CurrentMass General Brigham Health PlanPolicy N/A

Jelmyto (mitomycin pyelocalyceal solution) — Coverage Criteria (LG-UTUC)

Policy governs prior-authorization medical benefit use of Jelmyto for adults with low-grade upper tract urothelial cancer for Mass General Brigham Health Plan (MassHealth). It specifies criteria for initial authorization, continuation, limits, and prescriber requirements.

Policy Summary

PayerMass General Brigham Health Plan

PolicyJelmyto (mitomycin pyelocalyceal solution) — Coverage Criteria (LG-UTUC)

Policy CodePolicy N/A

Change TypeClarification

Effective DateFeb 18, 2025

Next Review DateFeb 18, 2025

Key ActionObtain prior authorization and provide documentation of diagnosis, prescriber specialty or consult notes, and appropriate dosing; for reauthorization submit documentation of complete response at 3 months.

SourceLink

POLICY UPDATE CHANGES

Clarified diagnosis and prescriber specialty.

Prior AuthorizationProgram type

6 weeksInitial approval

11 monthsReauthorization

1 yearMax treatment

CR @ 3 mo

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Coverage Criteria for Jelmyto

Initial Authorization Criteria

Authorization may be granted when ALL of the following are met:

Primary authorization criteria

Diagnosis of low-grade upper tract urothelial cancer (LG-UTUC)
Prescriber specialty: Prescriber is an oncologist or urologist or consult notes from an oncologist or urologist are provided
Dosing: Appropriate dosing

Reauthorization Criteria

Reauthorization requires BOTH of the following:

Continuation of therapy: Physician documentation of continuation of therapy as evidenced by a complete response three months after initiation3 months

Complete response required for reauthorization

Requests for members who are new to the plan and are already receiving the requested medication will be reviewed on a case-by-case basis. Exceptions to this case-by-case review include situations where the product was obtained as samples or provided through the manufacturer’s patient assistance program.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — Medical benefit. Jelmyto is covered under the medical benefit and requires prior authorization. Initial approvals are granted for 6 weeks; reauthorizations are granted for 11 months. Requests for treatment beyond one year will be reviewed on a case-by-case basis. Members already on treatment may be approved for any FDA‑approved indication for the remaining treatment time (maximum total treatment time = 1 year).

Medical benefit (not pharmacy)
Initial approval duration: 6 weeks
Reauthorization duration: 11 months
Max treatment time / beyond 1 year reviewed case‑by‑case
Members already on treatment: may be approved for remaining FDA‑approved treatment time (max 1 year)

Step Therapy

No step therapy requirement is specified for this policy.

Definitions

Low-grade upper tract urothelial cancer (LG-UTUC)

TermLow-grade upper tract urothelial cancer (LG-UTUC)

DefinitionUpper tract urothelial carcinoma of low histologic grade for which Jelmyto is indicated.

Patient populationAdult patients with LG-UTUC.

Background

Jelmyto (mitomycin pyelocalyceal solution) is an intraluminal mitomycin formulation indicated for the treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC). Policy aligns use with oncology or urology prescribers and requires appropriate documentation and evidence of response for continued therapy.

Documentation Required

Required Documentation

Provide supporting documentation with the prior authorization request. Required documentation includes: diagnosis of low‑grade upper tract urothelial cancer (LG‑UTUC); evidence that the prescriber is an oncologist or urologist or consult notes from an oncologist or urologist; and documentation of appropriate dosing. For reauthorization, include physician documentation of a complete response at three months after initiation.

Diagnosis: LG‑UTUC
Prescriber specialty OR consult notes from oncologist/urologist
Dosing details (regimen, concentration, schedule)
For reauthorization: documentation of complete response at 3 months

Denial Risk

Denial Risk for Missing Criteria

Requests may be denied if required criteria are not met or documentation is missing. Denial risk includes absence of a qualifying diagnosis (LG‑UTUC), lack of prescriber specialty or consult notes from an oncologist/urologist, or missing/insufficient dosing information. Reauthorization may be denied if physician documentation of clinical response at three months is not provided.

Denial if no diagnosis of LG‑UTUC
Denial if prescriber is not an oncologist/urologist and no consult notes provided
Denial if dosing information is missing or inappropriate
Denial of reauthorization if no documentation of complete response at 3 months