Last Updated : September 12, 2024
Details
FilesGeneric Name:
epcoritamab
Project Status:
Active
Therapeutic Area:
Relapsed or refractory diffuse large B-cell lymphoma
Manufacturer:
AbbVie Corporation
Call for patient/clinician input open:
Brand Name:
Epkinly
Project Line:
Reimbursement Review
Project Number:
PC0334-000
Call for patient/clinician input closed:
Tumour Type:
Lymphoma
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS), DLBCL transformed from indolent lymphoma, high grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL) or follicular lymphoma Grade 3B (FLG3b) after two or more lines of systemic therapy and who have previously received or are unable to receive CAR-T cell therapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS), DLBCL transformed from indolent lymphoma, high grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL) or follicular lymphoma Grade 3B (FLG3b) after two or more lines of systemic therapy and who have previously received or are unable to receive CAR-T cell therapy.
Recommendation Type:
Time-limited reimbursement recommendation
Final Recommendation:
- 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.
| Call for patient/clinician input open | September 29, 2023 |
|---|---|
| Call for patient/clinician input closed | November 27, 2023 |
| Clarification: - Patient input submission received from Lymphoma Canada and the Leukemia & Lymphoma Society of Canada | |
| Submission received | November 14, 2023 |
| Clarification: Eligible for consideration as a time-limited recommendation | |
| Submission accepted | November 28, 2023 |
| Review initiated | November 29, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | February 23, 2024 |
| Deadline for sponsors comments | March 05, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | March 28, 2024 |
| Expert committee meeting (initial) | April 10, 2024 |
| Draft recommendation issued to sponsor | April 24, 2024 |
| Draft recommendation posted for stakeholder feedback | May 02, 2024 |
| End of feedback period | May 16, 2024 |
| Final recommendation issued to sponsor and drug plans | May 31, 2024 |
| Final recommendation posted | June 18, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | June 14, 2024 |
| CADTH review report(s) posted | - |
Files
Last Updated : September 12, 2024