DIN/NPN/PIN 02282097 ORENCIA 250 MG / VIAL INJECTION ABATACEPT |
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Date Listed/Coverage Update: | 01-Oct-2008 | ||||
Unit Price: | 500.3400 | ||||
LCA Price: | N/A | ||||
MAC Price: |
N/A |
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Unit of Issue: | Vial | ||||
Manufacturer: | BRISTOL-MYERS SQUIBB (BMS) | ||||
ATC: | L04AA24 | ||||
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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 or other DMARDS, 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). '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 12 weeks as follows: - Abatacept intravenous infusion: five doses of up to 1000 mg/dose administered at 0, 2, 4, 8 and 12 weeks. Patients will be limited to receiving one dose of abatacept per prescription at their pharmacy. - Abatacept subcutaneous injection: a single IV loading dose of up to 1000 mg/dose followed by 125 mg subcutaneous injection within a day, then once-weekly 125 mg SC injections. Patients who are unable to receive an infusion may initiate weekly subcutaneous injections without an intravenous loading dose. Patients will be limited to receiving one-month supply of abatacept subcutaneous injection per prescription at their pharmacy. - Patients will be permitted to switch from one biologic agent to another (with the exception of anakinra) following an adequate trial of the first biologic agent if unresponsive to therapy, or due to serious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period). - Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy. - Patients will not be permitted to switch from anakinra to other biologic agents except under exceptional circumstances. - Patients are limited to receiving one biologic agent at a time regardless of the condition for which it is being prescribed. For continued coverage beyond 12 weeks, the patient must meet the following criteria: 1) The patient must be assessed by an RA Specialist after the initial 12 weeks 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 a period of 12 months. Coverage for abatacept will be provided for one intravenous dose of up to 1000 mg every 4 weeks, or one weekly 125 mg subcutaneous injection. 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." All requests (including renewal requests) for abatacept 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). "Special authorization coverage may be provided for the reduction in signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA) in patients 6 years of age and older who: - Have 5 or more active joints (defined by either swelling or limitation of motion plus pain and/or tenderness), AND - Are refractory to one or more disease modifying anti-rheumatic agents (DMARDS) conventionally used in children (minimum three month trial), AND - Are refractory to or intolerant to etanercept and/or adalimumab and/or tocilizumab (minimum 12 week trial). 'Refractory' is defined as lack of effect at the recommended doses and duration of treatments as listed above. 'Intolerant' is defined as demonstrating serious adverse effects or contraindications to treatments as defined in the product monographs. For coverage, this drug must be prescribed by a prescriber affiliated with a Pediatric Rheumatology Clinic in Edmonton or Calgary ("Pediatric Rheumatology Specialist"). - Coverage may be approved for one dose of 10 mg/kg (maximum dose 1000 mg) at 0, 2, 4, 8, 12 and 16 weeks (total of six doses). - Patients will be limited to receiving one dose of abatacept per prescription at their pharmacy. - Patients will be permitted to switch from one biologic agent to another (with the exception of abatacept) following an adequate trial of the first biologic agent if unresponsive to therapy, or due to serious adverse effects or contraindications. An adequate trial is defined as at a minimum the completion of induction dosing (e.g. initial coverage period). - Patients will not be permitted to switch back to a previously trialed biologic agent if they were deemed unresponsive to therapy. - Patients will not be permitted to switch from abatacept to other biologic agents except under exceptional circumstances. - Patients are limited to receiving one biologic agent at a time regardless of the condition for which it is being prescribed. For potential coverage for retreatment with abatacept following a subsequent disease flare, the patient must meet the following criteria: 1) The patient must be assessed by a Pediatric Rheumatology Specialist after the initial 16 weeks, but no longer than 20 weeks after, treatment with this biologic agent to determine and document initial treatment response. 2) The Pediatric Rheumatology Specialist must confirm in writing that the patient is a responder that meets the following criteria (ACR Pedi 30): - 30% improvement from baseline in at least three of the following six response variables, with worsening of 30% or more in no more than one of the six variables. The variables include: i. global assessment of the severity of the disease by the Pediatric Rheumatology Specialist, ii. global assessment of overall well-being by the patient or parent, iii. number of active joints (joints with swelling not due to deformity or joints with limitation of motion with pain tenderness or both), iv. number of joints with limitation of motion, v. functional ability based on CHAQ scores, vi. ESR or CRP 3) Data from all of the six variables comprising the ACR Pedi 30 and the CHAQ scores must be reported. Following assessment and confirmation of initial treatment response, coverage for retreatment with abatacept may be approved for one dose of 10 mg/kg (maximum dose 1000 mg) at 0, 2*, 4, 8, 12 and 16 weeks (total of up to six doses; *the week 2 dose on retreatment is optional, to be administered at the discretion of the Pediatric Rheumatology Specialist). In order to be considered for coverage for retreatment, the patient must meet the following criteria: 1) The patient has been assessed by a Pediatric Rheumatology Specialist and the presence of disease flare confirmed. Disease flare is defined as worsening of at least 30% or greater in at least 3 of 6 ACR Pedi 30 variables for pJIA and 30% or greater improvement in no more than one variable. 2) The Pediatric Rheumatology Specialist must confirm in writing that the patient has had an initial treatment response (as assessed above) and that the patient has experienced a disease flare (as defined above)." Please note: Coverage is provided for treatment of disease flares only. However, if a patient experiences a subsequent flare within 12 months of initiation of treatment with abatacept, they may be eligible for continuous coverage (i.e., one dose of 10 mg/kg (maximum dose 1000 mg) every 4 weeks) for a maximum period of two years, provided the patient has demonstrated a response to initial treatment." All requests (including renewal requests) for abatacept for Polyarticular Juvenile Idiopathic Arthritis must be completed using the Abatacept for Polyarticular Juvenile Idiopathic Arthritis Special Authorization Request Form (ABC 60010). |
Review Status / Past Decisions
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