| 581 | For the treatment of adults with severe active rheumatoid arthritis (RA) (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or anti-CCP postive, and radiographic evidence of rheumatoid arthritis) who meet ALL the following criteria.
1. Patient has experienced failure to respond, documented intolerance, or contraindication to optimal use of one of the following disease modifying, anti-rheumatic (DMARD) regimens:
A) i) Methotrexate (20mg/week) for at least 3 months, AND
ii) Leflunomide (20mg/day) for at least 3 months, in addition to
iii) An adequate trial of at least one combination of DMARDs for 3 months;
OR
B) i) Methotrexate (20mg/week) for at least 3 months, AND
ii) Leflunomide in combination with methotrexate for at least 3 months; OR
C) i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine 400mg/day) for at least 3 months.
(Hydroxychloroquine is based by weight up to 400mg per day.)
2. Patient has experienced failure to respond, documented intolerance, or contraindication to an adequate trial of at least ONE anti-TNF agent (e.g., adalimumab, etanercept, infliximab, golimumab, certolizumab pegol).
3. Patient is not using rituximab in a maintenance setting.
4. Patient is not using a treatment course of rituximab earlier than 6 months after the completion of a prior course of rituximab.
5. Rituximab is not used in combination with another biologic to treat the patient's RA.
6. Treatment must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology.
One course of treatment is 1000mg followed two weeks later by the second 1000mg dose.
|
| | LU Authorization Period: 3 Months |
| 582 | For the re-treatment of patients with severe active rheumatoid arthritis (RA) (greater than or equal to 5 swollen joints, and rheumatoid factor positive and/or anti-CCP positive, and radiographic evidence of rheumatoid arthritis) who meet ALL the following criteria:
1. Patient has met the initiation criteria for rituximab in accordance with RFU 581;
2. Patient has experienced loss of effect after having responded to the prior treatment course of rituximab (Response is defined as a 20% reduction in the swollen joint count compared to the joint count prior to the first, pre-treatment course evaluated at 3 to 4 months following the administered course AND improvement in 2 swollen joints); AND
3. Patient is not using rituximab in a maintenance setting; AND
4. Patient is not using a treatment course of rituximab earlier than 6 months after the completion of a prior course of rituximab; AND
5. Rituximab is not used in combination with another biologic to treat the patient's RA.
6. Treatment must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology.
One course of re-treatment is 1000mg followed two weeks later by the second 1000mg dose. |
| | LU Authorization Period: 3 Months |
| 616 | Rituximab is used in combination with glucocorticoids for the induction of remission in patients with severely active Granulomatosis with Polyangiitis [(GPA), also known as Wegener's Granulomatosis (WG)] OR microscopic polyangiitis (MPA), for patients who meet all of the following criteria:
1. The patient must have severe active disease that is life- or organ-threatening as supported by laboratory and/or imaging reports.
AND
2. There is a positive serum assay for either proteinase 3-ANCA (anti-neutrophil cytoplasmic autoantibodies) or myeloperoxidase-ANCA.
AND
3. Cyclophosphamide cannot be used by the patient for one of the following reasons:
a. The patient has failed a minimum of six IV pulses of cyclophosphamide; OR
b. The patient has failed three months of oral cyclophosphamide therapy; OR
c. The patient has a severe intolerance or an allergy to cyclophosphamide; OR
d. Cyclophosphamide is contraindicated; OR
e. The patient has received a cumulative lifetime dose of at least 25g of cyclophosphamide; OR
f. The patient wishes to preserve ovarian/testicular function for fertility.
4. The request is from a prescriber experienced in the diagnosis and management of GPA, MPA, and vasculitis.
Exclusion criteria:
The patient should not have received a course of rituximab in the prior 6 months.
The recommended dosing regimen for the initial treatment would be a once weekly infusion dosed at 375 milligrams per square metre x 4 weeks.
Case-by-case considerations for patients not meeting the LU criteria may be considered through the Exceptional Access Program. |
| | LU Authorization Period: 1 month (1 treatment course) |
| 617 | Rituximab (Riximyo) treatment will be used for patients with severely active Granulomatosis with Polyangiitis [(GPA), also known as Wegener's Granulomatosis (WG)] OR microscopic polyangiitis (MPA) who have achieved disease remission. Patient must meet all of the following criteria:
1. The patient must have severe active disease that is life- or organ-threatening as supported by laboratory and/or imaging reports.
2. There is a positive serum assay for either proteinase 3-ANCA (anti-neutrophil cytoplasmic autoantibodies) or myeloperoxidase-ANCA. A copy of the laboratory report must be provided.
3. Stabilization of the condition with induction doses of cyclophosphamide (injectable or oral doses are acceptable) and a glucocorticoid as combination over 4 to 6 months until disease remission prior to initiation of rituximab.
4. The request is from a prescriber experienced in the diagnosis and management of GPA, MPA, and vasculitis.
Exclusion criteria:
The patient should not have received a dose of rituximab in the prior 6 months. Doses of rituximab administered at intervals more frequently than every 6 months are not funded.
The recommended dosing regimen: A fixed dose regimen of Rituximab of 500mg IV every 6 months.
Case-by-case considerations for patients not meeting the LU criteria may be considered through the Exceptional Access Program. |
| | LU Authorization Period: 1 year |
