CDA | Evidence Driven
CDA | Evidence Driven

pembrolizumab

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Generic Name:
pembrolizumab
Project Status:
Active
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
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).
  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 openOctober 26, 2023
Call for patient/clinician input closedDecember 15, 2023
Clarification:

- Patient input submission received from CCRAN collectively with CCSN & GI Society

Submission receivedDecember 07, 2023
Submission acceptedDecember 21, 2023
Review initiatedDecember 22, 2023
Draft CADTH review report(s) provided to sponsor for commentMarch 18, 2024
Deadline for sponsors commentsMarch 27, 2024
CADTH review report(s) and responses to comments provided to sponsorApril 25, 2024
Expert committee meeting (initial)May 08, 2024
Draft recommendation issued to sponsorMay 22, 2024
Draft recommendation posted for stakeholder feedbackMay 30, 2024
End of feedback periodJune 13, 2024
Clarification:

- Reconsideration: minor revisions requested by drug programs

- Request for reconsideration accepted

Final recommendation issued to sponsor and drug plansJuly 11, 2024
Final recommendation posted-
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)July 25, 2024
CADTH review report(s) posted-

Files

Draft Recommendation View PDF
Last Updated : June 28, 2024