BlueCross BlueShield of Tennessee Medical Policy Manual

Mepolizumab

NDC CODE(S)

00173-0881-XX – Nucala 100 mg single dose vial (GSK)

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.

REFER TO DECISION SUPPORT TREE

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

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. (2016, October). AHFS DI. Mepolizumab. Retrieved November 9, 2016 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016, August). Mepolizumab. Retrieved November 9, 2016 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2015, November). Center for Drug Evaluation and Research. Nucala® (mepolizumab) for injection, for subcutaneous use. Retrieved November 9, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125526Orig1s000Lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2015

MOST RECENT REVIEW DATE:  12/1/2016

ID_MRx

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.

Pharmaceutical Decision Support Tree

Mepolizumab (Nucala ®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #8

  1. Is the individual 12 years if age or older with a diagnosis of severe asthma as considered by the following components of severity for classifying asthma?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for add-on treatment in individuals regularly receiving BOTH of the following?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the phenotype eosinophilic, defined as blood eosinophils >300cells/mcl within previous 12 months or 150cells/mcl within 6 weeks of dosing?

If yes, go to question #5

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1.  Has the individual had ANY ONE of the following?

If yes, go to question #6

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Will administration be by a healthcare professional with post-administration monitoring for biologic agents?

If yes, go to question #7

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 100 billable units every 28 days for dosage of 100 mg by subcutaneous administration every 4 weeks for an authorization period of six months?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial approval criteria in questions 2 through 7?

If yes, go to question #9

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity from the agent such as parasitic (helminth) infection, herpes zoster infection, headache, injection site reaction, back pain, and fatigue?

If yes, go to question #10

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Has treatment resulted in clinical improvement as documented by ANY ONE of the following?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.