Ensuring Patient Access to Asthma Therapy: Perspectives for Pharmacists

This article is sponsored by Teva Respiratory. Asthma is a chronic inflammatory respiratory disease that includes symptoms of airway obstruction, inflammation, and hyperresponsiveness.1 As of the most recent published estimates, asthma affects approximately 7.1 million children and 17.5 million adults in the United States, or approximately 8.2% of the population.2 The severity of asthma may be characterized by the number of days per week when symptoms manifest, use of medication for control of acute symptoms, whether or not symptoms interfere with normal activity, and lung function, as measured by forced expiratory volume in 1 second.1 Based on severity, asthma may be managed with a variety of medications, with inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA) combination medications being a crucial mainstay of therapy in moderate and severe asthma.1,3 Pharmacists have a crucial role in promoting appropriate use of inhaled medications for asthma and ensuring access to therapy.1,3 Available ICS/LABA Therapies Available ICS/LABA combination treatments include mometasone furoate/formoterol fumarate dihydrate (Dulera®), budesonide/formoterol fumarate dihydrate (Symbicort®), fluticasone furoate/vilanterol (Breo Ellipta®), and fluticasone propionate/salmeterol (Advair Diskus® and Advair HFA®). While these products are in the same class, the medications in each treatment are different in terms of active ingredients.4-8 As of January 27, 2017, the FDA granted approval for Teva Respiratory's ICS/LABA combination treatment, AirDuo RespiClick® (fluticasone propionate and salmeterol) Inhalation Powder for use in patients with asthma 12 years and older who have uncontrolled asthma despite long-term ICS treatment or whose disease necessitates the use of an ICS/LABA combination.9-10 AirDuo RespiClick® is not indicated for the relief of acute bronchospasm. AirDuo Respiclick® contains fluticasone propionate and salmeterol, the same molecules present in Advair Diskus® and Advair HFA®, although these products are not equivalent.6,7,10 Teva launched AirDuo RespiClick® and its authorized generic on April 20, 2017. IMPORTANT SAFETY INFORMATION for AirDuo RespiClick® and fluticasone propionate/salmeterol Inhalation Powder (multidose dry powder inhaler) WARNING: ASTHMA-RELATED DEATH Long&#8209;acting beta2&#8209;adrenergic agonists (LABA), such as salmeterol, one of the active ingredients in AirDuo RespiClick®, increase the risk of asthma&#8209;related death. Data from a large placebo&#8209;controlled US trial that compared the safety of salmeterol with placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol (13 deaths out of 13,176 subjects treated for 28 weeks on salmeterol versus 3 deaths out of 13,179 subjects on placebo). Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long&#8209;term asthma control drugs mitigates the increased risk of asthma&#8209;related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma&#8209;related hospitalization in pediatric and adolescent patients Therefore, when treating patients with asthma, physicians should only prescribe AirDuo RespiClick® for patients not adequately controlled on a long&#8209;term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue AirDuo RespiClick) if possible without loss of asthma control and maintain the patient on a long&#8209;term asthma control medication, such as an inhaled corticosteroid. Do not use AirDuo RespiClick® for patients whose asthma is adequately controlled on low&#8209; or medium&#8209;dose inhaled corticosteroids See additional Important Safety Information below. Dosing of ICS/LABA Therapies Understanding available doses among ICS/LABA therapies is important for pharmacists in the event they are asked to make recommendations for treatment with other ICS/LABA therapies. Medications within the ICS/LABA class are dosed with varying intensity, depending on patient needs (TABLE4-8,10). Some patients might be interested in a lower-cost combination product. Table is intended to show differences in dosing only and should not be construed to imply safety or efficacy similarities or differences. Patient Types in Asthma Therapy Patients having difficulty with hand/breath coordination are an important group that may be candidates for the use of a breath-actuated inhaler.10 The majority of patients with asthma have difficulty with inhaler technique, with hand-breath coordination being a common issue.3,12 The breath-actuated design of the RespiClick® device eliminates the need for hand/breath coordination.13 Patients who are already using another RespiClick® inhaler may be appropriate candidates for treatment with AirDuo RespiClick® or its authorized generic, as these patients are already familiar with use of the RespiClick