pembrolizumab

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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:
No
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:
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.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  1. 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