dinutuximab

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Generic 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:

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:

Recommendation Type:

Reimburse with clinical criteria and/or conditions

Final Recommendation:

July 23, 2021

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