Belimumab (Benlysta®) is a B-lymphocyte stimulator-specific inhibitor indicated for the treatment of adult patients (aged ≥ 18 years) with active, autoantibody-positive, systemic lupus erythematosus who are receiving standard therapy.  A standard of care systemic lupus erythematosus treatment regimen may comprise any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs, and immunosuppressives.

The recommended dosage regimen is 10 mg/kg at two-week intervals for the first three doses and at four-week intervals thereafter. Administer as an intravenous infusion.

The use of belimumab for all other indications is considered experimental/investigational, and therefore, not covered including:

• Patient with active central nervous system lupus, or
• Patients with severe lupus nephritis, active nephritis, or requiring hemodialysis, or
• Patients currently being treated with biologics or intravenous cyclophosphamide.

A participating, preferred, or network provider can bill the member for the non-covered service.

NOTE:

Coverage for belimumab is determined according to individual or group customer benefits.

Description

Belimumab is a human monoclonal antibody that specifically recognizes and blocks the biological activity of B-lymphocyte stimulator, or BLyS®, a naturally occurring protein which was discovered by scientists at Human Genome Sciences (HGS). Elevated levels of BLyS prolong the survival of B lymphocytes (B cells) which can contribute to the production of autoantibodies - antibodies that target the body's own tissues. Studies have shown that belimumab can reduce autoantibodiy levels and help control autoimmune disease activity.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or life-threatening condition and when medically necessary and appropriate for the patient's condition.

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Benlysta® (belimumab)[package insert]. Rockville, MD: Human Genome Sciences, Inc;03/2011.