Last Updated : October 20, 2023
Details
FilesGeneric Name:
avacopan
Project Status:
Complete
Therapeutic Area:
Antineutrophil cytoplasmic antibody-associated vasculitis
Manufacturer:
Otsuka Canada Pharmaceutical Inc.
Brand Name:
Tavneos
Project Line:
Reimbursement Review
Project Number:
SR0732-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard background therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard background therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.
Recommendation Type:
Do not reimburse
Final Recommendation:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
| Call for patient/clinician input open | March 31, 2022 |
|---|---|
| Call for patient/clinician input closed | May 20, 2022 |
| Submission received | October 14, 2022 |
| Submission accepted | October 28, 2022 |
| Review initiated | October 31, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | January 26, 2023 |
| Deadline for sponsors comments | February 07, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | March 09, 2023 |
| Expert committee meeting (initial) | March 22, 2023 |
| Draft recommendation issued to sponsor | April 04, 2023 |
| Draft recommendation posted for stakeholder feedback | April 13, 2023 |
| End of feedback period | April 27, 2023 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | July 26, 2023 |
| Final recommendation posted | August 28, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | August 24, 2023 |
| CADTH review report(s) posted | October 23, 2023 |
Files
Last Updated : October 20, 2023