Last Updated : October 3, 2022
Details
FilesGeneric Name:
lisocabtagene maraleucel
Project Status:
Complete
Therapeutic Area:
Relapsed or refractory large B-cell lymphoma
Manufacturer:
Celgene Inc., a Bristol Myers Squibb company (Celgene)
Brand Name:
Breyanzi
Project Line:
Reimbursement Review
Project Number:
PG0258-000
Tumour Type:
Lymphoma
NOC Status at Filing:
Pre NOC
Performance Metric:
N/A delay outside our control - Temporary suspension and/or submission of new information by sponsor
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule E
Tumour Type:
Lymphoma
Indications:
For the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.lymphoma, primary mediastinal large B-cell lymphoma (PMBCL), and follicular
lymphoma grade 3B (FL3B) after at least 2 prior therapies.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
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.
Key Milestones2 | |
|---|---|
| Call for patient/clinician input open | 09-Jul-21 |
| Call for patient/clinician input closed | 03-Sep-21 |
| Clarification: - Patient input submission received from Lymphoma Canada | |
| Submission received | 09-Aug-21 |
| Submission accepted | 23-Aug-21 |
| Clarification: - Submission temporarily suspended - Additional information has been received and the temporary suspension of the review has been lifted | |
| Review initiated | 24-Aug-21 |
| Draft CADTH review report(s) provided to sponsor for comment | 16-Dec-21 |
| Clarification: - Submission temporarily suspended | |
| Deadline for sponsors comments | 18-Jan-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 | 24-May-22 |
| Draft recommendation posted for stakeholder feedback | 02-Jun-22 |
| End of feedback period | 16-Jun-22 |
| Final recommendation issued to sponsor and drug plans | 29-Jun-22 |
| Final recommendation posted | 18-Jul-22 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 14-Jul-22 |
| CADTH review report(s) posted | 03-Oct-22 |
Files
Last Updated : October 3, 2022