Last Updated : April 25, 2024
Details
FilesGeneric Name:
olaparib
Project Status:
Complete
Therapeutic Area:
Metastatic castration-resistant prostate cancer (mCRPC)
Manufacturer:
AstraZeneca Canada Inc.
Call for patient/clinician input open:
Brand Name:
Lynparza
Project Line:
Reimbursement Review
Project Number:
PC0319-000
Call for patient/clinician input closed:
Tumour Type:
Genitourinary
NOC Status at Filing:
Pre NOC
Performance Metric:
N/A delay outside our control - Temporary suspension and/or submission of new information by sponsor
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Olaparib in combination with abiraterone and prednisone or prednisolone is indicated for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) for whom chemotherapy is not clinically indicated.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Olaparib in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC).
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 | March 15, 2023 |
|---|---|
| Call for patient/clinician input closed | May 09, 2023 |
| Clarification: - Patient input submission received from Canadian Cancer Society and Canadian Cancer Survivor Network | |
| Submission received | May 19, 2023 |
| Submission accepted | June 05, 2023 |
| Clarification: - Submission temporarily suspended - Additional information has been received and the temporary suspension of the review has been lifted | |
| Review initiated | June 06, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | October 13, 2023 |
| Deadline for sponsors comments | October 24, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | November 24, 2023 |
| Expert committee meeting (initial) | December 06, 2023 |
| Draft recommendation issued to sponsor | December 19, 2023 |
| Draft recommendation posted for stakeholder feedback | January 04, 2024 |
| End of feedback period | January 18, 2024 |
| Final recommendation issued to sponsor and drug plans | January 31, 2024 |
| Final recommendation posted | February 16, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | February 14, 2024 |
| CADTH review report(s) posted | April 25, 2024 |
Files
Last Updated : April 25, 2024