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 or consulted by a specialist (rheumatologist, clinical immunologist, nephrologist, neurologist, or dermatologist) 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 unless intolerance to standard of care
The drug is not covered for the following conditions:
- Patients who are autoantibody negative
- Patients with active lupus nephritis or CNS lupus
- Will not be used as monotherapy unless patient is intolerant to standard of care
- 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
- Initial approval for 4 months
- 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: September 4, 2018