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Stakeholder Insight: Asthma - Combination Therapy Appropriate for Everyone?

According to the US National Heart, Lung, and Blood Institute and the European Respiratory Society, the annual cost of asthma is estimated to be $16.1 billion in the US and $16.3 billion in the EU. Over 41.5 million people, equivalent to the population of Spain, are afflicted by asthma, including 9.5 million children, 24.5 million adults and 7.5 million seniors.

Scope

Comprehensive overview of asthma epidemiology by patient demographic and disease severity, with comments on future trends to 2015

Analysis of drug treatment choice per line therapy per region for asthma, in particular the use of combination products

Identification of key developmental compounds, with analysis of physicians' opinions on potential therapies

Report Highlights
Asthma prevalence rates are stabilizing and changing demographics, not increasing prevalence, will bear the greatest influence on the asthma burden in the coming years. The total population diagnosed with asthma will increase to 35.1 million by 2015, with the proportion of elderly patients with asthma increasing substantially.

Five million adult asthmatics may have predominantly neutrophilic inflammation, raising important implications for treatment practice. These asthmatics may have a diminished or suboptimal sensitivity to corticosteroids, and alternative anti-inflammatory agents are required.

There is considerable scope for expanding the patient base of combination products driven by high patient compliance, the certainty that long-acting bronchodilators are always prescribed with inhaled corticosteroids, and the simplification of disease management.

Reasons to Purchase

Gain up-to-date understanding of current therapy usage and selection choices per region

Review the risk factors, population size and clinical characteristics of asthmatics with predominantly neutrophilic inflammation

Justify internal unmet needs assessment versus external viewpoint

Table of Contents

• ABOUT DATAMONITOR HEALTHCARE - page 2
  • About the Respiratory & Infectious Disease analysis team - page 2
• CHAPTER 1 EXECUTIVE SUMMARY - page 3
  • Scope of the analysis - page 3
  • Datamonitor insight into the asthma market - page 4
    • Asthma prevalence rates are stabilizing within the seven major markets, and changing demographics, not increasing prevalence, will bear the greatest influence on the asthma burden in the coming years. By 2015, the total population diagnosed with asthma will increase to 35.1 million, a rise of 4.4% over 2005 estimates, with the proportion of elderly patients with asthma increasing substantially by 18%, especially in the US and Japan. - page 4
    • Five million adult asthmatics may have predominantly neutrophilic inflammation. Whilst this phenotype is most usually associated with severe asthma, it may be more common than currently appreciated across the range of disease severities. The emergence of an asthmatic phenotype where the inflammation is neutrophilic in nature raises important implications for treatment practice, in that these asthmatics may have a diminished or suboptimal sensitivity to corticosteroids. Alternative anti-inflammatory agents are needed for patients not responding to steroid therapy, including inhibition of targets such as IL-8 which may normalize the exaggerated accumulation of activated neutrophils in the airways. Additionally, the emerging interest in the role of airway smooth muscle cells, fibroblasts and stimuli arising from damaged epithelium, also suggests novel anti-fibrotic therapeutic targets that may be distinct from those involved in inflammation. Tools to identify noneosinophilic asthma to differentiate asthma therapy based on the predominating inflammatory phenotype are required. - page 4
    • There is considerable scope for expanding the patient base of combination inhaled steroid/long-acting bronchodilator products. This class can grow by 25% through product switching, increasing use as initial maintenance therapy across all disease severities, and by transferring patients receiving long-acting bronchodilator monotherapy to fixed combination inhalers. The appeal of fixed combinations lies in high patient compliance, the certainty that long-acting bronchodilators are always prescribed with inhaled corticosteroids, and the simplification of disease management. - page 4
  • Coverage of the Stakeholder Insight Survey - page 11
• CHAPTER 2 EPIDEMIOLOGY AND PATIENT SEGMENTATION - page 12
  • Disease definition - page 12
  • Asthma classification - page 13
    • Changes in asthma severity over time - page 17
  • Epidemiology of asthma - page 18
    • Diagnosis rates - page 23
    • Population estimates - page 24
    • Future trends - page 25
  • Key patient segmentations - page 27
    • Childhood Asthma - page 27
    • Adult asthma - page 29
    • Elderly asthmatics - page 30
    • Severe asthma in adults - page 31
    • Severe asthma in children - page 37
  • Co-morbidities, complications and risk factors - page 38
    • Risk factors - page 38
    • Co-morbidities - page 40
• CHAPTER 3 DIAGNOSIS AND TREATMENT OPTIONS - page 43
  • Presentation - page 43
  • Diagnosis - page 43
  • Disease awareness - page 45
  • Influences on diagnosis and treatment rates - page 46
  • Treatment options - page 47
  • Treatment guidelines - page 48
  • Current prescribing trends - page 50
    • Reliever versus preventer therapy - page 50
    • Initial maintenance therapy in mild-moderate persistent asthma - page 52
    • Maintenance therapies in persistent asthma - page 58
• CHAPTER 4 PRESCRIBING TRENDS AND INFLUENCING FACTORS - page 63
  • Prescribing trends - page 63
    • Combination therapies - page 63
    • ICS/LABA growth as initial maintenance therapy - page 64
    • Switching opportunities - page 69
    • Anticholinergics in asthma - page 71
  • Factors influencing physician decision making - page 72
    • Choice of drug: combination v separate inhalers - page 72
    • Direct-to-consumer marketing - page 74
    • Generic versus branded prescribing - page 75
• CHAPTER 5 IMPROVING TREATMENT OUTCOMES - page 76
  • Asthma control : impact of GOAL - page 76
  • Xolair indications - page 79
  • Emerging asthma therapies - page 82
    • Daxas (roflumilast) - page 82
    • Alvesco (ciclesonide) - page 83
  • New drug groups - page 84
  • Genetics - page 86
    • Genetic regulation of response to therapy - page 86
    • Genetic influences on disease severity - page 88
• CHAPTER 6 OPINION LEADER AND STAKEHOLDER TRANSCRIPTS - page 89
  • UK opinion leader - page 89
  • German opinion leader - page 96
  • Japanese opinion leader - page 107
  • UK opinion leader - page 111
  • Spanish opinion leader - page 112
  • US opinion leader - page 120
  • US opinion leader - page 133
  • US opinion leader - page 144
• APPENDIX A BIBLIOGRAPHY - page 153
  • Epidemiology - page 153
  • Bibliography - page 156
  • Key associations - page 162
• APPENDIX B - page 163
  • Physician research methodology - page 163
    • Physician sample breakdown - page 163
  • Contributing experts - page 166
• APPENDIX C - page 167
  • The survey questionnaire - page 167
    • Disclaimer - page 184


