Last Updated : July 24, 2023
Details
FilesGeneric Name:
selumetinib
Project Status:
Complete
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
Performance Metric:
Achieved
Biosimilar:
No
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).
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 | September 26, 2022 |
|---|---|
| Call for patient/clinician input closed | November 18, 2022 |
| Clarification: - Patient input submission received from Canadian Organization for Rare Disorders (CORD)and Tumour Foundation of BC | |
| Submission received | October 28, 2022 |
| Submission accepted | November 11, 2022 |
| Review initiated | November 14, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | February 03, 2023 |
| Deadline for sponsors comments | February 14, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | March 09, 2023 |
| Expert committee meeting (initial) | March 22, 2023 |
| Draft recommendation issued to sponsor | April 05, 2023 |
| Draft recommendation posted for stakeholder feedback | April 13, 2023 |
| End of feedback period | April 27, 2023 |
| Final recommendation issued to sponsor and drug plans | May 10, 2023 |
| Final recommendation posted | May 29, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | May 25, 2023 |
| CADTH review report(s) posted | July 20, 2023 |
Files
Last Updated : July 24, 2023