Erdafitinib (Balversa)

Canada’s Drug Agency (CDA-AMC) recommends that Balversa should be reimbursed by public drug plans for the treatment of locally advanced unresectable or metastatic urothelial carcinoma (UC) if certain conditions are met. Balversa should only be covered to treat patients with a diagnosis of locally advanced unresectable or metastatic UC harbouring susceptible FGFR3 genetic alterations who have disease progression during or following at least 1 line of prior therapy. Patients who experience disease recurrence within 12 months after chemotherapy before surgery (neoadjuvant) or following the removal of the bladder (adjuvant) are also eligible to receive Balversa. In patients who qualify for treatment with PD-1 or PD-L1 inhibitor, Balversa should only be reimbursed after patients have received PD-1 or PD-L1 therapy. Balversa should only be reimbursed if it is prescribed by a clinician with expertise in treating patients with UC with susceptible FGFR3 genetic alteration confirmed using a validated test. The price of Balversa should be reduced. It must also be feasible to test patients for FGFR3 genetic alterations.