Last Updated : April 19, 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).
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 | February 22, 2024 |
|---|---|
| Call for patient/clinician input closed | April 15, 2024 |
| Clarification: - Patient input submission received from The Canadian Association of PNH Patients & Aplastic Anemia | |
| Submission received | April 04, 2024 |
| Submission accepted | April 18, 2024 |
| Review initiated | April 19, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | July 05, 2024 |
| Deadline for sponsors comments | July 16, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | August 16, 2024 |
| Expert committee meeting (initial) | August 28, 2024 |
| Draft recommendation issued to sponsor | September 10, 2024 To September 12, 2024 |
| Draft recommendation posted for stakeholder feedback | September 19, 2024 |
| End of feedback period | October 04, 2024 |
Last Updated : April 19, 2024