Last Updated : June 8, 2023
Details
FilesGeneric Name:
ravulizumab
Project Status:
Complete
Therapeutic Area:
Atypical hemolytic uremic syndrome
Manufacturer:
Alexion Pharma GmBH
Brand Name:
Ultomiris
Project Line:
Reimbursement Review
Project Number:
SR0740-000
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adults and pediatric patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
The treatment of adult and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement mediated thrombotic microangiopathy (TMA).
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- 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 | May 10, 2022 |
|---|---|
| Call for patient/clinician input closed | July 04, 2022 |
| Clarification: - Patient input submission received from aHUS Canada | |
| Submission received | June 08, 2022 |
| Submission accepted | June 22, 2022 |
| Review initiated | June 23, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | September 08, 2022 |
| Deadline for sponsors comments | September 19, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | October 14, 2022 |
| Expert committee meeting (initial) | October 26, 2022 |
| Draft recommendation issued to sponsor | November 08, 2022 |
| Draft recommendation posted for stakeholder feedback | November 17, 2022 |
| End of feedback period | December 01, 2022 |
| Clarification: - Reconsideration: minor revisions requested by drug programs | |
| Final recommendation posted | March 15, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | March 13, 2023 |
| CADTH review report(s) posted | June 07, 2023 |
Files
Last Updated : June 8, 2023