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Stakeholder Insight: Psoriasis - Biologics are yet to make topical treatments obsolete

Published by: Datamonitor

Published: Mar. 10, 2009 - 192 Pages


Table of Contents



ABOUT DATAMONITOR HEALTHCARE

About the Immunology & Inflammation pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the psoriasis market

Contributing experts

Related reports

Upcoming related reports

CHAPTER 2 INTRODUCTION AND SCOPE

Coverage of the Stakeholder Insight Survey

Epidemiology and comorbidities of psoriasis

Patient segmentation, presentation and diagnosis

Treatment options and trends

Brand trends

Improving treatment outcomes

Future trends

CHAPTER 3 COUNTRY TREATMENT TREES

Introduction to treatment trees

US

Japan

France

Germany

Italy

Spain

UK

CHAPTER 4 EPIDEMIOLOGY AND COMORBIDITIES OF PSORIASIS

Disease definition and types

Plaque psoriasis affects the majority of psoriasis patients

Diagnostic criteria

Epidemiology of psoriasis

Studies of psoriasis prevalence in the US broadly align with each other

Psoriasis prevalence in Japan is lower than in the US and Europe

Europe

Estimates of psoriasis prevalence in France vary widely

German psoriasis prevalence estimates lead to a consensus figure

Two prevalence studies in Italy reach similar conclusions

Spanish psoriasis prevalence estimates vary within a narrow range

Two studies find similar psoriasis prevalence rates in the UK

Trends in psoriasis epidemiology

Psoriasis typically affects adolescents and middle-aged adults

Psoriasis affects slightly more men than women

Comorbidities, risk factors and complications

Comorbidities are common in psoriasis

Obesity and smoking are strongly associated with psoriasis

Physical trauma and infections can bring on psoriasis

Other autoimmune diseases affect over 20% of psoriasis patients with a comorbidity

CHAPTER 5 PATIENT SEGMENTATION, PRESENTATION AND DIAGNOSIS

Psoriasis diagnosis rates and awareness are relatively low

Reasons for the low diagnosis rates

Disease severity drives treatment-seeking behavior

Time to diagnosis

Many psoriasis patients wait over 10 months before presenting

Psoriasis diagnosis tends not to be immediate

Physicians do not perceive misdiagnosis as a key reason for lack of psoriasis diagnosis

Patient segmentation

The majority of psoriasis patients have mild or moderate disease

CHAPTER 6 TREATMENT OPTIONS AND TRENDS

Treatment guidelines

Various national treatment guidelines are interpreted and applied internationally

Non-pharmacological, pharmacological and combination treatment strategies

Non-pharmacological therapies

Phototherapy: principles and potential risks

Phototherapy usage is low in most markets

Excimer laser

Psoralen plus UVA (PUVA)

Ultraviolet light B

Sunlight

Balneophototherapy

Pharmacological therapies

Topical and systemic therapies

Use of systemic and combination therapy increases with disease severity

Treatment class options and trends

Topical vitamin derivatives

Topical vitamin derivative use is common in mild to moderate psoriasis

Cytotoxic agents

Cytotoxic agents may be used instead of biologics in moderate to severe psoriasis

Systemic corticosteroids

Systemic corticosteroids are used nearly exclusively in severe psoriasis

Topical corticosteroids

Topical corticosteroid use varies significantly from market to market

Immunosuppressants

Immunosuppressant usage relies on situation-specific cost-benefit analysis

Topical immunomodulators

Topical immunomodulators see limited off-label use in psoriasis

Systemic retinoids

Biologic therapy

The market for anti-TNF therapy in moderate to severe psoriasis is maturing

Less than 10% of severe psoriasis patients use other biologic drugs

Other drug classes

Analgesics are used sparingly in psoriasis

NSAIDs and COX-2 inhibitors are used sparingly to manage inflammation

Topical NSAIDs are uncommon in psoriasis treatment regardless of disease severity

Traditional DMARDs are rarely used in psoriasis

CHAPTER 7 BRAND TRENDS

Biologic usage by brand, line and response dynamics

Usage of biologic brands by percentage

Overall Enbrel is currently the predominant brand in psoriasis

Preference by line of therapy

Physicians strongly prefer Enbrel at first line

Humira shines at second line in the US but opinion is split in Europe

Remicade and Raptiva are the clear favorites at third line

Outcomes by brand of biologic

Enbrel is preferred at first line but fails for a significant proportion of patients

Importance of prescribing factors

Question design

Efficacy and safety are important to all classes

Disease modification is the primary rationale for biologics use

Side-effect profile comparatively more important for vitamin derivatives

Speed of action dictates the prescribing decision for steroids

Physician perception of key brands

Amevive (alefacept; Astellas, Biogen Idec)

