Interactive Drug Benefit List
DIN/NPN/PIN 02258595 HUMIRA (40 MG/0.8 ML INJ SYR) 40 MG / SYR INJECTION SYRINGE ADALIMUMAB
920000 MISCELLANEOUS THERAPEUTIC AGENTS
923600 DISEASE-MODIFYING ANTIRHEUMATIC AGENTS
Date Listed/Coverage Update: 09-Jun-2017
Unit Price: 762.5700
LCA Price: N/A
MAC Price:

N/A

Unit of Issue: Syringe
Manufacturer: ABBVIE CORPORATION (ABV)
ATC: L04AA17
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:

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

Adalimumab/Etanercept/Tocilizumab for Polyarticular Juvenile Idiopathic Arthritis Special Authorization Request Form (ABC 60011)

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

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

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

Adalimumab/Etanercept/Infliximab/Ixekizumab/Secukinumab/Ustekinumab for Plaque Psoriasis Special Authorization Request Form (ABC 60030)

Adalimumab/Vedolizumab for Crohn's/Infliximab for Crohn's/Fistulizing Crohn's Disease Special Authorization Request Form (ABC 60031)

Adalimumab for Hidradenitis Suppurativa Special Authorization Request Form (ABC 60058)

Expand all Collapse all



"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 five doses as follows: An initial 40 mg dose, followed by additional 40 mg doses at 2, 4, 6 and 8 weeks after the first dose.
- Patients will be limited to receiving a one-month supply of adalimumab 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 five doses, the patient must meet the following criteria:
1) The patient must be assessed by an RA Specialist after the initial five 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 40 mg every other week 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."

All requests (including renewal requests) for adalimumab 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).



"Special authorization coverage may be provided for use in combination with methotrexate for reducing signs and symptoms and inhibiting the progression of structural damage 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 40 mg administered every other week for 8 weeks.
- Patients will be limited to receiving a one-month supply of adalimumab 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 8 weeks, the patient must meet the following criteria:
1) The patient must be assessed by an RA Specialist after 8 weeks, but no longer than 12 weeks after, 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 doses of 40 mg every other week, for a period of 12 months. 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 adalimumab 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 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 12 weeks as follows: An initial 40 mg dose, followed by additional 40 mg doses administered every two weeks for up to 12 weeks after the first dose.
- Patients will be limited to receiving a one-month supply of adalimumab 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 12 weeks, the patient must meet the following criteria:
1) The patient must be assessed at 12 weeks by an RA Specialist after the initial 12 weeks of therapy 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 one 40 mg dose every other week for a period of 12 months. 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 adalimumab 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 approved for coverage of adalimumab for the reduction in signs and symptoms and induction and maintenance of clinical remission of Moderately to Severely Active Crohn's Disease in patients who meet the following criteria:

- Adalimumab must be prescribed by a Specialist in Gastroenterology or a physician appropriately trained by the University of Alberta or the University of Calgary and recognized as a prescriber by Alberta Blue Cross for adalimumab for coverage for the treatment of Moderately to Severely Active Crohn's Disease patients ('Specialist').
- Patients must be 18 years of age or older to be considered for coverage of adalimumab.
- Patients will be limited to receiving a one-month supply of adalimumab per prescription at their pharmacy.
- Patients may be allowed to switch from one biologic agent to another following an adequate trial of the first biologic agent if unresponsive to therapy (both primary loss of response and secondary loss of response) 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.

Prior to initiation of adalimumab therapy for New Patients:

'New Patients' are patients who have never been treated with adalimumab by any health care provider.

Moderately to Severely Active Crohn's Disease:

Prior to initiation of adalimumab therapy, New Patients must have a current Modified (without the physical exam) Harvey Bradshaw Index score of greater than or equal to 7 (New Patient's Baseline Score), AND be Refractory.

Refractory is defined as one or more of the following:
1) Serious adverse effects or reactions to the treatments specified below; OR
2) Contraindications (as defined in product monographs) to the treatments specified below; OR
3) Previous documented lack of effect at doses and for duration of all treatments specified below:
a) mesalamine: minimum of 3 grams/day for a minimum of 6 weeks; AND refractory to, or dependent on, glucocorticoids: following at least one tapering dosing schedule of 40 mg/day, tapering by 5 mg each week to 20 mg, then tapering by 2.5 mg each week to zero, or similar.

