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budesonide

Last Updated: December 22, 2020
Result type: Reports
Project Number: SR0666-000
Product Line: Reimbursement Review

Generic Name: budesonide

Brand Name: Jorveza

Manufacturer: AVIR Pharma Inc

Therapeutic Area: Maintenance of Eosinophilic esophagitis in adults

Indications: Indicated for the induction and maintenance of clinico-pathological remission in adults with eosinophilic esophagitis (EoE).

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

NOC Status at Filing: Pre NOC

Project Status: Active

Companion Diagnostics: No

Fee Schedule: Schedule A

  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 28, 2021
To
June 30, 2021
Draft recommendation posted for stakeholder feedback-