Last Updated : May 12, 2023
Details
FilesGeneric 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:
- 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 | July 05, 2022 |
|---|---|
| Call for patient/clinician input closed | August 26, 2022 |
| Clarification: - Patient input submission received from the Canadian Breast Cancer Network and Rethink Breast Cancer | |
| Submission received | August 03, 2022 |
| Submission accepted | August 17, 2022 |
| Review initiated | August 18, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | November 17, 2022 |
| Deadline for sponsors comments | November 28, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | December 22, 2022 |
| Expert committee meeting (initial) | January 11, 2023 |
| Draft recommendation issued to sponsor | January 24, 2023 |
| Draft recommendation posted for stakeholder feedback | February 02, 2023 |
| End of feedback period | February 16, 2023 |
| Final recommendation issued to sponsor and drug plans | March 01, 2023 |
| Final recommendation posted | March 20, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | March 15, 2023 |
| CADTH review report(s) posted | May 09, 2023 |
Files
Last Updated : May 12, 2023