Last Updated : February 10, 2023
Details
FilesGeneric 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
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:
- 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.
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 |
|
Files
Last Updated : February 10, 2023