Last Updated : February 20, 2024
Details
FilesGeneric Name:
niraparib abiraterone acetate
Project Status:
Active
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
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:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Call for patient/clinician input open | 21-Apr-23 |
---|---|
Call for patient/clinician input closed | 19-Jun-23 |
Clarification: - Patient input submission received from Canadian Cancer Survivor Network | |
Submission received | 14-Jun-23 |
Submission accepted | 28-Jun-23 |
Review initiated | 29-Jun-23 |
Draft CADTH review report(s) provided to sponsor for comment | 14-Sep-23 |
Deadline for sponsors comments | 25-Sep-23 |
CADTH review report(s) and responses to comments provided to sponsor | 27-Oct-23 |
Expert committee meeting (initial) | 08-Nov-23 |
Clarification: Recommendation deferred to December 6, 2023 pERC meeting due to additional clarification needed by committee | |
Draft recommendation issued to sponsor | 18-Dec-23 |
Draft recommendation posted for stakeholder feedback | 04-Jan-24 |
End of feedback period | 18-Jan-24 |
Final recommendation issued to sponsor and drug plans | 01-Feb-24 |
Final recommendation posted | 20-Feb-24 |
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 15-Feb-24 |
CADTH review report(s) posted | - |
Files
Last Updated : February 20, 2024