CurrentViva HealthPolicy IC-0531

Jelmyto® (mitomycin) (Intra-pyelocalyceal)

Policy governing coverage and authorization requirements for Jelmyto (mitomycin) instilled into the renal pelvis/pyelocalyceal system for treatment of low-grade upper tract urothelial carcinoma in adult members of Viva Health.

Policy Summary

PayerViva Health

PolicyJelmyto® (mitomycin) (Intra-pyelocalyceal)

Policy CodePolicy IC-0531

Change TypeNo material change

Effective DateMay 1, 2020

Next Review DateFeb 4, 2025

Key ActionObtain prior authorization with documentation of age ≥18, diagnosis of low-grade upper tract urothelial carcinoma with at least one measurable tumor 5–15 mm, and a dosing plan consistent with policy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 monthsinitial authorization length

11 monthssingle renewal period

17maximum total doses

J9281HCPCS code

≥18minimum age

≤15 mm

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Coverage Criteria for Jelmyto (mitomycin)

Initial Therapy

Covered when ALL of the following are met:

Initial approval criteria: Patient is at least 18 years of age; patient does not have a perforation of the bladder or upper urinary tract; therapy will be used for pyelocalyceal instillation only; used as a single agent; patient has low-grade upper tract urothelial cancer (LG-UTUC) as primary treatment; patient has at least one measurable tumor 5 to ≤ 15 mm; dosing plan consistent with policy (4 mg/mL via ureteral catheter or nephrostomy tube, instillation volume based on pyelography not to exceed 15 mL [60 mg total]; instill once weekly for 6 weeks).

Continuation / Maintenance Therapy

Renewal (one time) may be provided when ALL of the following are met:

Renewal criteria: Patient continues to meet the universal and indication-specific criteria; duration of authorization has not been exceeded (initial authorization 3 months with one-time renewal up to 11 months; maximum total 17 doses); disease response demonstrated (stabilization or decrease in tumor size or spread); patient has a complete response to initial therapy defined as negative ureteroscopic evaluation and negative urine cytology required to extend to maintenance; absence of unacceptable toxicity (e.g., severe ureteric obstruction, bone marrow suppression).

Patients with a perforation of the bladder or upper urinary tract are excluded from coverage for intrapelvocalyceal mitomycin (Jelmyto). This is a universal exclusion and must be confirmed prior to authorization.

Use of Jelmyto for indications other than low‑grade upper tract urothelial carcinoma (LG‑UTUC) as primary treatment with at least one measurable tumor 5 to ≤15 mm is not supported by this policy and is considered not medically necessary.

Coding, Dosing, and Tumor Size Limits

Covered HCPCS CodesHCPCSCovered

J9281

Mitomycin pyelocalyceal instillation, 1 mg; 1 billable unit = 1 mg

Covered Diagnosis CodesICD-10Covered

C65.1	Malignant neoplasm of right renal pelvis
C65.2	Malignant neoplasm of left renal pelvis
C65.9	Malignant neoplasm of unspecified renal pelvis

NDCsNDC

72493-0103-xx	Jelmyto single-dose kit
72493-0101-xx	Two 40 mg single-dose vials of lyophilized mitomycin
72493-0102-xx	20 mL single dose-vial of vehicle for reconstitution

Measurable tumor size — numeric bounds for eligible lesions

Per-lesion size requirementAt least one measurable tumor 5 to ≤15 mm (per policy: patient has at least one measurable tumor 5 to ≤15 mm)

Lower boundMinimum measurable lesion size: 5 mm

Upper boundMaximum measurable lesion size per lesion: ≤ 15 mm

Dosage per instillation / units — concentration, max volume/total mg, and HCPCS billing unit guidance

Concentration4 mg/mL per instillation (administered via ureteral catheter or nephrostomy tube)

Maximum volume / total mg per instillation

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit documentation showing the member is ≥18 years of age, diagnosis of low‑grade upper tract urothelial carcinoma (LG‑UTUC) when applicable, measurable tumor(s) per indication (5 to ≤15 mm for primary treatment), and that therapy will be used as single‑agent pyelocalyceal instillation.

