Last Updated : January 30, 2025
Details
FilesGeneric Name:
pembrolizumab
Project Status:
Complete
Therapeutic Area:
Gastric or gastroesophageal junction (GEJ) adenocarcinoma
Manufacturer:
Merck Canada
Call for patient/clinician input open:
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0356-000
Call for patient/clinician input closed:
Tumour Type:
Gastrointestinal
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Keytruda, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Keytruda, in combination with fluoropyrimidine- and
platinum-containing chemotherapy, is indicated for the first-line treatment of adult
patients with locally advanced unresectable or metastatic HER2-negative gastric or
gastroesophageal junction (GEJ) adenocarcinoma.
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 | February 08, 2024 |
|---|---|
| Call for patient/clinician input closed | April 02, 2024 |
| Clarification: - Patient input submission received from My Gut Feeling - Stomach Cancer Foundation of Canada | |
| Submission received | March 13, 2024 |
| Submission accepted | March 28, 2024 |
| Review initiated | April 01, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | June 20, 2024 |
| Deadline for sponsors comments | July 02, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | August 01, 2024 |
| Expert committee meeting (initial) | August 14, 2024 |
| Draft recommendation issued to sponsor | August 27, 2024 |
| Draft recommendation posted for stakeholder feedback | September 05, 2024 |
| End of feedback period | September 19, 2024 |
| Final recommendation issued to sponsor and drug plans | October 04, 2024 |
| Final recommendation posted | October 23, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | October 21, 2024 |
| CADTH review report(s) posted | January 30, 2025 |
Files
Last Updated : January 30, 2025