Last Updated : November 8, 2024
Details
FilesGeneric Name:
abemaciclib
Project Status:
Active
Therapeutic Area:
Adjuvant treatment of HR-positive, HER2-negative early breast cancer
Manufacturer:
Eli Lilly Canada Inc.
Call for patient/clinician input open:
Brand Name:
Verzenio
Project Line:
Reimbursement Review
Project Number:
PC0345-000
Call for patient/clinician input closed:
Tumour Type:
Breast
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
In combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of disease recurrence based on clinicopathological features.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
In combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of disease recurrence based on clinicopathological features.
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.
| Call for patient/clinician input open | 24-Oct-23 |
|---|---|
| Call for patient/clinician input closed | 15-Dec-23 |
| Clarification: - Patient input submission received from the Canadian Breast Cancer Network and Rethink Breast Cancer | |
| Submission received | 09-Feb-24 |
| Submission accepted | 26-Feb-24 |
| Review initiated | 27-Feb-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 27-May-24 |
| Clarification: - Submission temporarily suspended - Additional information has been received and the temporary suspension of the review has been lifted | |
| Draft CADTH review report(s) provided to sponsor for comment | 02-Jul-24 |
| Deadline for sponsors comments | 11-Jul-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 01-Aug-24 |
| Expert committee meeting (initial) | 14-Aug-24 |
| Draft recommendation issued to sponsor | 23-Aug-24 |
| Draft recommendation posted for stakeholder feedback | 05-Sep-24 |
| End of feedback period | 19-Sep-24 |
| Final recommendation issued to sponsor and drug plans | 03-Oct-24 |
| Final recommendation posted | 22-Oct-24 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 18-Oct-24 |
| CADTH review report(s) posted | - |
Files
Last Updated : November 8, 2024