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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J2000-63

Original Effective Date: 06/15/16

Reviewed: 01/11/17

Revised: 02/15/17

Subject: Reslizumab (Cinqair®) IV infusion

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Dosage/ Administration Position Statement Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates   Previous Information
           

DESCRIPTION:

Reslizumab (Cinqair), an interleukin-5 antagonist, was approved by the U.S. Food and Drug Administration (FDA) in March 2016 for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype. Reslizumab is not indicated for treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.

The safety and efficacy of reslizumab were evaluated in 2 randomized, double-blind, placebo-controlled studies (Studies I, II) 16 to 52 weeks in duration involving 953 patients age 12 years and older with asthma who were required to have a blood eosinophil count of at least 400/mcL (within 3 to 4 weeks of dosing), and at least 1 asthma exacerbation requiring systemic corticosteroid use over the past 12 months. The majority of patients (82%) were on medium-high dose inhaled corticosteroids plus a long-acting beta agonist (ICS/LABA) at baseline. Maintenance oral corticosteroids (OCS) (up to 10 mg of prednisone per day or equivalent) were allowed; 106 (11%) patients were on OCS at baseline. Reslizumab 3 mg/kg administered once every 4 weeks for a total of 13 doses was evaluated compared with placebo.

The primary endpoint for Studies I and II was the frequency of asthma exacerbations for each patient during the 52-week treatment period. An asthma exacerbation was defined as a worsening of asthma that required at least 1 of the following medical interventions: 1) Either the use of a systemic corticosteroid, or ≥ 2-fold an increase in the use of ICS for 3 or more days, and/or 2) Asthma-related emergency treatment including at least 1 of the following: an unscheduled visit to their healthcare professional for nebulizer treatment or other urgent treatment to prevent worsening of asthma symptoms; a visit to the emergency room for asthma-related treatment; or an asthma-related hospitalization.

In Studies I and II, reslizumab significantly reduced the annual rate of clinical asthma exacerbations compared with placebo (0.84 vs 1.81 events per patient/year). One or more exacerbations occurred in 32% of the reslizumab group and 50% of the placebo arm. Reslizumab produced a significantly greater change in FEV1 from baseline to week 16 (0.23 vs 0.11 L). Clinically important changes in patient-reported asthma control scores and quality of life scores were also significantly improved with reslizumab

Evidence-based practice guidelines or position statements from the American Academy of Allergy, Asthma and Immunology (AAAAI), European Respiratory Society/American Thoracic Society (ERS/ATS), Global Initiative for Chronic Obstructive Lung Disease (GOLD), and National Heart, Lung and Blood Institute (NHLBI) have not been updated to include recommendations surrounding the use of reslizumab.

POSITION STATEMENT:

Initiation of reslizumab (Cinqair) meets the definition of medical necessity when ALL of the following criteria are met:

1. Member is diagnosed with severe eosinophilic asthma

2. Member meets ONE of the following:

a. 18 years of age and older: FEV1 is less than 80% of the predicted value

b. 12 to 17 years of age: FEV1 is less than 90% of the predicted value OR FEV1/FVC ratio is less than 0.8

3. Member’s symptoms remain uncontrolled or inadequately controlled despite treatment with at least ONE of the following:

a. 12 months of high-dose inhaled corticosteroids (see table 1) used in combination with a long-acting beta agonist (e.g., formoterol fumarate (Foradil), salmeterol xinafoate (Serevent)) for a minimum of 3 months

b. 12 months of high-dose inhaled corticosteroids (see table 1) used in combination with a leukotriene modifier (e.g., montelukast, zafirlukast) for a minimum of 3 months

c. 12 months of high-dose inhaled corticosteroids (see table 1) used in combination with theophylline for a minimum of 3 months

d. 6 months of high-dose inhaled corticosteroids (see table 1) with daily oral corticosteroids used in combination with at least one additional controller medication (i.e., long-acting beta agonist, leukotriene modifier, theophylline) for a minimum of 3 months

4. Member has a history of two or more exacerbations requiring systemic glucocorticoids while being treated with a high-dose inhaled corticosteroid in the past year

