Interactive Drug Benefit List
DIN/NPN/PIN 02324776 SIMPONI 50 MG / SYR INJECTION SYRINGE GOLIMUMAB
920000 MISCELLANEOUS THERAPEUTIC AGENTS
923600 DISEASE-MODIFYING ANTIRHEUMATIC AGENTS
Date Listed/Coverage Update: 20-Jul-2010
Unit Price: 1,516.0000
LCA Price: N/A
MAC Price:

N/A

Unit of Issue: Syringe
Manufacturer: JANSSEN INC. (JAI)
ATC: L04AB06
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)
Alberta Human Services (AISH) (Group 19823)
Alberta Adult Health Benefit (AAHB) (Group 23609)

Special Authorization Request Form:

Adalimumab/Golimumab/Infliximab/Ozanimod/Tofacitinib/Vedolizumab for Ulcerative Colitis Special Authorization Request Form (ABC 60008)

Abatacept/Adalimumab/Anakinra/Baricitinib/Certolizumab/Etanercept/Golimumab/Infliximab/Sarilumab/Tocilizumab/Tofacitinib/Upadacitinib for Rheumatoid Arthritis Spec Auth Request Form (ABC 60027)

Adalimumab/Certolizumab/Etanercept/Golimumab/Infliximab/Secukinumab for Ankylosing Spondylitis Special Authorization Request Form (ABC 60028)

Adalimumab/Certolizumab/Etanercept/Golimumab/Guselkumab/ Infliximab/Ixekizumab/Secukinumab/Upadacitinib for Psoriatic Arthritis Special Authorization Request Form (ABC 60029)

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"Special authorization coverage may be provided for the reduction in the signs and symptoms of severely active Ankylosing Spondylitis, as defined by the Modified New York criteria for Ankylosing Spondylitis, in adult patients (18 years of age or older) who have active disease as demonstrated by:
- a BASDAI greater than or equal to 4 units, demonstrated on 2 occasions at least 8 weeks apart AND
- a Spinal Pain VAS of greater than or equal to 4 cm (on a 0-10 cm scale), demonstrated on 2 occasions at least 8 weeks apart AND
- who are refractory or intolerant to treatment with 2 or more NSAIDS each taken for a minimum of 4 weeks at maximum tolerated or recommended doses.

'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 50 mg once per month for four doses.
- Patients will be limited to receiving one dose (50 mg) of golimumab per prescription at their pharmacy.
- Patients will be permitted to switch from one biologic agent to another 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 are limited to receiving one biologic agent at a time regardless of the condition for which it is being prescribed.

For continued coverage beyond four doses the patient must meet the following criteria:
1) The patient must be assessed by an RA Specialist after the initial four doses to determine response.
2) The RA Specialist must confirm, in writing, that the patient is a 'responder' that meets the following criteria:
- Reduction of the BASDAI score by at least 50% of the pre-treatment value or by 2 or more units, AND
- Reduction of the Spinal Pain VAS by 2 cm or more.

Following this assessment, continued coverage may be approved for 50 mg once per month for a further 12 month period. Should continued coverage criteria be met, coverage will only be granted for 12 doses per 12 month period. Ongoing coverage may be considered if the patient is re-assessed by an RA Specialist every 12 months and is confirmed to be continuing to respond to therapy by meeting criteria as outlined in (2) above."

All requests (including renewal requests) for golimumab for Ankylosing Spondylitis must be completed using the Adalimumab/Certolizumab/Etanercept/Golimumab/Infliximab/Secukinumab for Ankylosing Spondylitis Special Authorization Request Form (ABC 60028).



"Special authorization coverage may be provided for use in combination with methotrexate for reducing signs and symptoms of active arthritis in adult patients (18 years of age or older) with moderate to severe polyarticular psoriatic arthritis (PsA) or pauciarticular PsA with involvement of knee or hip joint 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
- An adequate trial of another disease modifying anti-rheumatic agent(s) (minimum 4 month trial).

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 50 mg per month for four doses.
- Patients will be limited to receiving one dose (50 mg) of golimumab per prescription at their pharmacy.
- Patients will be permitted to switch from one biologic agent to another 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 are limited to receiving one biologic agent at a time regardless of the condition for which it is being prescribed.

For continued coverage beyond four doses, the patient must meet the following criteria:
1) The patient must be assessed by an RA Specialist after four doses 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 50 mg per month, for a further 12 month period. Should coverage criteria be met, coverage will only be granted for 12 doses per 12-month period. Ongoing coverage may be considered 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 golimumab for Psoriatic Arthritis must be completed using the Adalimumab/Certolizumab/Etanercept/Golimumab/Infliximab/Ixekizumab/Secukinumab for Psoriatic Arthritis Special Authorization Request Form (ABC 60029).



"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 50 mg per month for a total of four doses.
- Patients will be limited to receiving one dose (50 mg) of golimumab 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 four doses, the patient must meet the following criteria:
1) The patient must be assessed by an RA Specialist after four doses 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 50 mg per month, for a further 12 month period. Should continued coverage criteria be met, coverage will only be granted for 12 doses per 12 month period. 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 golimumab 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 and induction and maintenance of clinical remission of Ulcerative Colitis in adult patients (18 years of age or older) with active disease (characterized by a partial Mayo score >4 prior to initiation of biologic therapy) and who are refractory or intolerant to:
- mesalamine: minimum of 4 grams/day for a minimum of 4 weeks; AND
- corticosteroids (failure to respond to prednisone 40 mg daily for 2 weeks, or; steroid dependent i.e. failure to taper off steroids without recurrence of disease or disease requiring a second dose of steroids within 12 months of previous dose).

