ANCA-associated Vasculitis (AAV)
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Criteria
Rituximab for Granulomatosis with Polyangiitis or Microscopic Polyangiitis
Dosage Form/Strength
- 10 mg/mL intravenous injection
Brand(s)
- Biosimilars: Riximyo, Ruxience, Truxima
- Originator: Rituxan
Induction of Remission
Indication:
- Severely active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)
Combination Treatment:
- Glucocorticoids
Criteria for Induction:
- Severe Active Disease:
- Life- or organ-threatening.
- At least one supporting laboratory and/or imaging report.
- Specification of threatened organ(s).
- Positive Serum Assays:
- Proteinase 3-ANCA (anti-neutrophil cytoplasmic autoantibodies) or
- Myeloperoxidase-ANCA
- Copy of the laboratory report required.
- Cyclophosphamide Usage:
- Cyclophosphamide cannot be used for at least one of the following reasons:
- Failed a minimum of six IV pulses of cyclophosphamide.
- Failed three months of oral cyclophosphamide therapy.
- Severe intolerance or allergy to cyclophosphamide.
- Cyclophosphamide is contraindicated.
- Received a cumulative lifetime dose of at least 25 g of cyclophosphamide.
- Wishes to preserve ovarian/testicular function for fertility.
- Cyclophosphamide cannot be used for at least one of the following reasons:
Initial Treatment:
- Once weekly infusion dosed at 375 mg/m² for 4 weeks.
- Note: Treatment must not be a maintenance infusion as maintenance infusions are not funded.
Renewals:
- Considered if:
- Patient meets the same criteria for initial approval.
- Request for retreatment is made no less than 6 months after the last dose of the last treatment cycle with rituximab.
- Duration:
- First Renewal: 1 year
- Subsequent Renewals: Every 2 years
- Condition: Funded only upon flare of the condition, with an interval of at least 6 months.
Maintenance Therapy
Indication:
- Severely active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)
Criteria for Maintenance: a) Severe Active Disease:
- Life- or organ-threatening.
- At least one supporting laboratory and/or imaging report.
- Specification of threatened organ(s).
b) Positive Serum Assays:
- Proteinase 3-ANCA or Myeloperoxidase-ANCA
- Copy of the laboratory report required.
c) Stabilization with Induction Doses:
- Cyclophosphamide (IV or PO doses)
- Glucocorticoid as combination over 4 to 6 months until disease remission.
- Followed by rituximab at 500 mg doses every 6 months.
- Cyclophosphamide dosing must align with MAINRITSAN studies.
Post-Remission Administration:
- Option 1: Fixed Dose Regimen
- 500 mg on days 0 and 14.
- 500 mg at 6, 12, and 18 months.
- Combination with low-dose prednisone or another glucocorticoid.
- Duration: 18 months funding.
- Option 2: Tailored Dose Regimen
- 500 mg on day 0.
- Subsequent doses as early as every 3 months based on:
- CD19 exceeds 0/mm³, or
- ANCA reappears, or
- Titre increase
- Duration: 18 months funding.
Remission-Induction Therapy Details:
- Prednisone: Starting at 1 mg/kg/day, followed by gradual tapering.
- Methylprednisolone Pulses: 500 to 1000 mg daily for 1 to 3 consecutive days (in some patients).
- Pulse Cyclophosphamide:
- 0.6 g/m² on days 0, 14, and 28.
- Then 0.7 g/m² every 3 weeks for three to six additional pulses until remission (typically within a month).
- Oral Cyclophosphamide: Example dosing 150 mg daily.
- Approval Duration: 18 months.
Renewals
- Considered Case-by-Case:
- Include information on:
- Number of disease flares during funding period.
- Description of symptoms during flares.
- Dosing Interval:
- Must be maintained as every 6 months.
- Should be specified.
- Include information on: