Permanent J code for mitomycin for intravesical solution now in effect

Physicians and treatment centers can now utilize the permanent Healthcare Common Procedure Coding System 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 Pharma confirmed in a news release.¹

The code, J9282, assigned by the Centers for Medicare & Medicaid Services, became effective on January 1, 2026. According to UroGen, the code is expected to streamline billing and reimbursement processes, thus expanding patient access to the therapy.

“[Patients with] bladder cancer repeatedly share with us that delays in access to treatment, not just the disease itself, can be one of the most stressful parts of their care journey,” said Liz Barrett, president and CEO of UroGen, in the news release.¹ “With the permanent J Code now in effect for ZUSDURI, providers have a clearer, more efficient path to securing reimbursement, which in turn facilitates patient access to ZUSDURI without unnecessary administrative hurdles. This is a meaningful step toward more reliable, predictable access to an important therapy for those navigating this highly recurrent disease.”

The code may be used by physicians and treatment centers when submitting claims for eligible Medicare patients, subject to individual payer coverage policies.

“A permanent J Code may seem like a technical change, but for patients, it translates into more broad access to treatment,” added Meri-Margaret Deoudes, CEO of the Bladder Cancer Advocacy Network, in the news release.¹ “Streamlined billing helps treatment centers provide timely care, reduces financial uncertainty, and reduces administrative burden. We applaud the implementation of J9282 and the positive impact we anticipate it will have on the bladder cancer community.”

Mitomycin for intravesical solution utilizes the sustained release RTGel technology and is “delivered directly into the bladder by a trained health care 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 for intravesical solution.

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. Permanent J code for ZUSDURI™ now in effect, expanding patient access to innovative bladder cancer therapy. News release. UroGen Pharma. January 5, 2026. Accessed January 5, 2026. https://investors.urogen.com/news-releases/news-release-details/permanent-j-code-zusduritm-now-effect-expanding-patient-access

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 January 5, 2026. 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 January 5, 2026. https://clinicaltrials.gov/study/NCT05243550