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Jelmyto™ (mitomycin) (Intra-pyelocalyceal)
Policy Number: VP-0531
Intra-pyelocalyceal
Last Review Date: 05/02/2024
Date of Origin: 05/01/2020
Dates Reviewed: 05/2020, 10/2020, 01/2021, 05/2021, 5/2022, 05/2023, 05/2024
FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill. |
- Length of Authorization
Coverage will be provided initially for 3 months and may be renewed one time only for 11 months (maximum total of 17 doses from initial and maintenance treatments).
- Dosing Limits
- Quantity Limit (max daily dose) [NDC Unit]:
- Jelmyto single-use carton/kit: Initially, 1 carton per every 7 days for 6 weeks, followed by 1 carton per every 28 days for 11 months
- Max Units (per dose and over time) [HCPCS Unit]:
- Initial: 80 billable units per week for 6 weeks
- Maintenance: 80 billable units per month for 11 months
- Initial Approval Criteria 1
Coverage is provided in the following conditions:
- Patient is at least 18 years of age; AND
Universal Criteria 1
- Patient does not have a perforation of the bladder or upper urinary tract; AND
- Therapy will be used for intra-pyelocalyceal instillation only; AND
- Used as a single agent; AND
Urothelial Carcinoma † ‡ Ф 1-3
- Patient has low-grade upper tract urothelial cancer (LG-UTUC); AND
- Used as primary treatment; AND
- Patient has at least one measurable tumor 5 to ≤ 15 mm
† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug
- Renewal Criteria 1
Coverage may be renewed based upon the following criteria:
- Patient continues to meet the universal and indication specific criteria as identified in section III; AND
- Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
- Patient has a complete response (CR) to initial therapy (consisting of 3 months of therapy) defined as a negative ureteroscopic evaluation and negative urine cytology (required for extending treatment for an additional 11 monthly instillations); AND
- Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe ureteric obstruction (including ureteral stenosis and hydronephrosis), bone marrow suppression (i.e., severe thrombocytopenia and/or neutropenia), etc.; AND
- Patient has not received more than a total of 17 drug doses/instillations
- Dosage/Administration 1
Indication |
Dose |
Upper Tract Urothelial Carcinoma |
|
- Billing Code/Availability Information
HCPCS Code:
- J9281 – Mitomycin pyelocalyceal instillation, 1 mg; 1 billable unit = 1 mg
NDC(s):
- Jelmyto single-dose kit: 72493-0103-xx
- Two 40 mg (each) single-dose vials of lyophilized mitomycin: 72493-0101-xx
- One 20 mL single dose vial of vehicle for reconstitution: 72493-0102-xx
- References
- Jelmyto [package insert]. Princeton, NJ; Urogen Pharm, Inc; September 2022. Accessed April 2024.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for mitomycin. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed April 2024.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Bladder Cancer. Version 3.2024. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed April 2024.
- Kleinmann N, Pierorazio P, Matin S, et al. LBA25 Non-Surgical Management Of Low Grade Upper Tract Urothelial Cancer: An Interim Analysis Of The International Multicenter Olympus Trial (NCT02793128). J Uro 2018.199:45;e1166. https://doi.org/10.1016/j.juro.2018.03.097
- Kleinmann N, Matin SF, Pierorazio PM, 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 Jun;21(6):776-785.
Appendix 1 – Covered Diagnosis Codes
ICD-10 |
ICD-10 Description |
C65.1 |
Malignant neoplasm of right renal pelvis |
C65.2 |
Malignant neoplasm of left renal pelvis |
C65.9 |
Malignant neoplasm of unspecified renal pelvis |
Appendix 2 – Centers for Medicare and Medicaid Services (CMS)
The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.
Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A
Medicare Part B Administrative Contractor (MAC) Jurisdictions |
||
Jurisdiction |
Applicable State/US Territory |
Contractor |
E (1) |
CA, HI, NV, AS, GU, CNMI |
Noridian Healthcare Solutions, LLC |
F (2 & 3) |
AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ |
Noridian Healthcare Solutions, LLC |
5 |
KS, NE, IA, MO |
Wisconsin Physicians Service Insurance Corp (WPS) |
6 |
MN, WI, IL |
National Government Services, Inc. (NGS) |
H (4 & 7) |
LA, AR, MS, TX, OK, CO, NM |
Novitas Solutions, Inc. |
8 |
MI, IN |
Wisconsin Physicians Service Insurance Corp (WPS) |
N (9) |
FL, PR, VI |
First Coast Service Options, Inc. |
J (10) |
TN, GA, AL |
Palmetto GBA |
M (11) |
NC, SC, WV, VA (excluding below) |
Palmetto GBA |
L (12) |
DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA) |
Novitas Solutions, Inc. |
K (13 & 14) |
NY, CT, MA, RI, VT, ME, NH |
National Government Services, Inc. (NGS) |
15 |
KY, OH |
CGS Administrators, LLC |