device. In addition, cost-sensitive patients may be interested in a lower-cost ICS/LABA treatment option.3 According to international guidelines, cost is an important factor in asthma therapy.3 The authorized generic of AirDuo RespiClick® provides cost-conscious patients with a generic option in ICS/LABA therapy. Understanding the Status of the AirDuo RespiClick® Authorized Generic Authorized generics are the same as their brand-name counterparts, with 3 exceptions: the authorized generics are not labeled with the brand name,14 are not sold in the same packaging, and may be sold at a lower cost.14 Importantly, authorized generics have the same active ingredient, dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use as the brand name medication. Authorized generics are not approved through the Abbreviated New Drug Application (ANDA) process because they are actually the brand name drug, approved under the NDA process, but containing a generic label.14 Because authorized generics are not approved through an ANDA, they are not listed in the Orange Book. Also, bioequivalence does not need to be established because they are the same as the brand-name medication.14 Because Teva’s fluticasone/salmeterol multidose dry powder inhaler is an authorized generic of AirDuo RespiClick®, it is important to recognize that these products contain the same medication in the same dosage form. The authorized generic can be interchanged for branded AirDuo RespiClick® prescriptions, but it is not AB-rated to or interchangeable for Advair Diskus® or Advair HFA® prescriptions.14 Role of the Pharmacist The availability of AirDuo RespiClick® and its authorized generic represents an opportunity for pharmacists and patients to rethink ICS/LABA combination therapy, offering pharmacists an opportunity to reduce patient costs using a treatment option that does not require hand-breath coordination. In ensuring patient access to appropriate treatment doses, pharmacists must understand and communicate which groups of therapies are low-, medium-, and high-dose regimens among available products. By understanding which doses of available ICS/LABA combinations represent low-, medium-, and high-dose therapy, pharmacists can help ensure appropriate dosing of therapy to avoid disruptions in treatment from changes in preferred formulary status. By helping patients understand technique and cost options, pharmacists can help patients and providers select the ICS/LABA that may be right for them. IMPORTANT SAFETY INFORMATION (continued) Contraindications: AirDuo RespiClick® is contraindicated in: Primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures Patients with known severe hypersensitivity to milk proteins or any ingredients of AirDuo RespiClick® Deterioration of Disease and Acute Episodes: AirDuo RespiClick® should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma. AirDuo RespiClick® is not indicated for the relief of acute bronchospasm. An inhaled, short-acting beta2-agonist, not AirDuo RespiClick®, should be used to relieve acute symptoms such as shortness of breath Excessive Use and Use with Other Long acting Beta2-Agonists: AirDuo RespiClick® should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using AirDuo RespiClick® should not use another medicine containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason Local Effects of Inhaled Corticosteroids: Oropharyngeal candidiasis has occurred in patients treated with AirDuo RespiClick® .Advise patients to rinse the mouth with water without swallowing following inhalation Immunosuppression: Patients who use corticosteroids are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients. Use with caution in patients with the above because of the potential for worsening of these infections Transferring Patients from Systemic Corticosteroid Therapy: Particular care is needed for patients who have been transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to AirDuo RespiClick® Hypercorticism and Adrenal Suppression may occur with high doses of inhaled corticosteroids, including fluticasone propionate, or at the recommended dose in susceptible individuals. If such changes occur, discontinue AirDuo RespiClick® slowly Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors: The use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, ketoconazole) with AirDuo RespiClick® is not recommended because increased systemic corticosteroid and increased cardiovascular adverse effects may occur Paradoxical Bronchospasm and Upper Airway Symptoms: If paradoxical bronchospasm occurs, discontinue AirDuo RespiClick® immediately and institute alternative therapy Hypersensitivity Reactions, Including Anaphylaxis: Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of AirDuo RespiClick®. Discontinue AirDuo RespiClick® if such reactions occur Cardiovascular and Central Nervous System Effects: Salmeterol, a component of AirDuo RespiClick®, can produce clinically significant cardiovascular effects in some patients as measured by pulse rate, blood pressure, and/or symptoms. If such effects occur, AirDuo RespiClick may need to be discontinued. AirDuo RespiClick should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension Reduction in Bone Mineral Density (BMD): Decreases in BMD have been observed with long-term administration of products containing inhaled corticosteroids. