UroGen is committed to helping patients access their ZUSDURI treatment.
ZUSDURI is the only FDA-approved medication for adult patients with recurrent LG-IR-NMIBC.1
Coverage
Affordability Options
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Eligible patients may benefit from a range of financial assistance options, including commercial copay support (as little as $50 per dose for eligible patients, up to $14,000 annually), patient assistance programs, and charitable foundation support for those with government insurance. Eligibility criteria and terms and conditions apply
Pass-Through Status Granted and Will Continue for Up to 3 Years3
As of January 1, 2026, ZUSDURI received pass-through status in the hospital outpatient department (HOPD) for Medicare Fee-for-Service beneficiaries. The HCPCS code J9282 applies within the Medicare Outpatient Prospective Payment System (OPPS). The status indicator of G in the HOPD will denote pass-through for the J-Code.
Payment-Related Considerations
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On average, Medicare payments with a permanent J-Code take 14 to 21 days to process4
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Qualifying accounts are eligible for extended 60-day dating offered by the specialty distributor
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Our flexible policy allows for an approved replacement dose, which can be delivered in 3 to 5 business days†
ZUSDURI Established an Average Sales Price (ASP)
As of April 1, 2026, ZUSDURI established an ASP. Per CMS, the allowable amount for products under Part B is ASP +6%‡
CMS, Centers for Medicare & Medicaid Services; FDA, US Food and Drug Administration; LG-IR-NMIBC, low-grade intermediate-risk non-muscle invasive bladder cancer.
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Based on patient enrollments from January 2026 through April 2026 for patients covered across Medicare Part B, Medicare Advantage, and commercial plans.
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In most scenarios. Subject to eligibility rules. Please review the UroGen Return Goods Policy.
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The Medicare reimbursement rate of ASP +6% is reduced to ASP +4.3% due to a 2% sequestration cut to Medicare reimbursement. ASP information can be found within the CMS ASP Pricing File.
Indication and Important Safety Information
INDICATIONS AND USAGE
ZUSDURI™ is indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
IMPORTANT SAFETY INFORMATION
Contraindications
ZUSDURI is contraindicated in patients with perforation of the bladder or in patients with prior hypersensitivity reactions to mitomycin or any component of the product.
Warnings and Precautions
Risks in Patients with Perforated Bladder
ZUSDURI may lead to systemic exposure to mitomycin and severe adverse reactions if administered to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised. Evaluate the bladder before the intravesical instillation of ZUSDURI and do not administer to patients with a perforated bladder or mucosal compromise until bladder integrity has been restored.
Embryo-Fetal Toxicity
Based on findings in animals and mechanism of action, ZUSDURI can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of mitomycin resulted in teratogenicity. Advise females of reproductive potential to use effective contraception during treatment with ZUSDURI and for 6 months following the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ZUSDURI and for 3 months following the last dose.
Adverse Reactions
Common Adverse Reactions
The most common (≥10%) adverse reactions, including laboratory abnormalities, that occurred in patients treated with ZUSDURI 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.
Additional Adverse Reactions Information
Clinically relevant adverse reactions occurring in <10% of patients who received ZUSDURI included increased urinary frequency, fatigue, urinary incontinence, urinary retention, urethral stenosis, genital pain, urinary urgency, genital edema, genital pruritus, genital rash, urethritis, acute kidney injury, balanoposthitis, and nocturia.
Use in Specific Populations
Lactation
Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with ZUSDURI and for 1 week following the last dose.
Preparation and Administration Information
ZUSDURI is to be administered by intravesical instillation only. Do not administer ZUSDURI by pyelocalyceal instillation or by any other route.
ZUSDURI must be prepared and administered by a healthcare provider. To ensure proper dosing, it is important to follow the preparation instructions found in the ZUSDURI Instructions for Pharmacy and administration instructions found in the ZUSDURI Instructions for Administration.
ZUSDURI may discolor urine to a violet to blue color following the instillation procedure. Advise patients for at least 24 hours post-instillation to avoid urine contact with skin, to void urine sitting on a toilet, and to flush the toilet several times after use. Advise patients to wash hands, perineum or glans with soap and water after each instillation procedure.
ZUSDURI is a hazardous drug. Follow applicable special handling and disposal procedures.
Please click here for Full Prescribing Information.
UroGen® is a registered trademark and ZUSDURI™ and UroGen Support™ are trademarks of UroGen Pharma, Ltd. All other trademarks are the property of their respective owners.
This content is sponsored by UroGen, and Specialty Practice Network has not independently reviewed or verified the information provided by UroGen.
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