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| Project Number | PC0187-000 |
|---|---|
| Brand Name | Libtayo |
| Generic Name | Cemiplimab |
| Strength | 50mg/mL |
| Tumour Type | Skin & Melanoma |
| Indication | Cutaneous Squamous Cell Carcinoma |
| Funding Request | For the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. |
| Review Status | Complete |
| Pre Noc Submission | No |
| NOC Date | April 10, 2019 |
| Manufacturer | Sanofi Genzyme |
| Sponsor | Sanofi Genzyme |
| Submission Date | July 9, 2019 |
| Submission Deemed Complete | July 30, 2019 |
| Submission Type | Initial |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | July 23, 2019 |
| Check-point meeting | September 17, 2019 |
| pERC Meeting | December 12, 2019 |
| Initial Recommendation Issued | January 3, 2020 |
| Feedback Deadline ‡ | January 17, 2020 |
| pERC Reconsideration Meeting (target date) | |
| Final Recommendation Issued | January 22, 2020 |
| Notification to Implement Issued | February 6, 2020 |
| Therapeutic Area | Advanced Cutaneous Squamous Cell Carcinoma (CSCC) |
| Recommendation Type | Reimburse with clinical criteria and/or conditions |
‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.
