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
- Failure or clinically significant adverse effects to at least ONE standard therapy (i.e. corticosteroids, immunosuppressive/cytotoxic agents, antimalarials)
- 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.
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
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
- reduction steroid daily dose
- 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