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Get a Deep Insight Into the Stakeholder Insight: Asthma – Over-Prescribing Is Common in Intermittent and Mild Forms of Asthma

August 5, 2008

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Stakeholder Insight: Asthma – Over-prescribing is common in intermittent and mild forms of asthma

http://www.reportlinker.com/p091764/Stakeholder-Insight-Asthma—Over-prescribing-is-common-in-intermittent-and-mild-forms-of-asthma.html

Introduction

Asthma is managed using a step-wise approach, with bronchodilators to relieve symptoms of airflow limitation and controller medications to target underlying inflammation. Datamonitor’s research shows that almost all patients (even those with mild intermittent asthma) receive some type of controller medication as their baseline treatment, which is in line with international management guidelines.

Scope

– Patient segmentation with regards to disease severity, asthma phenotypes, co-morbidities and exacerbations

– Treatment choice split by line of therapy and disease severity

– Performance of asthma therapies in terms of factors such as efficacy, onset and duration of action, side effect profile, delivery method and cost

– Physician awareness and perception of drugs in development

Highlights

Recently, the classification of asthma has shifted to the concept of disease control in order to acknowledge the variability of the disease. Datamonitor research showed that around half of the physicians have taken on this new asthma classification, which may illustrate the transition away from the traditional severity classification.

The ICS class as a whole scored rather low on speed of onset, which may indicate an unmet need in this class. The traditional products Flixotide/Flovent (fluticasone) and Pulmicort (budesonide) scored consistently higher than the novel products Asmanex (mometasone) and Alvesco (ciclesonide).

Of the combination products in development, physicians were most aware of GSK’s Beyond Advair, probably due to the fact that GSK already has had Advair/Seretide on the market. The other four ICS/LABA combinations were less well-known since they all come from companies without a current combination product on the market.

Reasons to Purchase

– Target physicians more effectively through an understanding of prescribing behavior and its influences.

– Validate new product forecasting based on diagnosis and treatment rates, and the likely rate of uptake for new products.

– Benchmark brand awareness and perceptions surrounding product positioning in order to formulate competitive lifecycle management strategies.

ABOUT DATAMONITOR HEALTHCARE 2

About the Infectious Disease and Respiratory (ID&R) pharmaceutical analysis team 2

CHAPTER 1 EXECUTIVE SUMMARY 3

Scope of the analysis 3

Datamonitor insight into the asthma market 5

Contributing experts 6

Related reports 7

Upcoming related reports 7

CHAPTER 2 COUNTRY TREATMENT TREES 9

Introduction to treatment trees 9

US 10

5EU 12

Japan 14

France 16

Germany 18

Italy 20

Spain 22

UK 24

CHAPTER 3 PATIENT SEGMENTATION AND EPIDEMIOLOGY 26

Disease definition: the importance of inflammation 27

Asthma is caused by a combination of exogenous and genetic factors 27

Exogenous factors 28

Genetic factors 30

The role of airway inflammation, airway hyper-responsiveness and airway remodeling 31

Co-morbidities 35

Allergic rhinitis is the most common co-morbidity of asthma 35

Asthma and COPD can co-exist but true interaction between these diseases is unclear 36

Obesity may become even more important in the future of asthma 38

Disease classification – asthma control 39

Disease classification – asthma phenotypes 43

Allergic asthma is by far the most common phenotype 46

Asthma can be irreversible with chronic airflow obstruction 47

Awareness of nocturnal asthma as a phenotype may be low 48

Is exercise-induced asthma a separate phenotype? 49

Patients with steroid-resistant asthma have highest unmet needs 50

Why are phenotypes (not) used? 51

Asthma prevalence 53

Difference between physician’s impression and publicized data is related to asthma definition 56

