The Centers for Medicare & Medicaid Services (CMS) has issued a permanent billing code (J9183) for Inlexzo, the first FDA-approved intravesical system delivering gemcitabine directly to the bladder. This change makes billing easier for healthcare providers and helps patients access the therapy more quickly.
Inlexzo, approved in September 2025, treats patients with BCG-unresponsive non-muscle invasive bladder cancer. In the SunRISe-1 trial of 83 high-risk patients, 82% achieved a complete response, with most responding by the first evaluation after about 2.8 months. At 12 months, 46% of patients maintained their complete response, showing lasting benefit.
The new J-code standardizes billing, reduces administrative delays, and ensures consistent treatment schedules in urology practices, making it easier for patients to receive this innovative therapy.