Last Updated : October 14, 2021
Details
FilesGeneric Name:
budesonide
Project Status:
Complete
Therapeutic Area:
Maintenance of Eosinophilic esophagitis in adults
Manufacturer:
AVIR Pharma Inc
Brand Name:
Jorveza
Project Line:
Reimbursement Review
Project Number:
SR0666-000
NOC Status at Filing:
Pre 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 and maintenance 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 and maintenance 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/clinician input open | 07-Oct-20 |
| Call for patient/clinician input closed | 26-Nov-20 |
| Clarification: - Patient input submission received from the EOS Network (formerly FABED ), Food Allergy Canada and the Gastrointestinal Society | |
| Submission received | 05-Nov-20 |
| Submission accepted | 19-Nov-20 |
| Review initiated | 20-Nov-20 |
| Draft CADTH review report(s) provided to sponsor for comment | 23-Feb-21 |
| Deadline for sponsors comments | 04-Mar-21 |
| Clarification: - Submission temporarily suspended pending receipt of information - Additional information has been received and the temporary suspension of the review has been lifted | |
| CADTH responses on draft review report(s) provided to sponsor | 04-Jun-21 |
| Expert committee meeting (initial) | 16-Jun-21 |
| Draft recommendation issued to sponsor | 29-Jun-21 |
| Draft recommendation posted for stakeholder feedback | 08-Jul-21 |
| End of feedback period | 22-Jul-21 |
| Final recommendation issued to sponsor and drug plans | 05-Aug-21 |
| Final recommendation posted | 23-Aug-21 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 19-Aug-21 |
| CADTH review report(s) posted | 14-Oct-21 |
Files
Last Updated : October 14, 2021