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Limited coverage criteria – rituximab

Last updated on March 21, 2025

Generic name

rituximab (Truxima®, Ruxience®, Riximyo®)

Strength & form

10 mg/mL, solution for intravenous injection

Special Authority criteria

Approval period 

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 1 anti-TNF agent

AND

When a Special Authority request is submitted by a rheumatologist

2 courses:

Each course consists of 2 doses of 1000 mg, administered at 0 and 2 weeks

The 2 courses must be administered a minimum of 24 weeks apart

Renewal

For RA patients who:

Show a minimum 20% American College of Rheumatology response (ACR 20 response) compared to pre-rituximab status

AND

When a Special Authority request is submitted by a rheumatologist

2 courses, to be administered within 1 year

Each course consists of 2 doses of 1000 mg, administered at 0 and 2 weeks

The courses must be administered a minimum of 24 weeks apart

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 cyclophosphamide

OR

Who have failed an adequate trial of cyclophosphamide

AND

When a Special Authority request is submitted by a rheumatologist, nephrologist or respirologist

Up to 4 weeks

Renewal

For GPA and MPA patients who:

Have documented beneficial response to the initial induction therapy

AND

Have a current demonstrated need for re-treatment

AND

When a Special Authority request is submitted by a rheumatologist, nephrologist or respirologist

Up to 4 weeks

Relapsing remitting multiple sclerosis (RRMS)

Initial

As first-line monotherapy for the treatment of RRMS diagnosed according to the current clinical criteria and magnetic resonance imaging (MRI) evidence, when a Special Authority request is submitted by a neurologist from a designated MS clinic, for patients who meet all the following criteria:

Patient is ambulatory with or without aid (EDSS of 6.5 or less)

AND

Patient is 18 years of age or older

15 months

Initial course: 2 doses of 1000 mg, administered at 0 and 2 weeks

Maintenance course: 1000 mg administered 6 months after initial course

Renewal

As monotherapy, when a Special Authority request is submitted by a neurologist from a designated MS clinic, for the treatment of patients with RRMS, who have demonstrated that the therapeutic benefits outweigh any potential risks, as shown by relapse rate, EDSS, MRI scan, or overall clinical impression

24 months

1000 mg administered every 6 months

Change of therapy

As monotherapy, when a Special Authority request is submitted by a neurologist from a designated MS clinic, for the treatment of patients with RRMS who have experienced failure or intolerance to a previous disease-modifying therapy

15 months

Initial course: 2 doses of 1000 mg, administered at 0 and 2 weeks

Maintenance course: 1000 mg administered 6 months after initial course

Neuromyelitis optica spectrum disorder (NMOSD)

Initial:

For the treatment of NMOSD in patients and when a Special Authority request is submitted by a neurologist with expertise in the diagnosis and management of NMOSD in patients with:

  • Severe first attack (e.g., marked change in neurological functioning, requiring hospitalization or plasma exchange) or high disability with first attack (e.g., bilateral, or significant visual acuity loss worse than 6/60 or Expanded Disability Status Scale (EDSS) 5 at attack nadir)

OR

  • The patient must have had treatment failure resulting in at least one moderate to severe relapse of NMOSD within the previous 12 months despite a trial of optimally dosed first-line therapy1, or a documented intolerance or contraindication to a first-line therapy

12 months

Renewal:

  • Patient has maintained an EDSS score of less than 8 points taken within the 3-month period immediately preceding the renewal request

AND

  • When a Special Authority request is submitted by a neurologist with expertise in the diagnosis and management of NMOSD
 12 months

Practitioner exemptions

  • A Collaborative Prescribing Agreement (CPA) (PDF, 400KB) is available to neurologists specializing in MS whose primary place of practice is a designated MS clinic. Neurologists who have signed a CPA are not required to submit a Special Authority request for coverage for patients who meet the criteria specified in this agreement
  • For the diagnosis of NMOSD and other conditions, a SA coverage request must be submitted on the applicable form

Special notes

  • Special Authority requests for the treatment of other moderate to severe autoimmune conditions not specified above in patients who have had treatment failure or intolerance to immunosuppressants, when applicable, will be considered on a case-by-case basis. HLTH 5848 – Rituximab for Autoimmune Conditions form is a general form that can be submitted for consideration of coverage. Additional condition-specific forms are available via eForms
  • PharmaCare will not consider coverage of rituximab for indications that are under the scope of the BC Cancer Agency, BC Transplant, and BC Renal. Coverage will not be considered for hospital inpatient use (must be provided by the health authority), or for indications that do not have robust evidence to support use
  • The definition of ACR 20 response is a 20% reduction in tender joint count and swollen joint count, as well as a 20% improvement in at least 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 HLTH 5383 – Health Assessment Questionnaire must be submitted with the Special Authority request
  • For the treatment of GPA and MPA: a completed Birmingham Vasculitis Activity Score (BVAS) (PDF, 159KB) is required as part of the application process. This and other BVAS forms will be accepted as long as there is a clear distinction between new/worse symptoms and persistent disease activity
  • For the treatment of RRMS: discontinuation of therapy should be discussed with patients with stable or inactive disease who are 60 years of age or older
  • 1First line treatment for NMOSD may include azathioprine or tocilizumab

Special Authority request form(s)