tafasitamab

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Generic Name:
tafasitamab
Project Status:
Complete
Therapeutic Area:
Diffuse large B-cell lymphoma (DLBCL)
Manufacturer:
Incyte Biosciences Canada Corporation
Brand Name:
Minjuvi
Project Line:
Reimbursement Review
Project Number:
PC0266-000
Tumour Type:
Lymphoma
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
In combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, who are not eligible for autologous stem cell transplant (ASCT).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Tafasitamab is indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, who are not eligible for autologous stem cell transplant (ASCT).
Recommendation Type:
Do not reimburse
Final Recommendation:
  1. 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.

Procedural review: CADTH accepted a procedural review request from Incyte Biosciences Canada for the Final Recommendation from the CADTH pan-Canadian Oncology Review Expert Review Committee (pERC) for PC0266-000 Minjuvi.

Status: Concluded

Description: This matter was concluded following adjudication by a Procedural Review Panel (“the panel”). In its decision, the panel found that CADTH and pERC acted in accordance with the Procedures for CADTH Reimbursement Reviews for the review of Minjuvi.

The panel’s decision was provided in a memorandum report to CADTH. CADTH has prepared a response to the findings of the procedural review.

Outcome: The pERC Final Recommendation of Do Not Reimburse is upheld for Minjuvi.

Key Milestones

Call for patient/clinician input open 15-Oct-21
Call for patient/clinician input closed 09-Dec-21
Clarification:

- Patient input submission received from Lymphoma Canada

Submission received 19-Nov-21
Submission accepted 03-Dec-21
Review initiated 06-Dec-21
Draft CADTH review report(s) provided to sponsor for comment 25-Feb-22
Deadline for sponsors comments 08-Mar-22
CADTH review report(s) and responses to comments provided to sponsor 01-Apr-22
Expert committee meeting (initial) 13-Apr-22
Draft recommendation issued to sponsor 27-Apr-22
Draft recommendation posted for stakeholder feedback 05-May-22
End of feedback period 19-May-22
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meeting 14-Sep-22
Final recommendation issued to sponsor and drug plans 26-Sep-22
Final recommendation posted 13-Oct-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) 11-Oct-22
CADTH review report(s) posted 19-Jan-23
Procedural Review accepted 29-Nov-22
Procedural Review under way, decision due 10-Feb-23
Procedural review concluded 10-Feb-23
Clarification:

- Final recommendation upheld