Moxetumomab Pasudotox (Lumoxiti)

Section: Injections
Effective Date: October 01, 2019
Revised Date: September 30, 2019

Description

Moxetumomab pasudotox-tdfk (LumoxitiTM) is a CD22-directed cytotoxin composed of a recombinant, murine immunoglobulin variable domain genetically fused to a truncated form of Pseudomonas exotoxin, PE38, which inhibits protein synthesis. Moxetumomab pasudotox (Lumoxiti) is indicated for the treatment of adult individuals with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA).

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

FDA Indications

Moxetumomab pasudotox (Lumoxiti) may be considered medically necessary in adult individuals who meet ALL of the following criteria: 

  • Diagnosis of relapsed or refractory hairy cell leukemia (HCL); and
  • Previously treated with at least two (2) prior systemic therapies, including one PNA (eg.: cladribine, pentostatin); and
  • Has adequate renal function as indicated by creatinine clearance (CrCl) greater than or equal to 29 mL/min. 

NCCN Indications

Moxetumomab pasudotox (Lumoxiti) may be considered medically necessary in adult individuals for treatment as a single agent for progression of HCL after therapy for relapsed/refractory disease. 

Moxetumomab pasudotox (Lumoxiti) for the treatment of any other indication is considered experimental/investigational; there is a lack of scientific documentation supporting its use for any other indication.

Procedure Codes

J9313 

Note: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

C91.40  C91.42

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