CurrentViva HealthPolicy IC-0801

Zusduri (mitomycin) (Intravesical) — Coverage Criteria

Policy governing prior authorization, dosing, and coverage criteria for intravesical Zusduri (mitomycin) for adults with low-grade non–muscle-invasive bladder cancer; applies to Viva Health benefits for covered members.

Policy Summary

PayerViva Health

PolicyZusduri (mitomycin) (Intravesical) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateJul 1, 2025

Key ActionObtain prior authorization for up to 6 weekly intravesical doses (initial authorization covers 6 doses); renewals are not allowed.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 dosesinitial authorization duration

75 mg weeklyrecommended dose

80 units/weekmax units/week

J9282designated HCPCS

Coverage Criteria for Zusduri (mitomycin) Intravesical

Initial Approval Criteria

Covered when ALL of the following are met:

Age: Patient is at least 18 years of age

Concurrent mitomycin: Will not be used concurrently with other mitomycin formulations (e.g., Jelmyto)

Voiding function: Patient does not have a neurogenic bladder, active urinary retention or any other condition that would prohibit normal voiding of urine

Bladder integrity: No bladder perforation or mucosal compromise until bladder integrity restored

Policy Summary

PayerViva Health

PolicyZusduri (mitomycin) (Intravesical) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateJul 1, 2025

Key ActionObtain prior authorization for up to 6 weekly intravesical doses (initial authorization covers 6 doses); renewals are not allowed.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coding — HCPCS, NDCs, and Diagnosis Codes

HCPCS CodesHCPCS

J9282	Mitomycin, intravesical instillation, 1 mg; 1 billable unit = 1 mg (Effective 01/01/2026)
J9999	Not otherwise classified, antineoplastic drugs (Discontinue use on 01/01/2026)

NDCsNDC

72493-0106-xx	Zusduri single-dose kit
72493-0104-xx	Two 40 mg (each) single-dose vials of lyophilized mitomycin
72493-0105-xx	One 60 mL single dose-vial of hydrogel vehicle for reconstitution

Covered Diagnosis CodesICD-10Covered

C67.0	Malignant neoplasm of trigone of bladder
C67.1	Malignant neoplasm of dome of bladder
C67.2	Malignant neoplasm of lateral wall of bladder
C67.3	Malignant neoplasm of anterior wall of bladder
C67.4	Malignant neoplasm of posterior wall of bladder
C67.5	Malignant neoplasm of bladder neck
C67.6	Malignant neoplasm of ureteric orifice
C67.7	Malignant neoplasm of urachus
C67.8	Malignant neoplasm of overlapping sites of bladder
C67.9	Malignant neoplasm of bladder, unspecified

1–10 of 12

1/2

Maximum units and dosing — billable-unit cap and recommended dose/frequency

Weekly billable-unit cap80 billable units per week (applies for the 6-week course)

Recommended per-instillation dose75 mg (56 mL) instilled once weekly into the bladder via urinary catheter

Course duration/frequencyOnce weekly for six weeks (initial authorization covers 6 doses)

Billing unit definition1 billable unit = 1 mg (use HCPCS coding for intravesical mitomycin)

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required — Authorization Limits

Prior authorization is required and is limited to an initial course of up to 6 weekly doses (6 weeks). Renewal of prior authorization is not allowed; requests that exceed 6 weekly doses or request continuation beyond the initial authorization will be denied.

Authorization limit: up to 6 weekly doses (initial authorization only)
Renewal: prior authorization cannot be renewed — continuation requests will be denied

Documentation Required

Required Diagnosis Coding

Submit a covered diagnosis code from Appendix 1 with the authorization request. Acceptable ICD-10 diagnosis codes include C67.0–C67.9, D09.0, and Z85.51. Claims or authorizations submitted without one of these covered diagnosis codes may be denied.

Covered diagnosis codes: C67.0, C67.1, C67.2, C67.3, C67.4, C67.5, C67.6, C67.7, C67.8, C67.9, D09.0, Z85.51

Background

Zusduri is an intravesical mitomycin hydrogel intended for instillation into the bladder via urinary catheter for the treatment of non–muscle-invasive bladder cancer. The recommended regimen is 75 mg (56 mL) instilled once weekly for six weeks. Zusduri must be chilled to -3°C to 5°C (27°F to 41°F) prior to instillation and each syringe should be emptied within 30 seconds to avoid gelation. Patients should be counseled that urine may be discolored (violet to blue) after instillation and instructed on hygiene precautions for at least 24 hours post-procedure.

Definitions and Handling

Intravesical instillation — definition

DefinitionIntravesical instillation: placement of Zusduri into the bladder via a urinary catheter for local therapy of bladder cancer.

Route restrictionNot to be administered by pyelocaliceal or any non-intravesical route.

Required delivery devicesRequires syringes and a urinary catheter for instillation.

Handling and administration requirements

Syringe use timingEach syringe must be emptied within 30 seconds during instillation to avoid gelation.

Administration notesInstillation requires syringes and a urinary catheter; advise patients about urine discoloration and hygiene precautions for at least 24 hours post-instillation.