Combination Beta2-Agonist/Corticosteroid Inhalers

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1 Combination Beta2-Agonist/Corticosteroid Inhalers Policy Number: Last Review: 7/2017 Origination: 6/2014 Next Review: 7/2018 LoB: ACA Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for the combination beta2- agonist/corticosteroid inhalers when it is determined to be medically necessary because the following criteria are met. The affected products are: Advair Diskus (fluticasone propionate/salmeterol inhalation powder GlaxoSmithKline) Advair HFA (fluticasone propionate/salmeterol inhalation aerosol GlaxoSmithKline) AirDuo RespiClick (fluticasone propionate/salmeterol inhalation powder Teva; authorized generic available) Breo Ellipta (fluticasone furoate/vilanterol inhalation powder GlaxoSmithKline) Dulera (mometasone furoate/formoterol fumarate inhalation aerosol Merck) Symbicort (budesonide/formoterol fumarate inhalation aerosol AstraZeneca) When Policy Topic is covered Coverage of Advair Diskus, Advair HFA, AirDuo, Breo Ellipta, Dulera, or Symbicort is recommended in those who meet the following criteria: FDA-Approved Indications 1. Asthma/Reactive Airway Disease. Approve. Advair Diskus, Advair HFA, Breo Ellipta, Dulera, and Symbicort are indicated for the treatment of asthma Chronic Obstructive Pulmonary Disease (COPD). Approve. Advair Diskus, Breo Ellipta, and Symbicort are indicated for the maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. 1,3,5 Advair Diskus and Breo Ellipta are also indicated for the reduction of exacerbations in patients with COPD who have a history of exacerbations. 1,5 Advair HFA and Dulera are not FDA-approved for the treatment of COPD; however, both products have been studied for this use. 2,4,13-14 Additionally, the 2015 GOLD guidelines for the diagnosis, management, and prevention of COPD support the use of combination LABA/ICS therapy for some patients. 8 The GOLD guidelines refer to the combination ICS/LABA inhalers as a class and state that this therapy is more effective than the individual components in reducing exacerbations and improving lung function and health status in patients with moderate to very severe COPD. Other Uses with Supportive Evidence 3. Chronic Bronchitis. Approve.

2 According to ACCP guidelines, a LABA in combination with an ICS can be used to control chronic cough in stable patients with chronic bronchitis. 11 In patients with COPD, chronic bronchitis may be present. 8 Advair Diskus, Breo Ellipta, and Symbicort are indicated for the maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. 1,3,5 There are data to support the use of Advair HFA and Dulera in patients with COPD (including chronic bronchitis) as well Emphysema. Approve. COPD includes the terms chronic bronchitis and emphysema. 8 Emphysema defines the disease in terms of anatomic pathology. Advair Diskus, Symbicort, and Breo Ellipta are indicated for the maintenance treatment of airflow obstruction in patients with COPD including chronic bronchitis and emphysema. 1,3,5 There are data to support the use of Advair HFA and Dulera in patients with COPD (including emphysema) as well Postinfectious Cough (i.e., cough persisting after an acute respiratory infection has resolved). Approve for 2 months. Subacute postinfectious cough may have multiple possible underlying etiologies, including asthma The underlying cause of the cough must be determined before making therapeutic decisions. In this situation, ICS/LABA combination therapy may be used as diagnostic empiric therapy in determining the cause of cough (i.e., rule out asthma). When a patient with subacute cough presents with wheezes, rhonchi, or crackles with a normal chest radiograph, it may be a reasonable option to consider therapy with an inhaled bronchodilator and ICS. If cough following an URTI persists for > 8 weeks, diagnoses other than postinfectious cough should be considered. In the professional opinion of specialist physicians, this criterion has been adopted. When Policy Topic is not covered Coverage of Advair Diskus, Advair HFA, Breo Ellipta, Dulera, or Symbicort, is recommended in circumstances that are listed in the Recommended Authorization Criteria (FDA-Approved Indications and Other Uses with Supportive Evidence). The following provides rationale for specific Exclusions. This is not an exhaustive list of Exclusions. Non-covered indications would be investigational. 1. Treatment of Symptoms Associated with a Current Rhinovirus Infection/Cough Associated with a Current Episode of the Common Cold. There are no data to support the use of ICS/LABA combination therapy in treating this condition. The ACCP guidelines do not recommend using an ICS or a bronchodilator in treating this condition Treatment of Chronic Cough due to Gastroesophageal Reflux Disease (GERD). There are no data to support the use of ICS/LABA combination therapy in treating this condition. The ACCP recommended treatment for chronic cough due to GERD is treatment of the underlying GERD condition Treatment of Symptoms due to an Acute Respiratory Infection (e.g., acute bronchitis, sinusitis, pneumonia). (Note: an acute exacerbation of chronic bronchitis is not the same as acute bronchitis). In most patients with uncomplicated acute bronchitis, bronchial hyperresponsiveness is related to the acute infection and will resolve spontaneously. 10 The ACCP guidelines state that in most patients with a diagnosis of acute bronchitis, bronchodilators should not be routinely used to treat cough; however, in certain patients with acute bronchitis in which wheezing in addition to cough is present, a beta-agonist bronchodilator may be useful. 11 Because the inflammation process in acute bronchitis is transient and typically resolves soon after the infection clears, the ACCP guidelines do not recommend using an ICS in treating acute bronchitis. Bronchodilators are not a recommended therapeutic option in treating cough associated with acute bacterial sinusitis. 12 When a patient with subacute cough presents with wheezes, rhonchi, or crackles with a normal chest radiograph, it is a reasonable option to consider therapy with an

