Cemiplimab (Libtayo)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Libtayo (cemiplimab) be reimbursed by public drug plans as adjuvant therapy for adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation, and if certain conditions are met.
• The pan-Canadian Oncology Drug Review Expert Review Committee (pERC) determined that Libtayo demonstrates acceptable clinical value versus active surveillance as adjuvant treatment in patients with CSCC at high risk of recurrence after surgery and radiation. This determination was enough for pERC to recommend that Libtayo be reimbursed. Given that Libtayo is expected to be an additive treatment to active surveillance, acceptable clinical value refers to added value versus active surveillance.
• Evidence from a clinical trial (C-POST; N = 415) showed that treatment with Libtayo over 48 weeks improved disease-free survival (DFS) versus placebo (active surveillance) in patients with CSCC at high risk for disease recurrence who have had prior surgery and radiation therapy. However, the committee was unable to conclude that Libtayo extends patients’ lives.
• Libtayo meets some of the needs identified by patients, providing an additional treatment option that reduces the risk of disease recurrence and has manageable side effects. However, pERC could not conclude that Libtayo results in improved quality of life (QoL).