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care Effect on Growth: Inhaled corticosteroids, as well as poorly controlled asthma, may cause a reduction in growth velocity, and the long-term effect on final adult height is unknown. Patients should be maintained on the lowest dose of inhaled corticosteroid that effectively controls their asthma. Monitor growth of pediatric patients Glaucoma and Cataracts: Long-term use of inhaled corticosteroids, including fluticasone propionate, a component of AirDuo RespiClick®, may increase the risk for cataracts or glaucoma. Regular eye exams should be considered Eosinophilic Conditions and Churg&#8209;Strauss Syndrome: Systemic eosinophilic conditions, such as Churg-Strauss syndrome, may occur. Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy Coexisting Conditions: Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines Hypokalemia and Hyperglycemia: Be alert to hypokalemia and hyperglycemia Adverse Reactions: Most common adverse reactions (≥3%) in patients taking AirDuo RespiClick® 55/14 mcg twice daily, 113/14 mcg twice daily, 232/14 mcg twice daily, and placebo, respectively, were nasopharyngitis (8.6%, 4.8%, 6.9%, 4.4%), oral candidiasis (1.6%, 2.2%, 3.4%, 0.7%), back pain (3.1%, 0.7%, 0%, 1.8%), headache (5.5%, 4.8%, 2.8%, 4.4%), and cough (2.3%, 3.7%, 0.7%, 2.6%) Please see full Prescribing Information, including Boxed WARNING, and Medication Guide for AirDuo Respiclick®. Please see full Prescribing Information, including Boxed WARNING, and Medication Guide for fluticasone propionate/salmeterol Inhalation Powder multidose dry powder inhaler. References National Heart, Lung, and Blood Institute. National Asthma Education and Prevention Program. https://www.nhlbi.nih.gov/health-pro/guidelines/current/asthma-guidelines. Accessed July 2017. Winer RA, Qin X, Harrington T, Moorman J, Zahran H. Asthma incidence among children and adults: findings from the Behavioral Risk Factor Surveillance system asthma call-back survey--United States, 2006-2008. J Asthma. 2012;49(1):16-22. doi: 10.3109/02770903.2011.637594. 2017 GINA Report: global strategy for asthma management and prevention. Global Initiative for Asthma website. http://ginasthma.org/2017-gina-report-global-strategy-for-asthma-management-and-prevention/. Accessed July 2017. Dulera (mometasone furoate and formoterol fumarate dihydrate) [package insert]. Whitehouse Station, NJ: Merck & Co, Inc; 2015. Symbicort (budesonide and formoterol fumarate dihydrate) [package insert]. Wilmington, DE: AstraZeneca; 2010. Advair Diskus (fluticasone propionate and salmeterol inhalation powder) [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2017. Advair HFA (fluticasone propionate and salmeterol) [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2017. Breo Ellipta (fluticasone furoate) [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2017. FDA. AirDuo RespiClick® (fluticasone propionate/salmeterol). accessdata.fda.gov/drugsatfda_docs/nda/2017/208799Orig1s000TOC.cfm. Accessed July 2017. AirDuo RespiClick® (fluticasone propionate and salmeterol) [package insert]. Frazer, PA: Teva Respiratory, LLC. Aalderen W, Garcia-Marcos L, Gappa M, et al. How to match the optimal currently available inhaler device to an individual child with asthma or recurrent wheeze. Primary Care Respiratory Medicine. 2015;25:14088. doi: 10.1038/npjpcrm.2014.88. Dolovich MB, Ahrens RC, Hess DR, et al; American College of Chest Physicians; American College of Asthma, Allergy, and Immunology. Device selection and outcomes of aerosol therapy: evidence-based guidelines: American College of Chest Physicians/American College of Asthma, Allergy, and Immunology. Chest. 2005;127(1):335-371. doi: 10.1378/chest.127.1.335. ProAir RespiClick Patient Information Leaflet. Horsham, PA: Teva Respiratory, LLC. FDA. FDA list of authorized generic drugs. www.fda.gov/drugs/developmentapprovalprocess/ howdrugsaredevelopedandapproved/approvalapplications/ abbreviatednewdrugapplicationandagenerics/ucm126389.htm. Accessed July 2017. Advair Diskus® and Advair HFA® are registered trademarks of GlaxoSmithKline. Dulera® is a registered trademark of Merck, Sharp, Dohme. Symbicort® is a registered trademark of AstraZeneca. ADR-40108 October 2017

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