3 inhaled bronchodilator and corticosteroids; ICSs and bronchodilators are not recommended therapeutic options in patients with an abnormal chest radiograph. There are no data to support the use of ICS/LABA combination therapy in treating these conditions. 4. Treatment of Chronic Cough due to Non-Asthmatic Eosinophilic Bronchitis (NAEB). There are no data to support the use of ICS/LABA combination therapy in treating this condition. ICSs are first-line treatment for NAEB. 11 One of the diagnostic factors used in establishing NAEB is no evidence of variable airflow obstruction or airway hyperresponsiveness. As a result, beta-agonist bronchodilators would not be expected to be useful in treating this condition. 5. Treatment of Chronic Cough due to Bronchiolitis. The ACCP guidelines do not recommend bronchodilators as a therapeutic option in treating bronchiolitis. 11 Guidelines from the American Academy of Pediatrics regarding the diagnosis and management of bronchiolitis, most recently revised in 2014, do not recommend inhaled corticosteroids or bronchodilators be routinely used in the management of bronchiolitis Treatment of Chronic Cough due to Bronchiectasis. There are no data to support the use of ICS/LABA combination therapy in treating this condition. Limited data are available with budesonide/formoterol (foreign formulation of Symbicort) for the treatment of non-cystic fibrosis (CF) bronchiectasis. 16 In patients with bronchiectasis with airflow obstruction and/or bronchial hyperreactivity, bronchodilators may be of benefit. 11,17 However, the ACCP guidelines and the British Thoracic Society (BTS) guidelines for non-cf bronchiectasis do not recommend treatment with corticosteroids. There may be a role for combination ICS/LABA therapy in patients with coexisting asthma, but there is no evidence to support this therapy in patients without asthma Whooping Cough/Pertussis. There are no data to support the use of ICS/LABA combination therapy in treating this condition. According to the ACCP guidelines, LABAs and corticosteroids should not be offered to patients with whooping cough as there is no evidence to suggest benefit. 11 Although short-acting beta-agonists (along with other treatments) have been proposed as standard treatment for whooping cough, one review article reported that treatment with the short-acting SABA salbutamol resulted in no change in coughing ACE Inhibitor-Induced Cough. There are no data to support the use of ICS/LABA combination therapy in treating this condition. Discontinuation of the ACE inhibitor is the only uniformly effective treatment for ACE inhibitor-induced cough. In those patients in whom the ACE inhibitor cannot be discontinued, pharmacologic therapy aimed at suppressing cough should be attempted. ICSs and beta-agonists are not recommended therapeutic options Psychogenic Cough/Habit Cough/Tic Cough. There are no data to support the use of ICS/LABA combination therapy in treating these conditions. Non-pharmacological therapies, such as behavior modification, hypnosis and psychiatric therapy are the mainstays of treatment. 11, Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria. Criteria will be updated as new published data are available. Considerations Combination Beta2-Agonist/Corticosteroid Inhalers require prior authorization through the pharmacy services department. This Blue Cross and Blue Shield of Kansas City policy Statement was developed using available resources such as, but not limited to: Food and Drug Administration (FDA) approvals, Facts and Comparisons, National specialty guidelines, Local medical policies of other health plans, Medicare (CMS), Local providers.

