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Stakeholder Opinions: Physician perception of biologics in autoimmune disease - Targeted detailing is the key to success

ABOUT DATAMONITOR HEALTHCARE 2
About the Immunology and Inflammation (I&I) pharmaceutical analysis team 2

CHAPTER 1 EXECUTIVE SUMMARY 3
Datamonitor insight into the autoimmune biologics market 3
Contributing experts 5
Related reports 5
Upcoming 2009 reports 5

CHAPTER 2 PHYSICIAN DYNAMICS AND QUESTIONNAIRE DESIGN 7
Physician types surveyed 7
Questionnaire design 7
Importance of attributes 8
Rating of brands 8
Physician demographics 8
Rheumatologists 9
Dermatologists 10
Gastroenterologists 11

CHAPTER 3 FACTORS INFLUENCING PHYSICIAN DECISION MAKING 12
Comparative importance of factors to the prescribing decision 12
Disease modification and side-effects are the most important factors to all prescribing physicians 12
Variation by country and physician type 17
Little variation seen between physician type 18
The UK and US show commonality while Japan is still an outlier in all but rheumatology 19
Interpreting a map 20
Prescribing factors 22
Efficacy 22
Brand comparison shows novel drugs not perceived to be as effective 24
The ability to predict response is a key unmet need 30
Remicade leads in terms of speed of action, but this attribute requires further comparative investigation 31
Side effects 33
Infection rates and in particular tuberculosis reactivation is of primary concern 36
Dermatologists consider a drug's effect on child-bearing ability 36
Immunogenicity divides the brands 37
Formulary or reimbursement status 39
DMARDs are considered ineffective for ankylosing spondylitis, but insurance constraints can prevent move to biologics 43
Time spent on a biologic is limited by cost constraints 44
Dosing frequency and delivery method 45
Gastroenterologists consider method of administration important 46
Brand comparison shows iv Remicade is not well received by dermatologists 47
Marketing and familiarity 48
Smarter physician detailing needed 51
Time on market influences score but is not always the defining pressure 52
Anti-TNF brand websites provide examples of best practice 53
Brands with other mechanisms vary their messages 56

CHAPTER 4 BRAND DYNAMICS 58
Brand overview 58
Brand sales trends 62
Biologic sales overview shows Enbrel leads in terms of total brand sales for all indications 62
Rheumatoid arthritis underpins total brand sales in 2007 62
Growth driven by ulcerative colitis and spondyloarthropathies 63
Brand awareness 64
Trends in preliminary brand scores by physician type 67
Rheumatologist 69
Dermatologist 69
Gastroenterologist 71
Brand assessment comparisons 71
Total score by brand shows future promise for Humira 71
Interpreting a brand map 73
Trends in brand scores by country 77
Brand profiles 78
Enbrel (etanercept; Amgen, Wyeth) 78
Enbrel scores close to the average, driven down by dermatologists' opinion 79
Activation of Crohn's disease with ankylosing spondylitis patients treated with Enbrel 82
Remicade (infliximab; Centocor, Schering-Plough, Mitsubishi Tanabe) 83
A fast-acting effective drug but tuberculosis reactivation is an issue 83
Remicade considered less focused on each specific disease 85
Humira (adalimumab; Abbott) 88
Humira's dominance shows as brand scores above average on all factors 88
Abbott's US co-pay system praised but should be reinforced with dermatologists 92
Orencia (abatacept; Bristol-Myers Squibb) 92
Orencia is perceived as the safe option 92
Rituxan/MabThera (rituximab; Roche, Genentach, Biogen Idec) 94
Re-treatment data are needed and data from the latest SUNRISE trial should be communicated 95
Raptiva (efalizumab; Genentech, Xoma, Merck Serono) 97
Raptiva hit by multifocal leukoencephalopathy side-effect 98
Amevive (alfacept; Astellas, Biogen Idec) 101
Amevive's poor efficacy and unusual dosing regime relegate it to last place 102
Tysabri (natalizumab; Biogen Idec, Elan) 103
Tysabri recognized by most US and some EU gastroenterologists, but poorly rated by both 104
Pipeline profiles 106
Pipeline overview 106
Licensing opportunities 110
Pipeline anti-TNFs 112
The three available anti-TNFs are perceived to be similar, but pipeline anti-TNFs offer little apparent improvement 112
Cimzia (certolizumab; UCB) 113
Cimzia administration issues expected to be solved by arthritis approval 115
Perception of Cimzia is variable 116
Simponi (golimumab; Centocor, Schering-Plough, Mitsubishi Tanabe, Janssen) 117
Multiple formulation options do not improve perception 119
Other pipeline mechanisms 120
Stelara (ustekinumab; Centocor, Janssen Cilag) 120
Actemra (tocilizumab; Chugai, Roche) 122
BIBLIOGRAPHY 125
Journal papers 125
Websites 127
About Datamonitor 130
About Datamonitor Healthcare 130
Datamonitor Healthcare's research and analysis methodologies 131
Datamonitor Healthcare's therapy area capabilities 131
Disclaimer 133

