Padcev™

Drug - Padcev™ (enfortumab vedotin - ejfv) [Seattle Genetics, Inc.]

April 2020

Therapeutic area - Oncology

Initial approval criteria

Patient is at least 18 years old AND
Patient has a diagnosis of unresectable locally advanced or metastatic urothelial cancer AND
Padcev is being prescribed as subsequent therapy AND
Patient has experienced disease progression or recurrence after receiving treatment with the following:
- Platinum-based therapy (e.g., cisplatin, carboplatin) in any setting AND
- Immune checkpoint inhibitor therapy with a PD-directed agent (e.g., atezolizumab, avelumab, durvalumab, nivolumab, pembrolizumab) AND
Patient does not have uncontrolled diabetes mellitus (e.g., baseline serum glucose > 250 mg/dL or hemoglobin A1C ≥ 8%) AND
Patient does not have pre-existing peripheral neuropathy of grade ≥ 2 AND
Patient does not have active central nervous system (CNS) metastases AND
Female patient of child-bearing age must have a confirmed negative pregnancy test prior to therapy AND
Patient will use an effective form of contraception (i.e., females of reproductive potential should use effective contraception during treatment and for at least 2 months following the last dose and male patients with female partners of reproductive potential should use effective contraception during treatment and for at least 4 months after the last dose)
Initial approval is for 6 months

Patient must continue to meet the above criteria AND
Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread AND
Absence of unacceptable toxicity from the drug (e.g., severe hyperglycemia or diabetic ketoacidosis, severe peripheral neuropathy, ocular disorders including vision changes, severe skin reactions)
Renewal approval is for 6 months

Padcev must be billed as a medical claim.

MHCP Provider Call Center 651-431-2700 or 800-366-5411