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Reason for Use code 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. Coverage limit: LU Authorization Period: 3 Months Reason for Use code 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. Coverage limit: LU Authorization Period: 3 Months Reason for Use code 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. Coverage limit: LU Authorization Period: 1 month (1 treatment course) Reason for Use code 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. Coverage limit: LU Authorization Period: 1 year Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Rituximab (See funded biosimilar versions on the ODB formulary) Brand(s): Riximyo, Ruxience, Truxima, Rituxan (Approved EAP exemptions only) DOSAGE FORM/ STRENGTH: 10 mg/mL Intravenous injection 1Patients must have used a steroid dose equivalent to a 1 mg/kg prednisone dose equivalent (or a minimum of 60 mg/day for patients > 60 kg) for at least 4 to 6 weeks before attempting to taper to a lower dose. 2Patients must try at least one of the following at therapeutic doses: azathioprine, mycophenolate, cyclophosphamide, or methotrexate (in combination with a steroid). Dose: ONE course of treatment with rituximab is considered 375 mg/m2 administered weekly for 4 weeks (for a total of 4 doses) OR 1000 mg of rituximab administered at week 0 and week 2 (for a total of 2 doses) Re-treatment may be provided if the patient responded to rituximab therapy then experiences disease flare, as long as the request is made no less than 6 months after the last dose of the patient’s last treatment course/cycle with rituximab. Rejection Criteria: • Other dermatology diagnoses, such as pemphigus foliaceus and bullous pemphigoid • Maintenance infusions (i.e. regular maintenance doses to keep disease in remission) Duration of Approval: 1 year Maintenance Treatment is not funded. First Renewal: 1 year Subsequent Renewals after first renewal: 2 years (Rituximab is funded for course of therapy to be given at an interval of at least 6 months only upon flare of the condition.) 116 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 116, record 73, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Rituximab -See Formulary for funded biosimilars Brand(s): Riximyo, Ruxience, Truxima (biosimilars); Rituxan (Originator) DOSAGE FORM/ STRENGTH: 10 mg/mL intravenous injection Refer to the Executive Officer Communications on the Ministry website for the Ministry’s Biosimilar Policy including frequently asked questions and updates for the biosimilar policy updates. http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions. In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 to 8 of this document). It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on an originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, will be expected to be provided ongoing access of the originator biologic through the patient’s original payer mechanism (e.g. manufacturer’s patient support program) or to switch to an ODB funded biosimilar version upon meeting specified criteria. The Ministry will no longer consider funding of originator biologics that are part of the biosimilar policy with limited exemptions on or after December 29, 2023. 122 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 122, record 77, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Rituximab (See funded biosimilar versions on the ODB formulary) Brand(s): Riximyo, Ruxience, Truxima, Rituxan (Approved EAP exemptions only) DOSAGE FORM/ STRENGTH: 10 mg/mL Intravenous injection For the induction of remission of severely active Granulomatosis with Polyangiitis (GPA) OR microscopic polyangiitis (MPA) as combination treatment with glucocorticoids, in patients who meet all of the following criteria: 1. The patient must have severe active disease that is life- or organ-threatening. At least one supporting laboratory and/or imaging report must be provided. The organ(s) and how the organ(s) is (are) threatened must be specified. 2. There is a positive serum assays for either proteinase 3-ANCA (anti-neutrophil cytoplasmic autoantibodies) or myeloperoxidase-ANCA. A copy of the laboratory report must be provided. 