5. Member’s eosinophil count is at least 150 cells/microliter during the previous six weeks OR at least 300 cells/microliter during the previous year – laboratory documentation must be provided

6. Reslizumab is prescribed by a board certified allergist, immunologist, or pulmonologist

7. Reslizumab is not used in combination with mepolizumab (Nucala) or omalizumab (Xolair)

8. Dose does not exceed 3 mg/kg every 4 weeks

9. Member is 12 years of age or older

Approval duration: 12 months

Continuation of reslizumab (Cinqair) meets the definition of medical necessity for members meeting the following criteria:

1. Authorization/reauthorization has been previously approved by Florida Blue or another health plan in the past two years for the treatment of severe eosinophilic asthma, OR the member has previously met all indication-specific initiation criteria

2. Member has a beneficial response to treatment with reslizumab as indicated by at least ONE of the following and supported by documentation from the medical record:

a. Decreased frequency of exacerbations (defined as worsening of asthma that requires an increase in inhaled corticosteroid dose or treatment with systemic corticosteroids)

b. Increase in predicted FEV1 from pretreatment baseline

c. Reduction in reported asthma-related symptoms, such as, asthmatic symptoms upon awakening, coughing, fatigue, shortness of breath, sleep disturbance, or wheezing

3. Reslizumab is not used in combination with mepolizumab (Nucala) or omalizumab (Xolair)

4. Dose does not exceed 3 mg/kg every 4 weeks

Approval duration: 12 months

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved

Dose Adjustments

Drug Availability

PRECAUTIONS:

Boxed Warning

Contraindications

Precautions/Warnings

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

J2786

Injection, reslizumab, 1 mg

ICD-10 Diagnoses Codes That Support Medical Necessity (Effective 10/01/15)

J82

Pulmonary eosinophilia, not elsewhere classified

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

Medicare Advantage: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

DEFINITIONS:

FEV1:

FVC:

PEF:

Mild Intermittent Asthma:

Mild Persistent Asthma:

Moderate Persistent Asthma:

Severe Persistent Asthma:

RELATED GUIDELINES:

09-J2000-54, Mepolizumab

OTHER:

TABLE 1
Definition of high daily dose of various inhaled corticosteroids in relation to patient age

Inhaled corticosteroid

Threshold daily dose in mcg considered as high

 

Age 6–12 years

Age >12 years

Beclomethasone dipropionate

≥ 800 (DPI or CFC MDI)

≥ 2000 (DPI or CFC MDI)

 

≥ 320 (HFA MDI)

≥ 1000 (HFA MDI)

Budesonide

≥ 800 (MDI or DPI)

≥ 1600 (MDI or DPI)

Ciclesonide

≥ 160 (HFA MDI)

≥ 320 (HFA MDI)

Fluticasone propionate

≥ 500 (HFA MDI or DPI)

≥ 1000 (HFA MDI or DPI)

Mometasone furoate

≥ 500 (DPI)

≥ 800 (DPI)

Triamcinolone acetonide

≥ 1200

≥ 2000

Notes: 1) Designation of high doses is provided from manufacturers’ recommendations where possible. 2) As chlorofluorocarbon (CFC) preparations are being taken from the market, medication inserts for hydrofluoroalkane (HFA) preparations should be carefully reviewed by the clinician for the equivalent correct dosage.

DPI: dry powder inhaler; MDI: metered-dose inhaler

REFERENCES:

