CMS issues permanent J code for mitomycin for intravesical solution for LG-IR-NMIBC

The Centers for Medicare & Medicaid Services (CMS) have issued a permanent Healthcare Common Procedure Coding System (HCPCS) Level II J Code for mitomycin for intravesical solution (Zusduri) for patients with recurrent low-grade intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC), UroGen announced in a news release.¹

Urologists and other physicians can begin using the code, J9282, starting on January 1, 2026. HCPCS Level II codes are specifically used for billing non-oral medications.

“Securing a permanent J Code from CMS is an important operational milestone for the ZUSDURI launch,” said Liz Barrett, president and CEO of UroGen, in the news release.¹ “The new J Code is expected to simplify reimbursement processes for providers across sites of care, subject to individual payor coverage policies. More importantly, it represents another step in ensuring that patients with recurrent LG-IR-NMIBC have streamlined access to this innovative treatment option. By reducing administrative barriers, we are helping physicians focus on delivering care and helping patients access the therapy they need without unnecessary delays or uncertainty.”

Mitomycin for intravesical solution utilizes the sustained release RTGel technology and is “delivered directly into the bladder by a trained healthcare professional using a urinary catheter in an outpatient setting,” according to UroGen. The medication was approved by the FDA in June 2025 for adult patients with recurrent LG-IR-NMIBC, marking it as the first and only medication approved in this setting.²

The approval was supported by findings from the single-arm, phase 3 ENVISION trial (NCT05243550), which was designed to evaluate the safety and efficacy of mitomycin as a primary chemoablative therapy in patients with LG-IR-NMIBC. In total, the study enrolled 240 adult patients across 56 sites in the US and Europe. Those included in the study received 6 once-weekly intravesical instillations of mitomycin.

Overall, the ENVISION trial met its primary end point by demonstrating a 78% complete response rate in patients at 3 months following the first instillation of the therapy. The duration of response (DOR) ranged from 0 months to over 25 months, and 79% of responders remained event-free for at least 1 year.

The most common (10% or higher) adverse events, including laboratory abnormalities, were increased creatinine, increased potassium, dysuria, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, increased eosinophils, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria. UroGen also reported that "Serious adverse reactions occurred in 12% of patients who received ZUSDURI, including urinary retention (0.8%) and urethral stenosis (0.4%).”

The ENVISION trial remains ongoing, with final completion expected February 2028.³

REFERENCES

1. Centers for Medicare and Medicaid Services assigns permanent J code for ZUSDURI™ effective January 1, 2026. News release. UroGen. October 27, 2025. Accessed October 27, 2025. https://investors.urogen.com/news-releases/news-release-details/centers-medicare-and-medicaid-services-assigns-permanent-j-code

2. U.S. FDA approves UroGen’s ZUSDURI™ (mitomycin) for intravesical solution as the first and only medication for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). News release. June 12, 2025. Accessed October 27, 2025. https://investors.urogen.com/news-releases/news-release-details/us-fda-approves-urogens-zusduritm-mitomycin-intravesical

3. A phase 3 single-arm study of UGN-102 for treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (ENVISION). ClinicalTrials.gov. Last updated November 4, 2024. Accessed October 27, 2025. https://clinicaltrials.gov/study/NCT05243550