[Note: Patients who have used the above treatments in combination will not be required to be challenged with individual treatments as monotherapy]

AND
b) Immunosuppressive therapy as follows:
- Azathioprine: minimum of 2 mg/kg/day for a minimum of 3 months; OR
- 6-mercaptopurine: minimum of 1 mg/kg/day for a minimum of 3 months; OR
- Methotrexate: minimum or 15 mg/week for a minimum of 3 months.
OR
- Immunosuppressive therapy discontinued at less than 3 months due to serious adverse effects or reactions.

Applications for coverage must include information regarding the dosages and duration of trial of each treatment the patient received, a description of any adverse effects, reactions, contraindications and/or lack of effect, as well as any other information requested by Alberta Blue Cross.

Coverage Criteria for Moderately to Severely Active Crohn's Disease

- New Patients must meet the criteria above prior to being considered for approval.
- All approvals are also subject to the following applicable criteria.

Induction Dosing for New Patients:

- Coverage for Induction Dosing may only be approved for New Patients (those who have never been treated with adalimumab by any health care provider).
- 'Induction Dosing' means a maximum of one 160 mg dose of adalimumab per New Patient at week 0 followed by an 80 mg dose at week 2.
- New Patients are eligible to receive Induction Dosing only once, after which time the Maintenance Dosing for New Patients and Continued Coverage for Maintenance Dosing criteria will apply.
- As an interim measure, 40 mg doses of adalimumab will be provided at weeks 4, 6, 8 and 10 to allow time to determine whether the New Patient meets coverage criteria for Maintenance Dosing below.

Maintenance Dosing:

'Maintenance Dosing' means one 40 mg dose of adalimumab per patient provided no more often than every other week starting at week 4 for a period of 12 months to:
- New Patients following the completion of Induction Dosing; OR
- Existing Patients, who are patients that are being treated, or have previously been treated, with adalimumab.

Maintenance Dosing for New Patients after Completion of Induction Dosing:

- The New Patient must be assessed by a Specialist within 12 weeks after the initiation of Induction Dosing to determine response by obtaining a Modified Harvey Bradshaw Index score for patients with Moderately to Severely Active Crohn's Disease; AND
- The Specialist must confirm the Modified Harvey Bradshaw Index score shows a decrease from the New Patient's Baseline Score of greater than or equal to 3 points for patients with Moderately to Severely Active Crohn's.

Maintenance Dosing for Existing Patients:

- The patient must be assessed by a Specialist annually (within 2 months of the expiry of a patient's special authorization) at least 2 weeks after the day a dose of adalimumab was administered to the patient and prior to administration of the next dose to obtain: a Modified Harvey Bradshaw Index Score (Existing Patient's Baseline Score) for Moderately to Severely Active Crohn's Disease; AND
- these measures must be provided to Alberta Blue Cross for assessment for continued coverage for maintenance dosing.

Continued Coverage for Maintenance Dosing:

Continued coverage may be considered for one 40 mg dose of adalimumab per patient provided no more often than every other week for a period of 12 months, if the following criteria are met at the end of each 12 month period:

- The New Patient or the Existing Patient must be assessed by a Specialist annually (within 2 months of the expiry of a patient's special authorization) at least 2 weeks after the day a dose of adalimumab was administered to the patient and prior to administration of the next dose to obtain: a Modified Harvey Bradshaw Index Score for Moderately to Severely Active Crohn's Disease; AND
- For New Patients: The Specialist must confirm that the patient has maintained a greater than or equal to 3 point decrease from the New Patient's Baseline Score for Moderately to Severely Active Crohn's; OR
- For Existing Patients: The Specialist must confirm that the patient has maintained the Existing Patient's Baseline Score."

All requests (including renewal requests) for adalimumab for Moderately to Severely Active Crohn's Disease must be completed using the Adalimumab/Vedolizumab for Crohn's/Infliximab for Crohn's/Fistulizing Crohn's Special Authorization Request Form (ABC 60031).



"Special authorization coverage may be provided for the reduction in signs and symptoms of severe, debilitating psoriasis in patients who:
- Have a total PASI of 10 or more and a DLQI of more than 10, OR
- Who have significant involvement of the face, palms of the hands, soles of the feet or genital region; AND
- 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 experience gastrointestinal intolerance to PO methotrexate must have a trial of parenteral methotrexate before being accepted as refractory, OR
- Cyclosporine (6 weeks treatment); AND
- Phototherapy (unless restricted by geographic location)

Patients who have a contraindication to either cyclosporine or methotrexate will be required to complete an adequate trial of the other pre-requisite medication prior to potential coverage being considered.

