berotralstat


( Last Updated : January 19, 2023)
Generic Name:
berotralstat
Project Status:
Active
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

Details


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.
  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/clinician input openJanuary 24, 2022
Call for patient/clinician input closedMarch 18, 2022
Clarification:

- Patient input submission received from HAE Canada (HAEC)

Submission receivedFebruary 22, 2022
Submission acceptedMarch 08, 2022
Review initiatedMarch 09, 2022
Draft CADTH review report(s) provided to sponsor for commentMay 24, 2022
Deadline for sponsors commentsJune 02, 2022
CADTH review report(s) and responses to comments provided to sponsorJuly 15, 2022
Expert committee meeting (initial)July 27, 2022
Draft recommendation issued to sponsorAugust 09, 2022
Draft recommendation posted for stakeholder feedbackAugust 18, 2022
End of feedback periodSeptember 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 meetingDecember 21, 2022
Draft recommendation issued to sponsorJanuary 11, 2023
Draft recommendation posted for stakeholder feedbackJanuary 19, 2023
End of feedback periodFebruary 03, 2023