budesonide


( Last Updated : December 22, 2020)
Generic 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

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).
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  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 open07-Oct-20
Call for patient/clinician input closed26-Nov-20
Clarification:

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

Submission received05-Nov-20
Submission accepted19-Nov-20
Review initiated20-Nov-20
Draft CADTH review report(s) provided to sponsor for comment23-Feb-21
Deadline for sponsors comments04-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 sponsor04-Jun-21
Expert committee meeting (initial)16-Jun-21
Draft recommendation issued to sponsor29-Jun-21
Draft recommendation posted for stakeholder feedback08-Jul-21
End of feedback period22-Jul-21
Final recommendation issued to sponsor and drug plans05-Aug-21
Final recommendation posted23-Aug-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)19-Aug-21
CADTH review report(s) posted14-Oct-21