Some Payers Say They May Allow Off-Label Use of Jelmyto

On April 15, the FDA approved the first drug for patients with low-grade upper tract urothelial cancer, UroGen Pharma Ltd.’s Jelmyto (mitomycin). It offers patients a nonsurgical option for a condition that often requires numerous surgeries (see brief, p. 8). While most commercial payers surveyed about its management said they will manage it per its FDA label, a handful said they are likely to manage it less restrictively.

The cancer is rare and develops in the lining of the upper urinary tract, ureters and kidneys. Because of the complexity of the anatomy of the urinary tract system, the condition can be challenging to treat. According to UroGen, “The current standard of care includes multiple surgeries and most patients require a radical nephroureterectomy, which includes the removal of the renal pelvis, kidney, ureter and bladder cuff.” That most diagnoses are made in people at least 70 years old complicates their treatment as well, as many of them have compromised kidney functionality, and major surgery may result in additional complications.

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy (formerly called Specialty Pharmacy News) since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at HemAware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

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