Last Review Date: 12/03/2024

Date of Origin: 10/02/2018

Dates Reviewed: 10/2018, 11/2019, 11/2020, 11/2021, 11/2022, 11/2023, 12/2024

1. Length of Authorization ¹

Coverage is provided for 6 months (6 cycles) and may not be renewed.

2. Dosing Limits

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

• 1500 billable units every 28 days

3. Initial Approval Criteria ^1,3

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND
• Patient does not have severe renal impairment defined as CrCl ≤ 29 mL/min; AND
• Patient does not have prior history of severe thrombotic microangiopathy (TMA) or hemolytic uremic syndrome (HUS); AND
• Used as a single agent; AND

        Hairy Cell Leukemia (HCL) † Ф ^1-5

• Patient has a confirmed diagnosis of Hairy Cell Leukemia or a HCL variant; AND
• Patient has relapsed or refractory disease; AND
• Patient has previously failed at least TWO prior systemic therapies, including at least one purine analog (e.g., cladribine, pentostatin, etc.)

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

4. Renewal Criteria ¹

Duration of authorization has not been exceeded (refer to Section I)

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J9313 − Injection, moxetumomab pasudotox-tdfk, 0.01 mg; 1 billable unit = 0.01 mg

NDC:

• Lumoxiti 1 mg single-dose vial: 00310-4700-xx
  • IV solution stabilizer for use during administration: 00310-4715-xx

7. References

1. Lumoxiti [package insert]. Wilmington, DE; AstraZeneca; February 2022. Accessed September 2023.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) for moxetumomab pasudotox. 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 September 2023.
3. Kreitman RJ, Dearden C, Zingani PL, et al. Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia. Leukemia. 2018; 32(8): 1768–1777.
4. Robbins BA, Ellison DJ, Spinosa JC, et al. Diagnostic application of two-color flow cytometry in 161 cases of hairy cell leukemia. Blood 1993;82:1277-1287.
5. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Hairy Cell Leukemia. Version 1.2025. 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 November 2024.

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