CDA | Evidence Driven
CDA | Evidence Driven

mogamulizumab

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Generic Name:
mogamulizumab
Project Status:
Complete
Therapeutic Area:
mycosis fungoides (MF), Sézary syndrome (SS)
Manufacturer:
Kyowa Kirin Canada
Brand Name:
Poteligeo
Project Line:
Reimbursement Review
Project Number:
PC0244-000
Tumour Type:
Lymphoma
NOC Status at Filing:
Pre NOC
Performance Metric:
N/A delay outside our control - Application held awaiting decision by Health Canada
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
The treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
Lymphoma
Indications:
The treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.
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 Milestones2
Call for patient/clinician input open 13-Aug-21
Call for patient/clinician input closed 08-Oct-21
Clarification:

- Patient input submission received from Lymphoma Canada, Canadian Skin Patient Alliance and Cutaneous Lymphoma Foundation.
Submission received 13-Sep-21
Submission accepted 27-Sep-21
Review initiated 28-Sep-21
Draft CADTH review report(s) provided to sponsor for comment 14-Dec-21
Deadline for sponsors comments 23-Dec-21
CADTH review report(s) and responses to comments provided to sponsor 28-Jan-22
Expert committee meeting (initial) 09-Feb-22
Draft recommendation issued to sponsor 04-Jul-22
Clarification:

- pERC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements.
Draft recommendation posted for stakeholder feedback 14-Jul-22
End of feedback period 28-Jul-22
Final recommendation issued to sponsor and drug plans 12-Aug-22
Final recommendation posted 30-Aug-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) 26-Aug-22
CADTH review report(s) posted 02-Nov-22

Files

Recommendation and Reasons View PDF
Clinical, Pharmacoeconomic, and Stakeholder Input Combined Report View PDF
Stakeholder Feedback on Draft Recommendation View PDF
Last Updated : November 4, 2022