Last Updated : January 16, 2019
Details
FilesGeneric Name:
benralizumab
Project Status:
Complete
Therapeutic Area:
Asthma, severe eosinophilic
Manufacturer:
AstraZeneca Canada Inc.
Call for patient/clinician input open:
Brand Name:
Fasenra
Project Line:
Reimbursement Review
Project Number:
SR0561-000
Call for patient/clinician input closed:
Performance Metric:
Achieved
Biosimilar:
No
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
Fee Schedule:
Schedule A
Indications:
Asthma, severe eosinophilic
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency 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 |
| Clarification:
- 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 |
| Clarification:
- 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 |
| Clarification:
- 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 |
Files
Last Updated : January 16, 2019