budesonide


( Last Updated : December 10, 2020)
Generic Name:
budesonide
Project Status:
Complete
Therapeutic Area:
Eosinophilic esophagitis, adults
Manufacturer:
AVIR Pharma Inc.
Call for patient/clinician input open:
Brand Name:
Jorveza
Project Line:
Reimbursement Review
Project Number:
SR0634-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC

Details


Manufacturer Requested Reimbursement Criteria1:
For the induction 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 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 input posted September 03, 2019
Patient group input closed October 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 groups December 04, 2019
Patient group comments on input summary closed December 11, 2019
Clarification:

- Patient input summary feedback received

Submission received November 08, 2019
Submission accepted November 22, 2019
Review initiated November 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 sponsor March 24, 2020
Comments from sponsor on draft CADTH review report(s) received April 02, 2020
CADTH review team's comments on draft CADTH review report(s) sent to sponsor May 07, 2020
Canadian Drug Expert Committee (CDEC) meeting May 20, 2020
CDEC recommendation sent to sponsor and drug plans June 01, 2020
Embargo period ended July 14, 2020
Clarification:

- Request for extension to embargo period received from the sponsor

- Embargo extension request granted

- Reconsideration requested

Sponsor's request for reconsideration placed on CDEC agenda October 21, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans October 28, 2020
CDEC Final Recommendation posted October 30, 2020
Redaction requests from sponsor on draft CADTH review report(s) received November 11, 2020
Final CADTH review report(s) posted December 09, 2020