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Stakeholder Insight: Asthma

Published by: Datamonitor

Published: Jun. 25, 2008


Table of Contents


ABOUT DATAMONITOR HEALTHCARE

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

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

Abstract

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

Report 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.

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