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Last Updated: January 7, 2019
Result type: Reports
Project Number: SR0561-000
Product Line: Reimbursement Review

Generic Name: benralizumab

Brand Name: Fasenra

Manufacturer: AstraZeneca Canada Inc.

Therapeutic Area: Asthma, severe eosinophilic

Indications: Asthma, severe eosinophilic

Manufacturer Requested Reimbursement Criteria1: For add-on maintenance treatment of adult patients with severe eosinophilic asthma who are inadequately controlled with high-dose inhaled corticosteroids (ICS) and one or more additional asthma controller(s) (e.g., LABA), if one of the following clinical criteria are met: 1. Blood eosinophil count of 300 cells/L AND have experienced two or more clinically significant asthma exacerbations in the past 12 months, or 2. Blood eosinophil count of 150 cells/L and are treated chronically with oral corticosteroids (OCS).

Submission Type: Initial

Project Status: Complete

Biosimilar: No

Date Recommendation Issued: August 21, 2018

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

  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 January 25, 2018
Patient group input closed March 16, 2018

- Patient input submission received

Patient input summary sent for review to patient input groups March 23, 2018
Patient group comments on input summary closed April 02, 2018

- Patient input summary feedback received

Submission received February 23, 2018
Submission accepted for review March 09, 2018
Review initiated March 12, 2018
Draft CDR review report(s) sent to applicant May 25, 2018
Comments from applicant on draft CDR review report(s) received June 05, 2018
Redaction requests from applicant on draft CDR review report(s) received June 13, 2018

- Extension requested by applicant

- Request granted

CDR review team's comments on draft CDR review report(s) sent to applicant July 06, 2018
Canadian Drug Expert Committee (CDEC) meeting July 18, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans July 30, 2018
Embargo period ended and validation of redacted CDR review report(s) received August 14, 2018
CDEC Final Recommendation issued to applicant and drug plans August 21, 2018
CDEC Final Recommendation posted August 23, 2018
Final CDR review report(s) and patient input posted August 31, 2018