Canada’s Drug Agency | Drugs, Health Technologies and Systems.

lutetium vipivotide tetraxetan

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Generic Name:
lutetium vipivotide tetraxetan
Project Status:
Complete
Therapeutic Area:
Metastatic castration-resistant prostate cancer
Manufacturer:
Advanced Accelerator Applications USA, Inc.
Call for patient/clinician input open:
Brand Name:
Pluvicto
Project Line:
Reimbursement Review
Project Number:
PC0297-000
Call for patient/clinician input closed:
Tumour Type:
Genitourinary
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
The treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have received at least one androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy.
Submission Type:
Initial
Fee Schedule:
Schedule E
Tumour Type:
Genitourinary
Indications:
The treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have received at least one androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation/Report:
  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 open22-Jun-22
Call for patient/clinician input closed22-Aug-22
Clarification:

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

Submission received21-Jul-22
Submission accepted24-Aug-22
Review initiated25-Aug-22
Draft Canada's Drug Agency review report(s) provided to sponsor for comment16-Nov-22
Deadline for sponsors comments25-Nov-22
Canada's Drug Agency review report(s) and responses to comments provided to sponsor22-Dec-22
Expert committee meeting (initial)11-Jan-23
Draft recommendation issued to sponsor24-Jan-23
Draft recommendation posted for stakeholder feedback02-Feb-23
End of feedback period16-Feb-23
Final recommendation issued to sponsor and drug plans03-Mar-23
Final recommendation posted22-Mar-23
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)20-Mar-23
Canada's Drug Agency review report(s) posted18-May-23

Files

Recommendation and Reasons View PDF
Clinical, Pharmacoeconomic, Ethics, and Stakeholder Input Combined Report View PDF
Stakeholder Feedback on Draft Recommendation View PDF
Last Updated : July 24, 2024