Coverage Policies

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Effective Date: 01/01/2021 Title: Jelmyto
Revision Date: 11/01/2023 Document: BI675:00
CPT Code(s): J9281
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Jelmyto requires prior authorization.

2)    Jelmyto is used to treat urothelial cancer.

3)    Jelmyto is a specialty drug covered under the medical benefit.

Medical Statement

Jelmyto (mitomycin for pyelocalyceal solution) is considered medically necessary for members meeting the following criteria:

Low-Grade Upper Tract Urothelial Cancer (must meet all):


1)    Newly diagnosed or recurrent LG-UTUC above the ureteropelvic junction;

2)    Prescribed by or in consultation with an oncologist or urologist;

3)    Age > 18 years;

4)    Lesion(s) measure < 15mm;

5)    For the affected kidney(s), member does not have a recent history (within the last year) of carcinoma in situ in the urinary tract, invasive urothelial carcinoma, or high-grade papillary urothelial carcinoma;

6)    Member is not a candidate for or is not seeking nephroureterectomy as definitive treatment;

7)    Dose does not exceed 60mg once weekly for 6 instillations per kidney.

Approval Duration: 3 months (6 instillations per kidney)


Reauthorization Criteria (12 months, up to 17 instillations per kidney)

1)    If member has received 6 instillations, complete response (CR) has been achieved at 3 months after initiation of therapy as evidenced by complete absence of tumor lesions on urine cytology and ureteroscopy;

2)    Member has not received more than 17 instillations;

3)    If request is for a dose increase, requests meets one of the following (a or b):

a.    If member has completed < 6 weekly instillations: New dose does not exceed t0mg once weekly for up to 6 instillations per kidney;

b.    If member has completed > 6 weekly instillations: New dose does not exceed 60 mg once monthly for up to 11 instillations per kidney.



Codes Used In This BI:


1)    J9281       Mitomycin pyelocalyceal instillation, 1 mg


1. Jelmyto Prescribing Information. Princeton, NJ: UroGen Pharma, Inc.; January 2021. Available at Accessed April 25, 2022.


2. Kleinmann N, Matin S, Pierorazio P, et al. Primary chemoablation of low-grade upper tract urothelial carcinoma using UGN-101, a mitomycin-containing reverse thermal gel (OLYMPUS): an open-label, single-arm, phase 3 trial. Lancet Oncol 2020. Published online April 29, 2020. Available at


3. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: Accessed April 25, 2022.


4. National Comprehensive Cancer Network. Bladder Cancer Version 1.2022. Available at Accessed April 25, 2022.





1)    Effective 01-01-2021: Added new code J9281 – replaced code C904.

2)    Effective 11/01/2023: Updated criteria to include that member is not a candidate for / or seeking nephroureterectomy.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
This policy has recently been updated. Please use the index above or enter policy title in search bar for the latest version.