ModifiedNeighborhood Health Plan of Rhode IslandPolicy N/A

Jelmyto (mitomycin for pyelocalyceal instillation)

Defines accepted indications, contraindications, exclusion criteria, and coding for Jelmyto (mitomycin for pyelocalyceal instillation) including FDA-approved and off-label evidence requirements; applies to medication requests processed by Evolent for Neighborhood Health Plan of Rhode Island across listed lines of business.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyJelmyto (mitomycin for pyelocalyceal instillation)

Policy CodePolicy N/A

Change TypeTemplate conversion and updated indications/references

Effective Date

Next Review Date

Key ActionMedication requests must be processed and authorized by Evolent and supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature per CMS Chapter 15.

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and updated indication section and references.

Updated NCH verbiage to Evolent.

1Covered Indication (UTUC low-grade non-metastatic)

60 mgSingle dose maximum

17Maximum total instillations

5Applicable Lines of Business

Coverage Summary

Evolent covers Jelmyto (mitomycin for pyelocalyceal instillation) for the treatment of adult members with non-metastatic, low-grade upper tract urothelial carcinoma (UTUC) when criteria are met. This policy applies across lines of business: CHIP, Commercial, Exchange/Marketplace, Medicaid, and Medicare Advantage. Coverage and authorization decisions must align with FDA labeling, CMS-recognized compendia, NCCN, ASCO, or acceptable peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements; requests lacking such support may be deemed not approvable and not reimbursable.

Contraindications / Exclusions (Not Medically Necessary / Not Covered)

Denial Risk

Denial risk for dosing/duration/exclusions

Claims may be deemed not approvable and not reimbursable if dosing exceeds 60 mg per single dose, treatment exceeds 17 instillations, or when used for investigational/off-label indications lacking sufficient evidence.

Dosing > 60 mg single dose
Treatment > 17 total instillations
Investigational/off-label use without sufficient evidence (no CMS-recognized compendia or acceptable peer-reviewed literature meeting CMS standards)

Provider Actions & Authorization Requirements

Prior Authorization

Authorization requirement and evidence support

Medication requests must be processed and authorized by Evolent; use must be supported by FDA labeling, CMS-recognized compendia, NCCN, ASCO guidelines, or acceptable peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Affected code: J9281
Required evidence sources: FDA prescribing information; CMS-recognized compendia; NCCN; ASCO; acceptable peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15

Documentation Required

Continuation request documentation

For continuation of a not-approvable medication, provide documentation of no disease progression, proof of use within the last year without a lapse of more than 30 days of active authorization, and that no additional medications are being added to the continuation request.

No disease progression on the requested medication
Proof of use within the last year without >30 day lapse of active authorization
No additional medication(s) are being added to the continuation request

Clinical Evidence & References

OLYMPUS (Lancet Oncol. 2020; J Urol. 2022)Key RCT/Trial supporting primary chemoablation efficacy

Jelmyto PI, UroGen Pharma, 2024Prescribing information

Key evidence includes the OLYMPUS program: an open-label single-arm phase 3 trial and its final report demonstrating primary chemoablation efficacy of UGN-101 (mitomycin-containing reverse thermal gel) in low-grade UTUC. The policy references the OLYMPUS Lancet Oncology 2020 report and the J Urol 2022 final report as supporting literature.

Evolent requires that supporting evidence meet CMS standards: coverage support may come from CMS-recognized compendia, NCCN or ASCO guidance, FDA labeling, or peer-reviewed literature that satisfies the CMS Medicare Benefit Policy Manual Chapter 15. Per the policy, “Sufficient evidence” is defined by whether patient and treatment characteristics match published evidence, whether regimens and clinically meaningful outcomes are represented, whether study design is appropriate, and recognizes that non-randomized trials with substantial subject numbers may be supportive while case reports and abstracts without full articles are generally inadequate.

Background

Evolent processes medication requests for network ordering providers and requires that coverage decisions align with FDA labeling, CMS-recognized compendia, NCCN, ASCO, or acceptable peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15. The organization updated this guideline when converting to a new Evolent template and revised indication and references in June 2025.

Jelmyto (mitomycin for pyelocalyceal instillation) is indicated for chemoablation of low-grade UTUC as described in the policy: use as a single agent in adults with non-metastatic, low-grade UTUC following endoscopic ablation or for members who are not candidates for endoscopic/surgical primary treatment or for recurrent disease.

Revision History

June 2025material_changeLatest