• List of Tables
• Table 1: Classification of asthma severity - page 15
• Table 2: Mean % of asthma patients suffering from each disease severity at diagnosis, by country, 2004 - page 16
• Table 3: Asthma prevalence rates (%) in the seven major markets, by age - page 21
• Table 4: Asthma prevalence (%) in the general population, by age, in the seven major markets - page 22
• Table 5: Comparison of physician and literature based estimate of asthma prevalence (%) , in the seven major markets - page 22
• Table 6: Asthma prevalence (%) and diagnosed population (m) by country and age, 2005 - page 24
• Table 7: Prevalence of neutrophilic asthma (m), by disease severity, in late-onset adult asthma, by country, 2005 - page 37
• Table 8: Estimated population (m) of asthmatics with co-morbidities, by country - page 40
• Table 9: % drug prescribing levels by therapy type, and disease severity, in the seven major markets - page 51
• Table 10: Initial maintenance therapy in mild/moderate asthma patients (%), in seven major markets - page 54
• Table 11: Add-on therapy choice (%) in patients prescribed oral leukotriene antagonist as initial maintenance therapy, in six major markets, excluding Japan - page 55
• Table 12: Add-on therapy choice (%) in patients prescribed inhaled corticosteroids as initial maintenance therapy, in six major markets, excluding Japan - page 57
• Table 13: % of asthma patients receiving each drug class, by disease severity, in seven major markets - page 60
• Table 14: % of asthma patients receiving separate ICS/LABA inhalers vs. fixed combinations, by disease severity, in six major markets, excluding Japan - page 61
• Table 15: Projected growth of combination products as initial maintenance therapy in six major market, excluding Japan - page 64
• Table 16: Growth opportunities for switching from separate to fixed combination ICS/LABA therapies in six major market, excluding Japan - page 70
• Table 17: US physician sample breakdown, 2004 - page 163
• Table 18: Japan physician sample breakdown, 2004 - page 164
• Table 19: France physician sample breakdown, 2004 - page 164
• Table 20: Germany physician sample breakdown, 2004 - page 164
• Table 21: Italy physician sample breakdown, 2004 - page 165
• Table 22: Spain physician sample breakdown, 2004 - page 165
• Table 23: UK physician sample breakdown, 2004 - page 165


• List of Figures
• Figure 1: Why asthma makes it hard to breathe - page 13
• Figure 2: Mean % of asthma patients suffering from each disease severity at diagnosis, by country, 2004 - page 16
• Figure 3: Asthma patient pool (m), and diagnosed population (m), by age and country, in seven major markets, 2005 - page 25
• Figure 4: Growth in diagnosed asthma population (m), by age and country, in seven major markets, 2005-2015 - page 27
• Figure 5: Asthma is a heterogeneous disease - page 28
• Figure 6: Asthma phenotypes by age - page 29
• Figure 7: % asthma patients who experience daily of weekly symptoms, by age - page 31
• Figure 8: Characteristics of severe asthma - page 33
• Figure 9: Comparison of the pathophysiology of atopic and severe, non-atopic asthma - page 34
• Figure 10: Mean rating for risk factors/causes that precipitate asthma exacerbations and/or cause symptoms to persist - page 39
• Figure 11: % of diagnosed asthma patients with each co-morbidity in global market - page 41
• Figure 12: UK Media coverage of October 2004 launch of Merck's Singulair "Sprinkles" formulation - page 47
• Figure 13: Stepwise approach to long-term asthma management using preventer therapy - page 49
• Figure 14: % drug prescribing levels by therapy type, and disease severity, in the seven major markets - page 51
• Figure 15: Initial maintenance therapy in mild/moderate asthma patients (%), in seven major markets - page 53
• Figure 16: Add-on therapy choice (%) in patients prescribed oral leukotriene antagonist as initial maintenance therapy, in six major markets, excluding Japan - page 56
• Figure 17: Add-on therapy choice (%) in patients prescribed inhaled corticosteroids as initial maintenance therapy, in six major markets, excluding Japan - page 58
• Figure 18: Drug classes used as maintenance therapy (%), by disease severity, in seven major markets - page 59
• Figure 19: % of asthma patients receiving separate ICS/LABA inhalers vs. fixed combinations, by disease severity, in six major markets, excluding Japan - page 62
• Figure 20: Projected growth of combination products as initial maintenance therapy in six major market, excluding Japan - page 65
• Figure 21: The UK: a unique market? - page 66
• Figure 22: Growth opportunities for switching from separate to fixed combination ICS/LABA therapies in six major market, excluding Japan - page 71
• Figure 23: Mean points allocated to each attribute to indicate the extent to which they influence the prescribing of fixed combination versus separate ICS/LABA - page 74
• Figure 24: Asthma management guidelines based on control - page 77
• Figure 25: Potential to expand Xolair into a wider patient group - page 81

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