BlueCross BlueShield of Tennessee Medical Policy Manual

Reslizumab

NDC CODE(S)

59310-0610-XX – Cinqair 100 mg/10 mL single-use vial (Teva)

DESCRIPTION

Reslizumab is an interleukin-5 antagonist (IgG4, kappa) monoclonal antibody.  Interleukin-5, or IL-5, is the cytokine responsible for the life cycle of eosinophils.  By binding to IL-5, reslizumab blocks their bioactivity and reduces their production and survival.  One of their roles is in that of the process of inflammation, an important component in the pathogenesis of asthma.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Severe Asthma with an eosinophilic phenotype

3 mg/kg via IV infusion 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 reslizumab for the treatment of other conditions or diseases

SOURCES

Lexi-Comp Online. (2016, October). AHFS DI. Reslizumab. Retrieved November 21, 2016 from Lexi-Comp Online with AHFS-DI.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016, August). Reslizumab. Retrieved November 21, 2016 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2016, March). Center for Drug Evaluation and Research. Cinqair® (reslizumab) injection, for intravenous use. Retrieved November 21, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761033lbl.pdf.

ORIGINAL EFFECTIVE DATE:  4/6/2016

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

Reslizumab (Cinqair ®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #7

  1. Is the individual 18 years old or older with a diagnosis of severe asthma as classified by components of ANY ONE of the following?

If yes, go to question #3

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

  1. Does the individual have asthma of the eosinophilic phenotype indicated by blood eosinophils ≥ 400 cells/μL?

If yes, go to question #4

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

  1. Is the agent to be used for add-on maintenance treatment in an individual regularly receiving medium to high-dose inhaled corticosteroids PLUS another controller medication (e.g., long acting beta-2 agonist, leukotriene receptor antagonist, etc.)?

If yes, go to question #5

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

  1. Has the individual had at least 1 asthma exacerbation requiring systemic corticosteroid use over the past 12 months

If yes, go to question #6

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

  1. Is the request for 700 billable units every 14 days for dosage of up to 60 units/kg every other week as a 60 to 120 minute intravenous infusion in an authorization for 12 months with possible renewal?

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 6?

If yes, go to question #8

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

  1. Is there absence of unacceptable toxicity from the drug such as oropharyngeal pain, malignancy, helminth infection, and anaphylaxis?

If yes, go to question #9

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

  1. Has treatment resulted in clinical benefit, including, but not limited to:

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.