3. Cyclophosphamide cannot be used for the patient for at least ONE of the following reasons: i) The patient has failed a minimum of six IV pulses of cyclophosphamide; OR ii) The patient has failed three months of oral cyclophosphamide therapy; OR iii)The patient has a severe intolerance or an allergy to cyclophosphamide; OR iv) Cyclophosphamide is contraindicated; OR v) The patient has received a cumulative lifetime dose of at least 25 g of cyclophosphamide; OR vi) The patient wishes to preserve ovarian/testicular function for fertility. The initial treatment would be a once weekly infusion dosed at 375 mg/m2 x 4 weeks. The physician must confirm that the treatment would not be a maintenance infusion as maintenance infusions will not be funded. Renewals will be considered provided that, the patient meets the same criteria for initial approval and the request for retreatment is made no less than 6 months after the last dose of the patient’s last treatment cycle with rituximab. First Renewal:1year Subsequent Renewals after first renewal: 2 years (Rituximab is funded for course of therapy to be given at an interval of at least 6 months only upon flare of the condition.) 123 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 123, record 78, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Rituximab Brand(s): Riximyo, Ruxience, Truxima (Biosimilars; Rituxan (Originator) DOSAGE FORM/ STRENGTH: 10 mg/mL intravenous injection Rituximab will be funded as maintenance therapy for patients with severely active Granulomatosis with Polyangiitis [(GPA), also known as Wegener’s Granulomatosis (WG)] OR microscopic polyangiitis (MPA). Patient must meet all of the following criteria: a) The patient must have severe active disease that is life- or organ-threatening. At least one supporting laboratory and/or imaging report must be provided. The organ(s) and how the organ(s). is(are) threatened must be specified. b) 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. c) Stabilization of the condition with induction doses of cyclophosphamide (IV or PO doses) and a glucocorticoid as combination over 4 to 6 months until disease remission followed by rituximab at 500mg doses every 6 months. Cyclophosphamide dosing to align with MAINRITSAN studies1. After remission (typically within a month of remission), rituximab will be administered as one of the following: o A fixed dose regimen of Rituximab consisting of 500 mg dosed at days 0 and 14 followed by fixed doses of 500 mg at 6, 12, and 18 months, used in combination with low-dose prednisone of another glucocorticoid; x 18 months duration of funding OR o A tailored dose regimen of Rituximab based on CD19 and ANCA monitoring. Dose of Rituximab funded is 500 mg on day 0 followed by a dose as early as every 3 months if CD19 exceeds 0/mm3 or if ANCA reappears or if there is a titre increase x 18 months duration of funding. 1Remission-induction therapy included prednisone (starting at 1 mg per kilogram of body weight per day, followed by gradual tapering), preceded in some patients by methylprednisolone “pulses” (500 to 1000 mg daily for 1 to 3 consecutive days), and “pulse” cyclophosphamide (0.6 g per square meter of body-surface area on days 0, 14, and 28, then 0.7 g per square meter every 3 weeks for three to six additional pulses) until remission was attained, after 4 to 6 months. At that time, and within a maximum of 1 month after the last cyclophosphamide pulse, we have also accepted oral dosing (an example of oral cyclophosphamide dosing that has been used by clinicians is 150 mg daily). Approval duration: 18 months Renewals: Renewals will be considered case-by-case. Requests should include information pertaining to the number of disease flares during the period of funding and a description of symptoms during flares. The dosing interval of use must be maintained as every 6 months and should be specified. 124 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 124, record 79, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Rituximab Brand(s): Riximyo, Ruxience, and Truxima (biosimilar); Rituxan (only for those approved for biosimilar exemption) DOSAGE FORM/ STRENGTH: 10 mg/mL intravenous injection Effective date: July 29, 2022 Refer to the Executive Officer Communications on the Ministry website for the Ministry’s Biosimilar Policy including frequently asked questions and updates for the biosimilar policy updates. http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions. In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 to 8 of this document). It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on an originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, will be expected to be provided ongoing access of the originator biologic through the patient’s original payer mechanism (e.g. manufacturer’s patient support program) or to switch to an ODB funded biosimilar version upon meeting specified criteria. The Ministry will no longer consider funding of originator biologics that are part of the biosimilar policy with limited exemptions on or after December 29, 2023. 