Belimumab (Benlysta)

OFFICE ADMINISTRATION

Indications for Prior Authorization:

  • Treatment of adult (18 years old or greater) patients with active, autoantibody-positive (ANA, anti-ds-DNA, anti-Sm) systemic lupus erythematosus (SLE) prescribed by a rheumatologist AND
  • Failure or clinically significant adverse effects to at least ONE standard therapy (i.e. corticosteroids, immunosuppressive/cytotoxic agents, antimalarials) AND
  • Benlysta is prescribed in combination with standard therapy

The drug is not covered for the following conditions:

  • Patients who are autoantibody negative
  • Patients with active lupus nephritis or CNS lupus
  • Must not be used in combination with rituximab, IV cyclophosphamide, or any other biologics
  • Any condition not listed in the indication section above.

Dosing:

  • The recommended dosage regimen for Benlysta is 10 mg/kg at 2-week intervals for the first three doses and at 4-week intervals thereafter.
  • Benlysta is for intravenous infusion only (given over 1 hour) and must be reconstituted and diluted prior to administration.
  • The infusion must be discontinued immediately if the patient experiences a serious hypersensitivity reaction.
  • Prior to dosing with Benlysta, pre-medication for prophylaxis against infusion reactions and hypersensitivity reactions should be considered.
  • Benlysta should be administered by healthcare providers prepared to manage anaphylaxis

Approval Period:

  • Approve for 6 months
  • Renew for additional 6 months if patient condition has stabilized
  • Subsequent renew for one year if:
    • Reduction in number or severity of SLE flares OR
    • Reduction steroid daily dose OR
    • Improved physician global assessment
  • Renewal will not be granted for patients whose disease has progressed during therapy

 

Last review date: December 2, 2013