Last Updated : May 24, 2023
Details
FilesGeneric 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
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:
- 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 | June 22, 2022 |
|---|---|
| Call for patient/clinician input closed | August 22, 2022 |
| Clarification: - Patient input submission received from and the Canadian Cancer Society and the Canadian Cancer Survivor Network | |
| Submission received | July 21, 2022 |
| Submission accepted | August 24, 2022 |
| Review initiated | August 25, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | November 16, 2022 |
| Deadline for sponsors comments | November 25, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | December 22, 2022 |
| Expert committee meeting (initial) | January 11, 2023 |
| Draft recommendation issued to sponsor | January 24, 2023 |
| Draft recommendation posted for stakeholder feedback | February 02, 2023 |
| End of feedback period | February 16, 2023 |
| Final recommendation issued to sponsor and drug plans | March 03, 2023 |
| Final recommendation posted | March 22, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | March 20, 2023 |
| CADTH review report(s) posted | May 18, 2023 |
Files
Last Updated : May 24, 2023