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Kaunas University of Medicine Faculty of Pharmacy KAUNAS UNIVERSITY OF MEDICINE FACULTY OF PHARMACY DEPARTMENT OF BASIC AND CLINICAL PHARMACOLOGY UTILIZATION AND COSTS OF DRUGS FOR ASTHMA AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE TREATMENT IN LITHUANIA ON 2006-2009 YEAR MASTER WORK Supervised by: Edmundas Kaduševi čius, MD., PharmD., PhD., Assoc. professor of clinical pharmacology Performed by: Asta Petraityt ÷, Faculty of Pharmacy, 5/3 gr Kaunas, 2010 TABLE OF CONTENTS ABBREVIATIONS............................................................................................................................. 3 1. INTRODUCTION........................................................................................................................... 4 2. ASTHMA: BASIC FACTS AND PHARMACOLOGICAL MANAGEMENT ............................ 7 2.1. Epidemiology ........................................................................................................................... 7 2.2. Burden of asthma...................................................................................................................... 9 2.3. Classification of asthma.......................................................................................................... 10 2.4. Aetiology, pathogenesis and pathophysiology of asthma ...................................................... 11 2.5. Pharmacological management of asthma ............................................................................... 14 2.5.1. Reliever medications ....................................................................................................... 15 2.5.2. Long-term asthma management ...................................................................................... 17 2.5.3. Treatment steps................................................................................................................ 24 2.5.4. Inappropriate use of inhaled short acting β2-agonists and its association with patient health status ............................................................................................................................... 27 3. COPD: BASIC FACTS AND PHARMACOLOGICAL MANAGEMENT ................................ 29 3.1. Epidemiology ......................................................................................................................... 29 3.2. Burden of COPD .................................................................................................................... 30 3.3. Classification of COPD .......................................................................................................... 32 3.4. Aetiology, pathogenesis and pathophysiology of COPD....................................................... 33 3.5. Pharmacological management of COPD................................................................................ 35 4. OBJECTIVE AND AIMS ............................................................................................................. 37 5. MATERIAL AND METHODS..................................................................................................... 38 5.1. The ATC/DDD system........................................................................................................... 38 5.1.1. Anatomical Therapeutic Chemical (ATC) classification system .................................... 38 5.1.2. The concept of the defined daily dose (DDD)................................................................. 39 5.1.3. Drug utilization................................................................................................................ 40 5.2. Pharmacoeconomical analysis................................................................................................ 41 5.2.1. Cost-minimisation analysis ............................................................................................. 41 5.2.2. Reference price................................................................................................................ 42 5.3. Data sources………………………………………………………………………………….42 6. RESULTS...................................................................................................................................... 43 6.1. Consumption of drugs of the ATC Code R03........................................................................ 43 6.2. Pharmacoeconomical analysis of drugs for obstructive airway diseases ............................... 52 6.2.1. Reference price for long-acting β2-agonists .................................................................... 52 6.2.2. Reference price for inhaled corticosteroids..................................................................... 54 6.2.3. Reference price for inhaled corticosteroid/long-acting β2-agonist combinations ........... 57 7. DISCUSSION................................................................................................................................ 60 8. CONCLUSIONS ........................................................................................................................... 66 9. SUMMARY .................................................................................................................................. 67 10. SANTRAUKA ............................................................................................................................ 68 REFERENCES .................................................................................................................................. 69 ANNEXES ........................................................................................................................................ 77 2 ABBREVIATIONS AA Arachidonic Acid ATC Anatomical Therapeutic Chemical Classification ATS American Thoracic Society BMD Bone Mineral Density CEA Cost-Effectiveness Analysis CHIF Compulsory Health Insurance Fund COPD Chronic Obstructive Pulmonary Disease CRP C- reactive protein CysLT Cysteinyl Leukotriene DALY Disability-Adjusted Life Year DDD Defined Daily Dose DPI Dry Powder Inhaler ERS European Respiratory Society FEV 1 Forced Expiratory Volume in one second FVC Forced Vital Capacity GINA Global Initiative for Asthma GOLD Global Initiative for Obstructive Lung Disease HPA Hypothalamic–Pituitary–Adrenal ICER Incremental Cost-Effectiveness Ratio ICS Inhaled Corticosteroid IgE Immunoglobulin E LABA Long-Acting β2-Agonist 5-LO 5-Lipoxygenase LTD4 Leukotriene D4 (and similar) LTRA Leukotriene Receptor Antagonist MDI Metered-Dose Inhaler NICE National Institute for Health and Clinical Excellence NO Nitric oxide PEF Peak Expiratory Flow SABA Short-Acting β2-Agonist SR Slow-release WHO World Health Organization 3 1. INTRODUCTION Chronic diseases, such as heart disease, stroke, cancer, chronic respiratory diseases and diabetes, are by far the leading cause of mortality in the world, representing 60% of all deaths. This invisible epidemic is an under-appreciated cause of poverty and hinders the economic development of many countries [1]. Respiratory conditions impose an enormous burden on society . Hundreds of millions of people suffer every day from chronic respiratory diseases. According to the latest World Health Organization (WHO) estimates (2007), currently 300 million people have asthma, 210 million people have chronic obstructive pulmonary disease (COPD) while millions have allergic rhinitis and other often under-diagnosed chronic respiratory diseases. Furthermore, asthma is considered to be the most common chronic disease among children [2]. Chronic respiratory diseases are a group of chronic diseases affecting the airways and the other structures of the lungs. Common chronic respiratory diseases include asthma, bronchiectasis, COPD, chronic rhinosinusitis, lung cancer and neoplasms of respiratory and intrathoracic organs, lung fibrosis, chronic pleural diseases, pneumoconiosis, rhinitis and series of other chronic respiratory diseases. Concerning wide amount of the information on chronic respiratory conditions, this study focuses on the following chronic obstructive airway diseases: asthma and COPD. Asthma is an inflammatory disorder of the lungs that affects people of all ages and is a significant source of morbidity and mortality [3, 4]. Asthma is one of the most common chronic diseases in the world. Asthma prevalence increases globally by 50% every decade. If the current trends continue, it is estimated that the number of people with asthma could grow to as many as 400-450 million people worldwide by 2025 – there may be an additional 100 million more asthmatics [5]. COPD is also an increasing public health problem. In 1990 it was ranked as the twelfth leading cause of disability-adjusted life-years (DALYs) lost and, according to projections, it will become the fifth such cause in 2020 [6]. In 2002 COPD was the fifth leading cause of death, 3 million people died of COPD in 2005, which corresponds to 5% of all deaths globally. WHO predicts that it will become the third leading cause of death worldwide by 2030 [7]. The referred statements establish obstructive airway diseases as a serious health problem that affects people in all countries across the globe. With a high global prevalence, asthma and COPD place a considerable burden on patients, society and healthcare systems alike [8]. 4 COPD and asthma are costly diseases, generating considerable health-care costs as well as indirect costs. In the European Union, the total direct costs of respiratory diseases are estimated to be about 6% of the total health care budget, with COPD accounting for 56% (€38.6 billion) of this cost
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