abemaciclib

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Generic 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:
  1. 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 openFebruary 23, 2022
Call for patient/clinician input closedApril 14, 2022
Clarification:

- Patient input submission received from Canadian Breast Cancer Network and Rethink Breast Cancer

Submission receivedMarch 23, 2022
Submission acceptedApril 06, 2022
Review initiatedApril 07, 2022
Draft CADTH review report(s) provided to sponsor for commentJune 24, 2022
Deadline for sponsors commentsJuly 06, 2022
CADTH review report(s) and responses to comments provided to sponsorJuly 28, 2022
Expert committee meeting (initial)August 10, 2022
Draft recommendation issued to sponsorAugust 24, 2022
Draft recommendation posted for stakeholder feedbackSeptember 01, 2022
End of feedback periodSeptember 16, 2022
Final recommendation issued to sponsor and drug plansSeptember 29, 2022
Final recommendation postedOctober 18, 2022
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)October 14, 2022
CADTH review report(s) postedDecember 23, 2022