Exceptional Access Program (EAP)

EAP forms are to be completed when applying for MOH funding for drugs for rheumatological diseases through Ontario’s Exceptional Access Program (EAP).

ANCA-associated Vasculitis (AAV)

Documents 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:

  1. Severe Active Disease:
    • Life- or organ-threatening.
    • At least one supporting laboratory and/or imaging report.
    • Specification of threatened organ(s).
  2. Positive Serum Assays:
    • Proteinase 3-ANCA (anti-neutrophil cytoplasmic autoantibodies) or
    • Myeloperoxidase-ANCA
    • Copy of the laboratory report required.
  3. 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.

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.
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Biosimilars

 

Biosimilar

LU Code

Truxima

Manufacturer: Teva

View LU Codes

Riximyo

Manufacturer: Sandoz

View LU Codes

Ruxience

Manufacturer: Pfizer

View LU Codes