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INLEXZO™ (gemcitabine intravesical system) Assigned Permanent Billing Code, Supporting Access for Patients with Certain Bladder Cancers

  • INLEXZO permanent J-code (J9183) effective April 1
Reno, Nevada (UroToday.com) -- Johnson & Johnson (NYSE:JNJ) announced the permanent Healthcare Common Procedure Coding System (HCPCS) J-code for INLEXZO™ (gemcitabine intravesical system) is now in effect. Adult patients living with certain types of Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who have historically had limited options before possible bladder removal may benefit from a more standardized billing pathway for this therapy. The unique identifier, J9183, assigned by the Centers for Medicare & Medicaid Services (CMS), can be used by U.S. government and commercial payers, as well as physicians and their office staff, in the billing and reimbursement process for INLEXZO.
“Navigating reimbursement complexity shouldn’t stand between patients and a therapy that could change their disease trajectory,” said Scott White, Chief Operating Officer, North America, Johnson & Johnson. “This permanent code allows healthcare providers to focus on delivering innovative care by helping reduce administrative complexity associated with billing.”
INLEXZO was approved by the Food and Drug Administration (FDA) in September 2025 for the treatment of adult patients with BCG-unresponsive, NMIBC with carcinoma in situ (CIS), with or without papillary tumors.1 It is the first and only FDA-approved intravesical drug-releasing system (iDRS) to provide extended local delivery of a cancer medication into the bladder. This potentially practice-changing approach for treating patients with certain types of bladder cancer addresses a significant unmet need in patients who have failed BCG therapy and for patients refusing or ineligible for bladder removal surgery (radical cystectomy).1

INLEXZO_Zoom_In.jpg

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

“For two 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,” said Meri-Margaret Deoudes**, CEO, Bladder Cancer Advocacy Network (BCAN).

As of April 1, 2026, physicians and treatment centers can utilize J9183 for INLEXZO when submitting claims for eligible patients, subject to individual payer coverage policies.

Johnson & Johnson is committed to helping patients access our treatments. Once a patient and their doctor have decided that INLEXZO is right for the patient, J&J withMe provides a simple, comprehensive patient support program offering cost support, a dedicated Care Navigator, and educational resources, at no cost to the patient.†

References:

  1. INLEXZO™ U.S. Prescribing Information
Source: Johnson & Johnson. (2026). INLEXZO™ (gemcitabine intravesical system) Assigned Permanent Billing Code, Supporting Access for Patients with Certain Bladder Cancers [Press release]. https://www.jnj.com/media-center/press-releases/inlexzo-gemcitabine-intravesical-system-assigned-permanent-billing-code-supporting-access-for-patients-with-certain-bladder-cancers.