4 Description of Procedure or Service Advair Diskus, Advair HFA, Breo Ellipta, Dulera, and Symbicort are inhaled corticosteroid (ICS) and long-acting beta-agonist (LABA) combination products that exert local anti-inflammatory effects in the lungs and produce bronchial smooth muscle relaxation. 1-5 They are indicated for the treatment of respiratory conditions, such as chronic obstructive pulmonary disease (COPD) and asthma. None of the ICS/LABA combination products are indicated for the relief of acute bronchospasm; the Food and Drug Administration (FDA)-approved indications are in Table 1. Table 1. FDA-Approved Indications. 1-5 Brand (generic) COPD * Reduction of COPD Exacerbati ons Asthma (patients 18 years of age) Asthma (patients 12 to 17 years of age) Asthma (patients 4 to 12 years of age) Advair Diskus (fluticasone propionate and X X X X X salmeterol inhalation powder) Advair HFA (fluticasone propionate and X X -- salmeterol inhalation aerosol) Breo Ellipta (fluticasone furoate and vilanterol X X X inhalation powder) Dulera (mometasone furoate and formoterol X X -- fumarate inhalation aerosol) Symbicort (budesonide and formoterol fumarate inhalation aerosol) X -- X X -- FDA Food and Drug Administration; COPD Chronic obstructive pulmonary disease; * Maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema; In patients with a history of chronic obstructive pulmonary disease exacerbations; -- Not indicated for the condition. For the treatment of asthma, a low-dose ICS is the preferred first-line controller agent. 6 When a medium-dose ICS fails to achieve good asthma control, a LABA is the preferred-add-on medication. In this patient population, LABAs should only be used in combination with ICSs for long-term control and prevention of symptoms and should not be used as monotherapy. In contrast, short-acting betaagonists (SABAs) are indicated for the treatment of intermittent episodes of bronchospasm and are the therapy of choice for the treatment of acute symptoms such as cough, chest tightness, and wheezing. 6-7 In patients with COPD, combination maintenance therapy with an ICS and LABA is one of the initial options for pharmacologic therapy for all patients at a high risk for COPD exacerbations according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (2015). 8 The ICS/LABA combination products may also be used alone or in combination with an inhaled long-acting muscarinic

5 antagonist (LAMA) or a phosphodiesterase-4 inhibitor in highly-symptomatic patients at a high risk for exacerbations. Monotherapy with ICSs is not recommended in patients with COPD. Symptoms associated with several respiratory conditions may overlap with symptoms observed in asthma and COPD. For example, the obstructive symptoms of acute bronchitis are very similar to those of mild asthma. 10 Thus, it has been hypothesized that bronchodilating agents may provide symptomatic relief in patients with bronchitis. The few randomized, placebo-controlled trials that have examined the effect of beta-agonists for cough associated with acute bronchitis have involved small numbers of patients and have had mixed results. In these studies, daily cough scores and the likelihood of persistent cough after 7 days did not differ significantly between the active treatment and placebo groups in patients without preexisting lung disease. Even among patients with airflow obstruction, the potential benefit of beta-agonists is not well supported and should be balanced against the adverse events (AEs) related to treatment. Therefore, in patients who wheeze or have troublesome cough, therapy with an inhaled beta-agonist for 1 to 2 weeks can be considered. 10 In addition, an inflammatory response may be mounted in cases of bacterial or viral respiratory tract infection. In some cases it may be appropriate to treat both the inflammatory process as well as symptoms of bronchoconstriction (e.g., coughing, wheezing) in non-asthmatic respiratory conditions. The delay in onset of action with ICS therapy (usually 1 to 2 weeks) likely precludes a major benefit in treating acute respiratory conditions clinically known to resolve with time. Due to the acute nature of many of these processes, an ICS in combination with a SABA would be appropriate. Rationale In 2006, the American College of Chest Physicians (ACCP) published evidence-based clinical practice guidelines for the diagnosis and management of cough associated with several respiratory conditions; these guidelines have also been endorsed by the American Thoracic Society. 11 According to the guidelines, in addition to the respiratory conditions asthma and COPD, an ICS in combination with a LABA may be offered in treating stable patients with chronic cough due to chronic bronchitis. The combination of an ICS and a LABA or LABA monotherapy are not recommended for the treatment of cough for any other respiratory condition commonly associated with chronic cough. Estimation of duration of cough is the first step in identifying the underlying diagnosis. Duration of cough is often divided into three categories: acute cough (defined as cough present for less than 3 weeks), subacute cough (defined as cough lasting 3 weeks or greater but less than 8 weeks), and chronic cough (defined as cough lasting longer than 8 weeks). 12 It has also been proposed that cough persisting longer than 3 weeks be referred to as chronic cough. 10 Diagnostic considerations in patients with chronic cough differ from those in patients with a cough lasting less than 3 weeks. The most common causes of acute cough are upper respiratory tract infections (URTIs), such as the common cold, acute bacterial sinusitis, pertussis, exacerbations of COPD, allergic rhinitis, and rhinitis due to environmental irritants. For a cough that began with an URTI and has lasted for 3 to 8 weeks, the most common causes are postinfectious cough, bacterial sinusitis, and asthma. 12 Postinfectious cough is defined as cough with or without transient bronchial hyperresponsiveness that begins with an acute URTI uncomplicated by pneumonia that ultimately resolves without treatment. When a patient with subacute cough presents with wheezes, rhonchi, or crackles with a normal chest radiograph, it is a reasonable option to consider therapy with an inhaled bronchodilator and ICSs. Overall, trials of empiric therapies along with some laboratory testing are recommended in establishing a diagnosis in subacute cough. Most cases of chronic cough can be attributed to only a few diagnoses. Approximately 95% of cases of chronic cough are a result of upper airway cough syndrome (formerly referred to as postnasal drip syndrome), asthma, gastroesophageal reflux disease (GERD), chronic bronchitis, bronchiectasis, non-asthmatic eosinophilic bronchitis (NAEB), or an angiotensin converting enzyme (ACE) inhibitor. References 1. Advair Diskus [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; November 2014.

