DIN/NPN/PIN 02470608 XELJANZ XR 11 MG ORAL EXTENDED-RELEASE TABLET TOFACITINIB CITRATE |
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Date Listed/Coverage Update: | 01-Aug-2019 | ||||
Unit Price: | 49.5467 | ||||
LCA Price: | N/A | ||||
MAC Price: |
N/A |
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Unit of Issue: | Tablet | ||||
Manufacturer: | PFIZER CANADA ULC (PFI) | ||||
ATC: | L04AA29 | ||||
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Interchangeable Products: | No | ||||
Coverage Status: | SPECIAL AUTHORIZATION |
Applies to Clients of: | Non-Group Coverage (Group 1) Coverage for Seniors (Group 66) Palliative Coverage (Group 20514, Please note your client may have Group 1 or Group 66 coverage) Child and Family Services (Group 20403) Alberta Child Health Benefit (Group 20400) Children and Youth Services (Group 19824) Income Support (Group 19823) Alberta Human Services (AISH) (Group 19823) Alberta Adult Health Benefit (AAHB) (Group 23609) |
Special Authorization Request Form: | |
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"Special authorization coverage may be provided for use in combination with methotrexate for the reduction in signs and symptoms of severely active Rheumatoid Arthritis (RA) in adult patients (18 years of age or older) who are refractory or intolerant to: - Methotrexate at 20 mg (PO, SC or IM) or greater total weekly dosage (15 mg or greater if patient is 65 years of age or older) for more than 12 weeks. Patients who do not exhibit a clinical response to PO methotrexate or experience gastrointestinal intolerance to PO methotrexate must have a trial of parenteral methotrexate before being accepted as refractory; AND - Methotrexate with other disease modifying anti-rheumatic agent(s) (minimum 4 month trial) [e.g., methotrexate with hydroxychloroquine or methotrexate with sulfasalazine]; AND - Leflunomide (minimum 10 week trial at 20 mg daily). Special authorization coverage of this agent may be provided for use as monotherapy in adult patients for whom methotrexate is contraindicated and/or for those patients who have experienced serious adverse effects. 'Refractory' is defined as lack of effect at the recommended doses and for duration of treatments specified above. 'Intolerant' is defined as demonstrating serious adverse effects or contraindications to treatments as defined in product monographs. For coverage, this drug must be initiated by a Specialist in Rheumatology ("RA Specialist"). - Initial coverage may be approved for three months as follows: - Tofacitinib 5 mg tablet: one tablet twice daily. - Tofacitinib 11 mg extended-release tablet: one tablet daily. - Patients will be limited to receiving a one-month supply of tofacitinib per prescription at their pharmacy. - Patients will not be permitted to switch back to tofacitinib if they were deemed unresponsive to therapy. For continued coverage beyond three months, the patient must meet the following criteria: 1) The patient must be assessed by an RA Specialist after the initial three months to determine response. 2) The RA Specialist must confirm in writing that the patient is a 'responder' that meets the following criteria: - ACR20 OR an improvement of 1.2 units in the DAS28 score [reported to one (1) decimal place]; AND - An improvement of 0.22 in HAQ score [reported to two (2) decimal places]. It should be noted that the initial score for the DAS28 or HAQ score on record will be rounded to the correct number of decimal places as indicated above. Following this assessment, continued coverage may be approved for 5 mg twice daily or 11 mg once daily for a period of 12 months. Ongoing coverage may be considered only if the following criteria are met at the end of each 12-month period: 1) The patient has been assessed by an RA Specialist to determine response; 2) The RA Specialist must confirm in writing that the patient has maintained a response to therapy as indicated by: - confirmation of maintenance of ACR20, or - maintenance of a minimum improvement of 1.2 units in DAS28 score [reported to one (1) decimal place] from baseline. 3) A current HAQ score [reported to two (2) decimal places] must be included with all renewal requests. It should be noted that the initial score for the DAS28 or HAQ score on record will be rounded to the correct number of decimal places as indicated above. Coverage cannot be provided for tofacitinib when intended for use in combination with a biologic agent or other Janus kinase (JAK) inhibitors." All requests (including renewal requests) for tofacitinib for Rheumatoid Arthritis must be completed using the Abatacept/Adalimumab/Anakinra/Baricitinib/Certolizumab/Etanercept/Golimumab/Infliximab/Sarilumab/Tocilizumab/Tofacitinib for Rheumatoid Arthritis Special Authorization Request Form (ABC 60027). |
Review Status / Past Decisions
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