'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.

Immunosuppressive therapy as follows may also be initiated if in the clinician's judgment a trial is warranted:
i) Azathioprine: minimum of 2 mg/kg/day for a minimum of 2 months; OR
ii) 6-mercaptopurine: minimum of 1 mg/kg/day for a minimum of 2 months

For coverage, this drug must be prescribed by a Specialist in Gastroenterology as recognized by the College of Physicians and Surgeons and/or the Alberta Medical Association or a physician appropriately trained by the University of Alberta or the University of Calgary and recognized as a prescriber by Alberta Blue Cross ('Specialist').

Initial coverage may be approved for 200 mg of golimumab administered by subcutaneous injection at Week 0, followed by 100 mg at Week 2. As an interim measure, an additional dose of 50 mg of golimumab will be provided at weeks 6 and 10 to allow time to determine whether the patient meets coverage criteria for maintenance dosing, see below.
- Patients will be limited to receiving a one-month supply of golimumab per prescription at their pharmacy.
- Patients will be permitted to switch from one biologic agent to another 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 are limited to receiving one biologic agent at a time regardless of the condition for which it is being prescribed.

For continued coverage beyond three doses, the patient must meet the following criteria:
1) The patient must be assessed by a Specialist between week 12 and week 14 to determine response.
2) The Specialist must confirm in writing that the patient is a 'responder' that meets the following criteria:
- a decrease in the partial Mayo score of greater than or equal to 2 points

Following this assessment, continued coverage may be approved for a dose of 50 mg every 4 weeks 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 a Specialist to determine response;
2) The Specialist must confirm in writing that the patient has maintained a response to therapy as indicated by:
- a decrease in the partial Mayo score of greater than or equal to 2 points from the score prior to initiation of golimumab therapy

Note: For patients who showed a response to induction therapy then experienced secondary loss of response while on maintenance dosing with 50 mg, the maintenance dose may be adjusted from 50 mg to 100 mg by making an additional special authorization request to Alberta Blue Cross for the increased dose.

All requests (including renewal requests) for golimumab for Ulcerative Colitis must be completed using the Adalimumab/Golimumab/Infliximab/Ozanimod/Tofacitinib/Vedolizumab for Ulcerative Colitis Special Authorization Request Form (ABC 60008).

Review Status / Past Decisions

Indication Reviewing
Body
Submission
Completion
Date
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
Review
Status
ULCERATIVE COLITIS Common Drug Review 2013/07/19 2014/07/01 Under Review
ULCERATIVE COLITIS Common Drug Review 2013/07/19 2017/05/01 Special Authorization - Ulcerative Colitis
ULCERATIVE COLITIS Common Drug Review 2013/07/19 2014/03/19 View CDR - Do not list at the submitted price
PSORIATIC ARTHRITIS Common Drug Review 2009/09/15 2010/07/20 Special Authorization - Psoriatic Arthritis
RHEUMATOID ARTHRITIS Common Drug Review 2009/09/15 2010/07/20 Special Authorization - Rheumatoid Arthritis
ANKYLOSING SPONDYLITIS Common Drug Review 2009/09/15 2010/07/20 Special Authorization - Ankylosing Spondylitis
PSORIATIC ARTHRITIS Common Drug Review 2009/09/15 2010/03/17 View CDR - List in a similar manner
RHEUMATOID ARTHRITIS Common Drug Review 2009/09/15 2010/03/17 View CDR - List in a similar manner
ANKYLOSING SPONDYLITIS Common Drug Review 2009/09/15 2010/03/17 View CDR - List in a similar manner
Indication ULCERATIVE COLITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2013/07/19
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2014/07/01
CDR
Recommendation
Review
Status
Under Review
Indication ULCERATIVE COLITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2013/07/19
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2017/05/01
CDR
Recommendation
Review
Status
Special Authorization - Ulcerative Colitis
Indication ULCERATIVE COLITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2013/07/19
CDR
Recommendation
Date
2014/03/19
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
View
Review
Status
CDR - Do not list at the submitted price
Indication PSORIATIC ARTHRITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2009/09/15
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2010/07/20
CDR
Recommendation
Review
Status
Special Authorization - Psoriatic Arthritis
Indication RHEUMATOID ARTHRITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2009/09/15
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2010/07/20
CDR
Recommendation
Review
Status
Special Authorization - Rheumatoid Arthritis
Indication ANKYLOSING SPONDYLITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2009/09/15
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2010/07/20
CDR
Recommendation
Review
Status
Special Authorization - Ankylosing Spondylitis
Indication PSORIATIC ARTHRITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2009/09/15
CDR
Recommendation
Date
2010/03/17
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
View
Review
Status
CDR - List in a similar manner
Indication RHEUMATOID ARTHRITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2009/09/15
CDR
Recommendation
Date
2010/03/17
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
View
Review
Status
CDR - List in a similar manner
Indication ANKYLOSING SPONDYLITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2009/09/15
CDR
Recommendation
Date
2010/03/17
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
View
Review
Status
CDR - List in a similar manner
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The DBL, DBS and related publications require knowledgeable interpretation and are intended primarily for professional health care practitioners, pharmacies, hospitals and organizations associated with the manufacture, distribution and use of pharmaceutical preparations.
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Alberta Health reserves the right to make changes, without notice, to the List through the Interactive DBL(iDBL), and any such changes to the Interactive DBL(iDBL) are effective the date of the change (unless otherwise stated) and regardless of the date of publication in the paper version or updates.