CurrentEmblemHealthPolicy N/A

Jelmyto (mitomycin for pyelocalyceal instillation) — Coverage Criteria

Defines accepted indications, exclusions, and approval process for use of Jelmyto in treatment of upper tract urothelial carcinoma (UTUC) for EmblemHealth lines of business; applies to network ordering providers and utilization management reviewers.

Policy Summary

PayerEmblemHealth

PolicyJelmyto (mitomycin for pyelocalyceal instillation) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJune 28, 2024

Next Review DateN/A

Key ActionSubmit medication requests to Evolent/UM for utilization management review and obtain final approval from the Utilization Management Committee.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

17max instillations

60 mgsingle-dose mg

non-metastatic low-grade UTUCindication

FDA/ASCO/litevidence required

Jun 28, 2024effective

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Coverage Criteria for Jelmyto (mitomycin for pyelocalyceal instillation)

Covered Indications

Covered when ALL of the following are met:

Primary indication: Member has non-metastatic, low-grade upper tract urothelial carcinoma (UTUC)

Use setting: Jelmyto (mitomycin for pyelocalyceal instillation) is used as a single agent following endoscopic ablation OR used in members who are not candidates for endoscopic/surgical intervention as primary treatment or for treatment of recurrent disease

Continuation request exemption: For continuation requests: the requested medication was used within the last year AND the member has not experienced disease progression and/or intolerance AND no additional medication(s) are being added to the continuation request

Requests for coverage will be excluded when any of the following conditions apply: disease progression while the member is receiving Jelmyto; single-dose Jelmyto exceeds 60 mg; or treatment exceeds a total of 17 instillations. Additionally, uses that are investigational or off-label without sufficient supporting evidence (see investigational/evidence criteria) are not covered. These operational limits are applied at the time of utilization review and will result in denial when documented in the clinical record or request.

Off-label or investigational uses of Jelmyto are considered not medically necessary when the indication or regimen is not supported by adequate evidence. Sufficient evidence is defined by evaluation of whether the published literature adequately represents the patient and cancer characteristics, the administered regimen, and clinically meaningful outcomes; the appropriateness of study design; and the quality of evidence (for example, case reports and meeting abstracts without full peer‑reviewed publication generally do not provide adequate support). Uses lacking support from CMS‑recognized compendia or acceptable peer‑reviewed literature meeting these standards will be excluded from coverage.

Key Coding and Quantity Limits

Maximum total instillations — total treatment limit

Maximum total instillations17 total instillations (maximum treatment duration)

Exclusion if exceededRequests will be denied if treatment exceeds 17 total instillations

Related denial triggerDisease progression while on therapy is also listed as an exclusion

Single-dose limit — maximum mg per instillation

Single-dose maximum60 mg per single instillation of Jelmyto

Exclusion if exceededRequests will be denied when dosing exceeds the single-dose limit of 60 mg

Documentation relevance

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for all requests for Jelmyto (mitomycin for pyelocalyceal instillation). Evolent (on behalf of EmblemHealth) is responsible for processing medication requests; medications not authorized by Evolent may be deemed not approvable and not reimbursable. Review is performed by the Utilization Management Department with final approval by the Utilization Management Committee.

Prior authorization required for all initial and renewal requests
Evolent processes requests on behalf of the payer
Final approval authority: Utilization Management Committee

Prior Authorization

Continuation Request Exemption

Continuation (re‑authorization) requests may be exempt from full prior authorization review when all of the following are met: the medication was used within the prior 12 months; the member has not had disease progression or intolerance to Jelmyto; and no additional medications are being added to the continuation request.

Medication used within the last year

Indication Definitions

Non-metastatic, low-grade UTUC appropriate for intraluminal mitomycin instillation after endoscopic ablation or when patient is not a candidate for surgery

Indication populationNon-metastatic, low-grade upper tract urothelial carcinoma (UTUC)

Use setting — post-ablationMay be used as a single agent following endoscopic ablation

Use setting — nonsurgical candidatesMay be used in members who are not candidates for endoscopic/surgical intervention as primary treatment or for recurrent disease

Background

Jelmyto (mitomycin for pyelocalyceal instillation) is an intraluminal chemotherapeutic formulation used in the management of upper tract urothelial carcinoma. In this policy context, its use is subject to defined clinical and dosing limits (see exclusions) and must be supported by adequate evidence when used for off‑label indications.

Denial Risk

Exclusion‑Based Denial Triggers

Requests will be denied when exclusion criteria are met, including documented disease progression while on Jelmyto, dosing exceeding a single‑dose limit of 60 mg, total instillations exceeding 17, or use for investigational/off‑label indications lacking sufficient evidence (e.g., unsupported by CMS‑recognized compendia or acceptable peer‑reviewed literature). Insufficient evidence includes poorly represented patient/therapy characteristics, lack of clinically meaningful outcomes per ASCO standards, inadequate study design, reliance on uncontrolled case reports, or abstracts without full peer‑reviewed publication.

Denial triggers: disease progression on therapy
Denial triggers: single dose > 60 mg
Denial triggers: total instillations > 17
Denial triggers: investigational/off‑label use without sufficient evidence (see evidence standards)