olaparib

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Generic 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:
  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 openMarch 15, 2023
Call for patient/clinician input closedMay 09, 2023
Clarification:

- Patient input submission received from Canadian Cancer Society and Canadian Cancer Survivor Network

Submission receivedMay 19, 2023
Submission acceptedJune 05, 2023
Clarification:

- Submission temporarily suspended

- Additional information has been received and the temporary suspension of the review has been lifted

Review initiatedJune 06, 2023
Draft CADTH review report(s) provided to sponsor for commentOctober 13, 2023
Deadline for sponsors commentsOctober 24, 2023
CADTH review report(s) and responses to comments provided to sponsorNovember 24, 2023
Expert committee meeting (initial)December 06, 2023
Draft recommendation issued to sponsorDecember 19, 2023
Draft recommendation posted for stakeholder feedbackJanuary 04, 2024
End of feedback periodJanuary 18, 2024
Final recommendation issued to sponsor and drug plansJanuary 31, 2024
Final recommendation postedFebruary 16, 2024
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)February 14, 2024
CADTH review report(s) postedApril 25, 2024