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Stakeholder Insight: Rheumatoid Arthritis - DMARDs Gain Ground as Biologics Competition Intensifies
Datamonitor, July 2004, Pages: 192
CHAPTER 1 EXECUTIVE SUMMARY 3
Scope of the analysis 3
Insight into the RA market 5
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. 6
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. 9
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. 11
Key metrics 13
CHAPTER 2 INTRODUCTION AND SCOPE 22
Coverage of the Stakeholder Insight: Rheumatoid Arthritis survey 22
Country treatment trees 23
Supporting data sets 23
Key stakeholder organizations 24
CHAPTER 3 COUNTRY TREATMENT TREES 25
US 27
Japan 31
France 35
Germany 39
Italy 43
Spain 47
UK 51
CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION 55
Disease definition 55
Epidemiology of RA 55
Comorbidities 58
CHAPTER 5 DIAGNOSIS AND TREATMENT OPTIONS 61
Diagnosis and referral 61
Diagnosis 61
Referral 62
Treatment rates 64
Influences on diagnosis and treatment rates 67
Treatment guidelines 69
CHAPTER 6 PRESCRIBING TRENDS AND INFLUENCING FACTORS 72
Prescribing trends 72
Global trends 72
Mild RA 74
Moderate RA 75
Severe RA 75
Traditional NSAIDs and COX-II inhibitors 76
COX-II inhibitors and Japan 78
Traditional and biologic DMARDs 80
Biologic DMARDs and Japan 81
Oral and injectable steroids 82
Changes in therapy 85
Traditional DMARDs versus traditional NSAIDs 85
Drug combinations 87
NSAIDs plus traditional DMARDs 89
NSAIDs plus biologic DMARDs 90
NSAIDs plus traditional DMARDs plus biologic DMARDs 91
Traditional DMARDs plus biologic DMARDs 92
Factors influencing physician decision making 93
Factors influencing physician decision making: traditional DMARDs 96
Methotrexate 98
Plaquenil 99
Sulfasalazine 99
Arava 100
Gold 102
Penicillamine 102
Factors influencing physician decision making: biologic DMARDs 103
Remicade 104
Enbrel 105
Kineret 106
Humira 107
Biologic DMARDs compared 108
Traditional and biologic DMARDs: influences and issues 111
DMARD initiation 111
DMARD switching 112
DMARD combination therapy 114
Methotrexate response 115
Biologic DMARD initiation 116
Biologic DMARD switching and termination 117
Enbrel and methotrexate 119
Biologic DMARD side effects 121
Biologic DMARD safety 122
Biologic DMARD pricing 123
CHAPTER 7 IMPROVING TREATMENT OUTCOMES 125
Treatment outcomes 125
Compliance 126
Unmet needs 129
New product development 133
CHAPTER 8 OTHER STAKEHOLDER INFLUENCES 136
Improving diagnosis and treatment: the roles of stakeholders 136
PCP education 136
Consumer education 138
Patient advocacy groups: influence, impact, perspectives 138
CHAPTER 9 OPINION LEADER AND STAKEHOLDER TRANSCRIPTS 140
Opinion leader interviews: methodology 140
Opinion leader interviews: biographies 140
Professor Allan Gibofsky 140
Professor David Isenberg 141
Professor Philip Mease 141
Professor Gerald Weissmann 141
Opinion leader interviews: questions 143
Opinion leader interviews: answers 144
APPENDIX A 167
Bibliography 167
Physician research methodology 169
Physician sample breakdown 169
US 169
Japan 169
France 170
Germany 170
Italy 171
Spain 171
UK 172
APPENDIX B 173
Physician survey questionnaire 173
Section 1: Epidemiology 173
Section 2: Prescribing patterns and disease severity 177
Section 3: Treatment patterns and disease severity 180
Section 4: Prescribing factors 187
Section 5: Treatment outcomes 189
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