Frequently Asked Questions

Jelmyto may be administered in a variety of sites of care, including hospital outpatient departments (HOPDs), ambulatory surgical centers (ASCs), and clinics.² UroGen offers resources to help practices establish and operationalize Jelmyto at an appropriate site of care, including operational workflow, reimbursement, and coding and payment education and resources.

Access the Operational Workflow Guide

Access the Billing and Coding Guide

Yes. Jelmyto can be administered via an antegrade approach using a nephrostomy tube or a retrograde approach using a ureteral catheter.¹

In the phase 3 Olympus trial, Jelmyto was administered exclusively via the retrograde approach.² Antegrade administration has subsequently been described in real-world studies, providing additional data on the use of Jelmyto via both routes.^1,5-7

Studies of Jelmyto in real-world settings have evidentiary limitations. See real-world data for more details.

Access information on administration

Contact a rep to learn more about real-world data

The shelf life of reconstituted Jelmyto is 96 hours (or 4 days), allowing time for coordination with patient appointments. Note that reconstituted Jelmyto should be stored at 20°C to 25°C (68°F to 77°F) and protected from light.¹

View Instructions for Administration

View Full Prescribing Information

The dose of Jelmyto to be instilled is 4 mg per mL via ureteral catheter or nephrostomy tube. Before the first instillation, kidney volume is determined using volumetric pyelography. The instillation volume is equal to the measured kidney volume, up to a maximum of 15 mL (60 mg of mitomycin).¹

Kidney volume may be measured using either an antegrade or retrograde approach.⁸

View Instructions for Administration

View Nephrostomy Instructions

Equipment needs vary depending on whether Jelmyto is administered via an antegrade or retrograde approach. For retrograde administration, fluoroscopy is used to confirm ureteral catheter placement, and supplies include a guidewire, ureteral catheter, diluted contrast, administration syringe, an ice bath to chill the JELMYTO prior to administration, and the Uroject12 Syringe Lever.⁹

Antegrade administration requires a nephrostomy tube and route-specific supplies.⁸ Detailed equipment lists and step-by-step instructions are available for both administration approaches.

View Instructions for Administration

View Nephrostomy Instructions

Yes. Jelmyto requires pharmacy preparation prior to administration. Your facility can prepare Jelmyto on-site, or, if mixing services are needed, UroGen Support™ can coordinate preparation and delivery through a UroGen pharmacy partner.

Detailed Instructions for Pharmacy are available to support proper preparation of Jelmyto.

See the Instructions for Pharmacy

Learn more about UroGen Support

No. General anesthesia is not required for Jelmyto administration. In the phase 3 Olympus trial, general anesthesia was used in 37% of patients for at least 1 instillation during the treatment period.¹ Local anesthesia or sedation was used at the discretion of the treating physician.²

The use of general anesthesia, local anesthesia, or sedation may be determined by the treating urologist based on the individual patient.¹

Learn more about Jelmyto administration

The UroGen team can help your practice get set up and ready to order Jelmyto. New customers should complete the Account Setup Form to establish or verify an account with Cardinal Health SPD or Cencora-Besse Specialty Distributor and authorize UroGen Support™ to place product orders on their behalf. You can then register to get UroGen Support Portal access so you can manage your account.

Account setup can take up to 30 days, so practices are encouraged to begin the process early.

Start your account setup

Complete the Account Setup Form

UroGen Support^TM provides personalized support throughout the Jelmyto treatment journey, including patient enrollment, access and reimbursement support, affordability options, and product ordering and delivery coordination.

New to UroGen?

Complete the Account Setup Form to establish or verify your account with a specialty distributor. Once your account is established, complete the Jelmyto Patient Enrollment Form to enroll your patient in UroGen Support^TM.

Complete the Account Setup Form

Download the Patient Enrollment Form

Your UroGen team is available to support you throughout the Jelmyto treatment journey, from identifying appropriate patients and navigating access and reimbursement to preparing your practice for administration.

Depending on your needs, your team may include representatives who can provide clinical and product information, Field Reimbursement Managers who can help navigate access and reimbursement, and Clinical Nurse Educators who provide instillation education, in-service training, and first-instillation support.