Asthma prevalence seems to be stabilizing 56

US 58

Japan 61

Europe 63

France 64

Germany 65

Italy 66

Spain 68

UK 69

CHAPTER 4 DIAGNOSIS AND DIAGNOSTIC TESTS 71

Presentation of asthma – symptoms 72

Diagnosis of asthma 72

Spirometry and PEF measurements are still underused 73

Allergen skin tests mostly used for initial diagnosis 75

Airway responsiveness challenges are mainly useful for difficult-to-diagnose patients 76

Upcoming diagnostic tests: sputum eosinophil count and fraction exhaled nitric oxide (FENO) 77

CHAPTER 5 TREATMENT OPTIONS AND TRENDS 79

Treatment options 80

Bronchodilators (relievers) 80

Beta2-agonists 80

Anticholinergics 81

Combination beta2-agonist/anticholinergic 82

Methyl xanthines 82

Anti-inflammatories (controllers) 83

Inhaled corticosteroids 83

Systemic corticosteroids 84

Non-steroidal anti-inflammatory drugs (NSAIDs) 84

ICS/LABA combinations 85

Biologicals 86

Inhaler device options 87

The ideal inhaler device 89

Treatment guidelines 91

The Global Initiative for Asthma (GINA) guidelines are most important international guidelines 92

The National Heart, Lung, and Blood Institute (NHLBI) guidelines follow GINA’s focus on control 95

American Thoracic Society (ATS) and the European Respiratory Society (ERS) do not have specific asthma guidelines 97

National guidelines can supersede international guidelines 98

Most guidelines are now evidence-based 98

Treatment trends 101

Almost all patients receive some type of controller medication 102

Mild asthma is over-treated with long-term reliever medication 102

ICS/LABA combinations even used in mildest forms of asthma 103

Inhaled corticosteroids are less used as severity progresses 105

Long-acting bronchodilators mainly used in conjunction with an ICS 106

Antileukotriene drugs are especially popular in Japan 108

Short-acting bronchodilators is the most often used drug class in most severities 109

Theophylline is still prominent in Japanese treatment regimen 110

Omalizumab is reserved for the most severe asthma patients 111

CHAPTER 6 KEY PRESCRIBING INFLUENCES AND BRAND ASSESSMENT 114

Factors influencing physician decision making 115

Symptomatic improvement 116

Duration of action 119

Side-effect profile 121

Speed of onset 122

Recommended in treatment guidelines 124

Cost 125

Once-daily dosing 126

Flexible dosing 126

Device/mode of administration 127

Patient age 128

Physician perception of key products 129

Total scores per drug per country 131

Interpreting a brand map 133

The ICS/LABA combination class 135

The ICS/LABA combination products 136

The inhaled corticosteroid class 141

The inhaled corticosteroid products 142

The long-acting bronchodilator class 147

The long-acting bronchodilator products 148

The antileukotriene class 151

The antileukotriene products 152

Short-acting bronchodilators 153

Biologics – Xolair (omalizumab) 154

CHAPTER 7 TREATMENT OUTCOMES AND NEW PRODUCT DEVELOPMENT 157

Treatment outcomes 158

Unmet needs 160

Increase access to safe and effective immunotherapy 161

Improve therapeutic response by phenotyping 162

Reduce cost of medication 163

Reduce over-treatment of asthma 164

Develop ICS without side effects 165

Other unmet needs 166

New product development 167

Awareness of pipeline products 167

Combination products 167

LABAs and LAMAs 168

Novel mechanisms of action 169

Future use of pipeline products 170

Novel ICS/LABA combinations 171

Novel LABA/LAMA combinations 176

Novel LAMAs 177

Novel LABAs 179

Novel mechanisms of action 181

BIBLIOGRAPHY 185

Journal papers 185

Websites 204

Datamonitor reports 205

APPENDIX A 206

Physician research methodology 206

Physician sample breakdown 206

US 206

Japan 207

France 207

Germany 208

Italy 208

Spain 209

UK 209

Contributing experts 210

APPENDIX B 211

The survey questionnaire 211

Section 1 – Patient Segmentation 211

Section 2 – Diagnosis 215

Section 3 – Treatment 215

Section 4 – Treatment Outcomes 217

Section 5 – Product Profiles 218

Section 6 – Products in Development 223

APPENDIX C 226

About Datamonitor 226

About Datamonitor Healthcare 226

About the Infectious Disease and Respiratory (ID&R) analysis team 227

Disclaimer 228

List of Tables

Table 1: Percentage of physicians using each asthma classification system for each of the seven major markets, 2008 42

