Limited Coverage Drugs - Rituximab

Generic Name

rituximab

Strength

10 mg / mL
Form injection
Special Authority Criteria Approval Period
Treatment of severely active Rheumatoid Arthritis (RA)

Initial:

For the treatment of severely active Rheumatoid Arthritis (RA) in combination with methotrexate in patients who:

  • have contraindication(s) to anti-TNF agents

or

  • have failed to respond to an adequate trial of at least one (1) anti-TNF agent.

AND

Is prescribed by a rheumatologist.

2 courses:

One (1) course is two (2) doses of 1000 mg at 0 and 2 weeks.

Courses must be a minimum of 24 weeks apart.

Renewal:

RA patients must show a minimum 20% American College of Rheumatology response (ACR 20 response is defined below in Special Notes) compared to pre-rituximab status.

2 courses:

One (1) course is two (2) doses of 1000 mg at 0 and 2 weeks.

Courses must be a minimum of 24 weeks apart.

Induction of remission in severely active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)

Initial:

For the induction of remission in severely active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA) in patients who:

  • have had a severe intolerance or contraindication to cylophosphospamide

or

  • who have failed an adequate trial of cyclophosphamide

AND

Is prescribed by a rheumatologist, nephrologist or respirologist.

Up to 4 weeks

Renewal:

GPA and MPA patients must have documented beneficial response to initial induction therapy and have a current demonstrated need for retreatment.

Up to 4 weeks

Practitioner Exemptions

  • None

Special Notes

  • The definition of ACR 20 response is a 20% reduction in tender joint count and swollen joint count and 20% improvement in at least three (3) of the following: patient's assessment of pain, patient's global assessment, physician's global assessment, patient's assessment of disability, and acute phase reactant measures (i.e. ESR or CRP).
  • For the treatment of RA: A completed Health Assessment Questionnaire (HAQ) is required with application.
  • For the treatment of MPA/GPA and MPA: A completed Birmingham Vasculitis Activity Score (BVAS) is required as part of the application process. Please see the BVAS linked below which allows for clear notation of both new/worse as well as persistent disease manifestations. Other BVAS forms will be accepted as long as there is a clear distinction between new/worse symptoms and persistent disease activity.
    Link: www.canvasc.ca/pdf/BVAS3fullonly.pdf (PDF, 159KB)

Special Authority Request Form(s)