niraparib abiraterone acetate

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Generic Name:
niraparib abiraterone acetate
Project Status:
Complete
Therapeutic Area:
Metastatic castration-resistant prostate cancer (mCRPC)
Manufacturer:
Janssen Inc.
Call for patient/clinician input open:
Brand Name:
Akeega
Project Line:
Reimbursement Review
Project Number:
PC0326-000
Call for patient/clinician input closed:
Tumour Type:
Genitourinary
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Akeega is indicated with prednisone or prednisolone for: The treatment of adult patients with deleterious or suspected deleterious BRCA mutated (germline and/or somatic) metastatic castration resistant prostate cancer (mCRPC), who are asymptomatic/mildly symptomatic, and in whom chemotherapy is not clinically indicated. Patients must have confirmation of BRCA mutation before AKEEGA treatment is initiated.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
Akeega is indicated with prednisone or prednisolone for: The treatment of adult patients with deleterious or suspected deleterious BRCA mutated (germline and/or somatic) metastatic castration resistant prostate cancer (mCRPC), who are asymptomatic/mildly symptomatic, and in whom chemotherapy is not clinically indicated. Patients must have confirmation of BRCA mutation before AKEEGA™ 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 openApril 21, 2023
Call for patient/clinician input closedJune 19, 2023
Clarification:

- Patient input submission received from Canadian Cancer Survivor Network

Submission receivedJune 14, 2023
Submission acceptedJune 28, 2023
Review initiatedJune 29, 2023
Draft CADTH review report(s) provided to sponsor for commentSeptember 14, 2023
Deadline for sponsors commentsSeptember 25, 2023
CADTH review report(s) and responses to comments provided to sponsorOctober 27, 2023
Expert committee meeting (initial)November 08, 2023
Clarification:

Recommendation deferred to December 6, 2023 pERC meeting due to additional clarification needed by committee

Draft recommendation issued to sponsorDecember 18, 2023
Draft recommendation posted for stakeholder feedbackJanuary 04, 2024
End of feedback periodJanuary 18, 2024
Final recommendation issued to sponsor and drug plansFebruary 01, 2024
Final recommendation postedFebruary 20, 2024
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)February 15, 2024
CADTH review report(s) postedApril 29, 2024