Stakeholder Insight: Osteoporosis - Generic alendronate further establishes oral bisphosphonates as gold standard

Almost 100 million post-menopausal women suffer from osteopenia and osteoporosis in the seven major markets. Those diagnosed are often identified through screening for low bone mineral density or after presenting with a fracture. Although not all guidelines are clear on when to initiate pharmacological treatment, most base their assessment of the type of drug to treat with on cost-benefit analyses

Report Highlights
The asymptomatic characteristics of osteoporosis, the fact that the majority of fractures remain undetected and the lack of nationwide screening means that osteoporosis is severely under-diagnosed.

About two-thirds of the patients are treated initially by a specialist and stay with the specialist for long-term treatment across the seven major markets, although a small group of patients switch from initial treatment by a specialist to long-term treatment under their general practitioner

The most important factors that physicians consider when prescribing drugs for osteoporosis are efficacy on bone mineral density and fracture risk reduction. Bisphosphonates reached similar scores on efficacy and safety in Datamonitor's physician survey, but are differentiated in terms of cost, flexibility of administration, and intermittent dosing
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ABOUT DATAMONITOR HEALTHCARE 2
About the Women's Health pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Scope of the analysis 3
Datamonitor insight into the osteoporosis market 4
Contributing experts 5
Related reports 5
CHAPTER 2 COUNTRY TREATMENT TREES 8
Introduction to treatment trees 8
US 9
Japan 10
France 11
Germany 12
Italy 13
Spain 14
UK 15
CHAPTER 3 DISEASE BACKGROUND AND EPIDEMIOLOGY 16
Disease background 17
Osteoporosis classification: primary and secondary 19
Patient segmentation 19
Severity: osteopenia, osteoporosis and severe/established osteoporosis 20
Gender 23
Ethnicity 24
Osteoporosis in children 25
Niche populations with osteoporosis 25
Epidemiology 27
Methodological difficulties in assessing prevalence 27
Differences in the definition of osteopenia, osteoporosis, severe/established osteoporosis and vertebral fractures 27
Disparities in the reference points (T-score) used for bone mineral density measurement 28
Differences in the skeletal sites scanned to measure bone mineral density and diagnose osteoporosis 28
Patient populations include different age groups 30
Prevalence of osteopenia, osteoporosis and severe/established osteoporosis in postmenopausal women 30
US 40
Japan 42
France 43
Germany 45
Italy 46
Spain 47
UK 49
Ageing population expands osteoporosis patient potential 51
CHAPTER 4 PRESENTATION, DIAGNOSIS AND TREATMENT RATES 53
Presentation 54
Similar number of patients are diagnosed after screening as those presenting with a fracture 54
Initial presentation is most often with a specialist in an out-patient hospital setting 57
There is not one particular reason most common for presentation 59
Diagnosis 60
Under-diagnosis is a major problem in osteoporosis 60
Patients are most often diagnosed by a specialist in the out-patient setting 63
The combination of primary assessment and additional diagnostic techniques to achieve an osteoporosis diagnosis is underused 66
Patient history and physical exam are the most important parts of primary assessment 67
Dual-energy X-ray absorptiometry (DXA) of the spine/hip is most widely used additional diagnostic technique 69
Treatment rates 72
Treatment rates have been increasing but are still low 72
Guidelines base initiation of pharmacological treatment on cost-effectiveness 74
The US National Osteoporosis Foundation guidelines on the prevention and treatment of osteoporosis 78
The European Guidance for the diagnosis and management of osteoporosis in postmenopausal women 79
The UK National Institute of Clinical Excellence guidelines on primary and secondary prevention of fractures 81
The German Dachverband Osteologie guideline osteoporosis in women after menopause and in men after age 60 82
The use of pharmacological treatment increases with disease severity 83
Type of physician responsible for initial and long-term treatment varies per country 84
Most patients treated by specialists are treated in the out-patient setting 86
CHAPTER 5 TREATMENT OPTIONS AND TRENDS 88
Non-pharmacological treatment of osteoporosis 89
Overview of the available drug classes 90
Bisphosphonates 90
Bisphosphonate combinations 94
Selective estrogen receptor modulators (SERMs) 96
Parathyroid hormone (PTH) and analogs 98
Calcitonins 100
Dual action bone agents (DABAs) 102
Hormone replacement therapy (HRT) 103
Vitamin D 104
Guidelines often favor bisphosphonates as first-line therapy but do not give detailed recommendations 105
The European Guidance for the Diagnosis and Management of Osteoporosis in Postmenopausal Women 105
The National Institute for Health and Clinical Excellence (NICE) guidelines for the primary prevention of fractures 106
The National Institute for Health and Clinical Excellence (NICE) guidelines for the secondary prevention of fractures 106
The German Dachverband Osteologie (DVO) guidelines 107
The guidelines published by the National Osteoporosis Foundation (NOF) 107
