CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Jelmyto (mitomycin for pyelocalyceal instillation) — coverage criteria

Defines accepted indications, usage limits, contraindications, exclusions, and coding for Jelmyto (mitomycin for pyelocalyceal instillation) for treatment of upper tract urothelial carcinoma; applies to providers submitting medication requests to Evolent on behalf of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyJelmyto (mitomycin for pyelocalyceal instillation) — coverage criteria

Policy CodePolicy N/A

Change TypeTemplate conversion and clinical updates

Effective DateN/A

Next Review DateJune 2025

Key ActionSubmit prior authorization to Evolent; continuation requests may be exempt if prior authorization active within the past year without >30-day lapse and no disease progression.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced UM ONC_1415 Jelmyto guideline; updated indication section and references.

Updated verbiage from NCH to Evolent in prior revision.

60 mgsingle dose maximum

17max total instillations

J9281billing code

Commercial/Medicaidlines of business

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Coverage Criteria for Jelmyto (mitomycin for pyelocalyceal instillation)

Initial therapy

Covered when ALL of the following are met:

Initial Jelmyto coverage: Member is an adult with non-metastatic, low-grade upper tract urothelial carcinoma (UTUC)

Post-ablation or non-surgical candidate: Jelmyto is used following endoscopic ablation OR the member is not a candidate for endoscopic or surgical intervention (including use for recurrent disease)

Supportive evidence: Use is supported by FDA approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer-reviewed literature

Evolent requires one of these sources to support the request

Per policy, requests for Jelmyto (mitomycin for pyelocalyceal instillation) will be excluded when any of the following apply: disease progression while taking Jelmyto; a single dose exceeds 60 mg; the course of treatment exceeds 17 total instillations; or the requested use is investigational or an off‑label indication that lacks sufficient supporting evidence as defined by CMS‑recognized compendia or acceptable peer‑reviewed literature.

Contraindications include anatomical compromise of the urinary tract: specifically, perforation of the bladder or upper urinary tract is listed as a contraindication to Jelmyto administration.

Uses considered investigational or not medically necessary include off‑label indications for Jelmyto that are not supported by sufficient clinical evidence. Sufficient evidence is defined by the policy as support from FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature; the policy further specifies criteria for adequacy of evidence (representation of the patient population and regimen, clinically meaningful outcomes, and appropriate study design). Requests for indications that do not meet these evidence standards will be denied as investigational/off‑label.

Billing and Coding

Covered HCPCS CodesHCPCSCovered

J9281

Mitomycin pyelocalyceal instillation, 1 mg

inv-06: Single dose limit

Single-dose maximum60 mg per single instillation

Source restrictionRequests exceeding 60 mg per single dose will be excluded (denied)

Relevance to codingApplies to Jelmyto (mitomycin for pyelocalyceal instillation) dosing and authorization reviews

inv-07: Maximum number of instillations

Maximum total instillations17 total instillations

Denial conditionTreatment that exceeds 17 instillations will be excluded (denied)

Provider Actions, Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization and Continuation

Prior authorization is required for new requests for Jelmyto (mitomycin for pyelocalyceal instillation). Continuation requests may be exempt from prior authorization when ALL of the following are met: the member has not experienced disease progression while on the medication; the medication was used within the last year without a lapse of more than 30 days from an active authorization; and no additional medications are being added to the continuation request.

Continuation exemption requires no disease progression on the requested medication
Continuation exemption requires prior use within last year with ≤30-day lapse from active authorization
Continuation exemption prohibits addition of new medication(s) to the request

Documentation Required

Supporting Documentation

Supporting documentation must accompany all requests and demonstrate the requested use is consistent with FDA labeling, CMS-recognized compendia, NCCN or ASCO guidelines, or peer-reviewed literature meeting CMS standards. For UTUC indications, documentation should include clinical records showing non-metastatic, low-grade upper tract urothelial carcinoma diagnosis and evidence of prior endoscopic ablation or documentation that the member is not a candidate for endoscopic/surgical intervention.

Definitions

inv-13: UTUC definition

DefinitionUpper Tract Urothelial Carcinoma (UTUC): non-metastatic, low-grade urothelial carcinoma of the renal pelvis and/or ureter

Intended use of JelmytoJelmyto may be used as a single agent in adult members with non-metastatic, low-grade UTUC following endoscopic ablation or when patients are not candidates for endoscopic/surgical intervention

Treatment contextIncludes use as primary treatment or for treatment of recurrent disease in patients who are not candidates for endoscopic/surgical therapy

Background

Jelmyto (UGN‑101) is a mitomycin formulation designed for pyelocalyceal instillation to achieve chemoablation of low‑grade upper tract urothelial carcinoma (UTUC). It is intended for use as a single‑agent therapy in adult patients with non‑metastatic, low‑grade UTUC following endoscopic ablation or when patients are not candidates for endoscopic or surgical intervention.

Revision History

June 2025revisedLatest

Converted to new Evolent guideline template; replaced UM ONC_1415 Jelmyto prior guideline; updated indication section and references.

June 2024clarified

Updated verbiage from NCH to Evolent.