Last Updated : October 31, 2024
Details
FilesGeneric Name:
epcoritamab
Project Status:
Complete
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 | 29-Sep-23 |
|---|---|
| Call for patient/clinician input closed | 27-Nov-23 |
| Clarification: - Patient input submission received from Lymphoma Canada and the Leukemia & Lymphoma Society of Canada | |
| Submission received | 14-Nov-23 |
| Clarification: Eligible for consideration as a time-limited recommendation | |
| Submission accepted | 28-Nov-23 |
| Review initiated | 29-Nov-23 |
| Draft CADTH review report(s) provided to sponsor for comment | 23-Feb-24 |
| Deadline for sponsors comments | 05-Mar-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 28-Mar-24 |
| Expert committee meeting (initial) | 10-Apr-24 |
| Draft recommendation issued to sponsor | 24-Apr-24 |
| Draft recommendation posted for stakeholder feedback | 02-May-24 |
| End of feedback period | 16-May-24 |
| Final recommendation issued to sponsor and drug plans | 31-May-24 |
| Final recommendation posted | 18-Jun-24 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 14-Jun-24 |
| CADTH review report(s) posted | 30-Oct-24 |
Files
Last Updated : October 31, 2024