Market Report Source

Overview

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 of this report:

• 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

Research and analysis 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.

Key reasons to read this report:

• 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.

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY
Scope of the analysis
Datamonitor insight into the asthma market
Contributing experts
Related reports
Upcoming related reports

CHAPTER 2 COUNTRY TREATMENT TREES
Introduction to treatment trees

• US
• 5EU
• Japan
• France
• Germany
• Italy
• Spain
• UK

CHAPTER 3 PATIENT SEGMENTATION AND EPIDEMIOLOGY
Disease definition: the importance of inflammation
Asthma is caused by a combination of exogenous and genetic factors
Exogenous factors
Genetic factors
The role of airway inflammation, airway hyper-responsiveness and airway
remodeling
Co-morbidities
Allergic rhinitis is the most common co-morbidity of asthma
Asthma and COPD can co-exist but true interaction between these diseases is unclear
Obesity may become even more important in the future of asthma
Disease classification – asthma control
Disease classification – asthma phenotypes
Allergic asthma is by far the most common phenotype
Asthma can be irreversible with chronic airflow obstruction
Awareness of nocturnal asthma as a phenotype may be low
Is exercise-induced asthma a separate phenotype?
Patients with steroid-resistant asthma have highest unmet needs
Why are phenotypes (not) used?
Asthma prevalence
Difference between physician’s impression and publicized data is related to asthma
definition
Asthma prevalence seems to be stabilizing

• US
• Japan
• Europe
  • France
  • Germany
  • Italy
  • Spain
  • UK

CHAPTER 4 DIAGNOSIS AND DIAGNOSTIC TESTS
Presentation of asthma – symptoms
Diagnosis of asthma
Spirometry and PEF measurements are still underused
Allergen skin tests mostly used for initial diagnosis
Airway responsiveness challenges are mainly useful for difficult-to-diagnose patients
Upcoming diagnostic tests: sputum eosinophil count and fraction exhaled nitric oxide
(FENO)

CHAPTER 5 TREATMENT OPTIONS AND TRENDS
Treatment options
Bronchodilators (relievers)
Beta2-agonists
Anticholinergics
Combination beta2-agonist/anticholinergic
Methyl xanthines
Anti-inflammatories (controllers)
Inhaled corticosteroids
Systemic corticosteroids
Non-steroidal anti-inflammatory drugs (NSAIDs)
ICS/LABA combinations
Biologicals
Inhaler device options
The ideal inhaler device
Treatment guidelines
The Global Initiative for Asthma (GINA) guidelines are most important international
guidelines
The National Heart, Lung, and Blood Institute (NHLBI) guidelines follow GINA’s focus on
control
American Thoracic Society (ATS) and the European Respiratory Society (ERS) do not
have specific asthma guidelines
National guidelines can supersede international guidelines
Most guidelines are now evidence-based
Treatment trends
Almost all patients receive some type of controller medication
Mild asthma is over-treated with long-term reliever medication
ICS/LABA combinations even used in mildest forms of asthma
Inhaled corticosteroids are less used as severity progresses
Long-acting bronchodilators mainly used in conjunction with an ICS
Antileukotriene drugs are especially popular in Japan
Short-acting bronchodilators is the most often used drug class in most severities
Theophylline is still prominent in Japanese treatment regimen
Omalizumab is reserved for the most severe asthma patients

CHAPTER 6 KEY PRESCRIBING INFLUENCES AND BRAND ASSESSMENT
Factors influencing physician decision making
Symptomatic improvement
Duration of action
Side-effect profile
Speed of onset
Recommended in treatment guidelines
Cost
Once-daily dosing
Flexible dosing
Device/mode of administration
Patient age
Physician perception of key products
Total scores per drug per country
Interpreting a brand map
The ICS/LABA combination class
The ICS/LABA combination products
The inhaled corticosteroid class
The inhaled corticosteroid products
The long-acting bronchodilator class
The long-acting bronchodilator products
The antileukotriene class
The antileukotriene products
Short-acting bronchodilators
Biologics – Xolair (omalizumab)

CHAPTER 7 TREATMENT OUTCOMES AND NEW PRODUCT DEVELOPMENT
Treatment outcomes
Unmet needs
Increase access to safe and effective immunotherapy
Improve therapeutic response by phenotyping
Reduce cost of medication
Reduce over-treatment of asthma
Develop ICS without side effects
Other unmet needs
New product development
Awareness of pipeline products

• Combination products
• LABAs and LAMAs
• Novel mechanisms of action

Future use of pipeline products

• Novel ICS/LABA combinations
• Novel LABA/LAMA combinations
• Novel LAMAs
• Novel LABAs
• Novel mechanisms of action

