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2017.08 LABA-LAMA Combination Products Report.Pdf Utah Medicaid Pharmacy and Therapeutics Committee Drug Class Review Long-Acting β2-Agonist and Long-Acting Muscarinic Antagonist Combination Products AFHS classifications: Antimuscarinics/Antispasmodics 12:08.08, Selective Beta2-Adrenergic Agonists 12:12.08.12 Glycopyrrolate and formoterol fumarate (Bevespi Aerosphere) Glycopyrrolate and indacaterol (Utibron Neohaler) Tiotropium bromide and olodaterol (Stiolto Respimat) Umeclidinium and vilanterol (Anoro Ellipta) Final Report August 2017 Review prepared by: Elena Martinez Alonso, B.Pharm., MSc MTSI, Medical Writer Joanita Lake, B.Pharm., MSc EBHC (Oxon), Clinical Pharmacist Vicki Frydrych, B.Pharm., Pharm.D., Clinical Pharmacist Valerie Gonzales, Pharm.D., Clinical Pharmacist Michelle Fiander, MA, MLIS, Systematic Review/Evidence Synthesis Librarian Joanne LaFleur, Pharm.D., MSPH, Associate Professor University of Utah College of Pharmacy University of Utah College of Pharmacy, Drug Regimen Review Center Copyright © 2017 by University of Utah College of Pharmacy Salt Lake City, Utah. All rights reserved Table of Contents Executive Summary ...................................................................................................................................... 2 Introduction ................................................................................................................................................... 4 Table 1. FDA Approved LABA/LAMA Combination Products for COPD .................................... 5 Utah Medicaid Utilization Data 6 Table 2. Utah Medicaid FFS Patients diagnosed with COPD, Asthma or COPD/Asthma overlap . 7 Table 3. LABA/LAMA or ICS/LABA treatment in Utah Medicaid FFS patients for 2013-2017 period ................................................................................................................................................ 8 Disease Overview and Clinical Guidelines 9 A) Chronic Obstructive Pulmonary Disease 9 Table 4. Pharmacologic treatment algorithms for the management of COPD (GOLD Guidelines) ........................................................................................................................................................ 14 B) COPD and Asthma 18 Table 5. Recommendations for Initial Treatment in Patients with Asthma-COPD Overlap .......... 18 Pharmacology ............................................................................................................................................. 19 Table 6. Pharmacokinetics of LABA/LAMA Combination Products for COPD .......................... 20 Special Populations ..................................................................................................................................... 22 Table 7. Recommendations for Special Populations of LABA/LAMA Combination Products for COPD .............................................................................................................................................. 23 Methods ...................................................................................................................................................... 24 Clinical Efficacy ......................................................................................................................................... 26 Safety .......................................................................................................................................................... 28 Table 8. Adverse Effects and Warnings of LABA/LAMA Combination Products for COPD ...... 29 Summary ..................................................................................................................................................... 31 References ................................................................................................................................................... 32 Appendix A. Medications Commonly Used in COPD ............................................................................... 37 Appendix B. MEDLINE and EMBASE Literature Search Strategies of LABA/LAMA Combination Products for COPD ..................................................................................................................................... 40 Table 1. Medline Literature Search Strategy (via Ovid) for systematic reviews and randomized controlled trials ............................................................................................................................... 40 Table 2. EMBASE Literature Search Strategy (via EMBASE.com) ............................................. 41 Appendix C. Network Meta-analyses Comparing LABA/LAMA Combination Products for COPD ....... 41 Appendix D. Summary of Evidence of LABA/LAMA Combination Products for COPD ........................ 42 Appendix E. List of Excluded References .................................................................................................. 45 1 Executive Summary Introduction: Chronic Obstructive Pulmonary Disease (COPD) is a respiratory disease characterized by a progressive lung function impairment that causes disabilities and impacts the patient’s quality of life. COPD is associated with elevated morbidity and mortality rates and high social and economic burden. The prevalence of COPD is increasing worldwide and the major risk factor is the inhalation of tobacco smoke. This report evaluates the clinical efficacy and safety of long-acting β2-agonist (LABA) plus long-acting muscarinic antagonist (LAMA) combination products based on systematic reviews, meta-analyses and randomized controlled trials (RCTs) assessing head-to-head comparisons between these combination products. Currently, four LABA/LAMA fixed dose combination (FDCs) products available in a single inhaler are approved by the Federal Drug Administration (FDA) in the United States: formoterol fumarate/glycopyrrolate (Bevespi Aerosphere), indacaterol maleate/glycopyrrolate (Utibron Neohaler), olodaterol/tiotropium bromide (Stiolto Respimat) and vilanterol/umeclidinium (Anoro Ellipta). Combinations of LABA/LAMA bronchodilators with differing mechanisms of action produce a synergic increase in bronchodilation. Therefore, these combinations are recommended in patients with COPD not adequately controlled with monotherapy or when airflow obstruction is very severe and cannot be adequately treated with monotherapy. According to fee-for-service (FFS) utilization data, combination products containing LABA and inhaled corticosteroids (ICS) are more frequently prescribed for the treatment of moderate to severe COPD than LABA and LAMA combination products. This prescription pattern may reflect the old 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) guideline recommendations. However, the updated 2017 GOLD guidelines include new strategies for the management of COPD reflecting the available published literature. Current treatment recommendations for moderate to severe COPD places LABA/LAMA combination products as preferred treatment options over LABA/ICS combination products. LABA/LAMA provides superior efficacy versus LABA/ICS in terms of improvement in lung function and reduction in exacerbation risk in several recent clinical trials. However, there are some study limitations and unclear effects such as the benefit of LABA/LAMA on COPD-related mortality and comorbidities (e.g. cardiovascular disease). Evidence shows that further research is required to better characterize the comparative efficacy and safety among the current available combinations for COPD management. It is currently unclear which group of patients will benefit most from LABA/LAMA or LABA/ICS considering comorbidities (e.g. cardiovascular disease, osteoporosis, anxiety, depression, etc.) and the safety profile of each FDC (e.g. cardiovascular events associated with the use of LABA/LAMA or risk of pneumonia and other adverse events related to the long-term use of an inhaled corticosteroid). Clinical efficacy: The search strategy performed identified no head-to-head comparisons evaluating the efficacy and safety between LABA/LAMA fixed-dose combination products. A single network meta-analysis indirectly assessing the clinical benefits of four LABA/LAMA FDCs was identified for this review. Results from one comparison of interest involving two 2 FDCs approved in the U.S. (i.e. umeclidinium/vilanterol versus titropium/olodaterol) showed no significant differences between groups with respect to lung function (i.e. change in forced expiratory volume in one second or FEV1 from baseline), exacerbation rates and incidence of discontinuations due to adverse events. Nonetheless, inter-study heterogeneity including different patient’s disease severity and patient’s exacerbation history may have influenced the final results. Direct head-to-head comparisons are needed to better assess the comparative efficacy and safety between the four LABA/LAMA FDCs. Available clinical data regarding LABA/LAMA combination products is outlined in this review. Overall, clinical trials indicated that LABA/LAMA combination products improve lung function, symptoms and health-related quality of life compared to placebo and the mono-components alone. Moreover, trials demonstrated that these FDCs afforded significant benefits in lung function, dyspnea, symptoms, health status, exacerbation rate, rescue medication use, and incidence of pneumonia in comparison to LABA/ICS combinations. No studies compared LABA/LAMA FDCs in a single inhaler with the same drugs administered in separate inhalers. Clinical safety: Overall, LABA/LAMA
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