List of Tables
Table 1: Physician type surveyed 7
Table 2: Comparison of physician demographics 9
Table 3: Characteristics of rheumatologists surveyed across the seven major markets, 2008 10
Table 4: Characteristics of dermatologists surveyed across the seven major markets, 2008 10
Table 5: Characteristics of gastroenterologists surveyed across the seven major markets, 2007 11
Table 6: Attributes assessed by each physician type 13
Table 7: Anti-TNF prescribing information efficacy comparison across indications 27
Table 8: Other mechanism prescribing information efficacy data 29
Table 9: Summary of pros and cons of biomarkers to predict response to TNF therapy 31
Table 10: Summary of prescribing information black box and major warnings by brand 34
Table 11: Percent of patients showing positive antibodies against each brand according to prescribing information 38
Table 12: Formulary prices across the seven major markets, 2008 41
Table 13: Importance of dosing frequency and delivery method to prescribing of biologics, by country and by physician specialty, % 47
Table 14: Overview of brand details including mechanism, indications and launch dates 59
Table 15: Number and percent of physicians able to rate each brand, by country 65
Table 16: Score given to each brand by attribute, by rheumatologists, 2008 69
Table 17: Score given to each brand by attribute, by dermatologists, 2008 70
Table 18: Score given to each brand by attribute, by gastroenterologist, 2007 71
Table 19: Brand scores by country 78
Table 20: Enbrel's attribute scores, by country and physician type 80
Table 21: Remicade's attribute score, by country and physician type 85
Table 22: Humira's scores by country, attribute and physician type 89
Table 23: Orencia's scores from rheumatologists by country 93
Table 24: Rituxan/MabThera's scores, from rheumatologists by country 97
Table 25: Raptiva's scores by attribute and country, from dermatologists 101
Table 26: Amevive scores by country and attribute, from dermatologists 103
Table 27: Tysabri scores by country and attribute, from gastroenterologists 105
Table 28: Antibody products in clinical trials for autoimmune diseases (rheumatoid arthritis, inflammatory bowel disease, psoriasis) 107
Table 29: Late stage pipeline product profiles and status by indication and region 111
Table 30: Cimzia's attribute scores by country and physician type 115
Table 31: Simponi scores by country and attribute, from rheumatologists 119
Table 32: Stelara scores by country and attribute, from dermatologists 121
Table 33: Actemra scores by country and attribute, from rheumatologists 124

List of Figures
Figure 1: Grouped attribute average importance 14
Figure 2: Attribute importance, split by physician type 16
Figure 3: Average attribute importance to prescribing decision for biologic therapies, by country 17
Figure 4: Importance of grouped attributes to the prescribing decision by physician specialty 18
Figure 5: Mapping country dynamics with reference to attribute importance, split by physician type 21
Figure 6: Importance of efficacy factors to prescribing decision for biologic therapies, by country and specialist 23
Figure 7: Biologic comparative brand scores for efficacy factors, by physician type 25
Figure 8: Speed of action scores by dermatologists and gastroenterologists, non-weighted 32
Figure 9: Importance of a good side-effect profile to prescribing decision for biologic therapies, by country and specialist 33
Figure 10: Importance of formulary and reimbursement status to prescribing decision for biologic therapies, by country and specialist 40
Figure 11: Brand comparison scores for formulary/reimbursement status, by physician type 41
Figure 12: Ankylosing spondylitis treatment tree, 2008, seven major markets 44
Figure 13: Importance of dosing frequency and delivery method to prescribing of biologic, by country and by physician specialty 46
Figure 14: Brand scores comparison for administration attributes 48
Figure 15: Importance of marketing and familiarity to prescribing of biologics, by country and by physician specialty 49
Figure 16: Representation of influences of prescribing 50
Figure 17: Total representative count, 2003-2007 51
Figure 18: Brand scores comparison for marketing and familiarity attributes 52
Figure 19: Time on the market versus score for marketing/familiarity factors 53
Figure 20: Humira's website messages 54
Figure 21: Enbrel's directed messages for each indication 55
Figure 22: Remicade's US website messages 56
Figure 23: Online marketing for non-TNF mechanisms 57
Figure 24: Total brand sales for the top autoimmune biologics in the US, five major EU markets and Japan, $m, 2007 62
Figure 25: Total brand sales across the seven major markets, split by indication, $bn, 2007 63
Figure 26: Sales growth versus market share by indication for the major biologic brands in the seven major markets, 2004-07 64
Figure 27: Percentage of physicians able to rate each brand, by country 67
Figure 28: Sum of score for all attributes, by brand and physician type 68
Figure 29: Average score for each of the eight comparable attributes, by brand 72
Figure 30: Overview brand map of attributes versus brand perception by physician specialty 74
Figure 31: Average weighted brand scores by attribute 76
Figure 32: Brand scores by country 77
Figure 33: Enbrel's weighted score compared to average 79
Figure 34: Enbrel map, country preference to prescribing attributes 82
Figure 35: Remicade's weighted score compared to the average 84
Figure 36: Remicade map, country preference to prescribing attributes 87
Figure 37: Humira's weighted score compared to the average 89
Figure 38: Humira map, country preference for prescribing attributes 91
Figure 39: Orencia's weighted scores compared to all physicians average scores and rheumatologists average 93
Figure 40: Rituxan/MabThera's weighted scores compared to all physicians average scores and rheumatologists average 96
Figure 41: Raptiva's weighted score compared to all physicians average scores and dermatologists average 100
Figure 42: Amevive weighted score compared to all physicians average scores and dermatologists average 102
Figure 43: Tysabri weighted score compared to all physicians average scores and gastroenterologist average 104
Figure 44: Phase I to pre-registration projects in the pipeline, split by mechanism, 2009 106
Figure 45: Comparative physician perception of the pipeline and marketed anti-TNF inhibitors 112
Figure 46: Cimzia's weighted score compared to the average 114
Figure 47: Cimzia map, country preference for prescribing attributes 117
Figure 48: Simponi (golimumab) weighted score compared to the average 118
Figure 49: Stelara's weighted score compared to all physicians' average scores and dermatologists' average 121
Figure 50: Actemra's weighted score compared to all physicians average scores and rheumatologist average 123