ModifiedHealth NetPolicy CP PHAR.495

Mitomycin Instillation Solution (Jelmyto, Zusduri)

Medical necessity and authorization criteria for use of mitomycin pyelocalyceal solution (Jelmyto) and mitomycin intravesical solution (Zusduri) for specified urothelial cancers, applicable to Health Net lines of business (Commercial, HIM, Medicaid).

Policy Summary

PayerHealth Net

PolicyMitomycin Instillation Solution (Jelmyto, Zusduri)

Policy CodePolicy CP PHAR.495

Change TypeCriteria revisions and product addition

Effective Date09.01.20

Next Review Date

Key ActionSubmit prior authorization with documentation showing the member meets the product- and indication-specific criteria (including monotherapy and required clinical sequencing such as endoscopic resection when applicable).

SourceLink

POLICY UPDATE CHANGES

Removed requirement for cancer location above the ureteropelvic junction per NCCN.

Removed exclusion for recent history of carcinoma in situ, invasive urothelial carcinoma, or high-grade papillary urothelial carcinoma as this is not excluded per NCCN or the FDA indication.

Added requirement for use as monotherapy per NCCN.

Added criteria for newly approved Zusduri and renamed policy to Mitomycin Instillation Solution.

up to 17Jelmyto max instillations

up to 6Zusduri max instillations

60 mgJelmyto dose limit

75 mgZusduri dose

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Coverage and Medical Necessity Criteria

Initial Approval — Jelmyto for LG-UTUC

Covered when ALL of the following are met

Jelmyto initial criteria: 1) Request is for Jelmyto; 2) Newly diagnosed or recurrent low-grade upper tract urothelial cancer (LG-UTUC) that is non‑metastatic; 3) Patient is ≥18 years; 4) Prescribed by or in consultation with an oncologist or urologist; 5) Lesion(s) measure < 15 mm; 6) Member is not a candidate for or is not seeking nephroureterectomy as definitive treatment; 7) One of the following: (a) member has had complete or near-complete endoscopic resection or ablation OR (b) member is not a candidate for endoscopic/surgical intervention; 8) Prescribed as monotherapy; 9) Dose does not exceed 60 mg once weekly for 6 instillations per kidney (or dose supported by practice guidelines/peer-reviewed literature for relevant off-label use with supporting evidence); 10) Prescribed regimen must be FDA‑approved or recommended by NCCN.

Approval duration: 3 months (6 instillations per kidney)

Initial Approval — Zusduri for NMIBC

Covered when ALL of the following are met

Zusduri initial criteria: 1) Request is for Zusduri; 2) Diagnosis of non‑muscle invasive bladder cancer (NMIBC) characterized as Ta low‑grade and intermediate‑risk; 3) Patient is ≥18 years; 4) Prescribed by or in consultation with an oncologist or urologist; 5) Member has previously undergone transurethral resection of bladder tumor (TURBT); 6) Dose does not exceed 75 mg once weekly for 6 instillations into the bladder (or dose supported by practice guidelines/peer‑reviewed literature for relevant off‑label use with supporting evidence); 7) Prescribed regimen must be FDA‑approved or recommended by NCCN.

Approval duration: 3 months (up to 6 total intravesical instillations)

Continued Therapy

Covered when ALL of the following are met

Continued therapy general: 1) Member is currently receiving mitomycin instillation solution via the plan benefit, or documentation supports current use for a covered indication and member has received medication for at least 30 days; 2) For Jelmyto: if member has received 6 instillations, complete response (CR) is required at 3 months after initiation as evidenced by absence of tumor on urine cytology and ureteroscopy; member has not received more than 17 instillations; dosing options for maintenance include once monthly up to 11 additional instillations if CR achieved; 3) For Zusduri: member has not received more than 6 instillations total; if request is for a dose increase, new dose must meet specified limits (Jelmyto ≤60 mg once weekly or monthly maintenance per guidance; Zusduri ≤75 mg once weekly) or be supported by practice guidelines/peer‑reviewed literature with supporting evidence.

Approval durations: Jelmyto up to 12 months (up to 17 instillations per kidney); Zusduri 3 months (up to 6 instillations lifetime)

Coverage criteria (policy-level)

Covered when ALL of the following are met (policy-level updates):

Monotherapy requirement: Use of mitomycin instillation solution as monotherapy as per NCCN guidance

Added in 3Q 2025 review

Disease location: No requirement for cancer location above the ureteropelvic junction

Requirement removed in 3Q 2025 review

Histology exclusions removed: Prior exclusion for recent carcinoma in situ, invasive urothelial carcinoma, or high‑grade papillary urothelial carcinoma has been removed; these are not categorically excluded per NCCN or FDA

Removed in 3Q 2025 review

Endoscopic resection/ablation: If the member is a candidate per NCCN and New Century Health, endoscopic resection or ablation should be performed prior to instillation

Requests for indications that are not FDA‑approved and are not specifically addressed in this policy are excluded unless the provider supplies sufficient supporting documentation of efficacy and safety consistent with the Health Plan's off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or other applicable evidence-of-coverage documents.

