Stakeholder Insight: Rheumatoid Arthritis - DMARDs Gain Ground as Biologics Competition Intensifies

SUMMARY

Introduction

The treatment of RA has changed significantly as treatment shifts towards early, aggressive management of the disease. Although guidelines support early use of DMARDs, concomitant use of other drugs, such as NSAIDs, continues at significant levels. The convenience of Humira is challenging Enbrel and Remicade, and Medicare reform in the US promises to alter radically the dynamics of this sector

Scope

• Assessment of epidemiological trends and patient potential
• Analysis of RA treatment algorithms globally and by country, based on extensive primary research with 180 physicians
• Country treatment trees showing treatment practices in the seven major markets
• Transcripts of interviews with key RA opinion leaders in the US, UK, and mainland Europe

Report Highlights

The addition of a prescription drug benefit to Medicare will have significant effects on the RA market and treatment practices, in particular in the biologics sector. The advantage over its rivals of Remicade as an infusion product reimbursed under Medicare is set to narrow, transforming the dynamics of the biologic DMARDs sector.

Celltech and CAT have had licenses for RA products disputed or terminated, with serious consequences for licensors and licensees. Big pharma\'s need to boost pipelines through licensing makes it important that companies refrain from alienating biotechs, to avoid jeopardizing opportunities to conclude much needed licensing deals with future partners.

65 and overs account for 53% of US RA patients. 70% of 65-74s voted in the US election of 2000, to just 44% of 25-34s. The demographics of population and disease favor RA as a disease where advocacy groups should possess a powerful voice, but polarization of political issues makes it hard for RA groups to leverage their advantages in lobbying.

TABLE OF CONTENTS

CHAPTER 1 EXECUTIVE SUMMARY

• Scope of the analysis
• Datamonitor insight into the RA market
• Legislation overhauling the Medicare program has created, for the first time, a prescription drug benefit to complement existing coverage of medical services. The addition of this prescription drug benefit to Medicare in the 10 year, $400bn overhaul of the US federal health insurance program for those 65 and older will have significant effects on the RA market and treatment practices, in particular in the biologics sector. The advantage Remicade currently enjoys over its rivals as an infusion product reimbursed under Medicare is set to narrow, transforming the dynamics of the biologic DMARDs sector.
• Disputes over licensing deals have affected both marketed and pipeline RA products, with serious consequences for both licensors and licensees. Celltech and CAT have had licenses for RA products terminated or disputed, affecting these relatively small biotech players\' stability. The need for big pharma to supplement pipelines through in licensing makes it important that larger companies refrain from alienating the biotech sector, so as to avoid jeopardizing future opportunities to conclude much needed licensing agreements with potential biotech partners.
• The demographics of population and disease, and the realities of the political environment, appear to favor RA as a disease in which patient advocacy groups should possess a powerful lobbying voice. However, the polarization of political issues provides an explanation for why it is not always easy for RA advocacy groups to leverage their demographic advantages in lobbying for resources for RA patients.
• Key metrics

CHAPTER 2 INTRODUCTION AND SCOPE

• Coverage of the Stakeholder Insight: Rheumatoid Arthritis survey
• Country treatment trees
• Supporting data sets
• Key stakeholder organizations

CHAPTER 3 COUNTRY TREATMENT TREES

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

CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION

• Disease definition
• Epidemiology of RA
• Comorbidities

CHAPTER 5 DIAGNOSIS AND TREATMENT OPTIONS

• Diagnosis and referral
• Diagnosis
• Referral
• Treatment rates
• Influences on diagnosis and treatment rates
• Treatment guidelines

CHAPTER 6 PRESCRIBING TRENDS AND INFLUENCING FACTORS

• Prescribing trends
• Global trends
• Mild RA
• Moderate RA
• Severe RA
• Traditional NSAIDs and COX-II inhibitors
• Traditional and biologic DMARDs
• Oral and injectable steroids
• Changes in therapy
• Traditional DMARDs versus traditional NSAIDs
• Drug combinations
• Factors influencing physician decision making
• Factors influencing physician decision making: traditional DMARDs
• Factors influencing physician decision making: biologic DMARDs
• Biologic DMARDs compared
• Traditional and biologic DMARDs: influences and issues
• DMARD initiation
• DMARD switching
• DMARD combination therapy
• Methotrexate response
• Biologic DMARD initiation
• Biologic DMARD switching and termination
• Enbrel and methotrexate
• Biologic DMARD side effects
• Biologic DMARD safety
• Biologic DMARD pricing

CHAPTER 7 IMPROVING TREATMENT OUTCOMES

• Treatment outcomes
• Compliance
• Unmet needs
• New product development

CHAPTER 8 OTHER STAKEHOLDER INFLUENCES

• Improving diagnosis and treatment: the roles of stakeholders
• PCP education
• Consumer education
• Patient advocacy groups: influence, impact, perspectives