'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 prescribed by a Specialist in Dermatology ("Dermatology Specialist").

- Initial coverage may be approved for an initial dose of 80 mg, followed by one 40 mg dose every other week beginning one week after the first dose, for a total of nine doses.
- Patients will be limited to receiving a one-month supply of adalimumab 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 nine doses, the patient must meet all of the following criteria:
1) The patient must be assessed by a Dermatology Specialist after the initial nine doses to determine response.
2) The Dermatology Specialist must confirm, in writing, that the patient is a 'responder' that meets the following criteria:
- Greater than or equal to 75% reduction in PASI score, OR
- Greater than or equal to 50% reduction in PASI score AND improvement of greater than or equal to 5 points in the DLQI.

Following this assessment, continued coverage may be considered for one 40 mg dose of adalimumab every other week for a period of 12 months. Ongoing coverage may be considered if the patient is re-assessed by a Dermatology Specialist every 12 months and is confirmed to be continuing to respond to therapy by meeting criteria as outlined in (2) above."

PASI and DLQI scores are required for all requests for Plaque Psoriasis including those requests for patients that have significant involvement of the face, palms, soles of feet or genital region.

All requests (including renewal requests) for adalimumab for Plaque Psoriasis must be completed using the Adalimumab/Etanercept/Infliximab/Ixekizumab/Secukinumab/Ustekinumab for Plaque Psoriasis Special Authorization Request Form (ABC 60030).



"Special authorization coverage may be provided for the reduction in signs and symptoms of severely active polyarticular juvenile idiopathic arthritis (pJIA) in patients 4 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).

"Refractory" is defined as one or more of the following: lack of effect, serious adverse effects (e.g., leukopenia, hepatitis) 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 24 mg per square meter body surface area (maximum dose 40 mg) every other week for 12 weeks.
- Patients will be limited to receiving a one-month supply of adalimumab 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 continued coverage of this agent beyond 12 weeks, the patient must meet the following criteria:
1) The patient must be assessed by a Pediatric Rheumatology Specialist after 12 weeks, but no longer than 16 weeks after, treatment with this biologic agent to determine 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 in each request.

Following this assessment, continued coverage may be approved for 24 mg per square meter body surface area (maximum dose 40 mg) every other week, for a maximum of twelve months. After twelve months, in order to be considered for continued coverage, the patient must be re-assessed every twelve months by a Pediatric Rheumatology Specialist and must meet the following criteria:
1) The patient has been assessed by a Pediatric Rheumatology Specialist to determine response, and
2) The Pediatric Rheumatology Specialist must confirm in writing that the patient has maintained a response to therapy as indicated by maintenance of the ACR Pedi 30,
3) Data from all of the six variables comprising the ACR Pedi 30 and the CHAQ scores must be reported in each request.

Once a child with pJIA has had two disease-free years, it is common clinical practice for drug treatment to be stopped."

All requests (including renewal requests) for adalimumab for Polyarticular Juvenile Idiopathic Arthritis must be completed using the Adalimumab/Etanercept/Tocilizumab for Polyarticular Juvenile Idiopathic Arthritis Special Authorization Request Form (ABC 60011).



"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 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 an initial dose of 160 mg, followed by an 80 mg dose at week 2, then one 40 mg dose at weeks 4, 6 and 8. As an interim measure, an additional 40 mg dose of adalimumab will be provided at week 10 to allow time to determine whether the New Patient meetscoverage criteria for Maintenance Dosing below, for a total of six doses.

- Patients will be limited to receiving a one-month supply of adalimumab 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 the initial coverage period, the patient must meet the following criteria:
1) The patient must be assessed by a Specialist between weeks 8 and 12 after the initiation of therapy 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 40 mg every 2 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 in Gastroenterology 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 adalimumab therapy."

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



"Special authorization may be provided for the treatment of adult patients with active moderate to severe Hidradenitis Suppurativa who meet all of the following criteria:

- A total abscess and nodule (AN) count of 3 or greater.
- Lesions in at least two distinct anatomical areas, one of which must be Hurley Stage II or III.
- An inadequate response to a 90-day trial of systemic antibiotics AND documented non response to conventional therapy.
For coverage, this drug must be initiated by a Specialist in Dermatology ("Dermatology Specialist").

