00310-4700-XX Lumoxiti 1 mg (AstraZeneca)
Moxetumomab pasudotox-tdfk is a CD22-directed cytotoxin. Moxetumomab pasudotox-tdfk binds CD22 on the cell surface of B-cells and is internalized. Moxetumomab pasudotox-tdfk internalization results in ADP-ribosylation of elongation factor 2, inhibition of protein synthesis, and apoptotic cell death.
Moxetumomab pasudotox-tdfk for the treatment of relapsed or refractory hairy cell leukemia (HCL) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Moxetumomab pasudotox-tdfk for the treatment of other conditions/diseases is considered investigational.
Moxetumomab pasudotox-tdfk is considered medically appropriate if ALL of the following criteria are met:
Individual is 18 years of age or older
Individual is pseudomonas-immunotoxin naïve (e.g., moxetumomab pasudotox, etc.)
Individual does not have severe renal impairment defined as CrCl ≤ 29 mL/min
Diagnosis of Hairy Cell Leukemia or a HCL variant with ALL of the following:
Relapsed or refractory disease
Individual has previously failed at least TWO prior systemic therapies ANY ONE of the following:
Failure to two courses of purine analog therapy (e.g., cladribine, pentostatin, etc.)
Failure to at least one purine analog therapy AND one course of rituximab or a BRAF-inhibitor (e.g., vemurafenib, etc.)
Moxetumomab pasudotox-tdfk is NOT considered medically appropriate for renewal
|INDICATION(S)||DOSAGE & ADMINISTRATION|
Hairy Cell Leukemia (HCL)
Infuse 0.04 mg/kg intravenously on days 1, 3, and 5 of a 28-day cycle.Continue Lumoxiti for a maximum of 6 cycles or until disease progression or unacceptable toxicity.
LENGTH OF AUTHORIZATION
Coverage will be provided six months (6 cycles) and may not be renewed.
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BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, September). Moxetumomab Pasudotox-TDFK. Retrieved October 08, 2018 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Moxetumomab pasudotox-tdfk. Retrieved October 8, 2018 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2018, September). Center for Drug Evaluation and Research. Lumoxiti® (Moxetumomab Pasudotox-TDFK) for injection, for intravenous use. Retrieved October 2, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761104s000lbl.pdf.
ORIGINAL EFFECTIVE DATE: 1/31/2019
MOST RECENT REVIEW DATE: 1/31/2019
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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Maximum billable units per dose and over time by indication as a Medical Benefit