The policy language has been updated to remove an earlier exclusion for members with a recent history of carcinoma in situ, invasive urothelial carcinoma, or high‑grade papillary urothelial carcinoma. These histologies are no longer categorically excluded per current NCCN guidance and the FDA indication as reflected in the 3Q 2025 policy revision.

Use of mitomycin instillation solutions for clinical situations outside the specific, supported indications listed in this policy must be supported by appropriate evidence. Requests for such uses without sufficient documentation per the referenced off‑label policies or other supporting literature may be considered not medically necessary and may be denied.

Inclusion of a procedure or drug code in the policy (or its exclusion from the policy) is provided for informational purposes and does not by itself guarantee coverage. Providers should reference current coding guidance and submit required clinical documentation to demonstrate medical necessity when requesting authorization or submitting claims.

Product Codes, Doses, and Quantity Limits

NDC / Kit DescriptionsNDC

Jelmyto kit	Carton: Two 40 mg single-dose vials of mitomycin for pyelocalyceal solution; one 20 mL sterile hydrogel vial for reconstitution
Zusduri kit	Kit: Two 40 mg single-dose vials of mitomycin for intravesical solution; one 60 mL sterile hydrogel vial for reconstitution

Referenced HCPCS / J-codesHCPCS

J9281

Mitomycin, pyelocalyceal instillation, 1 mg (used for Jelmyto)

Other HCPCS / Misc J-codesHCPCS

J9999

Not otherwise classified, antineoplastic drugs (used for Zusduri)

Unclassified / C-codesHCPCS

C9399

Unclassified drugs or biologicals (used for Zusduri)

Maximum instillations — show Jelmyto up to 17 instillations per kidney; Zusduri up to 6 intravesical instillations per lifetime.

Jelmyto — Maximum instillationsUp to 17 total instillations per kidney (approval duration: 12 months)

Zusduri — Maximum instillationsUp to 6 total intravesical instillations per lifetime (approval duration: 3 months)

Per-instillation dose limits — Jelmyto max dose 60 mg/instillation; Zusduri dose 75 mg/instillation (volumes as applicable).

Jelmyto — Per-instillation dose limit60 mg per instillation (4 mg/mL, volume based on pyelography not to exceed 15 mL)

Zusduri — Per-instillation dose limit75 mg per instillation (56 mL)

Prior Authorization, Documentation, and Clinical Sequencing

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests for Jelmyto and Zusduri. Providers must obtain prior approval before dispensing these therapies and submit documentation that demonstrates the member meets all applicable policy criteria for the requested product and indication.

Prior authorization required for Jelmyto and Zusduri
Documentation must demonstrate criteria are met for requested product and indication

Prior Authorization

Prior Authorization and Criteria Updates

This policy was updated to add Zusduri and to align initial and continuation criteria with current NCCN and New Century Health guidance. Providers should follow the most recent policy criteria when submitting prior authorization requests and note that criteria changes (e.g., requirement for monotherapy, removal of cancer location restriction, addition of endoscopic resection/ablation expectations) are effective as of the policy approval date.

Policy updated to add Zusduri and align criteria with NCCN/New Century Health
Monotherapy requirement added for eligible indications (per NCCN)

Background and Clinical Context

Jelmyto (mitomycin for pyelocalyceal solution) is indicated for chemoablation of low‑grade upper tract urothelial cancer (LG‑UTUC) in patients who are not undergoing nephroureterectomy. This policy aligns coverage and prior authorization requirements with available FDA indications and current guideline recommendations (including NCCN), specifying product‑specific dosing and instillation limits and expectations for prior endoscopic resection or ablation when the member is a candidate.

Key Definitions

Intermediate‑risk NMIBC

DefinitionIntermediate-risk NMIBC is defined as having one or two of the following characteristics: presence of multiple tumors; a solitary tumor > 3 cm; and/or early or frequent recurrence (one occurrence of low-grade NMIBC within 1 year of the current diagnosis)

Source guidanceDefinition referenced in Appendix D: General Information and aligns with NCCN classification used in this policy

Clinical implicationPatients meeting this definition may be candidates for intravesical mitomycin (e.g., Zusduri) per the policy criteria

LG‑UTUC

TermLG-UTUC = low-grade upper tract urothelial cancer

ContextUsed to describe the indication for Jelmyto (mitomycin for pyelocalyceal solution) as chemoablation for non‑metastatic low-grade disease