6 2. Advair HFA [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; November Symbicort [prescribing information]. Wilmington, DE: AstraZeneca; May Dulera [prescribing information]. Whitehouse Statin, NJ: Merck, Sharpe, & Dohme Corp., a subsidiary of Merck & Co, Inc.; January Breo Ellipta inhalation powder [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; April Global Initiative for Asthma. Global strategy for asthma management and prevention. Updated April Accessed on August 3, Available at: 7. National Institutes of Health. National Heart, Lung, and Blood Institute. National Asthma Education and Prevention Program Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Full Report Accessed on August 3, Available at: 8. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated January Accessed on August 3, Available at: 9. Wenzel RP, Fowler AA. Acute bronchitis. N Engl J Med. 2006;355: Gonzales R, Sande MA. Uncomplicated acute bronchitis. Ann Intern Med. 2000;133: Irwin RS, Baumann MH, Boulet LP, et al. Diagnosis and management of cough executive summary: ACCP evidence-based clinical practice guidelines. Chest. 2006;129(1 Supplement):1S- 23S. 12. Irwin RS, Madison JM. The diagnosis and treatment of cough. N Engl J Med. 2000;343(23): Tashkin DP, Doherty DE, Kerwin E, et al. Efficacy and safety characteristics of mometasone furoate/formoterol fumarate fixed-dose combination in subjects with moderate to very severe COPD: findings from pooled analysis of two randomized, 52-week placebo-controlled trials. Int J Chron Obstruct Pulmon Dis. 2012;7: Koser A, Westerman J, Sharma S, et al. Safety and efficacy of fluticasone propionate/salmeterol hydrofluoroalkane 134a metered-dose-inhaler compared with fluticasone propionate/salmeterol diskus in patients with chronic obstructive pulmonary disease. Open Respir Med J. 2010;4: Ralston SL, Lieberthal AS, Meissner HC, et al. Clinical practice guidelines: the diagnosis, management, and prevention of bronchiolitis. Pediatrics. 2014;134(5):e1474-e Martinez-Garcia MA, Soler-Cataluna JJ, Catalan-Serra P, et al. Clinical efficacy and safety of budesonide-formoterol in non-cystic fibrosis bronchiectasis. Chest. 2012;141: Pasteur MC, Bilton D, Hill AT, et al. British Thoracic Society guideline for non-cf bronchiectasis. Thorax. 2010;65(suppl 1):i1-i Pillay V, Swingler G. Symptomatic treatment of the cough in whooping cough. Cochrane Database Syst Rev. 2003;(4):CD Vertigan AE, Murad MH, Pringsheim T, et al. Somatic cough syndrome (previously referred to as psychogenic cough) and tic cough (previously referred to as habit cough) in adults and children. CHEST guideline and expert panel report. Chest. 2015;148: Other References Utilized Goyal V, Chang AB. Combination inhaled corticosteroids and long-acting beta 2 -agonists for children and adults with bronchiectasis. Cochrane Database Syst Rev. 2014;(6):CD Irwin RS, French CT, Lewis SZ, et al. Overview of the management of cough. CHEST guidelines and expert panel report. Chest. 2014;146(4): Billing Coding/Physician Documentation Information NA Pharmacy Benefit Additional Policy Key Words Policy Number:

7 Policy Implementation/Update Information 06/2014 New Policy titled Combination Beta2-Agonist/Corticosteroid Inhalers 07/2015 Annual revision no changes made 07/2016 Annual Revision- no changes to policy statement 07/2017 Annual Revision- no changes to policy statement 07/2018 Annual review no changes to policy State and Federal mandates and health plan contract language, including specific provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The medical policies contained herein are for informational purposes. The medical policies do not constitute medical advice or medical care. Treating health care providers are independent contractors and are neither employees nor agents Blue KC and are solely responsible for diagnosis, treatment and medical advice. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, photocopying, or otherwise, without permission from Blue KC.