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.