Connect with the UroGen team

To get an appropriate patient started on Jelmyto, complete and submit the Jelmyto Patient Enrollment Form to UroGen Support^TM. Once enrolled, UroGen Support^TM can help your practice navigate access and reimbursement, product ordering and delivery, and other steps to help initiate treatment.

Download the Patient Enrollment Form

Learn more about UroGen Support^TM

Once a completed Patient Enrollment Form is received, UroGen Support^TM will confirm your patient’s enrollment status and help navigate next steps. Support may include a benefits investigation, information on prior authorization requirements and affordability options, and coordination of product ordering, preparation, and delivery.

UroGen Support^TM will continue to provide coordination throughout treatment, including confirmation of upcoming appointments and subsequent orders.

Learn more about UroGen Support^TM

The UroGen team, including Clinical Nurse Educators, can help your practice instill with confidence through in-service training, education, and first-instillation support. Your UroGen team can work with nurses and pharmacy staff to help support smooth, consistent Jelmyto mixing and instillation.

Contact your UroGen Field Representative to learn more about support

Yes. UroGen Support^TM can provide information and assistance throughout the prior authorization and coverage appeal process. Your practice can also access resources, including a Prior Authorization Checklist and customizable appeal letter, to help navigate payer requirements.

Access the Prior Authorization Checklist

Access the Appeal Letter

UroGen offers a hassle-free return policy for eligible unused product. Unmixed Jelmyto may be reassigned to a current patient, retained for future use, or returned if the product is expired and cannot be reassigned. For mixed product that cannot be administered, destroy the product and submit a request for a replacement dose, subject to eligibility.*

To start the process, complete the online Return Request Form or contact your UroGen Field Representative.

Submit a Return Request

Access the UroGen Return Goods Policy

Resources are available to help practices establish the operational process for Jelmyto, from process initiation through preprocedural and day-of-procedure protocols. The Scheduling and Ordering Quick Reference Guide also provides commonly requested product and coding information for widely used EMR systems to help streamline order-set setup.

Access the Operational Workflow Guide

Access the Scheduling and Ordering Quick Reference Guide

With UroGen Support^TM Auto-Ship, you don’t need to place a new order before each treatment. Auto-Ship coordinates weekly order fulfillment based on your patient’s treatment schedule, along with pharmacy coordination, shipping support, and simplified billing at the time of each shipment.

Download the Auto-Ship Resource

Jelmyto is billed using HCPCS code J9281 (mitomycin pyelocalyceal instillation, 1 mg). UroGen provides billing and reimbursement resources with guidance for physician, hospital outpatient, and ASC settings, including information about retrograde and antegrade JELMYTO instillations.

Access the Billing and Coding Guide

Jelmyto is supplied as a kit containing mitomycin for pyelocalyceal solution and sterile hydrogel. Each kit contains the components required for preparation of JELMYTO prior to administration and is accompanied by the Ureteral Catheter Administration Kit, which includes two 20 mL syringes, 2 OnGuard^®2 CSTD syringe adaptors, and a 7 French ureteral catheter.

Store Jelmyto at 20°C to 25°C (68°F to 77°F),¹ with excursions permitted between 15°C and 30°C (59°F and 86ºF; see USP Controlled Room Temperature). Jelmyto should be handled and disposed of in accordance with procedures for hazardous drugs.

Access the Product Fact Sheet

Yes. Jelmyto has 100% payer coverage across Medicare Fee-for-Service, Managed Medicare, and commercial insurance.*

Coverage does not guarantee reimbursement. Providers are encouraged to perform a full benefits investigation prior to treatment to confirm individual patient coverage.

Learn more about coverage and reimbursement

UroGen Support^TM offers affordability options for eligible patients. Commercially insured patients may qualify for the UroGen Support™ Copay Program and pay as little as $50 per dose of Jelmyto.* Uninsured patients may qualify for the Patient Assistance Program (PAP). Eligible patients with Medicare or Medicaid may also be able to receive financial assistance through independent charitable organizations.^†

Explore affordability options