lumasiran


( Last Updated : June 7, 2022)
Generic Name:
lumasiran
Project Status:
Active
Therapeutic Area:
Primary hyperoxaluria type 1
Manufacturer:
Alnylam Netherlands B.V.
Call for patient/clinician input open:
Brand Name:
Oxlumo
Project Line:
Reimbursement Review
Project Number:
SR0734-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC

Details

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:
  1. 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.

Key Milestones2

Call for patient/clinician input open11-Apr-22
Call for patient/clinician input closed06-Jun-22
Clarification:

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

Submission received10-May-22
Submission accepted26-May-22
Clarification:

- Submission was not accepted for review on 25 May 2022

Review initiated27-May-22
Draft CADTH review report(s) provided to sponsor for comment11-Aug-22
Deadline for sponsors comments22-Aug-22
CADTH review report(s) and responses to comments provided to sponsor16-Sep-22
Expert committee meeting (initial)28-Sep-22
Draft recommendation issued to sponsorOctober 11, 2022
To
October 13, 2022
Draft recommendation posted for stakeholder feedback20-Oct-22
End of feedback period03-Nov-22