Combination Beta2-Agonist/Corticosteroid Inhalers Policy Number: Last Review: Origination: Next Review: Policy When Policy Topic is covered:

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1 Combina ation Beta2-Agonist/Corticosteroid Inhalers Policy Number: Origination: 06/2014 Last Review: 07/2014 Next Review: 07/2015 Policy BCBSKC will provide coverage for the combination beta2-agonist/corticosteroid inhalers (Advair, Advair HFA, Breo, Dulera, Symbicort) when it is determined to be medically necessary because the following criteria are met. When Policy Topic is covered: Coverage of Advair Diskus, Advair HFA, Breo who meet the following criteria: Ellipta, Dulera, or Symbicort is recommended in those Food and Drug Administration (FDA)-Approved Indications 1. Asthma/Reactive Airway Disease. Approve. Advair Diskus, Advair HFA, Dulera, and Symbicort aree indicated for the treatment of asthma. 1-4 While Breo Ellipta is not currently indicated for the treatment of asthma, it has been studied for this use COPD. Approve. Advair Diskus and Breo Ellipta are indicated for the maintenance treatment of airflow obstruction in patients with COPD associated with chronic bronchitiss and for the reduction of exacerbations in patients with COPD who have a history of exacerbations. 1,5 Symbicort is indicatedd for the maintenance treatment of airflow obstruction in patients with COPD including chronic bronchitis and emphysema. 3 Advair HFA and Dulera are not indicated for COPD. 2,,4 However, the 2013 Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for the diagnosis, management, and preventionn of COPD support the use of combination LABA/ICS therapy for some patients. 15 The GOLD guidelines state combination LABA/ICS therapy is more effective than the individual components in reducing exacerbations and improving lung functionn and health status. The 2004 American Thoracic Society and the European Respiratory Society standards for the diagnosis and management of patients with COPD also recommend the combination of an inhaled LABA/ICS for some patients. 16 Other Uses with Supportive Evidence 3. Chronic Bronchitis. Approve. 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. 16 Advair Diskus is indicated for COPD associated with chronic bronchitis. 1 Breo Ellipta and Symbicort are indicated for the maintenance e treatment of airflow obstruction in patients with COPD 3,5 including chronic bronchitis and emphysema.

2 4. Emphysema. Approve. COPD includes the terms chronic bronchitis and emphysema. 16 Emphysema defines the disease in terms of anatomic pathology. Symbicort and Breo Ellipta are indicated for the maintenance treatment of airflow obstruction in patients with COPD including chronic bronchitis and emphysema. 3,5 5. 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 corticosteroids. 12 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. 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. 8,11 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 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

3 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, released in 2006, do not recommend corticosteroid medications 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 bronchiectasis. 18 In patients with bronchiectasis with airflow obstruction and/or bronchial hyperreactivity, bronchodilators may be of benefit. 11 However, the ACCP guidelines do not recommend treatment with corticosteroids. 7. 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 betaagonist 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. Behavior modification and psychiatric therapy are the mainstays of treatment. 11 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: Hayes Medical Technology Directory, Food and Drug Administration (FDA) approvals, Facts and Comparisons, National specialty guidelines, Local medical policies of other health plans, Medicare (CMS), Local providers. Description of Procedure or Service Advair Diskus, Advair HFA, Breo Ellipta, Dulera, and Symbicort are combination inhaled corticosteroid (ICS) and long-acting beta-agonist (LABA) products. 1-5 Advair Diskus is indicated for the long-term maintenance treatment of asthma in patients 4 years of age, for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis, and for the reduction of exacerbations in patients with COPD who have a history of exacerbations. 1 Advair HFA is indicated for the long-term maintenance treatment of asthma in patients 12 years of age. 2 Symbicort is indicated for the long-term maintenance treatment of asthma in patients 12 years of age and for the maintenance treatment of airflow obstruction in patients with COPD including chronic bronchitis and emphysema. 3 Dulera is indicated for the treatment of asthma in patients 12 years of age. 4 Breo Ellipta is indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema,

4 and to reduce exacerbations of COPD in patients with a history of exacerbations. 5 combination products are indicated for the relief of acute bronchospasm. 1-4 None of these Rationale In the treatment of asthma, LABAs should be used concomitantly with ICSs for long-term control and prevention of symptoms but should not be used as monotherapy. 6 In contrast, short-acting betaagonists 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 ICSs treat the inflammatory process while inhaled beta-agonists prevent and treat bronchial smooth muscle constriction. Symptoms associated with several respiratory conditions may overlap with symptoms seen in asthma and COPD. For example, the obstructive symptoms of acute bronchitis are very similar to those of mild asthma. Thus, it has been hypothesized that bronchodilating agents may provide symptomatic relief in patients with bronchitis. 8 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. 9 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 effects of 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 short-acting beta-agonist would be appropriate. 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 these 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 corticosteroids. 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.

5 References: 1. Advair Diskus [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; September Advair HFA [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; June Symbicort [prescribing information]. Wilmington, DE: AstraZeneca; June Dulera [prescribing information]. Whitehouse Statin, NJ: Schering Corporation, a subsidiary of Merck & Co, Inc.; May Breo Ellipta inhalation powder [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; May Global Initiative for Asthma. Global strategy for asthma management and prevention. Updated December Accessed on May 15, 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 May 15, Available at: 8. Hueston WJ, Mainous AG III. Acute bronchitis. Am Fam Physician. 1998;57(6):1270-6:1270-6, 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): GlaxoSmithKline Inc. Breo Ellipta (fluticasone furoate/vilanterol inhalation powder) for treatment of chronic obstructive pulmonary disease NDA FDA advisory committee briefing document, presented to: pulmonary-allergy drugs advisory committee. March 7, Available at: -AllergyDrugsAdvisoryCommittee/UCM pdf. Accessed on May 14, Busse WW, O Byrne PM, Bleecker ER, et al. Safety and tolerability of the novel inhaled corticosteroid fluticasone furoate in combination with the β2 agonist vilanterol administered once daily for 52 weeks in patients 12 years old with asthma: a randomized trial. Thorax Feb 25 [epub ahead of print]. 15. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated February Accessed on May 15, Available at: American Thoracic Society/European Respiratory Society. Standards for the Diagnosis and Management of COPD Accessed on May 15, Available at: Subcommittee on diagnosis and management of broncholitis. Diagnosis and management of bronchiolitis. Pediatrics. 2006;118: 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: Pillay V, Swingler G. Symptomatic treatment of the cough in whooping cough. Cochrane Database Syst Rev. 2003;(4):CD Billing Coding/Physician Documentation Information NA

6 Additional Policy Key Words Policy Number: Related Topics N/A Policy Implementation/Update Information 06/2014 New Policy titled Combination Beta2-Agonist/Corticosteroid Inhalers This Medical Policy is designed for informational purposes only and is not an authorization, an explanation of benefits, or a contract. Each benefit plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their providers will need to consult the member's benefit plan to determine if there is any exclusion or other benefit limitations applicable to this service or supply. Medical technology is constantly changing and Blue Cross and Blue Shield of Kansas City reserves the right to review and revise medical policy. This information is proprietary and confidential and cannot be shared without the written permission of Blue Cross and Blue Shield of Kansas City.

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