Last Updated : April 29, 2024
Details
FilesGeneric 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
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 | April 21, 2023 |
|---|---|
| Call for patient/clinician input closed | June 19, 2023 |
| Clarification: - Patient input submission received from Canadian Cancer Survivor Network | |
| Submission received | June 14, 2023 |
| Submission accepted | June 28, 2023 |
| Review initiated | June 29, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | September 14, 2023 |
| Deadline for sponsors comments | September 25, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | October 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 sponsor | December 18, 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 | February 01, 2024 |
| Final recommendation posted | February 20, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | February 15, 2024 |
| CADTH review report(s) posted | April 29, 2024 |
Files
Last Updated : April 29, 2024