cemiplimab

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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:
No
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:
  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 openJuly 21, 2021
Call for patient/clinician input closedSeptember 13, 2021
Clarification:

- Patient input submission received from Melanoma Network of Canada and Save Your Skin Foundation

Submission receivedAugust 19, 2021
Submission acceptedSeptember 02, 2021
Review initiatedSeptember 03, 2021
Draft CADTH review report(s) provided to sponsor for commentNovember 18, 2021
Deadline for sponsors commentsNovember 29, 2021
CADTH review report(s) and responses to comments provided to sponsorDecember 23, 2021
Expert committee meeting (initial)January 12, 2022
Draft recommendation issued to sponsorJanuary 26, 2022
Draft recommendation posted for stakeholder feedbackFebruary 03, 2022
End of feedback periodFebruary 17, 2022
Final recommendation issued to sponsor and drug plansMarch 04, 2022
Final recommendation postedMarch 22, 2022
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)March 18, 2022
CADTH review report(s) postedMay 04, 2022