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dinutuximab

Last Updated: March 12, 2021
Result type: Reports
Project Number: PC0222-000
Product Line: Reimbursement Review

Generic Name: dinutuximab

Brand Name: Unituxin

Manufacturer: United Therapeutics Corp.

Therapeutic Area: Neuroblastoma

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.

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

Tumour Type: Neurological

Project Status: Active

Companion Diagnostics: No

Fee Schedule1: Schedule A

  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.

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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 27, 2021
To
May 31, 2021
Draft recommendation posted for stakeholder feedback -