Return to Special Authority drug list
Generic name |
rituximab |
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---|---|---|
Strength & form |
10 mg/mL solution for intravenous injection |
Special Authority criteria |
Approval period |
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Rheumatoid arthritis (RA)InitialFor 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 RenewalFor 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 |
Initial: 2 courses
Renewal: 2 courses, to be administered within 1 year
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Granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)InitialFor 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 RenewalFor 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 |
Initial: Up to 4 weeks Renewal: Up to 4 weeks |
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Relapsing remitting multiple sclerosis (RRMS)InitialAs 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 RenewalAs 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 Change of therapyAs 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 |
Initial: 15 months
Renewal: 24 months
Change of therapy: 15 months
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Neuromyelitis optica spectrum disorder (NMOSD)InitialFor 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:
OR
Renewal
AND
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Initial: 12 months Renewal: 12 months |