CurrentUnitedHealthcarePolicy CS2026D0046AA

Benlysta (Belimumab) intravenous injection for SLE and active lupus nephritis

Defines UnitedHealthcare Community Plan medical benefit coverage criteria for Benlysta (belimumab) intravenous infusion for treatment of systemic lupus erythematosus (SLE) and active lupus nephritis (LN), including initial and continuation authorization criteria, exclusions (unproven indications), applicable J-code and ICD-10 diagnosis codes, and authorization durations. Does not apply to specified states where state-specific policies govern.

Policy Summary

PayerUnitedHealthcare

PolicyBenlysta (Belimumab) intravenous injection for SLE and active lupus nephritis

Policy CodePolicy CS2026D0046AA

Change TypeTemplate Update

Effective DateApr 1, 2026

Next Review Date

Key ActionAuthorization must document diagnosis, prior and current non-biologic standard of care therapy, absence of severe active CNS lupus and concomitant use with Lupkynis or Saphnelo, dosing per FDA labeling, and is limited to no more than 12 months per authorization.

POLICY UPDATE CHANGES

Template Update; Removed content/language pertaining to the state of Louisiana

2Covered Indications (SLE, Active Lupus Nephritis)

6Unproven / Not Medically Necessary Indications Listed

1Drug J-code Listed

12Max Authorization Duration (months)

Coverage Summary

UnitedHealthcare Community Plan medical benefit coverage for Benlysta (belimumab) intravenous infusion covers treatment of systemic lupus erythematosus (SLE) and active lupus nephritis (LN) under specified initial and continuation authorization criteria. The policy defines applicable J-code and ICD-10 diagnosis codes and lists exclusions for unproven indications. This policy does not apply to certain states with state-specific policies (e.g., Arizona, Florida, Indiana, Kansas, North Carolina, Ohio, Washington). Effective date: April 1, 2026; Last review: April 1, 2026.

Policy Metadata

Policy NumberCS2026D0046AA

Effective Date2026-04-01

Last Review2026-04-01

Next Review

Coverage Stancecovered_with_criteria

Authorization Maximum12 months

Initial Therapy Criteria — Systemic Lupus Erythematosus

Systemic Lupus Erythematosus - Initial Therapy

Benlysta is proven and medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of active systemic lupus erythematosus, without severe active central nervous system lupus
Standard therapy: Currently receiving at least one standard of care treatment for active systemic lupus erythematosus (e.g., antimalarials, corticosteroids, or immunosuppressants) that is not a biologic
Concomitant biologics: Patient is not receiving Benlysta in combination with Lupkynis (voclosporin) or Saphnelo (anifrolumab-fnia)

Continuation Therapy Criteria — Systemic Lupus Erythematosus

Systemic Lupus Erythematosus - Continuation Therapy

For continuation of therapy, ALL of the following must be met:

ALL of the following

Prior IV receipt: Patient has previously received Benlysta injection for intravenous infusion
Clinical response: Documentation of positive clinical response
Standard therapy: Currently receiving at least one standard of care treatment for active systemic lupus erythematosus (e.g., antimalarials, corticosteroids, or immunosuppressants) that is not a biologic

Initial Therapy Criteria — Active Lupus Nephritis

Active Lupus Nephritis - Initial Therapy

Benlysta is proven and medically necessary for active lupus nephritis when ALL of the following are met:

ALL of the following

Diagnosis of active lupus nephritis, without severe active central nervous system lupus
Standard therapy: Currently receiving at least one standard of care treatment for active systemic lupus erythematosus (e.g., antimalarials, corticosteroids, or immunosuppressants) that is not a biologic
Concomitant biologics: Patient is not receiving Benlysta in combination with Lupkynis (voclosporin) or Saphnelo (anifrolumab-fnia)

Continuation Therapy Criteria — Active Lupus Nephritis

Active Lupus Nephritis - Continuation Therapy

For continuation of therapy for active lupus nephritis, ALL of the following must be met:

ALL of the following

Prior IV receipt: Patient has previously received Benlysta injection for intravenous infusion
Requirement for documentation of prior IV receipt
Clinical response: Documentation of positive clinical response
Requirement for documentation of positive clinical response
Standard therapy: Currently receiving at least one standard of care treatment for active systemic lupus erythematosus (e.g., antimalarials, corticosteroids, or immunosuppressants) that is not a biologic

Unproven / Not Medically Necessary Indications

Benlysta is unproven and not medically necessary for the following indications:

ANY of the following

ANCA vasculitis: Antineutrophil cytoplasmic antibody-associated vasculitis
Rheumatoid arthritis
Severe CNS lupus: Severe active central nervous system (CNS) lupus
Sjögren's syndrome

Applicable Codes

Drug J-codeHCPCS

J0490

Injection, belimumab, 10 mg

Applicable Diagnosis Codes (reference only)ICD-10

M32.0	Drug-induced systemic lupus erythematosus
M32.10	Systemic lupus erythematosus, organ or system involvement unspecified
M32.11	Endocarditis in systemic lupus erythematosus
M32.12	Pericarditis in systemic lupus erythematosus
M32.13	Lung involvement in systemic lupus erythematosus
M32.14	Glomerular disease in systemic lupus erythematosus
M32.15	Tubulo-interstitial nephropathy in systemic lupus erythematosus
M32.19	Other organ or system involvement in systemic lupus erythematosus
M32.8	Other forms of systemic lupus erythematosus
M32.9	Systemic lupus erythematosus, unspecified

Provider Actions and Authorization Requirements

Prior Authorization

Prior authorization required for initial and continuation therapy

Authorization must document the patient's diagnosis of active SLE (or active lupus nephritis as applicable); prior and current non-biologic standard-of-care therapy (e.g., antimalarials, corticosteroids, or immunosuppressants); absence of severe active central nervous system (CNS) lupus; absence of concomitant use with Lupkynis (voclosporin) or Saphnelo (anifrolumab-fnia); dosing consistent with U.S. FDA labeled dosing for SLE; and the authorization is limited to no more than 12 months per authorization.

Affected code(s): J0490
Authorization duration limit: 12 months

Documentation Required

Documentation of positive clinical response for continuation

For continuation requests, submit documentation showing the patient previously received intravenous Benlysta and evidence of a positive clinical response to therapy.

Clinical Evidence

PERR higher with belimumabPERR at week 104 — proportion achieving PERR significantly higher with belimumab plus standard therapy vs placebo

Belimumab is a human monoclonal antibody specific for soluble B lymphocyte stimulator protein (BLyS/BAFF) that blocks BLyS binding to its receptors, inhibiting B-cell survival and reducing differentiation into immunoglobulin-producing plasma cells; the intravenous formulation (Benlysta injection for intravenous infusion) is addressed in this policy.

Definitions

Standard therapy: Antimalarials, corticosteroids, or immunosuppressants that are not biologics (examples provided in policy).

PERR: Primary Efficacy Renal Response defined by uPCR ≤ 0.7 g/g and eGFR ≥ 60 mL/min/1.73 m2 or no decrease in eGFR > 20% from pre-flare value at specified timepoints.

Revision History

2026-04-01revisedLatest

Template Update; Removed content/language pertaining to the state of Louisiana (is_material: false)