00173-0881-XX Nucala 100 MG SOLR (GLAXO SMITH KLINE)
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.
Mepolizumab for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Eosinophilic Granulomatosis with Polyangiitis (EGPA)
Mepolizumab for the treatment of other conditions/diseases is considered investigational.
Mepolizumab is considered medically appropriate if ANY ONE of the following criteria are met:
Diagnosis of asthma with ALL of the following:
Individual is 12 years of age or older
Disease is considered severe by ANY ONE of the following components of severity for classifying asthma:
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
Use is for add-on maintenance treatment in individuals regularly receiving BOTH of the following:
High-dose inhaled corticosteroids
An additional controller medication (e.g., long-acting beta agonist, etc.)
Phenotype is eosinophilic defined as blood eosinophils >300cells/mcl within previous 12 months or 150cells/mcl within 6 weeks of dosing
Individual must have ANY ONE of the following:
Two or more exacerbations in the previous year
Require daily oral corticosteroids (in addition to the regular maintenance therapy defined above)
Diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA) with ALL of the following:
Individual must be at least 18 years of age or older
Individual has a confirmed diagnosis of EGPA (aka Churg-Strauss Syndrome) defined by the following:
History or presence of asthma
Blood eosinophil level of 10% or an absolute count >1000 cells/mm3
Two or more of the following criteria:
Histopathologic evidence of eosinophilic vasculitis, perivascular eosinophilic infiltration or eosinophil rich granulomatous inflammation
Antineutrophil Cytoplasmic Antibody (ANCA) positivity
Individual must have blood eosinophils >150 cells/μL within 6 weeks of dosing
Individual has been on stable doses of concomitant oral corticosteroid therapy for at least 4 weeks (i.e. prednisone or prednisolone at a dose of 7.5 mg/day)
Physician has assessed baseline disease severity utilizing an objective measure/tool
Mepolizumab 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 agent such as parasitic (helminth) infection, herpes zoster infection, severe hypersensitivity reactions, etc.
For a diagnosis of ANY ONE of the following:
Severe asthma treatment has resulted in clinical improvement as documented by ANY ONE of the following:
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)
Eosinophilic Granulomatosis with Polyangiitis disease response as indicated by improvement in signs and symptoms compared to baseline as evidenced in one or more of the following:
Individual is in remission [defined as a Birmingham Vasculitis Activity Score (BVAS) score=0 and a prednisone/prednisolone daily dose of ≤ 7.5 mg]
Decrease in maintenance dose of systemic corticosteroids
Improvement in BVAS score compared to baseline
Improvement in asthma symptoms or asthma exacerbations
Improvement in duration of remission or decrease in the rate of relapses
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.
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).
No controlled studies were found in the published literature that validate the use of mepolizumab for the treatment of other conditions or diseases.
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
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