CHAPTER 9 OPINION LEADER AND STAKEHOLDER TRANSCRIPTS

• Opinion leader interviews: methodology
• Opinion leader interviews: biographies
• Professor Allan Gibofsky
• Professor David Isenberg
• Professor Philip Mease
• Professor Gerald Weissmann
• Opinion leader interviews: questions
• Opinion leader interviews: answers
• Bibliography
• Physician research methodology
• Physician sample breakdown
• Physician survey questionnaire
• Section 1: Epidemiology
• Section 2: Prescribing patterns and disease severity
• Section 3: Treatment patterns and disease severity
• Section 4: Prescribing factors
• Section 5: Treatment outcomes
• List of Tables
• Table 1: Growth in RA populations, seven major markets (000s), 2003...2010
• Table 2: RA patients receiving non-pharmacological and pharmacological therapy by disease severity, seven major markets (%), 2003
• Table 3: RA population by age and gender, US (000s), 2003
• Table 4: RA population by age and gender, Japan (000s), 2003
• Table 5: RA population by age and gender, Europe (000s), 2003
• Table 6: RA prevalence, Europe (%), 2003
• Table 7: Growth in RA populations, seven major markets (000s), 2003...2010
• Table 8: RA patients suffering from comorbidities, seven major markets (%), 2003
• Table 9: Diagnosed RA patients by disease severity, seven major markets (%), 2003
• Table 10: RA patients referred to other physicians by disease severity, seven major markets (%), 2003
• Table 11: Physicians referring RA patients to each physician type by disease severity, seven major markets combined (%), 2003
• Table 12: RA patients receiving non-pharmacological and pharmacological therapy by disease severity, seven major markets (%), 2003
• Table 13: RA patients receiving non-pharmacological therapy only, pharmacological therapy only, and pharmacological and non-pharmacological therapy by disease severity, seven major markets (%), 2003
• Table 14: Physicians following guidelines, seven major markets (%), 2003
• Table 15: RA patients receiving various drug classes by disease severity, seven major markets (%), 2003
• Table 16: RA patients receiving traditional NSAIDs by disease severity, seven major markets (%), 2003
• Table 17: RA patients receiving COX-II inhibitors by disease severity, seven major markets (%), 2003
• Table 18: RA patients receiving traditional DMARDs by disease severity, seven major markets (%), 2003
• Table 19: RA patients receiving biologic DMARDs by disease severity, seven major markets (%), 2003
• Table 20: RA patients receiving oral steroids by disease severity, seven major markets (%), 2003
• Table 21: RA patients receiving injectable steroids by disease severity, seven major markets (%), 2003
• Table 22: RA patients receiving steroids, seven major markets (%), 2003
• Table 23: RA patients receiving drug combinations by disease severity, seven major markets (%), 2003
• Table 24: Mean prescribing habits influence ratings, seven major markets combined, 2003
• Table 25: Reasons for prescribing methotrexate, seven major markets combined (%), 2003
• Table 26: Reasons for prescribing Plaquenil, six major markets combined (%), 2003
• Table 27: Reasons for prescribing sulfasalazine, seven major markets combined (%), 2003
• Table 28: Reasons for prescribing Arava, six major markets combined (%), 2003
• Table 29: Reasons for prescribing gold, seven major markets combined (%), 2003
• Table 30: Reasons for prescribing penicillamine, seven major markets combined (%), 2003
• Table 31: Reasons for prescribing Remicade, six major markets combined (%), 2003
• Table 32: Reasons for prescribing Enbrel, six major markets combined (%), 2003
• Table 33: Reasons for prescribing Kineret, six major markets combined (%), 2003
• Table 34: Reasons for prescribing Humira, six major markets combined (%), 2003
• Table 35: Physician preference points allocated to biologic DMARDs, six major markets, 2003
• Table 36: RA patients immediately placed on DMARDs, seven major markets (%), 2003
• Table 37: Time on first DMARD before switching to or adding another, seven major markets (months), 2003
• Table 38: RA patients receiving DMARDs receiving two or three or more DMARDs, six major markets (%), 2003
• Table 39: RA patients receiving methotrexate who respond to this treatment, seven major markets (%), 2003
• Table 40: Time before introduction of biologic DMARD, six major markets (months), 2003
• Table 41: Biologic DMARD patients terminating therapy or switching biologics, six major markets (%), 2003
• Table 42: Enbrel patients receiving methotrexate, six major markets (%), 2003
• Table 43: Patients at increased risk of secondary infection/disease as result of biologic DMARD use, six major markets (%), 2003
• Table 44: Extent to which safety concerns have hindered biologic DMARD use (mean rating), six major markets, 2003
