Interactive Drug Benefit List
DIN/NPN/PIN 02402475 ORENCIA 125 MG / SYR INJECTION ABATACEPT
920000 MISCELLANEOUS THERAPEUTIC AGENTS
923600 DISEASE-MODIFYING ANTIRHEUMATIC AGENTS
Date Listed/Coverage Update: 01-Nov-2013
Unit Price: 373.7875
LCA Price: N/A
MAC Price:

N/A

Unit of Issue: Syringe
Manufacturer: BRISTOL-MYERS SQUIBB (BMS)
ATC: L04AA24
1
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)
Learners Program (Group 22128)
Alberta Human Services (AISH) (Group 19823)
Alberta Adult Health Benefit (AAHB) (Group 23609)

Special Authorization Request Form:

Abatacept/Adalimumab/Anakinra/Certolizumab/Etanercept/Golimumab/Infliximab/Sarilumab/Tocilizumab/Tofacitinib for Rheumatoid Arthritis Special Authorization Request Form (ABC 60027)

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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 abacept 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/Certolizumab/Etanercept/Golimumab/Infliximab/Sarilumab/Tocilizumab/Tofacitinib for Rheumatoid Arthritis Special Authorization Request Form (ABC 60027).

Review Status / Past Decisions

Indication Reviewing
Body
Submission
Completion
Date
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
Review
Status
ARTHRITIS, RHEUMATOID Common Drug Review 2012/12/11 2013/11/01 Special Authorization
ARTHRITIS, RHEUMATOID Common Drug Review 2012/12/11 2013/07/18 View CDR - List with criteria/condition
Indication ARTHRITIS, RHEUMATOID
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2012/12/11
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2013/11/01
CDR
Recommendation
Review
Status
Special Authorization
Indication ARTHRITIS, RHEUMATOID
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2012/12/11
CDR
Recommendation
Date
2013/07/18
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
View
Review
Status
CDR - List with criteria/condition
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