CurrentUnitedHealthcarePolicy N/A

Benlysta (belimumab) subcutaneous — Prior Authorization Coverage Criteria

Prior authorization criteria and reauthorization rules for the subcutaneous formulation of belimumab (Benlysta) for treatment of systemic lupus erythematosus (SLE) and lupus nephritis in patients aged 5 years and older, for UnitedHealthcare pharmacy benefit plans.

Policy Summary

PayerUnitedHealthcare

PolicyBenlysta (belimumab) subcutaneous — Prior Authorization Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 1, 2025

Next Review DateJul 1, 2025

Key ActionObtain prior authorization and confirm patient is receiving standard immunosuppressive therapy before approving subcutaneous Benlysta.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

≥5 yrsminimum age

SC onlyformulation

3 groupsprohibited combos

Coverage Criteria for Subcutaneous Belimumab (Benlysta)

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Initial Therapy — SLE

Initial authorization for systemic lupus erythematosus (SLE): Covered when ALL of the following are met

SLE initial: (1) Diagnosis of systemic lupus erythematosus; (2) Patient is currently receiving standard immunosuppressive therapy [e.g., hydroxychloroquine, chloroquine, prednisone, azathioprine, methotrexate]; (3) Patient does not have severe active central nervous system lupus; (4) Patient is not receiving Benlysta in combination with any of the following: (a) Targeted immunomodulator (e.g., Enbrel [etanercept], Humira [adalimumab], Cimzia [certolizumab], Kineret [anakinra]); (b) Lupkynis (voclosporin); (c) Saphnelo (anifrolumab-fnia).

Initial Therapy — Lupus nephritis

Initial authorization for active lupus nephritis: Covered when ALL of the following are met

lupus nephritis initial: (1) Diagnosis of active lupus nephritis; (2) Patient is currently receiving standard immunosuppressive therapy for systemic lupus erythematosus [e.g., hydroxychloroquine, chloroquine, prednisone, azathioprine, methotrexate]; (3) Patient does not have severe active central nervous system lupus; (4) Patient is not receiving Benlysta in combination with any of the following: (a) Targeted immunomodulator (e.g., Enbrel [etanercept], Humira [adalimumab], Cimzia [certolizumab], Kineret [anakinra]); (b) Lupkynis (voclosporin); (c) Saphnelo (anifrolumab-fnia).

Reauthorization

Reauthorization (both SLE and lupus nephritis): Covered when ALL of the following are met

reauthorization: (1) Documentation of positive clinical response to Benlysta therapy; (2) Patient is not receiving Benlysta in combination with any of the following: (a) Targeted immunomodulator (e.g., Enbrel [etanercept], Humira [adalimumab], Cimzia [certolizumab], Kineret [anakinra]); (b) Lupkynis (voclosporin); (c) Saphnelo (anifrolumab-fnia).

Use of Benlysta (belimumab) is not recommended for patients with severe active central nervous system (CNS) lupus. The policy follows the product labeling which states that the efficacy of Benlysta has not been evaluated in this population and therefore it should not be used for severe active CNS lupus.

For initial authorization and reauthorization, members must not have severe active CNS lupus; presence of this condition means the request does not meet the policy’s coverage criteria.

Benlysta must not be used in combination with specified agents. Requests where the patient is receiving Benlysta concurrently with any of the following will not meet coverage criteria: (a) a targeted immunomodulator (examples given include etanercept, adalimumab, certolizumab, anakinra), (b) Lupkynis (voclosporin), or (c) Saphnelo (anifrolumab‑fnia).

This policy’s stance is to consider combination use with these listed biologic or targeted immunomodulatory agents as a contraindication to approval; such concurrent use should be discontinued before a request for coverage is considered, and reauthorization also requires absence of these prohibited combinations.

Initial Therapy — Operational Criteria

Initial Therapy — Consolidated criteria

Initial coverage criteria — top-level requirements for approval

initial: (1) Diagnosis of systemic lupus erythematosus or active lupus nephritis; (2) Patient is currently receiving standard immunosuppressive therapy [e.g., hydroxychloroquine, chloroquine, prednisone, azathioprine, methotrexate]; (3) Patient does not have severe active central nervous system lupus; (4) Patient is not receiving Benlysta in combination with any of the following: (a) Targeted immunomodulator (e.g., Enbrel [etanercept], Humira [adalimumab], Cimzia [certolizumab], Kineret [anakinra]); (b) Lupkynis (voclosporin); (c) Saphnelo (anifrolumab-fnia). Authorization will be issued for 12 months.

