berotralstat


( Last Updated : September 7, 2022)
Generic Name:
berotralstat
Project Status:
Active
Therapeutic Area:
hereditary angioedema (HAE)
Manufacturer:
BioCryst Pharmaceuticals Inc.
Call for patient/clinician input open:
Brand Name:
Orladeyo
Project Line:
Reimbursement Review
Project Number:
SR0723-000
Call for patient/clinician input closed:
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 open24-Jan-22
Call for patient/clinician input closed18-Mar-22
Clarification:

- Patient input submission received from HAE Canada (HAEC)

Submission received22-Feb-22
Submission accepted08-Mar-22
Review initiated09-Mar-22
Draft CADTH review report(s) provided to sponsor for comment24-May-22
Deadline for sponsors comments02-Jun-22
CADTH review report(s) and responses to comments provided to sponsor15-Jul-22
Expert committee meeting (initial)27-Jul-22
Draft recommendation issued to sponsor09-Aug-22
Draft recommendation posted for stakeholder feedback18-Aug-22
End of feedback period02-Sep-22
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