budesonide

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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

Biosimilar:

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:

August 23, 2021

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 open	07-Oct-20
Call for patient/clinician input closed	26-Nov-20
Clarification: - Patient input submission received from the EOS Network (formerly FABED ), Food Allergy Canada and the Gastrointestinal Society
Submission received	05-Nov-20
Submission accepted	19-Nov-20
Review initiated	20-Nov-20
Draft CADTH review report(s) provided to sponsor for comment	23-Feb-21
Deadline for sponsors comments	04-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 sponsor	04-Jun-21
Expert committee meeting (initial)	16-Jun-21
Draft recommendation issued to sponsor	29-Jun-21
Draft recommendation posted for stakeholder feedback	08-Jul-21
End of feedback period	22-Jul-21
Final recommendation issued to sponsor and drug plans	05-Aug-21
Final recommendation posted	23-Aug-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)	19-Aug-21
CADTH review report(s) posted	14-Oct-21

Last Updated : October 14, 2021