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 open26-Oct-23
Call for patient/clinician input closed15-Dec-23
Clarification:

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

Submission received07-Dec-23
Submission accepted21-Dec-23
Review initiated22-Dec-23
Draft CADTH review report(s) provided to sponsor for comment18-Mar-24
Deadline for sponsors comments27-Mar-24
CADTH review report(s) and responses to comments provided to sponsor25-Apr-24
Expert committee meeting (initial)08-May-24
Draft recommendation issued to sponsor22-May-24
Draft recommendation posted for stakeholder feedback30-May-24
End of feedback period13-Jun-24
Clarification:

- Reconsideration: minor revisions requested by drug programs