olaparib

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Generic Name:
olaparib
Project Status:
Complete
Therapeutic Area:
gBRCAm, HER2-negative high-risk early breast cancer
Manufacturer:
AstraZeneca Canada Inc.
Brand Name:
Lynparza
Project Line:
Reimbursement Review
Project Number:
PC0299-000
Tumour Type:
Breast
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
olaparib is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients must have confirmation of a germline BRCA mutation before Lynparza treatment is initiated.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Tumour Type:
Breast
Indications:
​Lynparza (olaparib) is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients must have confirmation of a germline BRCA mutation before Lynparza treatment is initiated.
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 openJuly 05, 2022
Call for patient/clinician input closedAugust 26, 2022
Clarification:

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

Submission receivedAugust 03, 2022
Submission acceptedAugust 17, 2022
Review initiatedAugust 18, 2022
Draft CADTH review report(s) provided to sponsor for commentNovember 17, 2022
Deadline for sponsors commentsNovember 28, 2022
CADTH review report(s) and responses to comments provided to sponsorDecember 22, 2022
Expert committee meeting (initial)January 11, 2023
Draft recommendation issued to sponsorJanuary 24, 2023
Draft recommendation posted for stakeholder feedbackFebruary 02, 2023
End of feedback periodFebruary 16, 2023
Final recommendation issued to sponsor and drug plansMarch 01, 2023
Final recommendation postedMarch 20, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)March 15, 2023
CADTH review report(s) postedMay 09, 2023