Vol. 5 No. 2 (2025): February
Reimbursement Recommendations

Zolbetuximab for Injection (Vyloy)

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Published February 14, 2025

Key Messages

  • Canada’s Drug Agency (CDA-AMC) recommends that Vyloy should be reimbursed by public drug plans for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma with tumours that are CLDN18.2 positive if certain conditions are met.
  • Vyloy should only be covered to treat patients with tumours that are CLDN18.2 positive and those who have not received previous treatment for HER2-negative advanced or metastatic gastric or GEJ cancer and have good performance status.
  • Vyloy should only be reimbursed if prescribed in combination with fluoropyrimidine- and platinum-containing chemotherapy by a clinician with expertise and experience in treating gastric and GEJ cancer, and if the cost of Vyloy in combination with chemotherapy is reduced to not exceed the drug program cost of treatment with nivolumab in combination with chemotherapy and pembrolizumab in combination with chemotherapy. Lastly, it must be feasible to test patients for CLDN18.2 status.