249 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 249, record 150, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Rituximab (See formulary for funded biosimilars) Brand(s): Riximyo, Ruxience, Truxima, Rituxan (Approved EAP exemptions only) DOSAGE FORM/ STRENGTH: 10 mg/mL Intravenous injection Initiation Criteria: For the treatment of adult patients with primary membranous nephropathy (PMN) who are at moderate to high risk of developing progressive kidney injury or complications of nephrotic syndrome meeting the following criteria: 1. Patient is 18 years of age or older (see Note 3): AND 2. Prescribed by a nephrologist with expertise in the diagnosis and treatment of (PMN); AND 3. Patient meets one of the following clinical circumstances: a. Has documented proteinuria greater than 5 g per day despite 6 months of therapy with an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) (Note that a shorter period of observation may be provided for patients with documented proteinuria greater than 8 g per day or high anti-PLA2R titres greater than 50 or eGFR less than 60 mL/min/1.73m2); OR b. Has documented proteinuria greater than 3.5 g per day with life- or organ- threatening complication(s) of nephrotic syndrome (i.e., venous thrombosis, arterial thrombosis, infection, or rapid decline in kidney function not otherwise explained); OR c. Has biopsy-proven or serology(anti-PLA2R)-proven recurrence in a patient who has received a kidney transplant and has proteinuria greater than 3.5 g per day. Approved dosage: 1,000 mg IV on day 0 and day 15 (i.e. 1,000 mg IV administered two weeks apart) No additional doses are required in patients who demonstrate complete remission. An additional course of rituximab may be administered at the above dosage after a minimum of 6 months has elapsed from the prior treatment course, if treatment with rituximab has resulted in a reduction in proteinuria from baseline by at least 25% without complete remission OR if the patient relapses following complete remission. Approval duration of initial criteria: 12 months 250 Rituximab (See formulary for funded biosimilars) Brand(s): Riximyo, Ruxience, Truxima, Rituxan (Approved EAP exemptions only) DOSAGE FORM/ STRENGTH: 10 mg/mL Intravenous injection Notes: 1. Rituximab can be discontinued in patients who have achieved complete remission. 2. Rituximab can be discontinued in non-responders. Retreatment of non-responders is not recommended. 3. Pediatric patients 17 years of age and younger may be considered on a case-by- case basis through external review. Please include relevant laboratory results, consult notes, and medications that have been used to manage the patient’s condition. 4. Definitions: Complete remission: Proteinuria less than 0.3 g per day or protein-creatinine ratio less than 30 mg/mmoL Partial remission: Reduction in proteinuria of at least 50% from baseline and final proteinuria between 0.3 g and 3.5 g per day Relapse: Recurrence of proteinuria (as per the initiation criteria) accompanied by a decrease in serum albumin to less than 30 g/L in patients who have achieved a complete or partial remission following prior rituximab treatment. Nonresponse: Lower than 25% reduction in proteinuria by 6 months after initial treatment course 251 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 250, record 151, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Rituximab Brand(s): Riximyo, Ruxience, and Truxima (biosimilar); Rituxan (Only for those approved for biosimilar exemption) DOSAGE FORM/ STRENGTH: 10 mg/mL intravenous injection Effective date: August 11, 2015 Refer to the Executive Officer Communications on the Ministry website for the Ministry’s Biosimilar Policy including frequently asked questions and updates for the biosimilar policy updates. http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions. In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 to 8 of this document). It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on an originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, will be expected to be provided ongoing access of the originator biologic through the patient’s original payer mechanism (e.g. manufacturer’s patient support program) or to switch to an ODB funded biosimilar version upon meeting specified criteria. The Ministry will no longer consider funding of originator biologics that are part of the biosimilar policy with limited exemptions on or after December 29, 2023. For the treatment of severe non-infectious ocular inflammatory disease (OID) in patients failed or did not tolerate treatment with infliximab or adalimumab; OR has contraindication to anti-TNF therapy AND who meet one of the following criteria; • Experienced failure, intolerance, or contraindication to oral corticosteroid (or topical corticosteroid for anterior uveitis) and failure or intolerance to at least one immunosuppressive therapy; OR • For the