Last Updated : April 25, 2023
Details
FilesGeneric Name:
lumasiran
Project Status:
Complete
Therapeutic Area:
Primary hyperoxaluria type 1
Manufacturer:
Alnylam Netherlands B.V.
Brand Name:
Oxlumo
Project Line:
Reimbursement Review
Project Number:
SR0734-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Treatment of primary hyperoxaluria type 1 (PH1) in pediatric and adult patients.
Submission Type:
Initial
Fee Schedule:
Schedule E
Tumour Type:
N/A
Indications:
Oxlumo (lumasiran) is indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.
Date NOC Issued:
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 Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
| Call for patient/clinician input open | April 11, 2022 |
|---|---|
| Call for patient/clinician input closed | June 06, 2022 |
| Clarification: - Patient input submission received from The Oxalosis & Hyperoxaluria Foundation (OHF) and the Canadian Organization for Rare Disorders (CORD) | |
| Submission received | May 10, 2022 |
| Submission accepted | May 26, 2022 |
| Clarification: - Submission was not accepted for review on 25 May 2022 | |
| Review initiated | May 27, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | August 11, 2022 |
| Deadline for sponsors comments | August 22, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | September 16, 2022 |
| Expert committee meeting (initial) | September 28, 2022 |
| Draft recommendation issued to sponsor | October 11, 2022 |
| Draft recommendation posted for stakeholder feedback | October 20, 2022 |
| End of feedback period | November 03, 2022 |
| Clarification: - Reconsideration: minor revisions requested by sponsor - Reconsideration accepted | |
| Final recommendation issued to sponsor and drug plans | February 08, 2023 |
| Final recommendation posted | February 27, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | February 23, 2023 |
| CADTH review report(s) posted | April 24, 2023 |
Files
Last Updated : April 25, 2023