pembrolizumab

Details

Files

Generic Name:

pembrolizumab

Project Status:

Complete

Therapeutic Area:

Classical Hodgkin lymphoma

Manufacturer:

Merck Canada

Brand Name:

Keytruda

Project Line:

Reimbursement Review

Project Number:

PC0236-000

Tumour Type:

Lymphoma

NOC Status at Filing:

Pre NOC

Performance Metric:

Achieved

Biosimilar:

Manufacturer Requested Reimbursement Criteria¹:

Adult and pediatric patients with refractory or relapsed classical Hodgkin Lymphoma (cHL), as monotherapy, who have failed autologous stem cell transplant (ASCT) or who are not candidates for multi-agent salvage chemotherapy and ASCT.

Submission Type:

Initial

Fee Schedule:

Schedule A

Indications:

Recommendation Type:

Reimburse with clinical criteria and/or conditions

Final Recommendation:

November 1, 2021

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.

Key Milestones
Call for patient/clinician input open	10-Dec-20
Call for patient/clinician input closed	05-Feb-21
Clarification: - Patient input submission received from Lymphoma Canada
Submission received	29-Jan-21
Submission accepted
Review initiated	11-Mar-21
Draft CADTH review report(s) provided to sponsor for comment	28-May-21
Deadline for sponsors comments	08-Jun-21
CADTH responses on draft review report(s) provided to sponsor	05-Jul-21
Expert committee meeting (initial)	15-Jul-21
Draft recommendation issued to sponsor	29-Jul-21
Draft recommendation posted for stakeholder feedback	12-Aug-21
End of feedback period	26-Aug-21
Clarification: - Reconsideration: minor revisions requested by drug programs.
Final recommendation issued to sponsor and drug plans	18-Oct-21
Final recommendation posted	01-Nov-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)	01-Nov-21
CADTH review report(s) posted