- Initial coverage may be approved for 12 weeks as follows: an initial dose of 160 mg, followed by one 80 mg dose two weeks later, then 40 mg every week beginning four weeks after the initial dose, for a total of eleven doses.
- Patients will be limited to receiving a one-month supply of adalimumab per prescription at their pharmacy.
- 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 the initial approval period the patient must meet the following criteria:

1) The patient must be assessed by a Dermatology Specialist after 12 weeks of treatment to determine response.
2) The Dermatology Specialist must confirm, in writing, that the patient is a 'responder' that meets the following criteria:

- Greater than or equal to 50% reduction in AN count from pre-treatment baseline AND
- no increase in abscess count or draining fistula count relative to pre-treatment baseline.

Note: Treatment with adalimumab should be discontinued if there is insufficient improvement after 12 weeks of treatment.

Following this assessment, continued coverage may be considered for one 40 mg dose of adalimumab every week for an additional period of 12 months. Ongoing coverage may be considered if the patient is re-assessed by a Dermatology 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 adalimumab for Hidradenitis Suppurativa must be completed using the Adalimumab for Hidradenitis Suppurativa Special Authorization Request Form (ABC 60058).

Review Status / Past Decisions

Indication Reviewing
Body
Submission
Completion
Date
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
Review
Status
N/A Expert Committee 2017/06/09 2017/09/01 No Special Authorization Criteria Change (Crohn's Disease)
CROHN'S DISEASE Expert Committee 2016/04/11 2016/07/01 No Special Authorization Criteria Change (Crohn's Disease)
CROHN'S DISEASE Expert Committee 2016/04/11 2017/02/01 No Special Authorization Criteria Change (Crohn's Disease)
HIDRADENITIS SUPPURATIVA Common Drug Review 2015/11/17 2018/04/01 Special Authorization - Hidradenitis Suppurativa
HIDRADENITIS SUPPURATIVA Common Drug Review 2015/11/17 2016/05/19 View CDR - List with clinical criteria and/or conditions
ULCERATIVE COLITIS Common Drug Review 2015/10/29 2017/10/01 Special Authorization - Ulcerative Colitis
ULCERATIVE COLITIS Common Drug Review 2015/10/29 2016/04/15 View CDR - Do not list at the submitted price
JUVENILE IDIOPATHIC ARTHRITIS Common Drug Review 2013/02/14 2014/03/01 Under Review
JUVENILE IDIOPATHIC ARTHRITIS Common Drug Review 2013/02/14 2013/07/18 View CDR - List with criteria/condition
JUVENILE IDIOPATHIC ARTHRITIS Common Drug Review 2013/02/14 2014/10/01 Special Authorization Criteria Change - Polyarticular Juvenile Idiopathic Arthritis
JUVENILE IDIOPATHIC ARTHRITIS Common Drug Review 2013/02/14 2014/02/01 Under Review
JUVENILE IDIOPATHIC ARTHRITIS Common Drug Review 2013/02/14 2013/11/01 Under Review
CROHN'S DISEASE Expert Committee 2009/11/12 2010/04/01 Special Authorization Criteria Change - Crohn's Disease
CROHN'S DISEASE Expert Committee 2008/11/13 2009/03/04 Special Authorization Criteria Change - Crohn's Disease/Fistulizing Crohn's Disease
PSORIASIS Common Drug Review 2008/04/22 2009/03/04 Special Authorization - Psoriasis
PSORIASIS Common Drug Review 2008/04/22 2008/10/16 View CDR - List with criteria/condition
PSORIASIS Common Drug Review 2008/04/22 2011/09/01 Special Authorization Criteria Change - Psoriasis
ANKYLOSING SPONDYLITIS Expert Committee 2008/02/11 2008/05/01 Under Review
ANKYLOSING SPONDYLITIS Expert Committee 2008/02/11 2008/06/01 Special Authorization - Ankylosing Spondylitis
ANKYLOSING SPONDYLITIS Expert Committee 2008/02/11 2009/03/04 Special Authorization Criteria Change - Ankylosing Spondylitis
CROHN'S DISEASE Common Drug Review 2007/07/12 2008/08/01 Special Authorization Criteria Change - Crohn's Disease
CROHN'S DISEASE Common Drug Review 2007/07/12 2007/12/19 View CDR - List with criteria/condition
ANKYLOSING SPONDYLITIS Common Drug Review 2006/11/24 2008/01/01 No Special Authorization Criteria Change - Anklylosing Spondylitis
ANKYLOSING SPONDYLITIS Common Drug Review 2006/11/24 2007/06/27 View CDR - List with criteria/condition
PSORIATIC ARTHRITIS Common Drug Review 2006/06/29 2009/03/04 Special Authorization Criteria Change - Psoriatic Arthritis
PSORIATIC ARTHRITIS Common Drug Review 2006/06/29 2006/11/29 View CDR - List with criteria/condition
PSORIATIC ARTHRITIS Common Drug Review 2006/06/29 2007/07/01 Special Authorization Criteria Change - Psoriatic Arthritis
PSORIATIC ARTHRITIS Common Drug Review 2006/06/29 2007/04/01 Special Authorization - Psoriatic Arthritis
RHEUMATOID ARTHRITIS Common Drug Review 2004/09/28 2009/10/01 Special Authorization Criteria Change - Rheumatoid Arthritis
RHEUMATOID ARTHRITIS Common Drug Review 2004/09/28 2005/10/01 Special Authorization - Rheumatoid Arthritis