Amevive: poorly understood or differentiated

Raptiva (efalizumab; Genentech, Xoma, Merck Serono)

Cases of PML spell trouble for Raptiva

Dermatologists rated Raptiva highly in terms of dosing frequency

Raptiva's safety profile continues to signal doom for the brand

Enbrel (etanercept; Amgen, Wyeth)

Enbrel loses out in terms of disease modification efficacy

Remicade (infliximab; Centocor, Schering-Plough, Mitsubishi Tanabe)

Remicade used for speed of action in more severe patients

Remicade's downfall in psoriasis is its method of administration

Humira (adalimumab; Abbott, Eisai)

Humira scores well on dose frequency, but loses out on top spot to Stelara for this attribute

Humira market share predicted to increase due to positive perception

Stelara (ustekinumab; Centocor, Janssen Cilag)

Fewer dermatologists were able to rate Stelara, but overall scores were high

Stelara awarded higher scores than other biologics on efficacy attributes

Stelara's perceived speed of action is similar to Humira but lower than Remicade

Stelara's dosing frequency sets it apart from other biologic brands

Dovonex (calcipotriol; Leo Pharma, Warner Chilcott)

Dovonex combines well with other therapies and rates positively in reimbursement status

Elocon (mometasone; Schering-Plough)

Elocon received similar attribute scores to Dovonex

CHAPTER 8 IMPROVING TREATMENT OUTCOMES

Measuring the severity of psoriasis

PASI score is the standard endpoint in psoriasis clinical research

In the EU, payers have an influence on clinical usage of the PASI scores

Dermatologists generally accept PASI 75, but some prefer PASI 50

Most physicians using PASI clinically aim for a PASI score of 5 to 10

Other measures of treatment efficacy in psoriasis

Achieving treatment outcomes

Most mild patients reach desired outcomes after six months of treatment

Treatment satisfaction in psoriasis

Satisfaction with current psoriasis treatments is moderate to high

Unmet needs in psoriasis

Better formulations to increase adherence and tools to improve prescribing

BIBLIOGRAPHY

Journal papers

Websites

Datamonitor reports

APPENDIX A

Physician research methodology

APPENDIX B

The survey questionnaire

About Datamonitor

About Datamonitor Healthcare

About the Immunology & Inflammation analysis team

Disclaimer

List of Tables

Table 1: Subtypes of psoriasis, percentage of diagnosed patients across the seven major markets, 2008

Table 2: Features that have been considered in different classifications of psoriasis

Table 3: Psoriasis prevalence across the seven major markets, 2008

Table 4: Percentages of psoriasis patients with selected comorbidities in the seven major markets, 2004 and 2008

Table 5: Selected additional common psoriasis comorbidities, percentage of diagnosed patients across the seven major markets, 2008

Table 6: Autoimmune psoriasis comorbidities, percentage of patients with a comorbidity, across the seven major markets, 2008

Table 7: Percentage of psoriasis sufferers diagnosed in the seven major markets, 2004 and 2008

Table 8: Mean rating given to each reason for patients remaining undiagnosed, 5 = strongly agree,, seven major markets, 2008

Table 9: Total length of time from onset of symptoms to psoriasis diagnosis across the seven major markets (months) 2008

Table 10: Percentage of diagnosed psoriasis patients by disease severity in the seven major markets, 2008

Table 11: Treatment strategies recommended to psoriasis patients across the seven major markets, by disease severity, 2008

Table 12: Percentage of patients estimated to use non-pharmacological therapy only, by disease severity and country, 2008

Table 13: Types of phototherapy used by patients receiving phototherapy for psoriasis, by country, 2008

Table 14: Mean percentages of psoriasis patients estimated to use treatment options, by disease severity, per country, 2008

Table 15: Overview of drug classes commonly used in psoriasis treatment in the seven major markets, 2008

Table 16: Topical vitamin derivative class usage in psoriasis by disease severity across the seven major markets, 2008

Table 17: Cytotoxic agent class usage in psoriasis by disease severity across the seven major markets, 2008

Table 18: Systemic corticosteroid class usage in psoriasis by disease severity across the seven major markets, 2008

Table 19: Topical corticosteroid class usage in psoriasis by disease severity, across the seven major markets, 2008

Table 20: Immunosuppressant class usage in psoriasis by disease severity, across the seven major markets, 2008

Table 21: Topical immunomodulators class usage in psoriasis by disease severity and patients with inverse psoriasis across the seven major markets, 2008

Table 22: Systemic retinoid class usage in psoriasis by disease severity across the seven major markets, 2008

