Last Updated : June 24, 2024
Details
Generic Name:
danicopan
Project Status:
Active
Therapeutic Area:
Paroxysmal nocturnal hemoglobinuria (PNH)
Manufacturer:
Alexion Pharma GmbH
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0815-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
As an add-on to Ultomiris or Soliris for the treatment of signs or symptoms of extravascular hemolysis (EVH) in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
As an add-on to Ultomiris or Soliris for the treatment of signs or symptoms of extravascular hemolysis (EVH) in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
- 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.
| Call for patient/clinician input open | 22-Feb-24 |
|---|---|
| Call for patient/clinician input closed | 15-Apr-24 |
| Clarification: - Patient input submission received from The Canadian Association of PNH Patients & Aplastic Anemia | |
| Submission received | 04-Apr-24 |
| Submission accepted | 18-Apr-24 |
| Review initiated | 19-Apr-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 11-Jul-24 |
| Deadline for sponsors comments | 22-Jul-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 16-Aug-24 |
| Expert committee meeting (initial) | 28-Aug-24 |
| Draft recommendation issued to sponsor | September 10, 2024 To September 12, 2024 |
| Draft recommendation posted for stakeholder feedback | 19-Sep-24 |
| End of feedback period | 04-Oct-24 |
Last Updated : June 24, 2024