BIBLIOGRAPHY
Journal papers
Websites
Datamonitor reports

APPENDIX A
Physician research methodology
Physician sample breakdown

• US
• Japan
• France
• Germany
• Italy
• Spain
• UK

Contributing experts

APPENDIX B
The survey questionnaire
Section 1 – Patient Segmentation
Section 2 – Diagnosis
Section 3 – Treatment
Section 4 – Treatment Outcomes
Section 5 – Product Profiles
Section 6 – Products in Development

APPENDIX C
About Datamonitor

• About Datamonitor Healthcare
• About the Infectious Disease and Respiratory (ID&R) analysis team
• Disclaimer

List of Tables
Table 1: Percentage of physicians using each asthma classification system for each of the seven major markets, 2008
Table 2: Prevalence of adult asthma, by severity and country in the seven major markets, 2008
Table 3: Prevalence of asthma per country, according to Datamonitor’s research among physicians and published literature, 2008
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
Table 5: Comparative analysis of the definition of the levels of evidence used in the asthma guidelines considered
Table 6: Primary endpoints of some of the ICS drugs used in asthma treatment
Table 7: Number and percentage of physicians able to rate each asthma drug, 2008
Table 8: Total scores (out of 100) of each asthma drug for each of the individual seven major markets
Table 9: Price differences between ICS/LABA* combination products in countries where Foster was available, 2007
Table 10: Price differences between ICS products in countries where all four products were available in 2007
Table 11: Mean percentage of asthma patients experiencing each number of exacerbations per year, by disease severity, across the seven major markets, 2008
Table 12: US physician sample breakdown, 2008
Table 13: Japan physician sample breakdown, 2008
Table 14: France physician sample breakdown, 2008
Table 15: Germany physician sample breakdown, 2008
Table 16: Italy physician sample breakdown, 2008
Table 17: Spain physician sample breakdown, 2008
Table 18: UK physician sample breakdown, 2008
Table 19: Percentage of all your current (diagnosed) asthma patients with each of the disease severities
Table 20: Classification that you primarily use to characterize your asthma patients
Table 21: Percentage of all your asthma patients presenting with each of the types of asthma
Table 22: Co-morbidities that your asthma patients present with and at which percentage
Table 23: Percentage of your asthma patients suffering from each number of exacerbations per year
Table 24: Percentage of all your current asthma patients receiving each of the following tests in order to facilitate diagnosis and track their status
Table 25: Percentage of all your current asthma patients receiving each of the following drug therapies as baseline therapy
Table 26: Relative importance of the factors when prescribing each of the drug classes for asthma
Table 27: Challenges in the management of asthma
Table 28: Rate of the performance or predicted performance of each of the ICS and ICS/LABA combinations
Table 29: Rate of the performance or predicted performance of each of the oral antileukotrienes and biologic
Table 30: Rate of the performance or predicted performance of each of the long-acting bronchodilators
Table 31: Points allocated to the importance of characteristics of a device
Table 32: Preference of device type per each drug class
Table 33: Awareness of pipeline products and how they would be prescribed