Table 23: Anti-TNF class usage in psoriasis by disease severity across the seven major markets, 2008

Table 24: Other biologics usage in psoriasis by disease severity across the seven major markets, 2008

Table 25: Analgesic usage in psoriasis by disease severity across the seven major markets, 2008

Table 26: Traditional systemic NSAID class usage in psoriasis by disease severity across the seven major markets, 2008

Table 27: COX-2 class usage in psoriasis by disease severity across the seven major markets, 2008

Table 28: Topical NSAID class usage in psoriasis by disease severity across the seven major markets, 2008

Table 29: DMARD class usage in psoriasis by disease severity across the seven major markets, 2008

Table 30: Percentage use by brand, for all patients receiving biologic therapy in the seven major markets, 2008

Table 31: Percentage of patients receiving each biologic brand with an initial inadequate response and who eventually become refractory

Table 32: Comparative importance of factors affecting dermatologist prescribing decisions, by country, for biologics

Table 33: Comparison of PASI 50, -75 and -90 scores between the biologic brands

Table 34: Comparative importance of factors affecting dermatologist prescribing decisions, by country, for vitamin derivatives

Table 35: Comparative importance of factors affecting dermatologist prescribing decisions, by country, for steroids

Table 36: Comparative scores across all brands assessed

Table 37: Amevive scores by attribute and country

Table 38: Raptiva scores by attribute and country

Table 39: Enbrel scores by attribute and country

Table 40: Remicade scores by attribute and country

Table 41: Humira scores by attribute and country

Table 42: Stelara scores by attribute and country

Table 43: Dovonex scores by attribute and country

Table 44: Elocon scores by attribute and country

Table 45: Percentages for successful PASI change across the seven major markets, 2008

Table 46: Percentages for minimum successful PASI change across the seven major markets, 2008

Table 47: Measures of treatment efficacy in psoriasis among physicians not using PASI score in clinical practice, 2008

Table 48: Percentage of patients reaching the desired outcome after 6 months of treatment, %

Table 49: Priority rating allocated by dermatologists to unmet needs in the treatment of psoriasis, 1=low priority, 2008

Table 50: Dermatologists surveyed regarding psoriasis, 2008

List of Figures

Figure 1: Psoriasis patient population, split by physician-estimated diagnoses, disease severity, drug-treated population and drug-class usage in the US, 2008

Figure 2: Preferred biologic drug brands by line of therapy in moderate to severe psoriasis in the US, 2008

Figure 3: Psoriasis patient population, split by physician-estimated diagnoses, disease severity, drug-treated population and drug-class usage in Japan, 2008

Figure 4: Psoriasis patient population, split by physician-estimated diagnoses, disease severity, drug-treated population and drug-class usage in France, 2008

Figure 5: Preferred biologic drug brands by line of therapy in moderate to severe psoriasis in France, 2008

Figure 6: Psoriasis patient population, split by physician-estimated diagnoses, disease severity, drug-treated population and drug-class usage in Germany, 2008

Figure 7: Preferred biologic drug brands by line of therapy in moderate to severe psoriasis in Germany, 2008

Figure 8: Psoriasis patient population, split by physician-estimated diagnoses, disease severity, drug-treated population and drug-class usage in Italy, 2008

Figure 9: Preferred biologic drug brands by line of therapy in moderate to severe psoriasis in Italy, 2008

Figure 10: Psoriasis patient population, split by physician-estimated diagnoses, disease severity, drug-treated population and drug-class usage in Spain, 2008

Figure 11: Preferred biologic drug brands by line of therapy in moderate to severe psoriasis in Spain, 2008

Figure 12: Psoriasis patient population, split by physician-estimated diagnoses, disease severity, drug-treated population and drug-class usage in the UK, 2008

Figure 13: Preferred biologic drug brands by line of therapy in moderate to severe psoriasis in the UK, 2008

Figure 14: Subtypes of psoriasis, percentage of diagnosed patients across the seven major markets, 2008

Figure 15: Mean percentage of psoriasis patients with at least one comorbidity in the seven major markets, 2008

Figure 16: Percentage of psoriasis patients with selected comorbidities in the seven major markets, 2004 and 2008

Figure 17: Selected additional common psoriasis comorbidities, percentage of diagnosed patients across the seven major markets, 2008

Figure 18: Autoimmune psoriasis comorbidities, percentage of patients with a comorbidity, across the seven major markets, 2008

Figure 19: Percentage of diagnosed versus undiagnosed psoriasis sufferers in the seven major markets, 2008

Figure 20: Total estimated psoriasis patient population, diagnosed versus undiagnosed, in the seven major markets, 2008

Figure 21: Mean rating given to each reason for patients remaining undiagnosed, seven major markets, 2008