Patient age ≥ 18
Single‑agent pyelocalyceal instillation only
Documented measurable tumor(s) when required (5 to ≤15 mm)

Step Therapy

No step therapy sequence is specified. Treatment is limited to single‑agent pyelocalyceal instillation.

Single‑agent pyelocalyceal instillation only

Definitions and Instillation Details

Complete Response (CR) — Definition required for maintenance extension

DefinitionComplete Response (CR) = negative ureteroscopic evaluation and negative urine cytology after initial therapy (documented at 3 months) — required to extend to maintenance therapy

Timing for assessmentAssessment of CR is performed at 3 months after initiation of therapy

Use for maintenance decisionA documented CR (negative ureteroscopy and negative urine cytology) is required to permit monthly maintenance instillations

Instillation dose/volume — concentration, route, and maximum volume/mg

Concentration and route4 mg/mL delivered via ureteral catheter or nephrostomy tube

Maximum volumeTotal instillation volume based on pyelography volumetric measurements and must not exceed 15 mL

Background

Jelmyto is mitomycin formulated in a reverse thermal gel designed for chemoablation via instillation into the pyelocalyceal system. The therapy is indicated for treatment of low‑grade upper tract urothelial carcinoma (LG‑UTUC) as a primary, single‑agent pyelocalyceal instillation when the patient has at least one measurable tumor between 5 and ≤15 mm. Dosing is administered as a 4 mg/mL concentration via ureteral catheter or nephrostomy tube with instillation volumes determined by pyelography and not to exceed 15 mL (60 mg total mitomycin) per instillation.

Policy Summary

PayerViva Health

PolicyJelmyto® (mitomycin) (Intra-pyelocalyceal)

Policy CodePolicy IC-0531

Change TypeNo material change

Effective DateMay 1, 2020

Next Review DateFeb 4, 2025

SourceLink

On This Page

Instillation volume determined by pyelography volumetric measurement, not to exceed 15 mL (maximum 60 mg mitomycin per instillation)

HCPCS billing guidanceHCPCS J9281 billed per mg: 1 billable unit = 1 mg (policy also lists max units: 80 units per dose)

Documentation Required

Required Documentation for Approval/Renewal

For initial approval and for renewal, include documentation of a ureteroscopic evaluation and urine cytology. For renewal beyond the initial 3‑month course, documentation must show a complete response (CR) to initial therapy defined as negative ureteroscopic evaluation and negative urine cytology.

Ureteroscopic evaluation (negative required for CR)
Negative urine cytology (required for CR)
Documentation that patient continues to meet universal and indication‑specific criteria

Denial Risk

Renewal Denial Triggers

Renewal will be denied if the duration limits are exceeded, a complete response to initial therapy is not demonstrated, disease progression occurs (no stabilization or decrease in tumor size/spread), or unacceptable drug toxicity is present (for example severe ureteric obstruction, ureteral stenosis, hydronephrosis, or severe bone marrow suppression).

Authorization duration must not exceed initial 3 months plus one renewal of 11 months (refer to Length of Authorization)
Renewal requires documented disease response (stabilization or decrease) or documented complete response after initial therapy
Renewal denied for unacceptable toxicity (e.g., severe ureteric obstruction, severe thrombocytopenia/neutropenia)

Note

Provider Submission Checklist

Ensure submitted records include: age, diagnosis and indication, measurable tumor documentation when applicable, initial treatment details (dose/instillation schedule), ureteroscopic findings, urine cytology results, and adverse event/toxicity assessments to support renewal.

Age and diagnosis
Measurable tumor documentation (size 5 to ≤15 mm when required)
Treatment details: dose, volume, instillation route and schedule (e.g., 4 mg/mL up to 15 mL; weekly ×6; monthly maintenance up to 11)
Ureteroscopic evaluation reports and urine cytology results
Documentation of disease response or complete response and absence of unacceptable toxicity

Maximum total mitomycin per instillationNot to exceed 60 mg per instillation (4 mg/mL × 15 mL)