pembrolizumab

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Generic Name:

pembrolizumab

Project Status:

Complete

Therapeutic Area:

Esophageal carcinoma, gastroesophageal junction adenocarcinoma

Manufacturer:

Merck Canada

Brand Name:

Keytruda

Project Line:

Reimbursement Review

Project Number:

PC0250-000

Tumour Type:

Head and Neck

NOC Status at Filing:

Pre NOC

Biosimilar:

Manufacturer Requested Reimbursement Criteria¹:

First-line treatment of locally advanced unresectable or metastatic, carcinoma of the esophagus or HER-2 negative gastroesophageal junction adenocarcinoma in combination with platinum and fluoropyrimidine based chemotherapy, in adult patients.

Submission Type:

Initial

Fee Schedule:

Schedule A

Indications:

Recommendation Type:

Reimburse with clinical criteria and/or conditions

Final Recommendation:

December 20, 2021

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 open	14-Apr-21
Call for patient/clinician input closed	04-Jun-21
Clarification: - Patient input submission received from Colorectal Cancer Canada, Gastrointestinal Society, and My Gut Feeling - Stomach Cancer Foundation of Canada.
Submission received	26-May-21
Submission accepted	09-Jun-21
Review initiated	10-Jun-21
Draft CADTH review report(s) provided to sponsor for comment	25-Aug-21
Deadline for sponsors comments	03-Sep-21
CADTH responses on draft review report(s) provided to sponsor	29-Sep-21
Expert committee meeting (initial)	13-Oct-21
Draft recommendation issued to sponsor	27-Oct-21
Draft recommendation posted for stakeholder feedback	04-Nov-21
End of feedback period	18-Nov-21
Final recommendation issued to sponsor and drug plans	02-Dec-21
Final recommendation posted	20-Dec-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)	16-Dec-21
CADTH review report(s) posted	04-Feb-22