Table 2: Prevalence of adult asthma, by severity and country in the seven major markets, 2008 55

Table 3: Prevalence of asthma per country, according to Datamonitor’s research among physicians and published literature, 2008 56

Table 4: Country totals for 12-month prevalence of asthma in both phases, average change per year and SE of the change by age, 2006 58

Table 5: Comparative analysis of the definition of the levels of evidence used in the asthma guidelines considered 100

Table 6: Primary endpoints of some of the ICS drugs used in asthma treatment 118

Table 7: Number and percentage of physicians able to rate each asthma drug, 2008 130

Table 8: Total scores (out of 100) of each asthma drug for each of the individual seven major markets 132 Table 9: Price differences between ICS/LABA combination products in countries where Foster was available, 2007 138

Table 10: Price differences between ICS products in countries where all four products were available in 2007 145

Table 11: Mean percentage of asthma patients experiencing each number of exacerbations per year, by disease severity, across the seven major markets, 2008 159

Table 12: US physician sample breakdown, 2008 206

Table 13: Japan physician sample breakdown, 2008 207

Table 14: France physician sample breakdown, 2008 207

Table 15: Germany physician sample breakdown, 2008 208

Table 16: Italy physician sample breakdown, 2008 208

Table 17: Spain physician sample breakdown, 2008 209

Table 18: UK physician sample breakdown, 2008 209

Table 19: Percentage of all your current (diagnosed) asthma patients with each of the disease severities 212

Table 20: Classification that you primarily use to characterize your asthma patients 212

Table 21: Percentage of all your asthma patients presenting with each of the types of asthma 213

Table 22: Co-morbidities that your asthma patients present with and at which percentage 214

Table 23: Percentage of your asthma patients suffering from each number of exacerbations per year 214

Table 24: Percentage of all your current asthma patients receiving each of the following tests in order to facilitate diagnosis and track their status 215

Table 25: Percentage of all your current asthma patients receiving each of the following drug therapies as baseline therapy 216

Table 26: Relative importance of the factors when prescribing each of the drug classes for asthma 217

Table 27: Challenges in the management of asthma 218

Table 28: Rate of the performance or predicted performance of each of the ICS and ICS/LABA combinations 219

Table 29: Rate of the performance or predicted performance of each of the oral antileukotrienes and biologic 220

Table 30: Rate of the performance or predicted performance of each of the long-acting bronchodilators 221

Table 31: Points allocated to the importance of characteristics of a device 222

Table 32: Preference of device type per each drug class 222

Table 33: Awareness of pipeline products and how they would be prescribed 224

List of Figures

Figure 1: Diagrammatic overview of the coverage of the Stakeholder Insight: Asthma survey, 2008 4

Figure 2: US treatment tree (ICS/LABA combination and steroids), 2008 10

Figure 3: US treatment tree (others), 2008 11

Figure 4: 5EU treatment tree (ICS/LABA combination and steroids), 200 12

Figure 5: 5EU treatment tree (others), 2008 13

Figure 6: Japan treatment tree (ICS/LABA combination and steroids), 2008 14

Figure 7: Japan treatment tree (others), 2008 15

Figure 8: France treatment tree (ICS/LABA combination and steroids), 2008 16

Figure 9: France treatment tree (others), 2008 17

Figure 10: Germany treatment tree (ICS/LABA combination and steroids), 2008 18

Figure 11: Germany treatment tree (others), 2008 19

Figure 12: Italy treatment tree (ICS/LABA combination and steroids), 2008 20

Figure 13: Italy treatment tree (others), 2008 21

Figure 14: Spain treatment tree (ICS/LABA combination and steroids), 2008 22

Figure 15: Spain treatment tree (others), 2008 23

Figure 16: UK treatment tree (ICS/LABA combination and steroids), 2008 24

Figure 17: UK treatment tree (others), 2008 25

Figure 18: Effect of the interaction between various types of exposures and various genetic backgrounds through pathways involving atopy, airway inflammation, airway hyperresponsiveness (AHR) or other, unknown factors 34

