lumasiran

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Generic 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:
  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 openApril 11, 2022
Call for patient/clinician input closedJune 06, 2022
Clarification:

- Patient input submission received from The Oxalosis & Hyperoxaluria Foundation (OHF) and the Canadian Organization for Rare Disorders (CORD)

Submission receivedMay 10, 2022
Submission acceptedMay 26, 2022
Clarification:

- Submission was not accepted for review on 25 May 2022

Review initiatedMay 27, 2022
Draft CADTH review report(s) provided to sponsor for commentAugust 11, 2022
Deadline for sponsors commentsAugust 22, 2022
CADTH review report(s) and responses to comments provided to sponsorSeptember 16, 2022
Expert committee meeting (initial)September 28, 2022
Draft recommendation issued to sponsorOctober 11, 2022
Draft recommendation posted for stakeholder feedbackOctober 20, 2022
End of feedback periodNovember 03, 2022
Clarification:

- Reconsideration: minor revisions requested by sponsor

- Reconsideration accepted

Final recommendation issued to sponsor and drug plansFebruary 08, 2023
Final recommendation postedFebruary 27, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)February 23, 2023
CADTH review report(s) postedApril 24, 2023