treatment of chronic Juvenile Idiopathic Arthritis (JIA)-associated uveitis after failure or intolerance to a first-line immunosuppressive agent; OR • For patients who have immediately vision-threatening OID and do not meet the above criteria, where consultation notes/ letter from an ophthalmologist expert • specializing in OIDs (who may be the requesting physician) confirm the severity of the patient’s condition and indicate detailed rationale for an immediate biologic 257 therapy (e.g. ocular inflammation associated with Behcet’s disease; severe non- necrotizing scleritis; necrotizing scleritis; etc.); AND • Patient must be followed by a uveitis specialist, a retina specialist familiar with ocular inflammatory diseases, or a pediatric ophthalmologist. Approved Dose: Rituximab up to 1000 mg IV per infusion at days 1 & 15 and 3rd infusion at 6-12 months. Note that maintenance rituximab infusions are not funded. Duration of Approval: 1 year Renewals will be considered for requests where; • Consultation notes or a letter is provided by the requesting physician to confirm that treatment has resulted in improvement/stability of vision and other treatment goals (e.g., remission from/control of ocular inflammation) have been met; AND Patients must also have demonstrated subsequent deterioration of symptoms, at least 6 months from the last dose of rituximab. Duration of Approval: 2 years Rituximab Brand(s): Riximyo, Ruxience, and Truxima (biosimilar); Rituxan ((biologic originator for those meeting biosimilar exemption) DOSAGE FORM/ STRENGTH: 10 mg/mL intravenous injection Effective date: July 29, 2022 Neuromyelitis Optica Spectrum Disorder (NMOSD) Initiation Criteria: For the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) in patients meeting the following criteria 1. NMOSD diagnosis meets international diagnostic criteria; AND 2. Patient is seropositive for the aquaporin-4 (AQP-4) antibody OR patient is AQP-4 antibody negative, but has had more than one attack within a 6-month timeframe while on azathioprine/mycophenolate with or without corticosteroids (i.e. aggressive disease); AND 3. The prescriber is a neurologist with expertise in the diagnosis and treatment of NMOSD. 258 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 257, record 157, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Rituximab (See formulary for funded biosimilars) Brand(s): Riximyo, Ruxience, Truxima, Rituxan (Approved EAP exemptions only) DOSAGE FORM/ STRENGTH: 10 mg/mL Intravenous injection Notes: 1. Rituximab should not be initiated during an acute episode of NMOSD. 2. Patients to be re-evaluated every 12 months. Exclusion: Rituximab will not be funded in combination with other biologics for NMOSD Dosage: Induction with 1,000mg IV x 2 doses 2 weeks apart for adults (4 weekly treatments of 375 mg/m2 for children) Repeat every 6 months Approval duration of initial criteria: 12 months Renewal criteria: Renewal of funding will be considered in patients who have not experienced a relapse of NMOSD or unacceptable toxicities from rituximab. Consideration of funding in patients who have experienced a relapse will require a description of the relapse, including any associated bloodwork to support the ongoing efficacy and safety of rituximab. Please submit relevant consult notes to support the request. Renewals: 2 years 259 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 259, record 158, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Etanercept – see Formulary for funded biosimilars Brand(s): Enbrel DOSAGE FORM/ STRENGTH: 25 mg/vial, 25 mg and 50 mg prefilled syringe or pens for subcutaneous injection per formulary listed options Adalimumab – see Formulary for funded biosimilars Brand(s): Humira and formulary listed biosimilars DOSAGE FORM/ STRENGTH: 40 mg/0.8mL prefilled syringe, 40 mg/0.8mL and and 20 mg/0.2 mL prefilled pens for subcutaneous injection Tociluzumab Brand(s): Actemra DOSAGE FORM/ STRENGTH: 80 mg/4 mL Vial, 200 mg/10 mL Vial, 400 mg/20 mL Vial, 162mg/0.9mL Inj (Prefilled syringe), 162mg/0.9mL Auto Injector Rituximab Brand(s): Riximyo, Ruxience, and Truxima (biosimilar); Rituxan (biologic originator for those meeting biosimilar exemption) DOSAGE FORM/ STRENGTH: 10 mg/mL intravenous injection Refer to the Executive Officer Communications on the Ministry website for the Ministry’s Biosimilar Policy including frequently asked questions and updates for the biosimilar policy updates. http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions. In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 to 8 of this document). It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on an originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, will be expected to be provided ongoing