Product Details

Taltz

Ixekizumab
80 mg/mL
Solution for Injection
1-mL Prefilled Autoinjector

DIN/PIN/NPN

02455102

Manufacturer

Eli Lilly Canada Inc.

Formulary Listing Date

2018-03-29  

Unit Price

1865.1400

Amount MOH Pays

1865.1400

Coverage Status

Limited Use Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L04AC13

Interchangeable Products

NO  

LU Clinical Criteria

LU Code Auth. Period Clinical Criteria
526 1 year

For the treatment of severe (see Note 1 below) plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies (see Note 2 below).

Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued.

Approvals will only allow for standard dosing for Taltz 160mg at week 0, followed by 80mg subcutaneously at weeks 2, 4, 6, 8, 10, and 12, and then 80mg every 4 weeks.  If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended and the physician should consider switching to an alternative biologic agent.

Note 1: Definition of severe plaque psoriasis:

- Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND

- Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND

- Dermatology Life Quality Index (DLQI) score of at least 10.

Note 2: Definition of failure, intolerance or contraindication to adequate trials of standard therapies:

- 6-month trial of at least 3 topical agents including vitamin D analogues and steroids, AND

- 12-week trial of phototherapy (unless not accessible), AND

- 6-month trial of at least 2 systemic, oral agents used alone or in combination

       - Methotrexate 15-30mg per week
       - Acitretin (could have been used with phototherapy)
       - Cyclosporine

Maintenance/Renewal:

After 3 months of therapy, patients who respond to therapy should have:

- at least 50% reduction in PASI, AND
- at least 50% reduction in BSA involvement, AND
- at least a 5-point reduction in DLQI score
 

EAP Criteria

Therapeutic Class Reimbursement Criteria
Psoriatic Arthritis Treatments

Ixekizumab

  • Brand(s): Taltz
  • Dosage Form/Strength: 80 mg/mL Autoinjector or 80 mg/mL Syringe for subcutaneous injection
  • Effective date: March 4, 2019

For the treatment of psoriatic arthritis (PsA) in patients who have:

  • Severe active disease (≥ 5 swollen joints and radiographic evidence of psoriatic arthritis) despite treatment with methotrexate (20mg/week) for at least 3 months and one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. 

If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1 g twice daily) for at least 3 months is required. Details of contraindications and intolerances must also be provided. 

Duration of Approval: 1 Year 

Renewals will be considered for patients with objective evidence of at least a 20% reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. 

For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided. 

Duration of Approval of first renewal: 1 Year 

Duration of Approval of Second and subsequent renewals: 2 years 

The planned dosing regimen for the requested biologic should be provided. 

Recommended Dose: 

  • For psoriatic arthritis (PsA) patients or those with PsA and coexistent mild plaque psoriasis: 160 mg (two 80 mg injections) SC at Week 0, followed by 80 mg every 4 weeks.

  • For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, you may wish to refer to the ODB formulary for access upon meeting the Limited Use Criteria for Plaque psoriasis. (EAP authorization would not be required)
    Dose recommended for such patients is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg every 2 weeks for 6 doses (i.e. weeks 2, 4, 6, 8, 10, and 12), then 80 mg every 4 weeks thereafter. 

Ixekizumab may be used alone or in combination with a conventional DMARD (e.g., methotrexate)

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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