Figure 19: Mean percentage of patients with each co-morbidity across the seven major markets, 2008 35

Figure 20: Levels of asthma control 40

Figure 21: Mean percentage of asthma patients with each asthma phenotype across the seven major markets, 2008 45

Figure 22: Familiarity with asthma phenotypes among physicians and their use in clinical practice, 2008 52

Figure 23: Severity of asthma as reported by physicians in the US (n=36) in the 2004 and 2008 Datamonitor surveys 60

Figure 24: Severity of asthma as reported by physicians in Japan (n=24) in the 2004 and 2008 Datamonitor surveys 62

Figure 25: Severity of asthma as reported by physicians in France (n=24) in the 2004 and 2008 Datamonitor surveys 64

Figure 26: Severity of asthma as reported by physicians in Germany (n=24) in the 2004 and 2008 Datamonitor surveys 65

Figure 27: Severity of asthma as reported by physicians in Italy (n=24) in the 2004 and 2008 Datamonitor surveys 67

Figure 28: Severity of asthma as reported by physicians in Spain (n=24) in the 2004 and 2008 Datamonitor surveys 68

Figure 29: Severity of asthma as reported by physicians in the UK (n=24) in the 2004 and 2008 Datamonitor surveys 70

Figure 30: Utilization per test for initial asthma diagnosis and to track a patient’s disease status (n=180), 2008 75

Figure 31: Advantages and disadvantages of the main three types of portable inhaler devices 88

Figure 32: Relative importance of each inhaler device characteristic for treating asthma patients (n=180), 2008 89

Figure 33: Factors influencing inhaler choice 90

Figure 34: Percentage of physicians following each guideline, 2004 93

Figure 35: GINA asthma management approach based on control, 2007 guidelines 95

Figure 36: NHLBI asthma management approach, 2007 guidelines 97

Figure 37: The prescription of different drug classes for the treatment of asthma on average in the seven major markets, 2008 101

Figure 38: Overview of the prescription of controller medications across the seven major markets, per asthma severity, 2008 102

Figure 39: Overview of the prescription of reliever medications across the seven major markets, per asthma severity, 2008 103

Figure 40: Overview of the prescription of ICS/LABA combinations across asthma severities, per country, 2008 104

Figure 41: Overview of the prescription of ICS across asthma severities, per country, 2008 106

Figure 42: Overview of the prescription of long-acting bronchodilators across asthma severities, per country, 2008 107

Figure 43: Overview of the prescription of antileukotrienes across asthma severities, per country, 2008 108

Figure 44: Overview of the prescription of short-acting bronchodilators across asthma severities, per country, 2008 110

Figure 45: Overview of the prescription of theophylline across asthma severities, per country, 2008 111

Figure 46: Overview of the prescription of omalizumab across asthma severities, per country, 2008 113

Figure 47: Number of points allocated to each factor to indicate its relative importance when prescribing each class of asthma drugs, seven major markets, 2008 115

Figure 48: Number of points allocated to each factor (across asthma drug classes) to indicate its relative importance in each country or region, 2008 116

Figure 49: Proportion of 100 points distributed to reflect the importance of symptomatic improvement for each of the asthma drug classes, by country, 2008 117

Figure 50: Proportion of 100 points distributed to reflect the importance of duration of action for each of the asthma drug classes by country, 2008 119

Figure 51: The duration of action of formoterol and salmeterol 120

Figure 52: Proportion of 100 points distributed to reflect the importance of side-effect profiles for each of the asthma drug classes by country, 2008 121