List of Figures
Figure 1: Diagrammatic overview of the coverage of the Stakeholder Insight: Asthma survey, 2008
Figure 2: US treatment tree (ICS/LABA combination and steroids), 2008
Figure 3: US treatment tree (others), 2008
Figure 4: 5EU treatment tree (ICS/LABA combination and steroids), 200
Figure 5: 5EU treatment tree (others), 2008
Figure 6: Japan treatment tree (ICS/LABA combination and steroids), 2008
Figure 7: Japan treatment tree (others), 2008
Figure 8: France treatment tree (ICS/LABA combination and steroids), 2008
Figure 9: France treatment tree (others), 2008
Figure 10: Germany treatment tree (ICS/LABA combination and steroids), 2008
Figure 11: Germany treatment tree (others), 2008
Figure 12: Italy treatment tree (ICS/LABA combination and steroids), 2008
Figure 13: Italy treatment tree (others), 2008
Figure 14: Spain treatment tree (ICS/LABA combination and steroids), 2008
Figure 15: Spain treatment tree (others), 2008
Figure 16: UK treatment tree (ICS/LABA combination and steroids), 2008
Figure 17: UK treatment tree (others), 2008
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
Figure 19: Mean percentage of patients with each co-morbidity across the seven major markets, 2008
Figure 20: Levels of asthma control
Figure 21: Mean percentage of asthma patients with each asthma phenotype across the seven major markets, 2008
Figure 22: Familiarity with asthma phenotypes among physicians and their use in clinical practice, 2008
Figure 23: Severity of asthma as reported by physicians in the US (n=36) in the 2004 and 2008 Datamonitor surveys
Figure 24: Severity of asthma as reported by physicians in Japan (n=24) in the 2004 and 2008 Datamonitor surveys
Figure 25: Severity of asthma as reported by physicians in France (n=24) in the 2004 and 2008 Datamonitor surveys
Figure 26: Severity of asthma as reported by physicians in Germany (n=24) in the 2004 and 2008 Datamonitor surveys
Figure 27: Severity of asthma as reported by physicians in Italy (n=24) in the 2004 and 2008 Datamonitor surveys
Figure 28: Severity of asthma as reported by physicians in Spain (n=24) in the 2004 and 2008 Datamonitor surveys
Figure 29: Severity of asthma as reported by physicians in the UK (n=24) in the 2004 and 2008 Datamonitor surveys
Figure 30: Utilization per test for initial asthma diagnosis and to track a patient’s disease status (n=180), 2008
Figure 31: Advantages and disadvantages of the main three types of portable inhaler devices
Figure 32: Relative importance of each inhaler device characteristic for treating asthma patients (n=180), 2008
Figure 33: Factors influencing inhaler choice
Figure 34: Percentage of physicians following each guideline, 2004
Figure 35: GINA asthma management approach based on control, 2007 guidelines
Figure 36: NHLBI asthma management approach, 2007 guidelines
Figure 37: The prescription of different drug classes for the treatment of asthma on average in the seven major markets, 2008
Figure 38: Overview of the prescription of controller medications across the seven major markets, per asthma severity, 2008
Figure 39: Overview of the prescription of reliever medications across the seven major markets, per asthma severity, 2008
Figure 40: Overview of the prescription of ICS/LABA combinations across asthma severities, per country, 2008
Figure 41: Overview of the prescription of ICS across asthma severities, per country, 2008
Figure 42: Overview of the prescription of long-acting bronchodilators across asthma severities, per country, 2008
Figure 43: Overview of the prescription of antileukotrienes across asthma severities, per country, 2008
Figure 44: Overview of the prescription of short-acting bronchodilators across asthma severities, per country, 2008
Figure 45: Overview of the prescription of theophylline across asthma severities, per country, 2008
Figure 46: Overview of the prescription of omalizumab across asthma severities, per country, 2008
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
Figure 48: Number of points allocated to each factor (across asthma drug classes) to indicate its relative importance in each country or region, 2008
Figure 49: Proportion of 100 points distributed to reflect the importance of symptomatic improvement for each of the asthma drug classes, by country, 2008
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
Figure 51: The duration of action of formoterol and salmeterol
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
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
Figure 54: Efficacy of twice-daily 100μg fluticasone in adolescent and adult patients receiving bronchodilators alone
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
Figure 56: Proportion of 100 points distributed to reflect the importance of costs for each of the asthma drug classes by country, 2008
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
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
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
Figure 60: Proportion of 100 points distributed to reflect the importance of patient age for each of the asthma drug classes by country, 2008
Figure 61: Brand map of the scoring attributes in relation to each other
Figure 62: Brand map of the scores of the individual products in relation to each other
Figure 63: Brand map highlighting the position of ICS/LABA combination products, 2008
Figure 64: Number of points allocated to each ICS/LABA combination product on all factors, seven major markets, 2008
Figure 65: Brand map highlighting the position of ICS products in the treatment of asthma, 2008
Figure 66: Number of points allocated to each ICS/LABA combination product on all factors, seven major markets, 2008
Figure 67: Brand map highlighting the position of long-acting bronchodilator products in the treatment of asthma, 2008
Figure 68: Number of points allocated to each long-acting bronchodilator product on all factors, seven major markets, 2008
Figure 69: Brand map highlighting the position of antileukotriene products in the treatment of asthma, 2008
Figure 70: Number of points allocated to each antileukotriene product on all factors, seven major markets, 2008
Figure 71: Brand map highlighting the position of biologic omalizumab in the treatment of asthma, 2008
Figure 72: Number of points allocated to Xolair on all factors, seven major markets, 2008
Figure 73: Rating of unmet needs in the management of asthma (n=180), 2008
Figure 74: The importance of increasing access to safe and effective immunotherapy, per country (n=180), 2008
Figure 75: The importance of improving therapeutic response by phenotyping, per country (n=180), 2008
Figure 76: The importance of reducing the cost of medication, per country (n=180), 2008
Figure 77: The importance of reducing over-treatment of asthma patients, per country (n=180), 2008
Figure 78: The importance of developing an ICS without side effects, per country (n=180), 2008
Figure 79: Level of awareness of novel ICS/LABA and LABA/LAMA combinations in each individual country, seven major markets, 2008
Figure 80: Level of awareness of novel LABAs and LAMAs in each individual country, seven major markets, 2008
Figure 81: Level of awareness of novel mechanisms in each individual country , seven major markets, 2008
Figure 82: Questions regarding pipeline asthma products, 2008
Figure 83: Future use of once-daily ICS/LABA combination pipeline products
Figure 84: Future use of me-too ICS/LABA combination pipeline products
Figure 85: Future use of LABA/LAMA combination pipeline products
Figure 86: Future use of LAMA pipeline products
Figure 87: Future use of LABA pipeline products
Figure 88: Future use of new mechanisms in asthma treatment, 2008