CurrentCentenePolicy CP.PHAR.551

Anifrolumab-fnia (Saphnelo) for systemic lupus erythematosus

Defines medical necessity criteria, authorization requirements, dosing limits, and exclusions for Saphnelo in adults with moderate to severe systemic lupus erythematosus for Centene lines of business.

Policy Summary

PayerCentene

PolicyAnifrolumab-fnia (Saphnelo) for systemic lupus erythematosus

Policy CodePolicy CP.PHAR.551

Change TypeMaterial updates and coding additions

Effective DateDec 1, 2021

Next Review Date

Key ActionPrior authorization required; provider must document that member meets the Initial or Continued Therapy criteria including diagnosis, autoantibody positivity, rheumatologist prescribing/consult, age ≥18, concomitant standard therapy, and absence of excluded conditions.

SourceLink

POLICY UPDATE CHANGES

Added exclusions for concurrent treatment with Lupkynis and diagnoses of severe active central nervous system lupus or severe active lupus nephritis.

Revised Medicaid and HIM initial approval durations to 12 months.

Added coding implications section including HCPCS code J0491 for anifrolumab-fnia.

300 mgmaximum dose per administration

q4wdosing interval

≥18age eligibility

autoantibody+serologic requirement

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Coverage Criteria for Anifrolumab-fnia (Saphnelo)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Initial SLE criteria: 1. Diagnosis of systemic lupus erythematosus (SLE). 2. Prescribed by or in consultation with a rheumatologist. 3. Age ≥ 18 years. 4. Documentation confirms member is positive for an SLE autoantibody (e.g., ANA, anti-dsDNA, anti‑Sm, anti‑RNP, anti‑Ro/SSA, anti‑La/SSB, antiphospholipid antibody). 5. Prescribed in combination with standard SLE therapy (one or more: glucocorticoid, antimalarial, or non-biologic immunosuppressant) unless all such agents are contraindicated. 6. Member is not receiving Saphnelo in combination with Lupkynis or another biologic agent. 7. Member does not have severe active central nervous system (CNS) lupus or severe active lupus nephritis. 8. Dose does not exceed 300 mg every 4 weeks.

Approval duration: Medicaid/HIM 12 months; Commercial 6 months or to member's renewal date, whichever is longer.

Continuation Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Continued SLE criteria: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria, or (b) currently receiving medication and continuity of care provisions apply. 2. Member is responding positively to therapy. 3. Prescribed in combination with standard SLE therapy (one or more: glucocorticoid, antimalarial, or non-biologic immunosuppressant) unless all such agents are contraindicated. 4. Member is not receiving Saphnelo in combination with Lupkynis or a biologic agent. 5. Member does not have severe active CNS lupus or severe active lupus nephritis. 6. If request is for a dose increase, new dose does not exceed 300 mg every 4 weeks.

Approval duration: Medicaid/HIM 12 months; Commercial 6 months or to member's renewal date, whichever is longer.

Other Indications / Off-label Handling

Alternate/Off-label handling: 1. If the drug has had a recent label change (within the last 6 months) not yet reflected in this policy (e.g., new indication, age expansion, or dosing change), refer to the appropriate formulary/non-formulary policy for the line of business. 2. If the requested use is not listed under the policy's 'Diagnoses/Indications for which coverage is NOT authorized' section and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09 for commercial; HIM.PA.154 for health insurance marketplace; CP.PMN.53 for Medicaid).

See referenced CP.* and HIM.* policies.

Coverage is not authorized for non‑FDA approved indications that are not specifically addressed in this policy unless the use is supported by the applicable off‑label use policy for the member's line of business (see referenced CP.CPA.09, HIM.PA.154, CP.PMN.53).

Coverage is also not authorized for autoantibody negative SLE; requests for Saphnelo for members without documented SLE autoantibody positivity will be denied per this policy.

Use of Saphnelo for autoantibody negative systemic lupus erythematosus (SLE) is explicitly not authorized as medically necessary under this policy.

Coding and Dosing

Referenced HCPCS CodesHCPCS

J0491

Injection, anifrolumab-fnia, 1 mg

inv-07: Maximum single dose — 300 mg every 4 weeks

Maximum single dose300 mg per administration (300 mg IV every 4 weeks)

Dosing intervalEvery 4 weeks

Dosing regimen sourceSLE dosing regimen specified as 300 mg IV every 4 weeks

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Saphnelo (HCPCS J0491). Provider must document that the member meets the Initial or Continued Therapy criteria in the policy.

Prior authorization required for Saphnelo (J0491)
Approval durations: Medicaid/HIM 12 months; Commercial 6 months or to member's renewal date, whichever is longer.

Documentation Required

Documentation Required to Support Request

Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria. Documentation should confirm diagnosis, autoantibody positivity, rheumatology involvement, current co-therapies, response to therapy for continuation requests, and any dose changes.

Examples: office notes, laboratory results (e.g., ANA, anti-dsDNA, anti-Sm, anti-RNP, anti-Ro/SSA, anti-La/SSB, antiphospholipid antibody), rheumatology consult notes, medication history.

Definitions

inv-13: Autoantibody positive SLE — definition and qualifying lab thresholds

DefinitionAutoantibody positive SLE: presence of at least one SLE autoantibody (e.g., ANA, anti-dsDNA, anti-Smith, anti-RNP, anti-Ro/SSA, anti-La/SSB, antiphospholipid antibody)

ANA thresholdPositive antinuclear antibody by immunofluorescent assay (IFA) at central laboratory with titer ≥ 1:80

Anti-dsDNA thresholdAnti-dsDNA antibodies at screening elevated above normal (including indeterminate) as per central laboratory

Anti-Smith thresholdAnti-Smith antibody at screening elevated above normal as per central laboratory

Background

Anifrolumab‑fnia (Saphnelo) is a type I interferon receptor antagonist indicated as an add‑on to standard therapy for adult patients with moderate to severe systemic lupus erythematosus (SLE). The approved dosing regimen for SLE is 300 mg intravenously every 4 weeks and should not exceed that dose per administration. The pivotal trials required documentation of SLE autoantibody positivity for enrollment; efficacy has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus.

This policy references HCPCS code J0491 (Injection, anifrolumab‑fnia, 1 mg) for coding purposes; inclusion or exclusion of codes does not guarantee coverage and providers should use current professional coding guidance when submitting claims.

Revision History

2025-07-15annual_reviewLatest

Revised Medicaid and HIM initial approval durations to 12 months; added coding implications section.

2024-07-19annual_review

Added exclusions for concurrent treatment with Lupkynis and diagnoses of severe active central nervous system lupus or severe active lupus nephritis.

2023-07-10annual_review