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budesonide

Last Updated: July 28, 2020
Result type: Reports
Project Number: SR0634-000
Product Line: Common Drug Review

Generic Name: budesonide

Brand Name: Jorveza

Manufacturer: AVIR Pharma Inc.

Indications: Eosinophilic esophagitis, adults

Manufacturer Requested Reimbursement Criteria1: For the induction of clinico-pathological remission in adults with eosinophilic esophagitis (EoE), as per Health Canada indication

Submission Type: New

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 input postedSeptember 03, 2019
Patient group input closedOctober 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 groupsDecember 04, 2019
Patient group comments on input summary closedDecember 11, 2019
Clarification:

- Patient input summary feedback received

Submission receivedNovember 08, 2019
Submission acceptedNovember 22, 2019
Review initiatedNovember 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 sponsorMarch 24, 2020
Comments from sponsor on draft CADTH review report(s) receivedApril 02, 2020
CADTH review team's comments on draft CADTH review report(s) sent to sponsorMay 07, 2020
Canadian Drug Expert Committee (CDEC) meetingMay 20, 2020
CDEC recommendation sent to sponsor and drug plansJune 01, 2020
Embargo period endedJuly 14, 2020
Clarification:

- Request for extension to embargo period received from the sponsor

- Embargo extension request granted

- Reconsideration requested

- Target CDEC reconsideration meeting date to be determined