Erdafitinib 

Avelumab 200 mg/10 mL concentrate for solution for infusion is recommended for inclusion on the Medication Assistance Fund (MAF) for maintenance treatment of locally advanced or metastatic UC that has not progressed with first-line platinum-based chemotherapy when used in line with the treatment regimen outlined in the Annex.

Pembrolizumab 100 mg/4 mL solution for infusion is recommended for inclusion on the MAF for treating patients with locally advanced or metastatic UC after receiving platinum-based chemotherapy in line with the following criteria:

• Patients must not have received prior treatment with a PD-1/PD-L1 inhibitor for locally advanced or metastatic UC; and
• Treatment with pembrolizumab should be stopped at 2 years, or earlier if disease progresses. Pembrolizumab retreatment is allowed at time of progression for up to 1 additional year if the initial treatment was stopped for reasons other than disease progression.

MAF assistance for the abovementioned treatments will be implemented from 1 September 2022.

MAF assistance does not apply to pembrolizumab when used for patients with untreated PD-L1-positive UC who are unable to receive cisplatin-based chemotherapy, or erdafitinib when used for treating UC with FGFR3 genetic alterations.

Clinical indications, subsidy class and MediShield Life claim limits for all drugs included in the evaluation are provided in the Annex.