cemiplimab

Details

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Generic Name:

cemiplimab

Project Status:

Complete

Therapeutic Area:

Basal cell carcinoma

Manufacturer:

Sanofi Genzyme, a division of sanofi-aventis Canada Inc.

Brand Name:

Libtayo

Project Line:

Reimbursement Review

Project Number:

PC0260-000

Tumour Type:

Skin & Melanoma

NOC Status at Filing:

Pre NOC

Performance Metric:

Achieved

Biosimilar:

Manufacturer Requested Reimbursement Criteria¹:

For the treatment of patients with locally advanced or metastatic basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI).

Submission Type:

Initial

Fee Schedule:

Schedule A

Indications:

For the treatment of patients with locally advanced or metastatic basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor.

Recommendation Type:

Reimburse with clinical criteria and/or conditions

Final Recommendation:

March 4, 2022

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
Milestones title	Date
Call for patient/clinician input open	July 21, 2021
Call for patient/clinician input closed	September 13, 2021
Clarification: - Patient input submission received from Melanoma Network of Canada and Save Your Skin Foundation
Submission received	August 19, 2021
Submission accepted	September 02, 2021
Review initiated	September 03, 2021
Draft CADTH review report(s) provided to sponsor for comment	November 18, 2021
Deadline for sponsors comments	November 29, 2021
CADTH review report(s) and responses to comments provided to sponsor	December 23, 2021
Expert committee meeting (initial)	January 12, 2022
Draft recommendation issued to sponsor	January 26, 2022
Draft recommendation posted for stakeholder feedback	February 03, 2022
End of feedback period	February 17, 2022
Final recommendation issued to sponsor and drug plans	March 04, 2022
Final recommendation posted	March 22, 2022
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)	March 18, 2022
CADTH review report(s) posted	May 04, 2022

Files

Recommendation and Reasons View PDF

Clinical and Pharmacoeconomic combined Report View PDF

Stakeholder feedback on Draft Recommendation View PDF

Last Updated : May 25, 2023