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Last Review Date: 01/04/2024

Date of Origin: 01/06/2020

Dates Reviewed: 01/2020, 07/2020, 07/2021, 07/2022, 05/2023, 01/2024

1. Length of Authorization

Coverage will be provided for 6 months and may be renewed.

2. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• Padcev 20 mg single-dose vial: 15 vials per 28 days
• Padcev 30 mg single-dose vial: 15 vials per 28 days

2. Max Units (per dose and over time) [HCPCS Unit]:

• 500 billable units (125 mg) x 3 doses every 28 days

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Urothelial Carcinoma (Bladder Cancer) † ‡ ^1-3

• Used in combination with pembrolizumab; AND
  • Patient has locally advanced or metastatic urothelial carcinoma †; AND
    • Used as first-line therapy; OR
  • Patient has one of the following diagnoses:
    • • • • • Muscle invasive bladder cancer with local recurrence or persistent disease in a preserved bladder treated with curative intent ‡
            • Metastatic or local bladder cancer recurrence post-cystectomy treated with curative intent ‡
            • Metastatic primary carcinoma of the urethra ‡
            • Metastatic upper genitourinary (GU) tract tumors ‡
            • Metastatic urothelial carcinoma of the prostate ‡; AND
        • Used as first-line therapy in cisplatin ineligible patients*; OR
• Used as a single agent; AND
  • Patient has one of the following diagnoses:
    • Locally advanced or metastatic urothelial carcinoma †; OR
    • Muscle invasive bladder cancer with local recurrence or persistent disease in a preserved bladder ‡; OR
    • Local or metastatic bladder cancer recurrence post-cystectomy ‡; OR
    • Primary carcinoma of the urethra ‡; AND

• • Used for recurrent (excluding recurrence of stage T3-4 disease or palpable inguinal lymph nodes) or metastatic disease; OR

• Metastatic upper genitourinary (GU) tract tumors ‡; OR
• Metastatic urothelial carcinoma of the prostate ‡; AND
  • • Used in one of the following treatment settings:
      • Patient previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor (i.e., nivolumab, pembrolizumab, avelumab, etc.); AND
        • Patient previously received platinum-containing chemotherapy (i.e., carboplatin, cisplatin, etc.); OR
• Used as subsequent therapy in patients ineligible for cisplatin-containing chemotherapy*

        † FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

Coverage can be renewed based upon the following criteria:

• Patient continues to meet the universal and indication-specific relevant 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
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe hyperglycemia or diabetic ketoacidosis, severe pneumonitis/interstitial lung disease (ILD), severe peripheral neuropathy, ocular disorders including vision changes, severe skin reactions (e.g., Steven Johnson syndrome, toxic epidermal necrolysis, etc.), infusion site extravasation, etc.

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J9177 – Injection, enfortumab vedotin-ejfv, 0.25 mg; 1 billable unit = 0.25 mg

NDC:

• Padcev 20 mg single-dose vial: 51144-0020-xx
• Padcev 30 mg single-dose vial: 51144-0030-xx

7. References

1. Padcev [package insert]. Northbrook, IL; Astellas Pharma US, Inc.; December 2023. Accessed December 2023.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for enfortumab vedotin-ejfv. National Comprehensive Cancer Network, 2023. 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 December 2023.
3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Bladder Cancer. Version 3.2023. National Comprehensive Cancer Network, 2023. 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 December 2023.
4. Rosenberg JE, O'Donnell PH, Balar AV, et al. Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma After Platinum and Anti-Programmed Death 1/Programmed Death Ligand 1 Therapy. J Clin Oncol. 2019 Oct 10;37(29):2592-2600.
5. Gupta S, Sonpavde G, Grivas P, et al. Defining “platinum-ineligible” patients with metastatic urothelial cancer (mUC). J Clin Oncol. 2019 Mar 1;37(7_suppl):451.
6. Fahrenbruch R, Kintzel P, Bott AM, et al. Dose Rounding of Biologic and Cytotoxic Anticancer Agents: A Position Statement of the Hematology/Oncology Pharmacy Association. J Oncol Pract. 2018 Mar;14(3):e130-e136.
7. Hematology/Oncology Pharmacy Association (2019). Intravenous Cancer Drug Waste Issue Brief. Retrieved from http://www.hoparx.org/images/hopa/advocacy/Issue-Briefs/Drug_Waste_2019.pdf
8. Bach PB, Conti RM, Muller RJ, et al. Overspending driven by oversized single dose vials of cancer drugs. BMJ. 2016 Feb 29;352:i788.
9. Powles T, Rosenberg JE, Sonpavde GP, et al. Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma. N Engl J Med. 2021 Mar 25;384(12):1125-1135. doi: 10.1056/NEJMoa2035807. Epub 2021 Feb 12.
10. Balar AV, McGregor BA, Rosenberg JE, et al. EV-201 Cohort 2: Enfortumab vedotin in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer who received prior PD-1/PD-L1 inhibitors. DOI: 10.1200/JCO.2021.39.6_suppl.394 Journal of Clinical Oncology 39, no. 6_suppl (February 20, 2021) 394-394.
11. Gupta S, Sonpavde G, Grivas P, et al. Defining “platinum-ineligible” patients with metastatic urothelial cancer (mUC). J Clin Oncol. 2019 Mar 1;37(7_suppl):451.
12. Gupta S, Bellmunt J, Plimack ER, et al. Defining “platinum-ineligible” patients with metastatic urothelial cancer (mUC). J Clin Oncol. 2022 June 1;40(16_suppl):4577.
13. Bellmunt, J. (2023). Treatment of metastatic urothelial cancer of the bladder and urinary tract. In Lerner SP, Shah S (Eds.), UptoDate. Last updated March 15, 2023. Accessed April 7, 2023. Available from https://www.uptodate.com/contents/treatment-of-metastatic-urothelial-cancer-of-the-bladder-and-urinary-tract?search=cisplatin%20ineligible&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1.
14. Hoimes CJ, Petrylak DP, Flaig TW, et al. EV-103 study: A phase 1b dose-escalation and dose-expansion study of enfortumab vedotin in combination with immune checkpoint inhibitor (CPI) therapy for treatment of patients with locally advanced or metastatic urothelial cancer. Journal of Clinical Oncology 2018 36:6_suppl, TPS532-TPS532.
15. Hoimes CJ, Petrylak DP, Flaig TW, et al. EV-103 study: A phase 1b dose-escalation and dose-expansion study of enfortumab vedotin in combination with immune checkpoint inhibitor (CPI) therapy for treatment of patients with locally advanced or metastatic urothelial cancer. Journal of Clinical Oncology 36, no. 6_suppl. DOI: 10.1200/JCO.2018.36.6_suppl.TPS532.

Appendix 1 – Covered Diagnosis Codes

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/LCA/LCD): N/A

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