Last Updated : November 21, 2024
Details
FilesGeneric Name:
pembrolizumab
Project Status:
Complete
Therapeutic Area:
Biliary tract carcinoma
Manufacturer:
Merck Canada Inc.
Call for patient/clinician input open:
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0344-000
Call for patient/clinician input closed:
Tumour Type:
Gastrointestinal
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
In combination with gemcitabine-based chemotherapy, is indicated for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract carcinoma (BTC).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
In combination with gemcitabine-based chemotherapy, is indicated for the treatment of adult patients with locally advanced unresectable or metastatic biliary tract carcinoma (BTC).
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 | October 26, 2023 |
|---|---|
| Call for patient/clinician input closed | December 15, 2023 |
| Clarification: - Patient input submission received from CCRAN collectively with CCSN & GI Society | |
| Submission received | December 07, 2023 |
| Submission accepted | December 21, 2023 |
| Review initiated | December 22, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | March 18, 2024 |
| Deadline for sponsors comments | March 27, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | April 25, 2024 |
| Expert committee meeting (initial) | May 08, 2024 |
| Draft recommendation issued to sponsor | May 22, 2024 |
| Draft recommendation posted for stakeholder feedback | May 30, 2024 |
| End of feedback period | June 13, 2024 |
| Clarification: - Reconsideration: minor revisions requested by drug programs - Request for reconsideration accepted | |
| Final recommendation issued to sponsor and drug plans | July 11, 2024 |
| Final recommendation posted | July 29, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | July 25, 2024 |
| CADTH review report(s) posted | November 21, 2024 |
Files
Last Updated : November 21, 2024