Last Updated : December 10, 2020
Details
FilesGeneric Name:
budesonide
Project Status:
Complete
Therapeutic Area:
Eosinophilic esophagitis, adults
Manufacturer:
AVIR Pharma Inc.
Call for patient/clinician input open:
Brand Name:
Jorveza
Project Line:
Reimbursement Review
Project Number:
SR0634-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
N/A delay outside our control - Temporary suspension and/or submission of new information by sponsor
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the induction of clinico-pathological remission in adults with eosinophilic esophagitis (EoE), as per Health Canada indication
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Indicated for the induction of clinico-pathological remission in adults with eosinophilic esophagitis (EoE)
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 | September 03, 2019 |
| Patient group input closed | October 23, 2019 |
| Clarification:
- Patient input submission received from AEDESEO, American Partnership for Eosinophilic Disorders, ausEE Inc., CURED foundation, Gastrointestinal Society and FABED Families Affected by Eosinophilic Disorder |
|
| Patient input summary sent for review to patient input groups | December 04, 2019 |
| Patient group comments on input summary closed | December 11, 2019 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | November 08, 2019 |
| Submission accepted | November 22, 2019 |
| Review initiated | November 25, 2019 |
| Clarification:
- Selected for CADTH/INESSS Joint Clinician Engagement - Submission temporarily suspended pending receipt of information - Additional information has been received and the temporary suspension of the review has been lifted |
|
| Draft CADTH review report(s) sent to sponsor | March 24, 2020 |
| Comments from sponsor on draft CADTH review report(s) received | April 02, 2020 |
| CADTH review team's comments on draft CADTH review report(s) sent to sponsor | May 07, 2020 |
| Canadian Drug Expert Committee (CDEC) meeting | May 20, 2020 |
| CDEC recommendation sent to sponsor and drug plans | June 01, 2020 |
| Embargo period ended | July 14, 2020 |
| Clarification:
- Request for extension to embargo period received from the sponsor - Embargo extension request granted - Reconsideration requested |
|
| Sponsor's request for reconsideration placed on CDEC agenda | October 21, 2020 |
| CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans | October 28, 2020 |
| CDEC Final Recommendation posted | October 30, 2020 |
| Redaction requests from sponsor on draft CADTH review report(s) received | November 11, 2020 |
| Final CADTH review report(s) posted | December 09, 2020 |
Files
Last Updated : December 10, 2020