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 who's disease has progressed during therapy


Western Health Advantage Pharmacy and Therapeutics Committee

Approved/Revised: July 2011 Reviewed: December 2013