access of the originator biologic through the patient’s original payer mechanism (e.g. manufacturer’s patient support program) or to switch to an ODB funded biosimilar version upon meeting specified criteria. The Ministry will no longer 438 consider funding of originator biologics that are part of the biosimilar policy with limited exemptions on or after December 29, 2023. For the first-line treatment of polyarticular-course juvenile idiopathic arthritis in patients meeting the following criteria: • Patient has active disease (≥ 3 swollen joints and ≥ 5 active joints) despite a trial of optimal dose of subcutaneously administered methotrexate (i.e. 15 mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication must be described in detail. Duration of Approval: 1 Year Renewal will be considered for patients with objective evidence of at least a 20% reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. Duration of Approval: 5 Year Dosing for Etanercept: The planned dosing regimen should be provided. The maximum recommended dose is 50mg once weekly. Recommended Dosing for Adalimumab: a) 24 mg/m2 (maximum 40 mg) every two weeks; OR b) 20 mg every 2 weeks, if the Patient weighs less than 30 kg; OR c) 40 mg every 2 weeks, if the Patient weighs more than 30 kg. Recommended dosing for tocilizumab in combination with methotrexate: IV dosing regimen: a) 10 mg/kg every 4 weeks, if the Patient weighs less than 30kg; OR b) 8 mg/kg every 4 weeks, if the Patient weighs more than or equal to 30kg. SC dosing regimen: a) 162 mg once every 3 weeks if the Patient weighs less than 30kg b) 162 mg once every 2 weeks if the Patient weighs 30kg or more 439 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 438, record 271, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Abatacept Brand(s): Orencia DOSAGE FORM/ STRENGTH: 250 mg/15 mL vial (Note that the sc injection is not approved for this indication) Infliximab - See formulary for funded biosimilars Brand(s): Avsola, Inflectra, Renflexis Biosimilars); Remicade (Only for those approved for biosimilar exemption) DOSAGE FORM/ STRENGTH: 100 mg/vial Rituximab -See formulary for funded biosimilars Brand(s): Riximyo, Ruxience, and Truxima (biosimilar); Rituxan (Only for those approved for biosimilar exemption) DOSAGE FORM/ STRENGTH: 10 mg/mL intravenous injection Refer to the Executive Officer Communications on the Ministry website for the Ministry’s Biosimilar Policy including frequently asked questions and updates for the biosimilar policy updates. http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions. In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 to 8 of this document). It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on an originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, will be expected to be provided ongoing access of the originator biologic through the patient’s original payer mechanism (e.g. manufacturer’s patient support program) or to switch to an ODB funded biosimilar version upon meeting specified criteria. The Ministry will no longer consider funding of originator biologics that are part of the biosimilar policy with limited exemptions on or after December 29, 2023. For the treatment of polyarticular-course juvenile idiopathic arthritis in patients meeting the following criteria; • Patient has active disease (a minimum of 3 (three) swollen joints and a total of 5 active joints); AND 440 • Patient has had an inadequate response to a three month course of methotrexate administered subcutaneously at a dosage of at least 15 mg/m2 per week for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate the nature of the intolerance or contraindication must be described in detail.; AND • Patient has had an inadequate response to a three month course of etanercept OR adalimumab OR tociluzumab. If the patient is unable to tolerate or has a contraindication to etanercept OR adalimumab OR tociluzumab, the nature of the intolerance or contraindication must be described in detail. Duration of Approval: 1 Year Renewals will be considered for patients with objective evidence of at least a 20% reduction in swollen joint count. For renewals beyond the second year, objective evidence of preservation of treatment effect should be provided. (i.e. the current joint count should be compared to the count prior to initiating treatment with the biologic agent) Duration of Approval: 5 Year Approved Dose: Abatacept refer to the Orencia product monograph for dosing information Infliximab dose up to 6mg/kg/dose at 0, 2 and 6 weeks followed by maintenance of up to 6mg/kg/dose every 8 weeks 441 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 440, record 274, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Rituximab – See Formulary for funded biosimilars Brand(s): Riximyo, Ruxience, Truxima (Biosimilar); Rituxan (Only for those approved for biosimilar exemption) DOSAGE FORM/ STRENGTH: 10 mg/mL intravenous injection Refer to the Executive Officer Communications on the Ministry website for the Ministry’s Biosimilar Policy including frequently asked questions and updates for the biosimilar policy updates. http://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/eo_communiq.aspx Effective March 31, 2023, the ODB program will start transitioning coverage for Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade®, and Rituxan® to their biosimilar versions. Effective December 29, 2023, coverage for these originator biologic drugs through the ODB program will not be available for patients and the ODB program will only provide coverage for the biosimilar version of these drugs for all ODB program recipients, with limited exemptions. In general, for ODB program recipients who are already on these biologic drugs, there is up to a 9-month transition period (see the biosimilar switch policy described on page 6 to 8 of this document). It should be noted that after the date when a biosimilar becomes publicly funded for an approved indication, patients initiated on an originator biologic for this same provincially funded indication through support from a manufacturer’s patient support program, will be expected to be provided ongoing access of the originator biologic through the patient’s original payer mechanism (e.g. manufacturer’s patient support program) or to switch to an ODB funded biosimilar version upon meeting specified criteria. The Ministry will no longer consider funding of originator biologics that are part of the biosimilar policy with limited exemptions on or after December 29, 2023. 446 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 446, record 282, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Rituximab (See formulary for funded biosimilars) Brand(s): Riximyo, Ruxience, Truxima, Rituxan (Only for those approved for biosimilar exemption) DOSAGE FORM/ STRENGTH: 10 mg/mL Intravenous injection First course of Rituximab for the treatment of rheumatoid arthritis in adult patients with: • Severe active disease (≥ 5 swollen joints and rheumatoid factor positive and/or radiographic evidence of rheumatoid arthritis); AND • Failure to respond to optimal use of DMARDs or documented intolerance or contraindications to DMARDs (per current EAP reimbursement criteria for anti-TNF agents); AND • Failure to respond to, or the patient has intolerance or contraindications to, an adequate trial of at least ONE anti-TNF agent (e.g., adalimumab, etanercept, infliximab, golimumab, certolizumab pegol) Initial approval: One year: One course of treatment is 1000 mg followed two weeks later by the second 1000mg dose. Two courses will be approved each year (courses should be at least 6 months apart with second course being given only AFTER loss of effect as noted in the re-treatment guidelines below). Second course is not approved for “maintenance” therapy. Renewal criteria: A joint count at 3-4 months indicating at least a 20% reduction in swollen joint count and a minimum of improvement in 2 swollen joints, should be recorded to indicate a response, and then re-treatment can be given after an interval of at least 6 months AND after a loss of effect. Details of all courses given and the subsequent response should be provided in the renewal request. Renewal approval: 1 year (2 courses). One course of treatment is 1000 mg followed two weeks later by the second 1000mg dose. Repeated courses are not approved for maintenance therapy. Note: Rituximab should not be used concomitantly with other anti-TNF agents. 447 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 447, record 283, corpus 2025-01-01; name match only, not an eligibility decision

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Riximyo · DIN 02498316 Manufacturer: Sandoz Canada Inc.; listing date 2020-07-31 Health Canada: Marketed since 2020-05-22 · brand RIXIMYO · ATC L01FA01 RITUXIMAB · form Solution · route Intravenous · ingredients RITUXIMAB 10 MG/ML · company Sandoz canada incorporated · schedule Schedule d, Prescription

DIN 02498316: Riximyo Raw flags: sec12=Y, sec3=Y Item: 100000316; group id 183; item number 0331; lccId 00338; manufacturer id SDZ Source form: Inj Sol (Preservative-Free); strength: 10mg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $29.7000; ministry $29.7000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02498316 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98809

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02498316

Shortage record checked 2026-09-13T08:10:21.292534+00:00