chlormethine hydrochloride

Details

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Generic Name:

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

Performance Metric:

Achieved

Biosimilar:

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:

November 24, 2021

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	23-Nov-20
Call for patient/clinician input closed	22-Jan-21
Clarification: - Patient input submission received from Lymphoma Canada, Canadian Skin Patient Alliance and Cutaneous Lymphoma Foundation
Submission received	21-Dec-20
Submission accepted	12-Jan-21
Review initiated	13-Jan-21
Draft CADTH review report(s) provided to sponsor for comment	16-Apr-21
Deadline for sponsors comments	27-Apr-21
CADTH responses on draft review report(s) provided to sponsor	31-May-21
Expert committee meeting (initial)	10-Jun-21
Draft recommendation issued to sponsor	24-Jun-21
Draft recommendation posted for stakeholder feedback	08-Jul-21
End of feedback period	22-Jul-21
Clarification: - Reconsideration: major revisions requested by sponsor
Final recommendation issued to sponsor and drug plans	24-Nov-21
Final recommendation posted	10-Dec-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)	17-Dec-21
CADTH review report(s) posted	24-Mar-22