Last Updated : April 27, 2023
Details
FilesGeneric Name:
berotralstat
Project Status:
Complete
Therapeutic Area:
hereditary angioedema (HAE)
Manufacturer:
BioCryst Pharmaceuticals Inc.
Brand Name:
Orladeyo
Project Line:
Reimbursement Review
Project Number:
SR0723-000
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and pediatric patients aged 12 years and older.
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
N/A
Indications:
For routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and pediatric patients aged 12 years and older.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
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 | January 24, 2022 |
|---|---|
| Call for patient/clinician input closed | March 18, 2022 |
| Clarification: - Patient input submission received from HAE Canada (HAEC) | |
| Submission received | February 22, 2022 |
| Submission accepted | March 08, 2022 |
| Review initiated | March 09, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | May 24, 2022 |
| Deadline for sponsors comments | June 02, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | July 15, 2022 |
| Expert committee meeting (initial) | July 27, 2022 |
| Draft recommendation issued to sponsor | August 09, 2022 |
| Draft recommendation posted for stakeholder feedback | August 18, 2022 |
| End of feedback period | September 02, 2022 |
| Clarification: Deadline for patient groups and clinician groups to provide feedback on the draft recommendations is 06-Sep-2022 - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | December 21, 2022 |
| Draft recommendation issued to sponsor | January 11, 2023 |
| Draft recommendation posted for stakeholder feedback | January 19, 2023 |
| End of feedback period | February 03, 2023 |
| Final recommendation posted | March 08, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | March 06, 2023 |
| CADTH review report(s) posted | April 27, 2023 |
Files
Last Updated : April 27, 2023