CMS issues permanent J-code to gemcitabine intravesical system

The Centers for Medicare & Medicaid Services (CMS) has established a permanent Healthcare Common Procedure Coding System (HCPCS) J-code to support physicians and treatment centers when submitting claims for the gemcitabine intravesical system (Inlexzo), Johnson & Johnson announced.¹ The therapy is indicated for patients with BCG–unresponsive non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.

The code, J9183, may be used by US government and commercial payers, as well as physicians and their office staff, for billing and reimbursement beginning April 1, 2026, subject to individual payer coverage policies. The unique identifier may help facilitate more standardized reimbursement processes and could improve access to this intravesical drug-releasing system in routine clinical practice.

“Patients often experience fear and frustration when treatments are available but inaccessible due to reimbursement delays,” said Aleksandar Alchev, DMD, MBA, Director of Business Development at Minnesota Urology, in a news release from Johnson & Johnson.¹ “INLEXZO’s permanent J-code may help support more consistent billing processes and may help facilitate the treatment process for patients over time.”

About the gemcitabine intravesical system

The gemcitabine intravesical system is an intravesical drug-releasing system designed to provide continuous local delivery of gemcitabine directly to the bladder over an extended period. The system is placed during an office-based procedure and does not require general anesthesia.

The therapy was approved by the FDA in September 2025 for adult patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors. The approval was supported by data from cohort 2 of the phase 2b SunRISe-1 trial (NCT04640623), which showed a centrally confirmed complete response (CR) rate of 82.4% (95% CI, 72.6 to 89.8) in this patient population. Further, 51% of patients remained in CR for at least 1 year.²

Overall, the SunRISe-1 trial is assessing the safety and efficacy of the gemcitabine intravesical system across 4 patient cohorts. Cohort 2 of the study, which is assessing the gemcitabine intravesical system as a monotherapy, included 85 patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors. The median age of patients was 71 years, and the majority of patients were male (80.0%) and White (87.1%).

Data from the trial, which were published in the Journal of Clinical Oncology,² showed that the median onset to CR was 2.8 months, with 96% of patients achieving a CR within the first 3 months. The 3-, 6-, and 12-month CR rates were 78.8% (95% CI, 68.6 to 86.9), 58.8% (95% CI, 47.6 to 69.4), and 45.9% (95% CI, 35.0 to 57.0), respectively. According to the authors, high CR rates were observed across all clinically relevant subgroups, including in those with and without concurrent papillary disease (82.1% and 82.5%, respectively). Data also showed a median duration of response of 25.8 months (95% CI, 8.3 to NE).

Regarding safety, the most common treatment-related adverse events (TRAEs) were low-grade lower urinary tract events, including pollakiuria (43.5%), dysuria (40.0%), micturition urgency (24.7%), and urinary tract infection (21.2%). Grade 3 or higher TRAEs were reported in 12.9% of patients, with the most frequent being urinary tract pain (4.7%). Serious TRAEs occurred in 5.9% of patients.

Meri-Margaret Deoudes, CEO of the Bladder Cancer Advocacy Network (BCAN), added, “For 2 decades, BCAN has been guided by the voices and experiences of people impacted by bladder cancer. New treatment options, including those with permanent billing codes, are welcome news for patients and their loved ones. They deserve access to therapies without unnecessary delays due to administrative steps.”

Ongoing studies, including SunRISe-3 (NCT05714202) and SunRISe-5 (NCT06211764), are further evaluating the gemcitabine intravesical system in NMIBC, and SunRISe-4 (NCT04919512) is investigating its use in muscle-invasive disease.

REFERENCES

1. INLEXZO™ (gemcitabine intravesical system) assigned permanent billing code, supporting access for patients with certain bladder cancers. News release. Johnson & Johnson. April 1, 2026. Accessed April 2, 2026. https://www.jnj.com/media-center/press-releases/inlexzo-gemcitabine-intravesical-system-assigned-permanent-billing-code-supporting-access-for-patients-with-certain-bladder-cancers

2. Daneshmand S, Heijden MSV, Jacob JM, et al. TAR-200 for Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer: Results from the phase IIb SunRISe-1 study. J Clin Oncol. 2025:101200JCO2501651. doi:10.1200/JCO-25-01651