Trends in pharmacological treatment 108
Compliance is an important issue in the treatment of osteoporosis 108
Trends in first-line treatment 112
Oral bisphosphonates dominate all severities across the seven major markets 114
Injectable bisphosphonates are mainly reserved for most severe disease 116
Selective estrogen receptor modulators (SERMs) are most often prescribed in osteopenia 118
Parathyroid hormones (PTHs) are most often prescribed in severe osteoporosis 120
Calcitonins are still prominent in Japanese treatment regimens 121
Strontium ranelate particularly popular in France, Italy and Spain 123
Reasons to switch to second-line treatment 124
Trends in second-line treatment 127
Entry of generic alendronate in the US and Japan 129
CHAPTER 6 PRESCRIBING INFLUENCES AND BRAND ASSESSMENT 132
Factors influencing physician decision making 133
Physician perception of key brands 134
Total scores per drug per country 135
Interpreting a brand map 137
The bisphosphonate class 139
Bisphosphonates brand map 139
Bisphosphonates individual scores 140
Bisphosphonates treatment trends 143
Overview of key brands 144
The selective estrogen receptor modulator (SERM) class 149
Selective estrogen receptor modulator (SERM) brand map 149
Selective estrogen receptor modulator (SERM) individual scores 151
Selective estrogen receptor modulator (SERM) treatment trends 152
Overview of key brands 153
Products from other drug classes 155
Products from other drug classes brand map 155
Products from other drug classes individual scores 156
Products from other drug classes prescribing trends 157
Overview of key brands 158
BIBLIOGRAPHY 162
Articles 162
Websites 175
Press releases 176
APPENDIX A 177
Physician research methodology 177
Physician sample breakdown 177
US 177
Japan 178
France 179
Germany 180
Italy 181
Spain 182
UK 183
Contributing experts 184
APPENDIX B 185
The survey questionnaire 185
Section 1 - Patient Segmentation 185
Section 2 - Presentation and diagnosis 186
Section 3 - Treatment options 187
Section 4 - Treatments 187
Section 5 - Product Profiles 189
Section 6 -Generic Erosion 190
About Datamonitor 191
About Datamonitor Healthcare 191
About the Women's Health and Urology analysis team 192
Disclaimer 193
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Table 1: Niche populations with osteoporosis 25
Table 2: Overview of studies estimating the prevalence of osteopenia in the seven major markets, 2008 32
Table 3: Overview of studies estimating the prevalence of osteoporosis in the seven major markets 33
Table 4: Overview of studies estimating the prevalence of severe/established osteoporosis in the seven major markets 35
Table 5: Prevalence of osteopenia in postmenopausal women across the seven major markets, 2008 37
Table 6: Prevalence of osteoporosis in postmenopausal women across the seven major markets, 2008 38
Table 7: Prevalence of severe/established osteoporosis in postmenopausal women across the seven major markets, 2008 39
Table 8: Overview of the postmenopausal patient populations across the seven major markets with each severity of osteoporosis, 2008 40
Table 9: Osteoporosis management of hip fracture patients by study site in the US 74
Table 10: Guideline recommendations on when to initiate pharmacological treatment of osteoporosis, 2008 76
Table 11: Overview of level of evidence for three bisphosphonates in the primary and secondary prevention of fractures in postmenopausal osteoporosis 92
Table 12: Overview of the key bisphosphonates available for osteoporosis (sales are osteoporosis-specific), 2008 93
Table 13: Overview of the key bisphosphonate combinations available for osteoporosis (sales are osteoporosis-specific), 2008 95
Table 14: Overview of the only selective estrogen receptor modulators (SERM) available for osteoporosis (sales are osteoporosis-specific), 2008 97
Table 15: Overview of the key parathyroid hormone (PTH) and analogs available for osteoporosis (sales are osteoporosis-specific), 2008 99
Table 16: Overview of the key calcitonins available for osteoporosis (sales are osteoporosis-specific), 2008 101
Table 17: Overview of the only dual action bone agent available for osteoporosis in the seven major markets, 2008 103
Table 18: First-line recommendations of a selection of osteoporosis guidelines, 2008 105
Table 19: Anti-fracture efficacy of the most frequently used treatments for postmenopausal osteoporosis when given with calcium and vitamin D, as derived from randomized controlled trials 114
Table 20: Number and percentage of physicians able to rate each osteoporosis drug, 2008 134
Table 21: Total scores (out of 100) of each osteoporosis drug for each of the individual seven major markets 136
Table 22: US physician sample breakdown, 2008 177
Table 23: Japan physician sample breakdown, 2008 178
Table 24: France physician sample breakdown, 2008 179
Table 25: Germany physician sample breakdown, 2008 180
Table 26: Italy physician sample breakdown, 2008 181
Table 27: Spain physician sample breakdown, 2008 182
Table 28: UK physician sample breakdown, 2008 183
Figure 1: US treatment tree, 2008 9
Figure 2: Japan treatment tree, 2008 10
Figure 3: France treatment tree, 2008 11
Figure 4: Germany treatment tree, 2008 12
Figure 5: Italy treatment tree, 2008 13
Figure 6: Spain treatment tree, 2008 14
