Benlysta (belimumab) — Medical Mutual

Lupus Nephritis

Initial criteria

If the request is Belimumab for intravenous administration, the patient’s age is > 5 years OR if the request is Belimumab for subcutaneous administration, the patient’s age is > 18 years
Severe active central nervous system lupus erythematosus is not present
Belimumab will not be used in combination with another biologic agent
Belimumab will be used in combination with conventional medical therapy (e.g., corticosteroids, antimalarials, or other immunosuppressants with or without nonsteroidal anti-inflammatories)
Patient has active lupus nephritis Class III, IV, or V as confirmed by renal biopsy
Patient has a confirmed diagnosis of SLE with at least 4 diagnostic features (see SLE diagnosis criteria) one of which must include a positive autoantibody test
Patient has failed to respond adequately to standard therapies including corticosteroids AND either cyclophosphamide or mycophenolate mofetil
Baseline measurement of one or more of the following: urine protein:creatinine ratio (uPCR), estimated glomerular filtration rate (eGFR), or urine protein
Site of care medical necessity is met

For initial renewal (after 6 months), the patient has responded to therapy as determined by the prescribing physician
The patient has disease stability and/or improvement as indicated by one or more of the following compared to pre-treatment baseline after 12 months: urine protein:creatinine ratio (uPCR) OR estimated glomerular filtration rate (eGFR) OR urine protein
There is an absence of unacceptable toxicity or side effects from the drug

initial 6 months, renewal 12 months