Overview

This document addresses the use of Lumoxiti (moxetumomab pasudotox-tdfk), a CD22-directed cytotoxin. Moxetumomab pasudotox-tdfk binds CD22 on the cell surface of B-cell and is released into the malignant cells upon binding to cause cell death. It is used to treat Hairy Cell Leukemia (HCL).

Lumoxiti is FDA approved to treat relapsed or refractory HCL in patients who received at least two prior systemic therapies, including treatment with a purine nucleoside analog. Similarly, the National Comprehensive Cancer Network® (NCCN) provides recommendations with a category 2A level of evidence for the use of Lumoxiti for progression after therapy for relapsed/refractory disease.

Lumoxiti has a black box warning for capillary leak syndrome (CLS) and hemolytic uremic syndrome (HUS). CLS and HUS, including life-threatening cases, have occurred in patients receiving Lumoxiti. Monitor weight and blood pressure; if CLS is suspected, check labs, including albumin. Delay dosing or discontinue as recommended. Monitor hemoglobin, platelet count, serum creatinine, and ensure adequate hydration; discontinue in patients with HUS.

Definitions and Measures

• Purine nucleoside analog: a type of cancer drug that blocks important enzymes needed to make DNA and RNA; examples include cladribine and pentostatin
• Refractory Disease: Illness or disease that does not respond to treatment.
• Relapse or recurrence: After a period of improvement, during which time a disease (for example, cancer) could not be detected, the return of signs and symptoms of illness or disease. For cancer, it may come back to the same place as the original (primary) tumor or to another place in the body.

Clinical Criteria

When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose.

Lumoxiti (moxetumomab pasudotox-tdfk)

1. Individual has a diagnosis of relapsed or refractory hairy cell leukemia (HCL); AND
2. Individual has received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA).

1. All other indications not included above; OR
2. Individuals with severe renal impairment (CrCl ≤ 29 mL/min).

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

HCPCS

Injection, moxetumomab pasudotox-tdfk, 0.01 mg [Lumoxiti]

ICD-10 Diagnosis

Hairy cell leukemia, NOS
Hairy cell leukemia, in remission
Hairy cell leukemia, in relapse

Document History

Reviewed: 08/18/2023