Last Updated : November 12, 2024
Details
FilesGeneric Name:
pembrolizumab
Project Status:
Complete
Therapeutic Area:
Gastric or gastroesophageal junction adenocarcinoma
Manufacturer:
Merck Canada
Call for patient/clinician input open:
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0343-000
Call for patient/clinician input closed:
Tumour Type:
Gastrointestinal
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Keytruda in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumors express PD-L1 [Combined Positive Score (CPS) 1] as determined by a validated test.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
Keytruda in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2‑positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test.
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 | 11-Oct-23 |
|---|---|
| Call for patient/clinician input closed | 01-Dec-23 |
| Clarification: - Patient input submission received from My Gut Feeling - Stomach Cancer Foundation of Canada | |
| Submission received | 22-Nov-23 |
| Submission accepted | 06-Dec-23 |
| Review initiated | 07-Dec-23 |
| Draft CADTH review report(s) provided to sponsor for comment | 29-Feb-24 |
| Deadline for sponsors comments | 11-Mar-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 25-Apr-24 |
| Expert committee meeting (initial) | 08-May-24 |
| Draft recommendation issued to sponsor | 21-May-24 |
| Draft recommendation posted for stakeholder feedback | 30-May-24 |
| End of feedback period | 13-Jun-24 |
| Final recommendation issued to sponsor and drug plans | 26-Jun-24 |
| Final recommendation posted | 15-Jul-24 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 11-Jul-24 |
| CADTH review report(s) posted | 08-Nov-24 |
Files
Last Updated : November 12, 2024