Last Updated : September 23, 2022
Details
FilesGeneric Name:
zanubrutinib
Project Status:
Complete
Therapeutic Area:
Mantle cell lymphoma (MCL)
Manufacturer:
BeiGene Canada ULC
Call for patient/clinician input open:
Brand Name:
Brukinsa
Project Line:
Reimbursement Review
Project Number:
PC0267-000
Call for patient/clinician input closed:
Tumour Type:
Lymphoma
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
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.
Key Milestones2 | |
|---|---|
| Call for patient/clinician input open | 21-Sep-21 |
| Call for patient/clinician input closed | 12-Nov-21 |
| Clarification: - Patient input submission received from Lymphoma Canada | |
| Submission received | 30-Sep-21 |
| Submission accepted | 15-Oct-21 |
| Review initiated | 21-Oct-21 |
| Draft CADTH review report(s) provided to sponsor for comment | 11-Jan-22 |
| Deadline for sponsors comments | 20-Jan-22 |
| CADTH review report(s) and responses to comments provided to sponsor | 25-Feb-22 |
| Expert committee meeting (initial) | 09-Mar-22 |
| Draft recommendation issued to sponsor | 23-Mar-22 |
| Draft recommendation posted for stakeholder feedback | 31-Mar-22 |
| End of feedback period | 14-Apr-22 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | 13-Jul-22 |
| Final recommendation issued to sponsor and drug plans | 27-Jul-22 |
| Final recommendation posted | 15-Aug-22 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 11-Aug-22 |
| CADTH review report(s) posted | 21-Sep-22 |
Files
Last Updated : September 23, 2022