dinutuximab


( Last Updated : August 16, 2021)
Generic Name:
dinutuximab
Project Status:
Completed
Therapeutic Area:
Neuroblastoma
Manufacturer:
United Therapeutics Corp.
Brand Name:
Unituxin
Project Line:
Reimbursement Review
Project Number:
PC0222-000
Tumour Type:
Neurological

Details


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:
  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 open October 22, 2020
Call for patient/clinician input closed December 10, 2020
Clarification:

- Patient input submission received from Neuroblastoma Canada, the Canadian Organization for Rare Disorders, and Ontario Parents Advocating for Children with Cancer

Submission received November 23, 2020
Submission accepted December 16, 2020
Clarification:

- Submission was not accepted for review on 7 Dec 20

Review initiated December 17, 2020
Draft CADTH review report(s) provided to sponsor for comment March 10, 2021
Deadline for sponsors comments March 19, 2021
CADTH responses on draft review report(s) provided to sponsor May 03, 2021
Expert committee meeting (initial) May 14, 2021
Draft recommendation issued to sponsor May 31, 2021
Draft recommendation posted for stakeholder feedback June 10, 2021
End of feedback period June 24, 2021
Final recommendation issued to sponsor and drug plans July 07, 2021
Final recommendation posted July 23, 2021
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) July 08, 2021
CADTH review report(s) posted August 16, 2021