Mitomycin Intravesical Solution (Zusduri)

Number: 1086

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

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Policy

Scope of Policy

This Clinical Policy Bulletin addresses [CPB title but not capitalized] for commercial medical plans. For Medicare criteria, see Medicare Part B Criteria.

Note: Requires Precertification: 

Precertification of mitomycin (Zusduri) is required of all Aetna participating providers and members in applicable plan designs. For precertification of mitomycin (Zusduri), call (866) 752-7021, or fax (888) 267-3277. For Statement of Medical Necessity (SMN) precertification forms, see Specialty Pharmacy Precertification.   

 

1. Criteria for Initial Approval

   Bladder Cancer

   Aetna considers mitomycin (Zusduri) medically necessary for treatment (6 doses) of recurrent low-grade intermediate-risk (e.g., presence of multiple tumors, solitary tumor greater than 3 cm, and/or early or frequent recurrence) non-muscle invasive bladder cancer (LG-IR-NMIBC) when all of the following criteria are met:

   1. The requested drug will be given via intravesical instillation; and
   2. The requested drug will be administered once weekly for six weeks.

   Aetna considers all other indications as experimental, investigational, or unproven.

2. Continuation of Therapy

   Aetna considers continuation of mitomycin (Zusduri) therapy medically necessary for all members (including new members) requesting authorization who meet all selection requirements in the criteria for initial approval section.

Dosage and Administration

Mitomycin for intravesical solution is supplied as a kit containing the following:

• Two 40 mg (each) single-dose vials of Zusduri for intravesical solution.
• One vial of 60 mL sterile hydrogel for reconstituion.

Administer Zusduri by intravesical instillation only. Do not administer by pyelocalyceal instillation or by any other route.

The recommended dose of Zusduri is 75 mg (56 mL) instilled once weekly for six weeks.

Source: UroGen Pharma, 2025

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Table:

CPT Codes / HCPCS Codes / ICD-10 Codes

Code	Code Description
HCPCS codes covered if selection criteria are met:
J9282	Mitomycin, intravesical instillation, 1 mg
Other CPT codes related to the CPB:
51720	Bladder instillation of anticarcinogenic agent (including retention time)
ICD-10 codes covered if selection criteria are met:
C67.0 - C67.9	Malignant neoplasm of bladder
D09.0	Carcinoma in situ of bladder

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Background

U.S. Food and Drug Administration (FDA)-Approved Indications

• Zusduri (mitomycin) is indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

Mitomycin (also known as mitomycin-C) for intravesical solution is available as Zusduri (UroGen Pharma, Inc.) is an alkylating drug isolated from the broth of Streptomyces. Zusduri inhibits the synthesis of deoxyribonucleic acid (DNA). The guanine and cytosine content correlates with the degree of Zusduri-induced cross-linking. At high concentrations, Zusduri suppresses cellular ribonucleic acid (RNA) and protein synthesis. (UroGen Pharma, 2025).

According to the prescribing information, Zusduri carries the following warnings and precautions and adverse reactions:

• Warnings and precautions
  
  
  • Risks in patients with perforated bladder:
    
    
    • Evaluate the bladder before the intravesical instillation of Zusduri.
    • Do not administer to patients with a perforated bladder or in whom the integrity of the bladder mucosa has been compromised.
      
      
  • Embryo-fetal toxicity:
    
    
    • Can cause fetal harm.
    • Advise of potential risk to a fetus and to use effective contraception.
      
      
• Adverse reactions
  
  
  • The most common (≥ 10%) adverse reactions, including laboratory abnormalities, that occurred in patients 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.

On June 12, 2025, the U.S. Food and Drug Administration (FDA) approved mitomycin intravesical solution (Zusduri) for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The FDA approval was based on supporting data from the ENVISION study (FDA, 2025).

In the ENVISION study, a single-arm, multicenter, phase 3 trial, the investigators evaluated the efficacy of mitomycin intravesical solution (Zusduri) in 240 adults with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) that recurred after prior transurethral resection of bladder tumor (TURBT) and met 1 or 2 of the follwoing criteria: the presence of multiple tumors, a solitary tumor > 3 cm, and/or early or frequent recurrence (≥ 1 occurrence of LG-NMIBC within 1 year of the current diagnosis) (FDA, 2025; UroGen Pharma, 2025). 

Patients received Zusduri 75 mg solution by intravesical instillation (urinary catheter) once a week for 6 consecutive weeks. Assessment of tumor status was performed every 3 months bycystoscopy, for-cause biopsy, and urine cytology. The major efficacy outcome measures included complete response (CR) at 3 months (defined as no detectable disease in the bladder by cystoscopy, biopsy [if warranted], and urine cytology) and duration of response (DOR) (FDA, 2025; UroGen Pharma, 2025).

Out of the 240 patients, 223 were evaluable for response, 78% (95% Confidence Interval [CI]: 72, 83) had a CR. The DOR ranged from 0 to 25+ months and 79% of responding patients maintained response for at least 12 months (FDA, 2025; UroGen Pharma, 2025).

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References