physician's Global Assessment (PGA) score ≥ 1.
SLEDAI-2K score ≥ 6.
BILAG-2004 organ domain B score ≥ 2.
Prior therapy history showing failure of ≥2 standard therapies and trial/contraindication to Benlysta.
Evidence Saphnelo will be used with standard therapy and not concurrently with Benlysta, Lupkynis, or another biologic.
Documentation that the patient does not have an active infection, has not received a live vaccine within 30 days before or concurrently with Saphnelo, and does not have severe active CNS lupus or active lupus nephritis.

Denial Risk

Triggers for Denial / Non-Payment

Requests that do not meet the policy criteria or lack required documentation may be denied or result in non-payment.

Denial triggers include: patient < 18 years; no documented diagnosis of active moderate to severe SLE; insufficient evidence of disease activity (PGA <1, SLEDAI-2K <6, or BILAG-2004 B <2).
Denial triggers include: failure to document trials of ≥2 standard therapies or absence of prior Benlysta trial or documented contraindication to Benlysta.
Denial triggers include: concurrent use with Benlysta, Lupkynis, or another biologic; active infection; recent live vaccine within 30 days; severe active CNS lupus or active lupus nephritis.
Operational non-payment triggers: missing required scores (PGA, SLEDAI-2K, BILAG-2004), incomplete prior therapy history, or lacking documentation of treatment response/tolerability for continuation requests.

OpenPayer

Saphnelo (anifrolumab-fnia) (Intravenous)

Coverage Criteria for Saphnelo (anifrolumab-fnia)

Coding and Clinical Thresholds

Prior Authorization, Documentation, and Denial Triggers

Background

Definitions and Clinical Criteria