BlueCross BlueShield of Tennessee Medical Policy Manual

Mepolizumab

NDC CODE(S)

00173-0881-XX Nucala 100 MG SOLR (GLAXO SMITH KLINE)

DESCRIPTION

Mepolizumab is a monoclonal antibody which is an antagonist for interleukin-5 (IL-5), the major cytokine responsible for the growth and activity of eosinophils.  Eosinophils, along with multiple other cell types such as mast cells, neutrophils, macrophages, lymphocytes and mediators such as histamine, leukotrienes and cytokines are involved in inflammation.  By blocking the signalling activity of IL-5 on eosinophils with mepolizumab, the inflammation component of asthma has been found to be diminished, although the exact mechanism is not definitively understood.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Severe Asthma - eosinophilic phenotype

100 mg administered subcutaneously, by a healthcare professional, every 4 weeks

Eosinophilic Granulomatosis with Polyangiitis

300 mg administered once every 4 weeks by subcutaneously as 3 separate 100-mg injections. Administer each injection at least 2 inches apart.

LENGTH OF AUTHORIZATION

Coverage is provided for six months and is eligible for renewal.

Click here to view DOSAGE LIMITS  

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

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.

IMPORTANT REMINDER

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.

ADDITIONAL INFORMATION

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).

No controlled studies were found in the published literature that validate the use of mepolizumab for the treatment of other conditions or diseases.

SOURCES

Lexicomp Online. (2017, March). AHFS DI. Mepolizumab. Retrieved January 23, 2018 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2017, December). Mepolizumab. Retrieved January 23, 2018 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2017, December). Center for Drug Evaluation and Research. Nucala® (mepolizumab) for injection, for subcutaneous use. Retrieved January 23, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125526s004Lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2015

MOST RECENT REVIEW DATE:  4/10/2018

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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.

This document has been classified as public information.

 

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit

DIAGNOSIS

BILLABLE UNIT

MAXIMUM UNITS

Severe Asthma with an eosinophilic phenotype

1 billable unit = 1 mg

100 mg (billable units) every 28 days

Eosinophilic Granulomatosis with Polyangiitis  (EGPA)

1 billable unit = 1 mg

300 mg (billable units) every 28 days