Last Updated : December 23, 2022
Details
FilesGeneric Name:
abemaciclib
Project Status:
Complete
Therapeutic Area:
Adjuvant treatment of HR-positive, HER2-negative early breast cancer
Manufacturer:
Eli Lilly Canada Inc. (Eli Lilly)
Call for patient/clinician input open:
Brand Name:
Verzenio
Project Line:
Reimbursement Review
Project Number:
PC0282-000
Call for patient/clinician input closed:
Tumour Type:
Breast
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Eli Lilly Canada Inc. (Eli Lilly) is requesting reimbursement for VERZENIO® (abemaciclib), 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 and a Ki-67 score 20%.
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
Breast
Indications:
Verzenio is indicated 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 and a Ki-67 score ≥20%.
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 | February 23, 2022 |
| Call for patient/clinician input closed | April 14, 2022 |
| Clarification: - Patient input submission received from Canadian Breast Cancer Network and Rethink Breast Cancer | |
| Submission received | March 23, 2022 |
| Submission accepted | April 06, 2022 |
| Review initiated | April 07, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | June 24, 2022 |
| Deadline for sponsors comments | July 06, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | July 28, 2022 |
| Expert committee meeting (initial) | August 10, 2022 |
| Draft recommendation issued to sponsor | August 24, 2022 |
| Draft recommendation posted for stakeholder feedback | September 01, 2022 |
| End of feedback period | September 16, 2022 |
| Final recommendation issued to sponsor and drug plans | September 29, 2022 |
| Final recommendation posted | October 18, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | October 14, 2022 |
| CADTH review report(s) posted | December 23, 2022 |
Files
Last Updated : December 23, 2022