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

relugolix

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Generic Name:
relugolix
Project Status:
Complete
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:
  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 open29-Sep-23
Call for patient/clinician input closed27-Nov-23
Clarification:

- Patient input submission received from The Androgen Deprivation Therapy Education Program, the Canadian Cancer Society and PROCURE - CANCER PROSTATE

Submission received14-Nov-23
Submission accepted28-Nov-23
Review initiated29-Nov-23
Draft Canada's Drug Agency review report(s) provided to sponsor for comment23-Feb-24
Deadline for sponsors comments05-Mar-24
Canada's Drug Agency review report(s) and responses to comments provided to sponsor28-Mar-24
Expert committee meeting (initial)10-Apr-24
Draft recommendation issued to sponsor23-Apr-24
Draft recommendation posted for stakeholder feedback02-May-24
End of feedback period16-May-24
Clarification:

- Reconsideration: minor revisions requested by drug programs

- Request for reconsideration accepted

Final recommendation issued to sponsor and drug plans22-Jul-24
Final recommendation posted08-Aug-24
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)13-Jun-24
Canada's Drug Agency review report(s) posted29-Oct-24

Files

Recommendation and Reason View PDF
Clinical and Pharmacoeconomic Combined Report View PDF
Stakeholder feedback on Draft Recommendation View PDF
Patient and Clinician Group input View PDF
Last Updated : October 29, 2024