Benlysta SC

Belimumab

• Brand(s): Benlysta
• Dosage Form/Strength: 120 mg/5 mL, 400 mg/20 mL Vial for Injection
• Effective Date: April 17, 2024

Initiation criteria:

For the treatment of active lupus nephritis (LN) in patients on standard therapy who meet the following criteria:

1. Age 18 years and older;
   AND
2. Diagnosed with biopsy-proven (Note 1) active LN of International Society of Nephrology and Renal Pathology Society class III (focal LN) or IV (diffuse LN) with or without class V (membranous LN), or pure class V disease;
   AND
3. Belimumab is being administered in addition to standard therapy for LN (Note 2);
   AND
4. Patient has started standard induction therapy within the prior 60 days before the request for belimumab;
   AND
5. Patient has not demonstrated treatment failure to both cyclophosphamide and mycophenolate mofetil (or other forms of mycophenolate) used previously as induction therapies;
   AND
6. Patient has an eGFR greater than or equal to 30 mL/min/1.73 m²;
   AND
7. Prescribed by a rheumatologist or nephrologist with experience in managing Lupus nephritis.

Discontinuation criteria: Treatment with belimumab must be discontinued if the patient does not meet all of the renewal criteria or if the patient has any of the following:

1. An eGFR decrease to less than 30 mL/min/1.73 m²
2. Patient requires addition of other immunosuppressant agents (other than as part of the induction and maintenance regimens), corticosteroid use outside of the limits, anti– tumour necrosis factor therapy, or other biologics to manage their LN.

Renewal Criteria:

First renewal

Renewal of funding will be considered for patients who do not meet the discontinuation criteria and who meet the following criteria after the first 12 months of treatment with belimumab:

1. Patient has reduced their baseline oral corticosteroid doses to at least 7.5 mg per day or lower OR for those who remain at doses higher than 7.5 mg per day, patients will be considered for renewal if they are able to reduce their corticosteroid dose to at least 50% from their baseline levels;
   AND
2. Patient must demonstrate stabilization or improvement in eGFR with a documented estimated eGFR that is no more than 20?low the value before the renal flare (preflare value) or that is greater than or the same as 60 mL/min/1.73 m2 after 12 months of therapy;
   AND
3. Patient has documented improvement in proteinuria defined as one of the following:
   a. proteinuria no greater than 0.7 g/24 hours after 12 months of therapy if baseline proteinuria was less than 3.5 g/24 hours;
   b. proteinuria no greater than 0.7 g/24 hours after 18 to 24 months of therapy if baseline proteinuria was greater than 3.5 g/24 hours;

(Note: Patients who meet the corticosteroid and renal improvement in the renewal criteria above but who had baseline “nephrotic” levels of proteinuria, will be approved for an additional 6 to 12 months on a case-by-case basis if they have been unable to reduce their proteinuria level to at least 0.7g/24 hours after the first 12 months of belimumab treatment.)

Second and Subsequent renewals

The prescriber must provide documentation that the initial response achieved after the first 12 months of therapy with belimumab has been maintained.

Notes:

Patients unable to provide a kidney biopsy may be considered on a case-by-case basis. Applications must include documented rationale and relevant clinical details as to why a kidney biopsy cannot be provided.

1. Standard induction therapy is defined as corticosteroids with either cyclophosphamide or mycophenolate mofetil or other forms of mycophenolate, or azathioprine. Outside of induction therapy, patients are expected to be receiving other standard-of-care therapies for LN (e.g., antimalarials and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) as appropriate and indicated.
2. Prescribers must submit laboratory reports with documentation of relevant lab work required within the belimumab funding criteria. (e.g. eGFR, serum creatinine, albumin, urine protein, etc.)

Exclusion criteria: Patients with a diagnosis of active Systemic Lupus Erythematosus (SLE) but without active LN are excluded from funding of belimumab.

Recommended Dose for LN:10 mg/kg IV at 2-week intervals for the first 3 doses and at 4-week intervals thereafter.

Approval duration for initials and renewals: Up to 12 months