chlormethine hydrochloride

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Generic Name:
chlormethine hydrochloride
Project Status:
Complete
Therapeutic Area:
T-cell lymphoma
Manufacturer:
Recordati Rare Diseases Canada Inc.
Brand Name:
Ledaga
Project Line:
Reimbursement Review
Project Number:
PC0242-000
Tumour Type:
Lymphoma
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the topical treatment of stage IA and IB mycosis fungoidestype cutaneous Tcell Lymphoma (MF-CTCL) in adult patients who have received prior skindirected therapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the topical treatment of stage IA and IB mycosis fungoidestype cutaneous Tcell Lymphoma (MF-CTCL) in adult patients who have received prior skindirected therapy.
Recommendation Type:
Do not reimburse
Final Recommendation:
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient/clinician input open23-Nov-20
Call for patient/clinician input closed22-Jan-21
Clarification:

- Patient input submission received from Lymphoma Canada, Canadian Skin Patient Alliance and Cutaneous Lymphoma Foundation

Submission received21-Dec-20
Submission accepted12-Jan-21
Review initiated13-Jan-21
Draft CADTH review report(s) provided to sponsor for comment16-Apr-21
Deadline for sponsors comments27-Apr-21
CADTH responses on draft review report(s) provided to sponsor31-May-21
Expert committee meeting (initial)10-Jun-21
Draft recommendation issued to sponsor24-Jun-21
Draft recommendation posted for stakeholder feedback08-Jul-21
End of feedback period22-Jul-21
Clarification:

- Reconsideration: major revisions requested by sponsor

Final recommendation issued to sponsor and drug plans24-Nov-21
Final recommendation posted10-Dec-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)17-Dec-21
CADTH review report(s) posted24-Mar-22