CDA | Evidence Driven
CDA | Evidence Driven

capivasertib

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Generic Name:
capivasertib
Project Status:
Active
Therapeutic Area:
HR-positive, HER2-negative locally advanced or metastatic breast cancer
Manufacturer:
AstraZeneca Canada Inc
Call for patient/clinician input open:
Brand Name:
Truqap
Project Line:
Reimbursement Review
Project Number:
PC0341-000
Call for patient/clinician input closed:
Tumour Type:
Breast
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
​For the treatment of adult females with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
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 open03-Jan-24
Call for patient/clinician input closed26-Feb-24
Clarification:

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

Submission received14-Feb-24
Submission accepted29-Feb-24
Review initiated01-Mar-24
Draft CADTH review report(s) provided to sponsor for comment27-May-24
Deadline for sponsors comments05-Jun-24
CADTH review report(s) and responses to comments provided to sponsor27-Jun-24
Expert committee meeting (initial)10-Jul-24
Draft recommendation issued to sponsor23-Jul-24
Draft recommendation posted for stakeholder feedback01-Aug-24
End of feedback period16-Aug-24
Final recommendation issued to sponsor and drug plans30-Aug-24
Final recommendation posted18-Sep-24
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)16-Sep-24
CADTH review report(s) posted-

Files

Recommendation and Reasons View PDF
Patient and Clinician Group Input View PDF
Last Updated : October 21, 2024