Figure 53: Proportion of 100 points distributed to reflect the importance of speed of onset for each of the asthma drug classes by country, 2008 122

Figure 54: Efficacy of twice-daily 100A-A?1/2g fluticasone in adolescent and adult patients receiving bronchodilators alone 123

Figure 55: Proportion of 100 points distributed to reflect the importance of recommendations in guidelines for each of the asthma drug classes by country, 2008 124

Figure 56: Proportion of 100 points distributed to reflect the importance of costs for each of the asthma drug classes by country, 2008 125

Figure 57: Proportion of 100 points distributed to reflect the importance of once-daily dosing for each of the asthma drug classes by country, 2008 126

Figure 58: Proportion of 100 points distributed to reflect the importance of a flexible dosing for each of the asthma drug classes by country, 2008 127

Figure 59: Proportion of 100 points distributed to reflect the importance of the device/mode of administration for each of the asthma drug classes by country, 2008 128

Figure 60: Proportion of 100 points distributed to reflect the importance of patient age for each of the asthma drug classes by country, 2008 129

Figure 61: Brand map of the scoring attributes in relation to each other 134

Figure 62: Brand map of the scores of the individual products in relation to each other 135

Figure 63: Brand map highlighting the position of ICS/LABA combination products, 2008 136

Figure 64: Number of points allocated to each ICS/LABA combination product on all factors, seven major markets, 2008 137

Figure 65: Brand map highlighting the position of ICS products in the treatment of asthma, 2008 142

Figure 66: Number of points allocated to each ICS/LABA combination product on all factors, seven major markets, 2008 143

Figure 67: Brand map highlighting the position of long-acting bronchodilator products in the treatment of asthma, 2008 148

Figure 68: Number of points allocated to each long-acting bronchodilator product on all factors, seven major markets, 2008 149

Figure 69: Brand map highlighting the position of antileukotriene products in the treatment of asthma, 2008 151

Figure 70: Number of points allocated to each antileukotriene product on all factors, seven major markets, 2008 152 Figure 71: Brand map highlighting the position of biologic omalizumab in the treatment of asthma, 2008 155

Figure 72: Number of points allocated to Xolair on all factors, seven major markets, 2008 156

Figure 73: Rating of unmet needs in the management of asthma (n=180), 2008 161

Figure 74: The importance of increasing access to safe and effective immunotherapy, per country (n=180), 2008 162

Figure 75: The importance of improving therapeutic response by phenotyping, per country (n=180), 2008 163

Figure 76: The importance of reducing the cost of medication, per country (n=180), 2008 164

Figure 77: The importance of reducing over-treatment of asthma patients, per country (n=180), 2008 165

Figure 78: The importance of developing an ICS without side effects, per country (n=180), 2008 166

Figure 79: Level of awareness of novel ICS/LABA and LABA/LAMA combinations in each individual country, seven major markets, 2008 168

Figure 80: Level of awareness of novel LABAs and LAMAs in each individual country, seven major markets, 2008 169

Figure 81: Level of awareness of novel mechanisms in each individual country , seven major markets, 2008 170

Figure 82: Questions regarding pipeline asthma products, 2008 171

Figure 83: Future use of once-daily ICS/LABA combination pipeline products 173

Figure 84: Future use of me-too ICS/LABA combination pipeline products 175

Figure 85: Future use of LABA/LAMA combination pipeline products 177

Figure 86: Future use of LAMA pipeline products 179

Figure 87: Future use of LABA pipeline products 181

Figure 88: Future use of new mechanisms in asthma treatment, 2008 183

Figure 89: Severities of asthma 211

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Stakeholder Insight: Asthma – Over-prescribing is common in intermittent and mild forms of asthma

http://www.reportlinker.com/p091764/Stakeholder-Insight-Asthma—Over-prescribing-is-common-in-intermittent-and-mild-forms-of-asthma.html

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