Last Updated : January 29, 2025
Details
FilesGeneric 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:
- 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.
| Call for patient/clinician input open | December 10, 2020 |
|---|---|
| Call for patient/clinician input closed | February 05, 2021 |
| Clarification: - Patient input submission received from Lymphoma Canada | |
| Submission received | January 29, 2021 |
| Submission accepted | - |
| Review initiated | March 11, 2021 |
| Draft CADTH review report(s) provided to sponsor for comment | May 28, 2021 |
| Deadline for sponsors comments | June 08, 2021 |
| CADTH responses on draft review report(s) provided to sponsor | July 05, 2021 |
| Expert committee meeting (initial) | July 15, 2021 |
| Draft recommendation issued to sponsor | July 29, 2021 |
| Draft recommendation posted for stakeholder feedback | August 12, 2021 |
| End of feedback period | August 26, 2021 |
| Clarification: - Reconsideration: minor revisions requested by drug programs. | |
| Final recommendation issued to sponsor and drug plans | October 18, 2021 |
| Final recommendation posted | November 01, 2021 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | November 01, 2021 |
| CADTH review report(s) posted | - |
Files
Last Updated : January 29, 2025