Interactive Drug Benefit List
DIN/NPN/PIN 02455102 TALTZ AUTOINJECTOR 80 MG / SYR INJECTION SYRINGE IXEKIZUMAB
840000 SKIN AND MUCOUS MEMBRANE AGENTS
849200 MISCELLANEOUS SKIN AND MUCOUS MEMBRANE AGENTS
Date Listed/Coverage Update: 01-Jun-2018
Unit Price: 1,702.8700
LCA Price: N/A
MAC Price:

N/A

Unit of Issue: Syringe
Manufacturer: ELI LILLY CANADA INC. (LIL)
ATC: L04AC13
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/Certolizumab/Etanercept/Golimumab/Guselkumab/ Infliximab/Ixekizumab/Secukinumab/Upadacitinib for Psoriatic Arthritis Special Authorization Request Form (ABC 60029)

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

Expand all Collapse all



"Special authorization coverage may be provided for the reduction in signs and symptoms of severe, debilitating plaque 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 to 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 one 160 mg dose (two 80 mg injections) at weeks 0, followed by 80 mg (one injection) at Weeks 2, 4, 6, 8, 10, and 12.
- Patients will be limited to receiving a one-month supply of ixekizumab 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, the patient must meet all of the following criteria:

1) The patient must be assessed by a Dermatology Specialist after the initial 12 weeks of therapy 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 80 mg every 4 weeks 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 ixekizumab for Plaque Psoriasis must be completed using the Adalimumab/Etanercept/Infliximab/Ixekizumab/Risankizumab/Secukinumab/Tildrakizumab/Ustekinumab for Plaque Psoriasis Special Authorization Request Form (ABC 60030).



"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 one 160 mg dose (two 80 mg injections) at week 0, followed by 80 mg (one injection) at weeks 4, 8, 12, 16, 20 & 24.

- Patients will be limited to receiving a one-month supply of ixekizumab 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 24 weeks, the patient must meet the following criteria:
1) The patient must be assessed by an RA Specialist after the initial 24 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 considered for 80 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 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 ixekizumab for Psoriatic Arthritis must be completed using the Adalimumab/Certolizumab/Etanercept/Golimumab/Infliximab/Ixekizumab/Secukinumab for Psoriatic Arthritis Special Authorization Request Form (ABC 60029).

Review Status / Past Decisions

Indication Reviewing
Body
Submission
Completion
Date
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
Review
Status
ANKYLOSING SPONDYLITIS Common Drug Review 2019/10/08 2020/03/24 View CDR - List with clinical criteria and/or conditions
PSORIATIC ARTHRITIS Common Drug Review 2018/03/06 2018/08/21 View CDR - List with clinical criteria and/or conditions
PSORIATIC ARTHRITIS Common Drug Review 2018/03/06 2019/03/01 Special Authorization - Psoriatic Arthritis
PSORIASIS (MODERATE TO SEVERE PLAQUE) Common Drug Review 2016/04/07 2018/06/01 Special Authorization - Psoriasis
PSORIASIS (MODERATE TO SEVERE PLAQUE) Common Drug Review 2016/04/07 2016/10/25 View CDR - List with clinical criteria and/or conditions
Indication ANKYLOSING SPONDYLITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2019/10/08
CDR
Recommendation
Date
2020/03/24
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
View
Review
Status
CDR - List with clinical criteria and/or conditions
Indication PSORIATIC ARTHRITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2018/03/06
CDR
Recommendation
Date
2018/08/21
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
View
Review
Status
CDR - List with clinical criteria and/or conditions
Indication PSORIATIC ARTHRITIS
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2018/03/06
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2019/03/01
CDR
Recommendation
Review
Status
Special Authorization - Psoriatic Arthritis
Indication PSORIASIS (MODERATE TO SEVERE PLAQUE)
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2016/04/07
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2018/06/01
CDR
Recommendation
Review
Status
Special Authorization - Psoriasis
Indication PSORIASIS (MODERATE TO SEVERE PLAQUE)
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2016/04/07
CDR
Recommendation
Date
2016/10/25
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
View
Review
Status
CDR - List with clinical criteria and/or conditions
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.