• Table 45: Extent to which price of biologic DMARDs influences prescribing (mean rating), six major markets, 2003
• Table 46: RA patients reaching desired outcome by disease severity, seven major markets (%), 2003
• Table 47: Mild RA patients at each compliance level, seven major markets (%), 2003
• Table 48: Moderate RA patients at each compliance level, seven major markets (%), 2003
• Table 49: Severe RA patients at each compliance level, seven major markets (%), 2003
• Table 50: Physicians citing RA unmet needs, seven major markets combined (%), 2003
• Table 51: US physician sample breakdown, 2003
• Table 52: Japan physician sample breakdown, 2003
• Table 53: France physician sample breakdown, 2003
• Table 54: Germany physician sample breakdown, 2003
• Table 55: Italy physician sample breakdown, 2003
• Table 56: Spain physician sample breakdown, 2003
• Table 57: UK physician sample breakdown, 2003
• List of Figures
• Figure 1: Typical annual cost to patients of drugs under Medicare prescription drug benefit ($), 2006
• Figure 2: Physician preference points allocated to biologic DMARDs, six major markets, 2003
• Figure 3: US RA population: severity and drug treatment, 2003
• Figure 4: US RA population: compliance and outcomes, 2003
• Figure 5: US mild RA drug treated population: drug classes, 2003
• Figure 6: US moderate RA drug treated population: drug classes, 2003
• Figure 7: US severe RA drug treated population: drug classes, 2003
• Figure 8: Japanese RA population: severity and drug treatment, 2003
• Figure 9: Japanese RA population: compliance and outcomes, 2003
• Figure 10: Japanese mild RA drug treated population: drug classes, 2003
• Figure 11: Japanese moderate RA drug treated population: drug classes, 2003
• Figure 12: Japanese severe RA drug treated population: drug classes, 2003
• Figure 13: French RA population: severity and drug treatment, 2003
• Figure 14: French RA population: compliance and outcomes, 2003
• Figure 15: French mild RA drug treated population: drug classes, 2003
• Figure 16: French moderate RA drug treated population: drug classes, 2003
• Figure 17: French severe RA drug treated population: drug classes, 2003
• Figure 18: German RA population: severity and drug treatment, 2003
• Figure 19: German RA population: compliance and outcomes, 2003
• Figure 20: German mild RA drug treated population: drug classes, 2003
• Figure 21: German moderate RA drug treated population: drug classes, 2003
• Figure 22: German severe RA drug treated population: drug classes, 2003
• Figure 23: Italian RA population: severity and drug treatment, 2003
• Figure 24: Italian RA population: compliance and outcomes, 2003
• Figure 25: Italian mild RA drug treated population: drug classes, 2003
• Figure 26: Italian moderate RA drug treated population: drug classes, 2003
• Figure 27: Italian severe RA drug treated population: drug classes, 2003
• Figure 28: Spanish RA population: severity and drug treatment, 2003
• Figure 29: Spanish RA population: compliance and outcomes, 2003
• Figure 30: Spanish mild RA drug treated population: drug classes, 2003
• Figure 31: Spanish moderate RA drug treated population: drug classes, 2003
• Figure 32: Spanish severe RA drug treated population: drug classes, 2003
• Figure 33: UK RA population: severity and drug treatment, 2003
• Figure 34: UK RA population: compliance and outcomes, 2003
• Figure 35: UK mild RA drug treated population: drug classes, 2003
• Figure 36: UK moderate RA drug treated population: drug classes, 2003
• Figure 37: UK severe RA drug treated population: drug classes, 2003
• Figure 38: Guideline adherence, mean ratings, seven major markets, 2003
• Figure 39: Mild RA patients receiving traditional DMARDs and traditional NSAIDs, seven major markets (%), 2003
• Figure 40: Moderate RA patients receiving traditional DMARDs and traditional NSAIDs, seven major markets (%), 2003
• Figure 41: Severe RA patients receiving traditional DMARDs and traditional NSAIDs, seven major markets (%), 2003
• Figure 42: RA patients receiving NSAIDs plus traditional DMARDs/immunosuppressants by disease severity, seven major markets (%), 2003
• Figure 43: RA patients receiving NSAIDs plus biologic DMARDs by disease severity, seven major markets (%), 2003
• Figure 44: RA patients receiving NSAIDs plus traditional DMARDs/immunosuppressants plus biologic DMARDs by disease severity, seven major markets (%), 2003
• Figure 45: RA patients receiving traditional DMARDs/immunosuppressants plus biologic DMARDs by disease severity, seven major markets (%), 2003
• Figure 46: Mean prescribing habits influence ratings, seven major markets, 2003
• Figure 47: Physicians citing RA unmet needs, seven major markets combined (%), 2003