niraparib abiraterone acetate

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Generic 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:
  1. 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.
Key Milestones2
Call for patient/clinician input open21-Apr-23
Call for patient/clinician input closed19-Jun-23
Clarification:

- Patient input submission received from Canadian Cancer Survivor Network

Submission received14-Jun-23
Submission accepted28-Jun-23
Review initiated29-Jun-23
Draft CADTH review report(s) provided to sponsor for comment14-Sep-23
Deadline for sponsors comments25-Sep-23
CADTH review report(s) and responses to comments provided to sponsor27-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 sponsor18-Dec-23
Draft recommendation posted for stakeholder feedback04-Jan-24
End of feedback period18-Jan-24
Final recommendation issued to sponsor and drug plans01-Feb-24
Final recommendation posted20-Feb-24
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)15-Feb-24
CADTH review report(s) posted-