RHEUMATOID ARTHRITIS Common Drug Review 2004/09/28 2007/10/01 Special Authorization Criteria Change - Rheumatoid Arthritis
RHEUMATOID ARTHRITIS Common Drug Review 2004/09/28 2010/04/01 Special Authorization Criteria Change - Rheumatoid Arthritis
RHEUMATOID ARTHRITIS Common Drug Review 2004/09/28 2012/08/01 Special Authorization Criteria Change - Rheumatoid Arthritis
RHEUMATOID ARTHRITIS Common Drug Review 2004/09/28 2005/07/01 Under Review - Rheumatoid Arthritis
RHEUMATOID ARTHRITIS Common Drug Review 2004/09/28 2009/03/04 Special Authorization Criteria Change - Rheumatoid Arthritis
RHEUMATOID ARTHRITIS Common Drug Review 2004/09/28 2005/02/11 View CDR - List with criteria/condition
Indication N/A
Reviewing
Body
Expert Committee
Submission
Completion
Date
2017/06/09
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2017/09/01
CDR
Recommendation
Review
Status
No Special Authorization Criteria Change (Crohn's Disease)
Indication CROHN'S DISEASE
Reviewing
Body
Expert Committee
Submission
Completion
Date
2016/04/11
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2016/07/01
CDR
Recommendation
Review
Status
No Special Authorization Criteria Change (Crohn's Disease)
Indication CROHN'S DISEASE
Reviewing
Body
Expert Committee
Submission
Completion
Date
2016/04/11
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2017/02/01
CDR
Recommendation
Review
Status
No Special Authorization Criteria Change (Crohn's Disease)
Indication HIDRADENITIS SUPPURATIVA
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2015/11/17
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2018/04/01
CDR
Recommendation
Review
Status
Special Authorization - Hidradenitis Suppurativa
Indication HIDRADENITIS SUPPURATIVA
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2015/11/17
CDR
Recommendation
Date
2016/05/19
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
View
Review
Status
CDR - List with clinical criteria and/or conditions
Indication ULCERATIVE COLITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2015/10/29
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2017/10/01
CDR
Recommendation
Review
Status
Special Authorization - Ulcerative Colitis
Indication ULCERATIVE COLITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2015/10/29
CDR
Recommendation
Date
2016/04/15
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
View
Review
Status
CDR - Do not list at the submitted price
Indication JUVENILE IDIOPATHIC ARTHRITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2013/02/14
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2014/03/01
CDR
Recommendation
Review
Status
Under Review
Indication JUVENILE IDIOPATHIC ARTHRITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2013/02/14
CDR
Recommendation
Date
2013/07/18
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
View
Review
Status
CDR - List with criteria/condition
Indication JUVENILE IDIOPATHIC ARTHRITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2013/02/14
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2014/10/01
CDR
Recommendation
Review
Status
Special Authorization Criteria Change - Polyarticular Juvenile Idiopathic Arthritis
Indication JUVENILE IDIOPATHIC ARTHRITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2013/02/14
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2014/02/01
CDR
Recommendation
Review
Status
Under Review
Indication JUVENILE IDIOPATHIC ARTHRITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2013/02/14
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2013/11/01
CDR
Recommendation
Review
Status
Under Review
Indication CROHN'S DISEASE
Reviewing
Body
Expert Committee
Submission
Completion
Date
2009/11/12
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2010/04/01
CDR
Recommendation
Review
Status
Special Authorization Criteria Change - Crohn's Disease
Indication CROHN'S DISEASE
Reviewing
Body
Expert Committee
Submission
Completion
Date
2008/11/13
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2009/03/04
CDR
Recommendation
Review
Status
Special Authorization Criteria Change - Crohn's Disease/Fistulizing Crohn's Disease
Indication PSORIASIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2008/04/22
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2009/03/04
CDR
Recommendation
Review
Status
Special Authorization - Psoriasis
Indication PSORIASIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2008/04/22
CDR
Recommendation
Date
2008/10/16
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
View
Review
Status
CDR - List with criteria/condition
Indication PSORIASIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2008/04/22
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2011/09/01
CDR
Recommendation
Review
Status
Special Authorization Criteria Change - Psoriasis
Indication ANKYLOSING SPONDYLITIS
Reviewing
Body
Expert Committee
Submission
Completion
Date
2008/02/11
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2008/05/01
CDR
Recommendation
Review
