budesonide


( Last Updated : December 22, 2020)
Generic Name:
budesonide
Project Status:
Active
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

Details


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).
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient/clinician input openOctober 07, 2020
Call for patient/clinician input closedNovember 26, 2020
Clarification:

- Patient input submission received from the EOS Network (formerly FABED ), Food Allergy Canada and the Gastrointestinal Society

Submission receivedNovember 05, 2020
Submission acceptedNovember 19, 2020
Review initiatedNovember 20, 2020
Draft CADTH review report(s) provided to sponsor for commentFebruary 23, 2021
Deadline for sponsors commentsMarch 04, 2021
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 sponsorJune 04, 2021
Expert committee meeting (initial)June 16, 2021
Draft recommendation issued to sponsorJune 29, 2021
Draft recommendation posted for stakeholder feedbackJuly 08, 2021
End of feedback periodJuly 22, 2021
Final recommendation issued to sponsor and drug plansAugust 05, 2021
Final recommendation posted
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)
CADTH review report(s) posted