Last Updated : November 6, 2019
Details
FilesGeneric Name:
mepolizumab
Project Status:
Complete
Therapeutic Area:
Asthma, severe eosinophilic
Manufacturer:
GlaxoSmithKline Inc.
Call for patient/clinician input open:
Brand Name:
Nucala
Project Line:
Reimbursement Review
Project Number:
SF0593-000
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:
- 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:
- Request for Clarification received from CDR Participating Drug Plans |
|
| 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 |
Files
Last Updated : November 6, 2019