CMS Issues J-code for Gemcitabine Intravesical System in NMIBC

The Centers for Medicare & Medicaid Services has assigned a permanent Healthcare Common Procedure Coding System (HCPCS) J-code to gemcitabine intravesical system (Inlexzo), according to a release from Johnson & Johnson, the manufacturer.¹ The code, J9183, can be used by government and commercial payers for billing and reimbursement processes.

The agent received approval in September 2025 for patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, and represents the first FDA-approved intravesical drug-releasing system to provide extended local delivery of medication into the bladder.²

The approval was based on efficacy findings from cohort 2 of the SunRISe-1 trial (NCT04640623), a single-arm, multicenter trial enrolling 83 patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors following transurethral resection. Patients received the gemcitabine intravesical system into the bladder every 3 weeks for 6 months, followed by once every 12 weeks for up to 18 months.

Tumor status was assessed with cystoscopy and urine cytology every 12 weeks during the initial 2 years of treatment, after which cystoscopy was performed at least every 24 weeks. Mandatory biopsies were performed at 24 and 48 weeks after treatment initiation.

The major efficacy outcome measures were complete response (CR) at any time (defined as negative results for cystoscopy [with TURBT/biopsies as applicable] and urine cytology) and duration of response (DOR). CR assessment at each time point was based on central pathology review.

Findings From SunRISe-1
The CR rate was 82% (95% CI, 72.6%-89.8%) with 70 of 85 patients achieving CR.³ Investigator-assessed CR rate was 83.5% (95% CI, 73.9%-90.7%), and the overall concordance between central- and investigator-assessed CR rates was 95.0%. At the median time to respond of 2.8 months, 96% of responses were achieved at first disease evaluation. The remaining patients who achieved CR were nonevaluable for disease response at week 12 owing to missing sample or assessment but achieved CR at the next disease evaluation. At 3, 6, and 12 months after treatment initiation, CR rates were 78.8% (95% CI, 68.6%-86.9%), 58.8% (95% CI, 47.6%-69.4%), and 45.9% (95% CI, 35.0%-57.0%), respectively.

“Navigating reimbursement complexity shouldn’t stand between patients and a therapy that could change their disease trajectory,” Scott White, chief operating officer, North America, Johnson & Johnson, said in the release. “This permanent code allows healthcare providers to focus on delivering innovative care by helping reduce administrative complexity associated with billing.”

“Patients often experience fear and frustration when treatments are available but inaccessible due to reimbursement delays,” Aleksandar Alchev, DMD, MBA, director, business development, Minnesota Urology, said. “Inlexzo’s permanent J-code may help support more consistent billing processes and may help facilitate the treatment process for patients over time.”

REFERENCES

1. Inlexzo (gemcitabine intravesical system) Assigned Permanent Billing Code, Supporting Access for Patients with Certain Bladder Cancers. News release. April 1, 2026. Accessed April 1, 2026. https://tinyurl.com/4pjdzud5

2. FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer. FDA release. September 9, 2025. Accessed April 1, 2026. https://tinyurl.com/bdes53wd

3. Daneshmand S, Van der Heijden MS, 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;43(33):3578-3588. doi:10.1200/JCO-25-01651