Moxetumomab Pasudotox-tdfk (Lumoxiti)

Policy ID: I-204-007

Section: Injections

Effective Date: June 01, 2019

Revised Date: July 10, 2023

Revision Effective Date: September 01, 2023

Last Reviewed: July 26, 2023

Applies To: Commercial and Medicaid Expansion

Description

Moxetumomab pasudotox-tdfk (Lumoxiti ^TM ) 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.

Moxetumomab pasudotox-tdfk (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; or

Compendia Sources

Moxetumomab pasudotox-tdfk (Lumoxiti) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

Moxetumomab pasudotox-tdfk (Lumoxiti) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J9313

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

C91.40

C91.42

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 5-15-2019 Adopted policy

Internal Medical Policy Committee 7-22-2020 Annual review,

Changed procedure code J9313 to precertification drug; and
Removed renal function criteria

Internal Medical Policy Committee 7-22-2021 Annual review, no clinical content change

Internal Medical Policy Committee 3-23-2022

Removed NCCN recommendations; and
Added this statement 'Moxetumomab pasudotox-tdfk (Lumoxiti) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.'; and
Updated experimental/investigational statement

Internal Medical Policy Committee 3-23-2023 Annual review, no clinical content change

Internal Medical Policy Committee 7-26-2023 - Effective September 01, 2023

Updated order of the criteria, no clinical content change
Updated experimental/investigational statement

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: I-204-006

Section: Injections

Effective Date: June 01, 2019

Revised Date: March 14, 2022

Revision Effective Date: May 01, 2022

Last Reviewed: March 23, 2023

Archived Date: August 31, 2023

Applies To: Commercial and Medicaid Expansion

Description

Moxetumomab pasudotox-tdfk (Lumoxiti^TM) 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.

Compendia Sources

Moxetumomab pasudotox-tdfk (Lumoxiti) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

Moxetumomab pasudotox-tdfk (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

Moxetumomab pasudotox-tdfk (Lumoxiti) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

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.

Diagnosis Codes

C91.40

C91.42

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 5-15-2019 Adopted policy

Internal Medical Policy Committee 7-22-2020 Annual review,

Changed procedure code J9313 to precertification drug; and
Removed renal function criteria

Internal Medical Policy Committee 7-22-2021 Annual review, no clinical content change

Internal Medical Policy Committee 3-23-2022

Removed NCCN recommendations; and
Added this statement "Moxetumomab pasudotox-tdfk (Lumoxiti) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations."; and
Updated experimental/investigational statement

Internal Medical Policy Committee 3-23-2023 Annual review, no clinical content change

Links

References (PDF)

Disclaimer

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Medical Policies Quick Search

Moxetumomab Pasudotox-tdfk (Lumoxiti)

Description

Criteria

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Criteria

Procedure Codes

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer