Mitomycin for Pyelocalyceal Solution (Jelmyto) Form

Mitomycin for pyelocalyceal solution (Jelmyto®) is an alkylating drug. FDA Approved Indication(s) Jelmyto is indicated for the treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC). Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Jelmyto is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. 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 ≤ 15 mm;
   5. For the affected kidney(s), member does not have a recent history (with the last year) of carcinoma in situ in the urinary tract, invasive urothelial carcinoma, or high-grade papillary urothelial carcinoma;
2. Member is not a candidate for or is not seeking nephroureterectomy as definitive treatment;
3. Request meets one of the following (a or b): a. Dose does not exceed 60 mg once weekly for 6 instillations per kidney; b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN
   Approval duration: 3 months (6 instillations per kidney) B. Other diagnoses/indications (must meet 1 or 2):

4. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: Page 1 of 6

   CLINICAL POLICY Mitomycin for Pyelocalyceal Solution CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

5. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Low-Grade Upper Tract Urothelial Cancer (must meet all):
6. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Jelmyto for a covered indication and has received this medication for at least 30 days;
7. 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;
8. Member has not received more than 17 instillations;
   
   4. If request is for a dose increase, request meets one of the following (a, b, or c): a. If member has completed < 6 weekly instillations: New dose does not exceed 60 mg 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; c. New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). Prescribed regimen must be FDA-approved or recommended by NCCN Approval duration: 12 months (up to 17 total instillations per kidney) B. Other diagnoses/indications (must meet 1 or 2):
9. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

10. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line Page 2 of 6

    CLINICAL POLICY Mitomycin for Pyelocalyceal Solution of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.
    IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration NCCN: National Comprehensive Cancer Network LG-UTUC: low-grade upper tract urothelial cancer Appendix B: Therapeutic Alternatives
    Not applicable Appendix C: Contraindications/Boxed Warnings • Contraindication(s): perforation of the bladder or upper urinary tract • Boxed warning(s): none reported Appendix D: General Information • NCCN Compendium currently recommend Jelmyto with a Category 2A recommendation for primary treatment for a non-metastatic, residual, low-grade, low volume (5-15 mm), solitary tumor in the upper urinary tract for a patient who is not a candidate for or not seeking nephroureterectomy as a definitive treatment. Complete or near complete endoscopic resection or ablation is recommended prior to mitomycin ureteral gel application. V. Dosage and Administration
    Indication Dosing Regimen LG-UTUC Jelmyto is for pyelocalyceal use only and not for intravenous use, topical use, or oral administration. Maximum Dose 60 mg; 17 instillations The dose of Jelmyto to be instilled is 4 mg/mL via ureteral catheter or nephrostomy tube, with total instillation volume based on volumetric measurements using pyelography, not to exceed 15 mL (60 mg of mitomycin). Instill Jelmyto once weekly for six weeks. For patients with a complete response 3 months after Jelmyto initiation, Jelmyto instillations may be administered once a month for a maximum of 11 additional instillations. Page 3 of 6

    CLINICAL POLICY Mitomycin for Pyelocalyceal Solution VI. Product Availability
    For pyelocalyceal solution – carton containing the following: • Two 40 mg (each) single-dose vials of mitomycin for pyelocalyceal solution • One vial of 20 mL sterile hydrogel for reconstitution VII.