Figure 7: UK treatment tree, 2008 15
Figure 8: Osteoporotic fractures occur most commonly at the spine, hip and wrist 18
Figure 9: World Health Organization classification of osteoporotic bone loss 20
Figure 10: Average prevalence according to osteoporosis severity across the seven major markets, 2008 22
Figure 11: Average age at diagnosis for each severity of osteoporosis across the seven major markets, 2008 23
Figure 12: Rising percentage of women over 50 years of age in the seven major markets, 2008 and 2020 51
Figure 13: Different routes of diagnosis: screening and presenting with a fracture - average across the seven major markets, 2008 55
Figure 14: Percentage of patients who present initially to each type of physician, 2008 58
Figure 15: Percentage of patients who present initially to a specialist in each location, 2008 59
Figure 16: Percentage of osteopenic and osteoporotic patients who present for each reason, 2008 60
Figure 17: Percentage of patients who are diagnosed by each type of physician, 2008 64
Figure 18: Percentage of patients who are diagnosed by a specialist in each location, 2008 65
Figure 19: Use of each method of patient assessment by PCPs/GPs and specialists in order to reach osteoporosis diagnosis, 2008 67
Figure 20: Potentially osteoporotic patients who receive each method of primary assessment, 2008 68
Figure 21: Potentially osteoporotic patients who receive each method of additional diagnostic technique, 2008 71
Figure 22: Advantages of central dual-energy X-ray absorptiometry (DXA) 72
Figure 23: Treatment of Caucasian women aged 60 years or older with osteoporosis or vertebral fractures by primary care physicians, by drug type, 1993-97 73
Figure 24: Management algorithm in postmenopausal women based on an health economic analysis for the UK, 2008 80
Figure 25: Osteopenic, osteoporotic and severe/established osteoporotic patients receiving each type of treatment, 2008 84
Figure 26: Percentage of patients who are treated (initially and long-term) by each type of physician, 2008 85
Figure 27: Percentage of patients who are treated by a specialist in each location, 2008 87
Figure 28: Percentage of patients discontinuing pharmacological treatment due to non-compliance at different times across the seven major markets, 2008 111
Figure 29: Osteopenic, osteoporotic and severe/established osteoporotic patients receiving each drug class in the 7MM, 2008 112
Figure 30: Overview of the prescription of oral bisphosphonates across osteoporosis severities, per country, 2008 115
Figure 31: Overview of the prescription of injectable bisphosphonates across osteoporosis severities, per country, 2008 117
Figure 32: Overview of the prescription of selective estrogen receptor modulators (SERMs) across osteoporosis severities, per country, 2008 119
Figure 33: Overview of the prescription of parathyroid hormones across osteoporosis severities, per country, 2008 121
Figure 34: Overview of the prescription of calcitonins across osteoporosis severities, per country, 2008 122
Figure 35: Overview of the prescription of drugs from other drug classes across osteoporosis severities, per country, 2008 124
Figure 36: Percentage of patients switching from first-line therapy to second-line therapy due to a new or recurrent fracture, 2008 125
Figure 37: Percentage of patients switching from first-line therapy to second-line therapy for other reasons, 2008 126
Figure 38: Osteopenic, osteoporotic and severe/established osteoporotic patients receiving each drug class in first-line, second-line due to fracture and second-line for another reason, 2008 128
Figure 39: Sales of Fosamax and generic Fosamax in the five major European countries, 2003-07 130
Figure 40: Percentage of patients in the US and Japan who will be switched to generic alendronate from Fosamax, a different bisphosphonate or a drug from a different class, 2008 131
Figure 41: Number of points allocated to each factor to indicate its relative importance in each country or region, 2008 133
Figure 42: Brand map of the scoring attributes of osteoporosis drugs in relation to each other 138
Figure 43: Brand map of the scores of the individual products in relation to each other 139
Figure 44: Brand map highlighting the position of bisphosphonate products, 2008 140
Figure 45: Number of points allocated to each bisphosphonate on all factors, seven major markets, 2008 141
Figure 46: Osteopenic, osteoporotic and severe/established osteoporotic patients receiving each bisphosphonate brand, 2008 144
Figure 47: Brand map highlighting the position of selective estrogen receptor modulators (SERMs), 2008 150
Figure 48: Number of points allocated to each selective estrogen receptor modulator (SERM) on all factors, seven major markets, 2008 151
Figure 49: Osteopenic, osteoporotic and severe/established osteoporotic patients receiving each selective estrogen receptor modulator (SERM) brand, 2008 152
Figure 50: Brand map highlighting the position of products from other drug classes, 2008 155
Figure 51: Number of points allocated to products in other drug classes on all factors, seven major markets, 2008 156
Figure 52: Osteopenic, osteoporotic and severe/established osteoporotic patients receiving each drug from other drug classes, 2008 157
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