PADCEV (enfortumab vendotin-ejfv)

PADCEV (enfortumab vendotin-ejfv)

OFFICE ADMINISTRATION – IV infusion

Indications for Prior Authorization:

• Indicated for the treatment of adults with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.

Patient must meet the following criteria for the indication(s) above:

• Patient is 18 years old or older, AND
• Prescribed by or in consultation with an oncologist, AND
• Diagnosis of locally advanced or metastatic urothelial cancer (mUC), AND
• Patient has received prior treatment with a platinum-based chemotherapy (e.g., carboplatin, cisplatin) in the neoadjuvant/adjuvant, locally advanced or metastatic setting, AND
• Patient has received prior treatment with one immune checkpoint inhibitor (CPI) in the neoadjuvant/adjuvant, locally advanced or metastatic setting unless contraindicated
  • Programmed death receptor-1 (PD-1) inhibitor (e.g., Opdivo® (nivolumab), Keytruda® (pembrolizumab)), OR
  • Programmed death-ligand 1 (PD-L1) inhibitor (e.g., Tecentriq® (atezolizumab), Imfinzi™ (durvalumab), Bavencio® (avelumab))

• Avoid use of Padcev™ in patients with moderate or severe hepatic impairment.

Dosing:

• 1.25 mg/kg (up to a maximum dose of 125 mg) given as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity
• Dose modified for adverse reactions

Approval:

• 1 year