Continuation / Reauthorization Criteria

Continuation Therapy — Reauthorization Criteria

Reauthorization — Continuation therapy will be approved when ALL of the following are met:

ALL of the following

Prior authorization was previously granted for initial therapy and the member has been receiving therapy under that authorization
Provider must have obtained initial prior authorization before continuation request.
Documentation of positive clinical response to therapy, as evidenced by clinician notes showing symptom improvement, stabilization of disease activity, or other objective measures appropriate to the condition
Attach clinical progress notes, relevant lab results, or disease activity scores demonstrating benefit.
Member has had an adequate trial of standard therapies when applicable and either had an inadequate response, intolerance, or contraindication to those therapies
Document prior standard therapy use, reasons for discontinuation, or intolerance/toxicity.
Reauthorization requests must include supporting documentation per plan requirements (see callout)

Authorization period

Authorization will be issued for 12 months
State mandates, federal regulatory requirements, and member-specific benefit plan coverage may affect coverage; other policies and UM programs may apply.

Prior Authorization

Provider Action Required

Prior authorization required. Reauthorization requests must include documentation of positive clinical response and evidence that standard therapy prerequisites were met or were inappropriate for the member.

Prior authorization required for both initial and continuation therapy
Reauthorization documentation: clinical progress notes, relevant labs, disease activity scores, or other objective evidence of benefit
Standard therapy prerequisite: documentation of trial, intolerance, contraindication, or inadequate response to standard therapies when applicable
Authorization duration: up to 12 months (subject to state mandates and member benefit plan terms)

Provider Actions and Requirements

Prior Authorization

Obtain prior authorization for subcutaneous Benlysta

Prior authorization is required for the subcutaneous formulation of Benlysta. Initial approval requires a diagnosis of systemic lupus erythematosus (SLE) or active lupus nephritis and that the patient is receiving standard immunosuppressive therapy.

Step Therapy

Confirm patient is on standard immunosuppressive therapy

Ensure the patient is currently receiving standard immunosuppressive therapy (examples listed in policy) prior to approval; this is a required prerequisite for initial authorization.

Examples include hydroxychloroquine, chloroquine, prednisone, azathioprine, or methotrexate as noted in the policy.

Denial Risk

Exclude requests with prohibited combination therapies

Do not submit or approve requests for Benlysta when the patient is receiving it in combination with specified therapies listed in the policy; such combinations will not meet coverage criteria.

Prohibited combinations include targeted immunomodulators (e.g., etanercept, adalimumab, certolizumab, anakinra), Lupkynis (voclosporin), and Saphnelo (anifrolumab‑fnia).

Denial Risk

Severe active CNS lupus is an exclusion

Requests for patients with severe active central nervous system (CNS) lupus are not recommended/covered; presence of severe active CNS lupus excludes approval.

Standard immunosuppressive therapy (examples)
hydroxychloroquine
chloroquine
prednisone
azathioprine
methotrexate

Definitions and Standard Therapies

Standard immunosuppressive therapy (examples)

HydroxychloroquineListed example of standard immunosuppressive therapy required prior to approval

ChloroquineListed example of standard immunosuppressive therapy required prior to approval

PrednisoneListed example of standard immunosuppressive therapy required prior to approval

AzathioprineListed example of standard immunosuppressive therapy required prior to approval

MethotrexateListed example of standard immunosuppressive therapy required prior to approval

Site of Care and Benefit Routing

Note

Site-of-care and benefit routing for Benlysta formulations

Subcutaneous dosing of Benlysta is covered through the pharmacy benefit; the intravenous formulation is typically covered under the medical benefit—refer to UnitedHealthcare medical drug policy for routing guidance.

Routing of IV infusions follows UnitedHealthcare medical drug policy; pharmacy benefit applies to the SC formulation.

Background

Belimumab (Benlysta) is a B‑lymphocyte stimulator (BLyS)‑specific inhibitor indicated as adjunctive therapy for patients aged 5 years and older with active systemic lupus erythematosus and for patients aged 5 years and older with active lupus nephritis, when used in combination with standard therapy.

The policy applies to the subcutaneous formulation of belimumab for these indications; initial authorization requires documentation of the diagnosis (SLE or active lupus nephritis) and that the patient is receiving standard immunosuppressive therapy prior to approval.