selumetinib


( Last Updated : November 21, 2022)
Generic Name:
selumetinib
Project Status:
Active
Therapeutic Area:
Neurofibromatosis type 1
Manufacturer:
Alexion Pharma GmbH
Brand Name:
Koselugo
Project Line:
Reimbursement Review
Project Number:
SR0764-000
NOC Status at Filing:
Post NOC

Details


Manufacturer Requested Reimbursement Criteria1:
For the treatment of pediatric patients aged 2 years and above, with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). (As per Health Canada approved Product Monograph).
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
​For the treatment of pediatric patients aged 2 years and above, with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
  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 openSeptember 26, 2022
Call for patient/clinician input closedNovember 18, 2022
Clarification:

- Patient input submission received from Canadian Organization for Rare Disorders (CORD)and Tumour Foundation of BC

Submission receivedOctober 28, 2022
Submission acceptedNovember 11, 2022
Review initiatedNovember 14, 2022
Draft CADTH review report(s) provided to sponsor for commentFebruary 02, 2023
Deadline for sponsors commentsFebruary 13, 2023
CADTH review report(s) and responses to comments provided to sponsorMarch 10, 2023
Expert committee meeting (initial)March 22, 2023
Draft recommendation issued to sponsorApril 03, 2023
To
April 05, 2023
Draft recommendation posted for stakeholder feedbackApril 13, 2023
End of feedback periodApril 27, 2023