Status
Under Review
Indication ANKYLOSING SPONDYLITIS
Reviewing
Body
Expert Committee
Submission
Completion
Date
2008/02/11
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2008/06/01
CDR
Recommendation
Review
Status
Special Authorization - Ankylosing Spondylitis
Indication ANKYLOSING SPONDYLITIS
Reviewing
Body
Expert Committee
Submission
Completion
Date
2008/02/11
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2009/03/04
CDR
Recommendation
Review
Status
Special Authorization Criteria Change - Ankylosing Spondylitis
Indication CROHN'S DISEASE
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2007/07/12
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2008/08/01
CDR
Recommendation
Review
Status
Special Authorization Criteria Change - Crohn's Disease
Indication CROHN'S DISEASE
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2007/07/12
CDR
Recommendation
Date
2007/12/19
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
View
Review
Status
CDR - List with criteria/condition
Indication ANKYLOSING SPONDYLITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2006/11/24
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2008/01/01
CDR
Recommendation
Review
Status
No Special Authorization Criteria Change - Anklylosing Spondylitis
Indication ANKYLOSING SPONDYLITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2006/11/24
CDR
Recommendation
Date
2007/06/27
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
View
Review
Status
CDR - List with criteria/condition
Indication PSORIATIC ARTHRITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2006/06/29
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2009/03/04
CDR
Recommendation
Review
Status
Special Authorization Criteria Change - Psoriatic Arthritis
Indication PSORIATIC ARTHRITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2006/06/29
CDR
Recommendation
Date
2006/11/29
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
View
Review
Status
CDR - List with criteria/condition
Indication PSORIATIC ARTHRITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2006/06/29
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2007/07/01
CDR
Recommendation
Review
Status
Special Authorization Criteria Change - Psoriatic Arthritis
Indication PSORIATIC ARTHRITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2006/06/29
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2007/04/01
CDR
Recommendation
Review
Status
Special Authorization - Psoriatic Arthritis
Indication RHEUMATOID ARTHRITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2004/09/28
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2009/10/01
CDR
Recommendation
Review
Status
Special Authorization Criteria Change - Rheumatoid Arthritis
Indication RHEUMATOID ARTHRITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2004/09/28
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2005/10/01
CDR
Recommendation
Review
Status
Special Authorization - Rheumatoid Arthritis
Indication RHEUMATOID ARTHRITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2004/09/28
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2007/10/01
CDR
Recommendation
Review
Status
Special Authorization Criteria Change - Rheumatoid Arthritis
Indication RHEUMATOID ARTHRITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2004/09/28
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2010/04/01
CDR
Recommendation
Review
Status
Special Authorization Criteria Change - Rheumatoid Arthritis
Indication RHEUMATOID ARTHRITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2004/09/28
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2012/08/01
CDR
Recommendation
Review
Status
Special Authorization Criteria Change - Rheumatoid Arthritis
Indication RHEUMATOID ARTHRITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2004/09/28
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2005/07/01
CDR
Recommendation
Review
Status
Under Review - Rheumatoid Arthritis
Indication RHEUMATOID ARTHRITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2004/09/28
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2009/03/04
CDR
Recommendation
Review
Status
Special Authorization Criteria Change - Rheumatoid Arthritis
Indication RHEUMATOID ARTHRITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2004/09/28
CDR
Recommendation
Date
2005/02/11
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
View
Review
Status
CDR - List with criteria/condition
To return to the printable Drug Benefit List and related publications, click here
Last Updated:
NOTICE:
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.
Electronic versions of all DBL and DBS related publications are unofficial versions and are provided for convenience and private use only. Official paper versions can be obtained from Alberta Blue Cross who publishes them on behalf of Alberta Health and Alberta Human Services.
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.