Last Updated : August 8, 2024
Details
FilesGeneric Name:
relugolix
Project Status:
Active
Therapeutic Area:
Advanced prostate cancer
Manufacturer:
Sumitomo Pharma Canada, Inc.
Call for patient/clinician input open:
Brand Name:
Orgovyx
Project Line:
Reimbursement Review
Project Number:
PC0342-000
Call for patient/clinician input closed:
Tumour Type:
Genitourinary
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with advanced prostate cancer.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of adult patients with advanced prostate cancer.
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 Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
| Call for patient/clinician input open | 29-Sep-23 |
|---|---|
| Call for patient/clinician input closed | 27-Nov-23 |
| Clarification: - Patient input submission received from The Androgen Deprivation Therapy Education Program, the Canadian Cancer Society and PROCURE - CANCER PROSTATE | |
| Submission received | 14-Nov-23 |
| Submission accepted | 28-Nov-23 |
| Review initiated | 29-Nov-23 |
| Draft CADTH review report(s) provided to sponsor for comment | 23-Feb-24 |
| Deadline for sponsors comments | 05-Mar-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 28-Mar-24 |
| Expert committee meeting (initial) | 10-Apr-24 |
| Draft recommendation issued to sponsor | 23-Apr-24 |
| Draft recommendation posted for stakeholder feedback | 02-May-24 |
| End of feedback period | 16-May-24 |
| Clarification: - Reconsideration: minor revisions requested by drug programs - Request for reconsideration accepted | |
| Final recommendation issued to sponsor and drug plans | 22-Jul-24 |
| Final recommendation posted | 08-Aug-24 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 13-Jun-24 |
| CADTH review report(s) posted | - |
Files
Last Updated : August 8, 2024