Last Updated : May 17, 2022
Details
FilesGeneric Name:
dinutuximab
Project Status:
Complete
Therapeutic Area:
Neuroblastoma
Manufacturer:
United Therapeutics Corp.
Brand Name:
Unituxin
Project Line:
Reimbursement Review
Project Number:
PC0222-000
Tumour Type:
Neurological
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of high-risk neuroblastoma patients in their first relapse or determination of refractory disease, in combination with irinotecan, temozolomide, and granulocyte macrophage colony-stimulating factor.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of high-risk neuroblastoma patients in their first relapse or determination of refractory disease, in combination with irinotecan, temozolomide, and granulocyte macrophage colony-stimulating factor.
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.
Key Milestones2 | |
|---|---|
| Call for patient/clinician input open | 22-Oct-20 |
| Call for patient/clinician input closed | 10-Dec-20 |
| Clarification: - Patient input submission received from Neuroblastoma Canada, the Canadian Organization for Rare Disorders, and Ontario Parents Advocating for Children with Cancer | |
| Submission received | 23-Nov-20 |
| Submission accepted | 16-Dec-20 |
| Clarification: - Submission was not accepted for review on 7 Dec 20 | |
| Review initiated | 17-Dec-20 |
| Draft CADTH review report(s) provided to sponsor for comment | 10-Mar-21 |
| Deadline for sponsors comments | 19-Mar-21 |
| CADTH responses on draft review report(s) provided to sponsor | 03-May-21 |
| Expert committee meeting (initial) | 14-May-21 |
| Draft recommendation issued to sponsor | 31-May-21 |
| Draft recommendation posted for stakeholder feedback | 10-Jun-21 |
| End of feedback period | 24-Jun-21 |
| Final recommendation issued to sponsor and drug plans | 07-Jul-21 |
| Final recommendation posted | 23-Jul-21 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 08-Jul-21 |
| CADTH review report(s) posted | 16-Aug-21 |
Files
Last Updated : May 17, 2022