  1. AHFS Drug Information. Bethesda (MD): American Society of Health-System Pharmacists, Inc; 2016 [cited 1/3/17]. In: STAT! Ref Online Electronic Medical Library [Internet]. Available from: http://online.statref.com/.
  2. Akinbami LJ, Moorman JE, Bailey C, et al. Trends in asthma prevalence, health care use, and mortality in the United States, 2001–2010. National Center for Health Statistics (NCHS) Data Brief No.94; May 2012. Hyattsville, MD: National Center for Health Statistics. Available at: http://www.cdc.gov/nchs/data/databriefs/db94.htm. Accessed on November 4, 2015.
  3. American Academy of Allergy Asthma and Immunology (AAAAI). AAAAI allergy & asthma medication guide. Available at: http://www.aaaai.org/conditions-and-treatments/treatments/drug-guide/inhaled-corticosteroids.aspx. Accessed on September 12, 2015
  4. American Academy of Allergy Asthma and Immunology (AAAAI). Conditions and treatments. Asthma. Available at: http://www.aaaai.org. Accessed on November 4, 2015.
  5. Assa'ad AH, Gupta SK, Collins MH, et al. An antibody against IL-5 reduces numbers of esophageal intraepithelial eosinophils in children with eosinophilic esophagitis. Gastroenterology. 2011; 141:1593.
  6. Bradding P. Asthma: eosinophil disease, mast cell disease, or both? Allergy, Asthma, and Clinical Immunology. 2008; (4)2:84-90.
  7. British Thoracic Society and Scottish Intercollegiate Guidelines Network (BTS/SIGN) national clinical guideline on management of asthma.
  8. Castro M, Zangrilli J, Wechsler ME, et al. Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet Respir Med. May 2015;3(5):355-366.
  9. Centers for Disease Control and Prevention (CDC). Asthma FastStats. May 2015. Available at: http://www.cdc.gov/nchs/fastats/asthma.htm.
  10. Chung KF, Wenzel SE, Brozek JL, et al. International European Respiratory Society/American Thoracic Society guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014; 43(2):343-373.
  11. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2016 [cited 1/3/17]. Available from: http://www.clinicalpharmacology.com/.
  12. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine; 2000 Feb 29 - [cited 1/3/17]. Available from: http://clinicaltrials.gov/.
  13. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 1/3/17]. Available from: http://www.thomsonhc.com/.
  14. European Respiratory Society/American Thoracic Society (ERS/ATS) guideline on definition, evaluation, and treatment of severe asthma. Eur Respir J 2014 Feb;43(2):343.
  15. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention, Global Initiative for Asthma (GINA) 2015. Available at: http://www.ginasthma.org. Accessed on November 4, 2015.
  16. Joint Task Force on Practice Parameters, American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology and Joint Council of Allergy, Asthma and Immunology. Attaining optimal asthma control: a practice parameter. J Allergy Clin Immunol. 2005; 116(5):S3-S11.
  17. National Asthma Education and Prevention Program (NAEPP). Expert Panel Report 3: Guidelines for the diagnosis and management of asthma. NIH Publication Number 08-5846. Updated August 5, 2008. Available at: http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm. Accessed on November 4, 2015.
  18. National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138.
  19. National Heart, Lung and Blood Institute/National Asthma Education and Prevention Program (NHLBI/NAEPP). Guidelines for the Diagnosis and Management of Asthma (EPR-3). 2007. Available here: http://www.nhlbi.nih.gov/health-pro/guidelines/current/asthma-guidelines
  20. National Heart, Lung, and Blood Institute (NHLBI). National Institutes of Health (NIH). Health information for the public. Lung diseases. Available at: http://www.nhlbi.nih.gov/health/. Accessed on November 4, 2015.
  21. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2015 [cited 1/3/17]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.
  22. Otani IM, Anilkumar AA, Newbury RO, et al. Anti-IL-5 therapy reduces mast cell and IL-9 cell numbers in pediatric patients with eosinophilic esophagitis. J Allergy Clin Immunol. 2013; 131(6):1576-1582.
  23. Spergel JM, Rothenberg ME, Collins MH, et al. Reslizumab in children and adolescents with eosinophilic esophagitis: results of a double-blind, randomized, placebo-controlled trial. J Allergy Clin Immunol. Feb 2012;129(2):456-463, 463 e451-453. PMID
  24. Teva. Cinqair (reslizumab) injection. 2016. [cited 2016-09-26]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=053b9158-2a5b-48b9-bf47-5fa78a35ec33.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 01/11/17.

GUIDELINE UPDATE INFORMATION:

06/15/16

New Medical Coverage Guideline.

07/15/16

Revision to Position Statement.

10/01/16

Revision: New HCPCS code C9481 added.

01/01/17

Revision: added HCPCS code J2786.

02/15/17

Review and revision; updated references.

Date Printed: August 22, 2017: 07:04 AM