benralizumab

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Generic 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:
SF0592-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Not applicable.
Submission Type:
Request For Advice
Indications:
Asthma, severe eosinophilic
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Biosimilar Summary Dossier Issued:
Final Recommendation:
  1. 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 Milestones1

Call for patient input posted October 24, 2018
Patient group input closed December 12, 2018
Clarification:

- Patient input submission received from Asthma Canada and The Ontario Lung Association

Patient input summary sent for review to patient input groups December 17, 2018
Patient group comments on input summary closed December 20, 2018
Clarification:

- Patient input summary feedback received

Request for Advice received October 24, 2018
Manufacturer informed of request for advice October 24, 2018
Manufacturer information or comments due November 07, 2018
Request for Advice initiated October 29, 2018
Draft CDR Request for Advice report sent to manufacturer December 05, 2018
Comments from manufacturer on draft CDR Request for Advice report received December 14, 2018
Redaction requests from manufacturer on draft CDR Request for Advice report received December 21, 2018
CDR review team's comments on draft CDR Request for Advice report sent to manufacturer January 04, 2019
Canadian Drug Expert Committee (CDEC) meeting January 16, 2019
CDEC recommendation & redacted CDR Request for Advice report sent to manufacturer and drug plans January 28, 2019
Embargo period ended and validation of redacted CDR Request for Advice report received February 11, 2019
Clarification:

- Reconsideration requested

- Clarification requested by CDR-participating drug plans

Manufacturer's request for reconsideration placed on CDEC agenda March 20, 2019
Drug plans' request for clarification placed on CDEC agenda March 20, 2019
Response to request for clarification and CDEC Final Recommendation sent to sponsor and drug plans March 27, 2019
CDEC Final Recommendation posted March 29, 2019
Final CDR review report(s) posted April 23, 2019