59310-0610-XX CINQAIR 10MG/ML Solution (TEVA RESPIRATORY)
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.
Reslizumab for the treatment of asthma is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Reslizumab for the treatment of other conditions/diseases is considered investigational.
Reslizumab is considered medically appropriate if ANY ONE of the following:
Diagnosis of asthma if ALL of the following criteria are met:
Individual is 18 years of age or older
Must not be used in combination with another monoclonal antibody (e.g., benralizumab, mepolizumab, omalizumab, etc.)
Disease is severe as classified by any of the following components of severity (not all inclusive):
Symptoms throughout the day
Nighttime awakenings often 7x/week
SABA use for symptom control occurs several times per day
Extremely limited normal activities
Lung function (percent predicted FEV1) <60%
Exacerbations requiring oral systemic corticosteroids are generally more frequent and intense relative to mild or moderate asthma
Eosinophilic phenotype indicated by blood eosinophils ≥ 400 cells/μL within 4 weeks of dosing
Must be used for add-on maintenance treatment in an individual regularly receiving both medium to high-dose inhaled corticosteroids PLUS another controller medication (e.g., long acting beta agonist, leukotriene modifiers, etc.)
two or more exacerbations in the previous year requiring
daily oral corticosteroids for at least 3 days (in addition to
the regular maintenance therapy defined above)
Will not be used for treatment of eosinophilic conditions (other than indicated), acute bronchospasm, or status asthmaticus
Baseline measurement of at least one of the following for assessment of clinical status:
Use of systemic corticosteroids
Use of inhaled corticosteroids
Number of hospitalizations, ER visits, or unscheduled visits to healthcare provider due to condition
Forced expiratory volume in 1 second (FEV1)
Reslizumab is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: malignancy, parasitic (helminth) infection, and anaphylaxis
Treatment has resulted in clinical benefit, including, but not limited to:
Improvement in asthma symptoms or asthma exacerbations as evidenced by decrease in one or more of the following:
Use of systemic corticosteroids
Two-fold or greater decrease in inhaled corticosteroid use for at least 3 days
Unscheduled visits to healthcare provider
Improvement from baseline in forced expiratory volume in 1 second (FEV1)
DOSAGE & ADMINISTRATION
Severe Asthma with an eosinophilic phenotype
3 mg/kg via IV infusion every 4 weeks
LENGTH OF AUTHORIZATION
Coverage will be provided for six months and may be renewed.
Refer to DOSAGE LIMITS below
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.
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).
Chung, K. F., Wenzel, S. E., Brozek, J. L., Bush, A., Castro, M., Sterk, P. J., et al. (2014) International ERS/ATS Guidelines on Definition, Evaluation, and Treatment of Severe Asthma. European Respiratory Journal 43 (2) 343-373. Retrieved October, 2019 from https://erj.ersjournals.com/content/43/2/343.long
Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention. 2020 Available from: www.ginasthma.org. Accessed October 26, 2020.
Lexi-Comp Online. (2020, March). AHFS DI. Reslizumab. Retrieved October 26, 2020 from Lexi-Comp Online with AHFS-DI.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2019, November). Reslizumab. Retrieved October 26, 2020 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2019, January). Center for Drug Evaluation and Research. Cinqair® (reslizumab) injection, for intravenous use. Retrieved October 26, 2020 fromhttp://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761033lbl.pdf.
ORIGINAL EFFECTIVE DATE: 4/6/2016
MOST RECENT REVIEW DATE: 3/2/2021
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.