osilodrostat

Details

Generic Name:
osilodrostat
Project Status:
Suspended
Therapeutic Area:
Endogenous Cushing’s syndrome
Manufacturer:
Recordati Rare Diseases Canada Inc.
Call for patient/clinician input open:
Brand Name:
Isturisa
Project Line:
Reimbursement Review
Project Number:
SR0804-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of endogenous Cushing’s syndrome in adults.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​For the treatment of endogenous Cushing’s syndrome in adults.
  1. 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.
Key Milestones2
Call for patient/clinician input open17-Aug-23
Call for patient/clinician input closed10-Oct-23
Clarification:

- Patient input submission received from Canadian Organization for Rare Disorders

Submission received16-Oct-23
Submission accepted30-Oct-23
Review initiated31-Oct-23
Clarification:

- Submission temporarily suspended

Draft CADTH review report(s) provided to sponsor for comment-
Deadline for sponsors comments-
CADTH review report(s) and responses to comments provided to sponsor-
Expert committee meeting (initial)-
Draft recommendation issued to sponsor-
Draft recommendation posted for stakeholder feedback-
End of feedback period-