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
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/Report:
  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 Milestones2
Call for patient/clinician input openDecember 10, 2020
Call for patient/clinician input closedFebruary 05, 2021
Clarification:

- Patient input submission received from Lymphoma Canada

Submission receivedJanuary 29, 2021
Submission accepted-
Review initiatedMarch 11, 2021
Draft CADTH review report(s) provided to sponsor for commentMay 28, 2021
Deadline for sponsors commentsJune 08, 2021
CADTH responses on draft review report(s) provided to sponsorJuly 05, 2021
Expert committee meeting (initial)July 15, 2021
Draft recommendation issued to sponsorJuly 29, 2021
Draft recommendation posted for stakeholder feedbackAugust 12, 2021
End of feedback periodAugust 26, 2021
Clarification:

- Reconsideration: minor revisions requested by drug programs.

Final recommendation issued to sponsor and drug plansOctober 18, 2021
Final recommendation postedNovember 01, 2021
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)November 01, 2021
CADTH review report(s) posted-