Product Details

Dupixent

Dupilumab
200 mg/1.14 mL (175 mg/mL)
Solution for Subcutaneous Injection
Single-Use 1.14-mL Pre-Filled Pen (Preservative-Free)

DIN/PIN/NPN

02524252

Manufacturer

Sanofi Genzyme, a Division of Sanofi-Aventis Canada Inc.

Formulary Listing Date

2022-12-01  

Unit Price

978.7000

Amount MOH Pays

978.7000

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

D11AH05

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Asthma

Dupilumab

  • Brand(s): Dupixent
  • Dosage Form/Strength: 200 mg/ 1.14 mL Prefilled syringe and prefilled pen, 300 mg/ 2mL prefilled syringe and prefilled pen
  • Effective Date: May 17, 2023

Initiation Criteria:

For the treatment of severe asthma in patients meeting the following criteria:

  1. Patient is aged 6 years old or older; AND

  1. Dupilumab is being used as an add-on maintenance therapy; AND

  1. Patients 6 to 11 years of age with a type 2 or eosinophilic phenotype and a documented blood eosinophil count equal to or greater than 150 cells/µL within the past 12 months

    OR

    Patients 12 years of age or older with a type 2 or eosinophilic phenotype and a documented blood eosinophil count equal to or greater than 150 cells/µL within the past 12 months and/or has oral corticosteroid (OCS) dependent asthma; AND

  1. Asthma is inadequately controlled using optimal treatment.

    i) For patients 6 to 11 years of age, this is defined as high dose inhaled corticosteroids (ICS) (greater than or equal to 400 mcg fluticasone priopionate daily or equivalent) alone OR medium- to high dose ICS plus 1 controller (e.g. a long-acting beta-agonists) AND experiencing at least one severe exacerbation (defined as having been treated with a systemic corticosteroid, hospitalized, or having visited an emergency department for worsening asthma) in the past 12 months

    ii) For patients 12 years and older, this is defined as using high dose ICS (greater than or equal to 500 mcg of fluticasone propionate or equivalent daily), and 1 or more additional asthma controller(s) (e.g., LABAs)1

  1. Patient is not using any other biologics to treat asthma; AND

  1. A baseline assessment of asthma symptom control using a validated asthma control questionnaire must be completed prior to initiation of dupilumab treatment.

  1. Request is submitted by a specialist in respirology, or allergy/clinical immunology, or by a physician with expertise in the treatment of asthma, unless the request confirms that the patient does not have access to such specialists, in which case the request may be submitted by an authorized prescriber. 

1Patients with type 2 or eosinophilic phenotypes are considered to be inadequately controlled if they have worsening of asthma resulting in administration of systemic corticosteroids for at least 3 days, or an emergency room visit, or hospitalization, in the past 12 months

Renewal criteria: 

Renewals will be considered on a case-by-case basis for patients 6 years of age or older with type 2 or eosinophilic asthma who do not meet any of the following discontinuation/stopping criteria:

  • Patient’s 12-month follow-up asthma control questionnaire score using the same validated asthma control questionnaire completed at baseline does not show improvement, such as a decrease of less than 0.5 points on the ACQ or an increase of less than 3 points on the ACT;

  • Patient’s subsequent asthma control questionnaire scores have not been maintained at the score seen following the first 12-months of therapy;

  • The number of clinically significant exacerbations defined as worsening of asthma resulting in administration of systemic corticosteroids, an emergency room visit or hospitalization, has increased within the previous 12 months. 

Renewals will be considered on a case-by-case basis for patients 12 years of age or older on maintenance treatment with OCS dependent asthma who do not meet any of the following stopping criteria:

  • there has been no decrease in the OCS dose in the first 12 months of treatment 

  • the reduction in the dose of OCS achieved after the first 12 months of treatment is not maintained or improved subsequently 

Approval duration of initial and renewals: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests
Dermatology Drugs

Dupilumab

  • Brand(s): Dupixent
  • Dosage Form/Strength: 200mg/1.14mL, 300mg/2ml (Prefilled syringe and prefilled pen)
  • Effective date: May 6, 2021
  • Updated: December 3, 2021 and December 1, 2022
  • Updated: April 28, 2023

Initiation Criteria:

For the treatment of moderate to severe atopic dermatitis in patients meeting the all the following criteria:

  1. 12 years of age or older; AND

  1. Diagnosed with moderate-to-severe atopic dermatitis (AD) by the Eczema Area and Severity Index (EASI) score equal to or greater than 16 points and the Investigators (Physician) Global Assessment score of 3 to 4; AND 

  1. Failure to maintain adequate control of their dermatitis with maximally tolerated medical topical therapies for AD combined with phototherapy (where available); (Note 1 and 2) AND 

  1. Failure to maintain adequate control of their dermatitis with maximally tolerated medical topical therapies for AD combined with at least 1 of the 4 systemic immunomodulators (methotrexate, cyclosporine, mycophenolate mofetil, or azathioprine). (Note 1 and 2).

  1. Dupilumab is prescribed by a dermatologist, allergist, pediatrician or clinical immunologist, or in consultation with one of these specialists. (Please include the consult note with the EAP application.) 

Exclusion Criteria: 

Dupilumab will not be funded if it is used in combination with phototherapy or any immunomodulatory drugs (including biologics (Note 3) or a Janus kinase [JAK] inhibitor treatment) for treatment of AD.

Notes: 

  1. For each treatment used, provide documentation of refractory disease and/or intolerance (including a description of the adverse effect and severity of reaction). If a patient is deemed to be ineligible or contraindicated to receive the treatment, provide the reason(s) for their ineligibility. 

  1. An adequate trial for patients with AD who undergo therapy with phototherapy, methotrexate, cyclosporine, mycophenolate mofetil, and azathioprine is defined as follows:
    •     For phototherapy: the typical duration would be considered 12 weeks (3 times per week).
    •     For methotrexate: an adequate trial would be 10 mg to 20 mg per week for 12 weeks.
    •     For cyclosporine: an adequate trial would be 2.5 mg/kg to 5 mg/kg per day for 12 weeks.
    •     For mycophenolate mofetil: an adequate trial would be 1 g twice daily for 12 weeks.
    •     For azathioprine: an adequate trial would be 1.5 to 2.5 mg/kg/day for 12 weeks.

  1. The concurrent use of dupilumab used in combination with other biologics used for other conditions will be considered on a case-by-case basis. 

Renewal Criteria: 

First renewal:
Renewal of funding will be considered in patients with documentation of benefit from treatment. Benefit from treatment is defined as a 75% or greater improvement from baseline in the Eczema Area and Severity Index (EASI) score (EASI-75) within six months of treatment initiation. 

Subsequent renewals:
Subsequent renewal of funding will be considered in patient who maintain the 75% or greater improvement in EASI-75 score response from baseline. 

Duration of Approval for initial requests: 6 months 

Duration of Approval for first and second renewal: 6 months 

Duration of Approval for 3rd and subsequent renewals: 1 year 

Recommended dose: 

Adults: An initial dose of 600 mg followed by 300 mg every other week.

Refer to the product monograph for dosing in adolescents 17 years of age and younger.

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

View Monograph