Limited coverage drugs – rituximab

rituximab (Truxima^®, Ruxience^®, Riximyo^®)

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 prescribed 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

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 prescribed 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

Up to 4 weeks

Initial

As first-line monotherapy for the treatment of relapsing-remitting multiple sclerosis (MS) diagnosed according to the current clinical criteria and magnetic resonance imaging (MRI) evidence, when prescribed by a neurologist from a designated MS clinic, for patients who meet all the following criteria:

• The patient is ambulatory with or without aid (EDSS of 6.5 or less)

AND

• The 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 prescribed by a neurologist from a designated MS clinic, for the treatment of patients with relapsing-remitting MS, 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 prescribed by a neurologist from a designated MS clinic, for the treatment of patients with relapsing-remitting MS 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 neuromyelitis optica spectrum disorder (NMOSD) in patients and when requested 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 coverage is requested by a neurologist with expertise in the diagnosis and management of NMOSD