dupilumab

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Generic Name:

dupilumab

Project Status:

Complete

Therapeutic Area:

Asthma

Manufacturer:

Sanofi Genzyme, a division of sanofi-aventis Canada Inc.

Brand Name:

Dupixent

Project Line:

Reimbursement Review

Project Number:

SR0667-000

NOC Status at Filing:

Post NOC

Biosimilar:

Manufacturer Requested Reimbursement Criteria¹:

Add-on maintenance treatment in patients aged 12 years and older with severe asthma with a type 2/eosinophilic phenotype or oral corticosteroid dependent asthma with the following characteristics: 2 or more clinically significant asthma exacerbations in the last 12 months AND Blood eosinophils 150/mcL; OR FeNO 25 ppb; OR Treatment with maintenance oral corticosteroids; OR Clinically allergen-driven asthma

Submission Type:

Initial

Fee Schedule:

Schedule A

Indications:

Dupixent is indicated as an add-on maintenance treatment in patients aged 12 years and older with severe asthma with a type 2/eosinophilic phenotype or oral corticosteroid-dependent asthma.

Recommendation Type:

Reimburse with clinical criteria and/or conditions

Final Recommendation:

June 8, 2021

The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones²
Call for patient/clinician input open	October 29, 2020
Call for patient/clinician input closed	December 17, 2020
Clarification: - Patient input submission received from the Lung Health Foundation / Ontario Lung Association
Submission received	November 26, 2020
Submission accepted	December 10, 2020
Review initiated	December 11, 2020
Draft CADTH review report(s) provided to sponsor for comment	March 04, 2021
Deadline for sponsors comments	March 15, 2021
CADTH responses on draft review report(s) provided to sponsor	April 09, 2021
Expert committee meeting (initial)	April 21, 2021
Draft recommendation issued to sponsor	May 05, 2021
Draft recommendation posted for stakeholder feedback	May 13, 2021
End of feedback period	May 28, 2021
Final recommendation issued to sponsor and drug plans	June 08, 2021
Final recommendation posted	June 24, 2021
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)	June 22, 2021
CADTH review report(s) posted	August 10, 2021