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Last Updated: June 12, 2020
Result type: Reports
Project Number: SR0636-000
Product Line: Reimbursement Review

Generic Name: dupilumab

Brand Name: Dupixent

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

Therapeutic Area: atopic dermatitis

Indications: atopic dermatitis

Manufacturer Requested Reimbursement Criteria1: For the treatment of patients aged 12 years and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable and/or who are refractory to or ineligible for systemic immunosuppressant therapies (i.e., due to contraindications, intolerance, or need for long-term treatment).

Submission Type: Initial

Project Status: Complete

Companion Diagnostics: No

Date Recommendation Issued: April 22, 2020

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule B

  1. 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 input posted September 23, 2019
Patient group input closed November 12, 2019

- Patient input submission received from Eczema Society of Canada

-Canadian Skin Patient Alliance

Patient input summary sent for review to patient input groups November 27, 2019

- Patient input summary feedback received

Patient group comments on input summary closed December 09, 2019
Submission received October 22, 2019
Submission accepted November 05, 2019
Review initiated November 06, 2019
Draft CADTH review report(s) sent to sponsor February 03, 2020
Comments from sponsor on draft CADTH review report(s) received February 12, 2020
CADTH review team's comments on draft CADTH review report(s) sent to sponsor March 06, 2020
Canadian Drug Expert Committee (CDEC) meeting March 18, 2020
CDEC recommendation sent to sponsor and drug plans March 31, 2020
Embargo period ended April 15, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans April 22, 2020
CDEC Final Recommendation posted April 24, 2020
Redaction requests from sponsor on draft CADTH review report(s) received May 06, 2020
Redacted CADTH review report(s) sent to sponsor and drug plans May 19, 2020
Validation of redacted CADTH review report(s) received May 26, 2020
Final CADTH review report(s) posted June 11, 2020