trifluridine and tipiracil

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Generic Name:
trifluridine and tipiracil
Project Status:
Active
Therapeutic Area:
Metastatic colorectal cancer
Manufacturer:
Taiho Pharma Canada, Inc.
Call for patient/clinician input open:
Brand Name:
Lonsurf
Project Line:
Reimbursement Review
Project Number:
PC0330-000
Call for patient/clinician input closed:
Tumour Type:
Gastrointestinal
NOC Status at Filing:
N/A
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
LONSURF, in combination with bevacizumab, for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF biological agents, and, if RAS wild-type, anti-EGFR agents.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​LONSURF, in combination with bevacizumab, for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF biological agents, and, if RAS wild-type, anti-EGFR agents.
  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 open04-Jul-23
Call for patient/clinician input closed25-Aug-23
Clarification:

- Patient input submission received from Colorectal Cancer Canada, and Colorectal Cancer Resource & Action Network (CCRAN)

Submission received15-Aug-23
Submission accepted-
Review initiated30-Aug-23
Draft CADTH review report(s) provided to sponsor for comment16-Nov-23
Deadline for sponsors comments27-Nov-23
CADTH review report(s) and responses to comments provided to sponsor21-Dec-23
Expert committee meeting (initial)10-Jan-24
Draft recommendation issued to sponsor23-Jan-24
Draft recommendation posted for stakeholder feedback01-Feb-24
End of feedback period15-Feb-24
Final recommendation issued to sponsor and drug plans29-Feb-24
Final recommendation posted-
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)14-Mar-24
CADTH review report(s) posted-