Figure 22: Total length of time from onset of symptoms to psoriasis diagnosis across the seven major markets, 2008

Figure 23: Physicians indicating that psoriasis is diagnosed immediately upon presentation versus those who believe that patients experience a delay in receiving a diagnosis, 2008

Figure 24: Percentage of diagnosed psoriasis patients by disease severity in the seven major markets, 2008

Figure 25: Treatment strategies used by psoriasis patients across the seven major markets, by disease severity, 2008

Figure 26: Percentage of patients estimated to use non-pharmacological therapy strategies, by disease severity, across the seven major markets, 2008

Figure 27: Percentage of patients estimated to use non-pharmacological therapy only, by disease severity and country, 2008

Figure 28: Mean estimated percentages of patients recommended to use phototherapy, by country, 2008

Figure 29: Distribution of percentages of patients to whom phototherapy is recommended in the seven major markets, 2008

Figure 30: Types of phototherapy used by patients receiving phototherapy for psoriasis, by country, 2008

Figure 31: Mean percentages of psoriasis patients estimated to use topical and/or systemic treatment options, by disease severity, across the seven major markets, 2008

Figure 32: Percentage use by brand, for all patients receiving biologic therapy in the seven major markets, 2008,

Figure 33: Preferred biologic drug brands by line of therapy in moderate to severe psoriasis, US verses average of five major EU counties, 2008

Figure 34: Percentage of patients receiving each biologic brand with an initial inadequate response and who eventually become refractory

Figure 35: Comparative importance of factors affecting dermatologist prescribing decisions, by class

Figure 36: Comparative scores across all brands assessed

Figure 37: Stelara's clinical response between Week 0 and Week 28

Figure 38: Percentage of physicians using the PASI score across the seven major markets, 2008

Figure 39: Successful percentage of PASI change across the seven major markets, 2008

Figure 40: Successful minimum PASI change, %, across the seven major markets, 2008

Figure 41: Physicians stating 41%-50%, 61%-70% and 71%-80% as acceptable PASI scores, by country, 2008

Figure 42: Mean PASI scores physicians aim to reach in the seven major markets, 2008

Figure 43: Measures of treatment efficacy in psoriasis among physicians not using PASI score in clinical practice, seven major markets, 2008

Figure 44: Measures of treatment efficacy in psoriasis among US physicians not using PASI score in clinical practice, 2008

Figure 45: Distribution of physician responses for percentage of patients reaching the desired outcome, by severity

Figure 46: Dermatologists' satisfaction with currently available psoriasis treatments across the seven major markets, 2008

Figure 47: Distribution of dermatologists' ratings of satisfaction with currently available psoriasis treatments across the seven major markets, 2008

Figure 48: Priority rating allocated by dermatologists to unmet needs in the treatment of psoriasis,


Abstract

Introduction

Patient perception of disease severity drives treatment-seeking behavior in psoriasis. New therapeutic options targeting specific mechanisms are set to reshape severe psoriasis therapy. However, current biologics have not undermined first-line topical therapy. In addition to efficacy, reimbursement plays a crucial role in physicians' prescribing decisions.

Scope

Opinion from 180 practicing dermatologists, each treating at least 40 psoriasis patients per month Including data from physicians and opinion leaders across the seven major markets of the US, Japan, France, Germany, Spain, Italy and the UK Analysis of psoriasis population attributes, physicians' prescribing decisions, therapy outcomes and treatment satisfaction Brand analysis of key pharmaceuticals used in psoriasis, including biologics and branded topical formulations

Highlights

The low estimated diagnosis rate of 54% reflects a lack of treatment-seeking by mild sufferers. Despite nearly 10 million diagnosed patients, the market value of psoriasis is constrained by reliance on generic and non-prescription treatments in mild disease.

Biologics' risk-benefit and cost-benefit ratios are coming under review. Humira (adalimumab) and Stelara (ustekinumab) stand to benefit from the withdrawal of Raptiva (efalizumab) from the EU and more stringent labeling in the US. The position of biologics in moderate to severe psoriasis is up for challenge by payers attempting to control costs.

Topical treatments are the foundation of therapy, used alone by at least 82% of mild patients. Phototherapy is a cost-effective treatment option in psoriasis unresponsive to topical therapy. Most physicians surveyed recommend phototherapy to up to 30% of patients, and payers may influence greater use of phototherapy.

Reasons to Purchase

Understand how patient behavior controls the size of the psoriasis market
Interpret physicians' priorities in prescribing personalized psoriasis treatment regimens
Assess the regional dynamics of therapy choice in psoriasis, dictated by product availability, regulation and reimbursement

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