CurrentCareSourcePolicy N/A

Jelmyto (mitomycin) — Prior Authorization and Coverage Criteria

This policy governs prior authorization and medical coverage criteria for Jelmyto (mitomycin solution for pyelocalyceal administration) in adults with low-grade upper tract urothelial cancer, including dosing limits and prescriber requirements.

Policy Summary

PayerCareSource

PolicyJelmyto (mitomycin) — Prior Authorization and Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateMay 7, 2025

Key ActionSubmit prior authorization for Jelmyto and ensure prescribing or consultation is by an oncologist or urologist with dosing within policy limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6initial weekly instillations

15 mLmax volume per dose

1 yearapproval duration

NCapplicable state

Coverage Criteria for Jelmyto (mitomycin)

Initial Therapy

Covered when ALL of the following are met:

Initial Therapy Criteria: A) Patient is ≥ 18 years of age; AND B) Patient has non-metastatic disease; AND C) Patient has undergone endoscopic resection or ablation; AND D) Patient has low-grade disease; AND E) The medication is prescribed by or in consultation with an oncologist or urologist; AND F) Dosing conforms to: each dose ≤ 15 mL instilled into the pyelocalyceal system once weekly for 6 doses, then no more frequently than once a month.

Approve for 1 year if all criteria are met.

Coverage is recommended only when the patient and treatment meet the specific conditions listed in the Recommended Authorization Criteria. Coverage is not recommended for situations not listed in those criteria; the criteria will be updated as new published data become available.

Use of Jelmyto outside the specified Recommended Authorization Criteria is not recommended for approval and will be treated as not recommended/denied unless new evidence supports an expansion of the criteria.

Product Coding and Administration Limits

Product / HCPCSmixed

mitomycin solution (Jelmyto)

Jelmyto (mitomycin solution for pyelocalyceal administration) — dosing described in policy

Policy Summary

PayerCareSource

PolicyJelmyto (mitomycin) — Prior Authorization and Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateMay 7, 2025

Key ActionSubmit prior authorization for Jelmyto and ensure prescribing or consultation is by an oncologist or urologist with dosing within policy limits.

SourceLink

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Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization Recommended. Prior authorization is recommended for medical benefit coverage of Jelmyto. Approval is recommended for members who meet the Recommended Authorization Criteria (see criteria). Approvals are provided for a duration of 1 year when criteria are met. Because of the specialized skills required for evaluation and monitoring of patients treated with Jelmyto, the medication must be prescribed by or in consultation with a physician who specializes in the condition treated.

Approval duration: 1 year when Recommended Authorization Criteria are met
Age requirement: ≥ 18 years
Non‑metastatic disease required
Endoscopic resection or ablation performed
Dosing limits: each dose ≤ 15 mL instilled once weekly for 6 doses, then no more frequently than once a month

Note

Provider Action

Submit prior authorization with documentation of the criteria (age, non‑metastatic status, endoscopic documentation, histologic grade) and dosing plan. Requests for dosing outside the established dosing will be considered on a case‑by‑case basis by a clinician (Medical Director or Pharmacist).

Provide endoscopic operative report or pathology showing low‑grade upper tract urothelial carcinoma
Include name of prescribing specialist and consultation notes if applicable
Document planned dosing schedule and prior therapies

Documentation Required

Prescriber / Consultation Required

Prescriber/consultation requirement: Approval requires Jelmyto to be prescribed by or in consultation with a specialist (e.g., oncologist or urologist) who manages upper tract urothelial carcinoma.

Prescription by or consultation with an oncologist or urologist required
Include specialist name and specialty on the prior authorization request

Denial Risk

Requests not meeting the Recommended Authorization Criteria are not recommended for approval.

OpenPayer

Jelmyto (mitomycin) — Prior Authorization and Coverage Criteria

Coverage Criteria for Jelmyto (mitomycin)

Product Coding and Administration Limits

Provider Actions and Prior Authorization

Background

Definitions