Osteoporosis in the European Union: a compendium of country-specific reports

Archives of Osteoporosis, Dec 2013

Summary This report describes epidemiology, burden, and treatment of osteoporosis in each of the 27 countries of the European Union (EU27). Introduction In 2010, 22 million women and 5.5 million men were estimated to have osteoporosis in the EU; and 3.5 million new fragility fractures were sustained, comprising 620,000 hip fractures, 520,000 vertebral fractures, 560,000 forearm fractures and 1,800,000 other fractures. The economic burden of incident and prior fragility fractures was estimated at € 37 billion. Previous and incident fractures also accounted for 1,180,000 quality-adjusted life years lost during 2010. The costs are expected to increase by 25 % in 2025. The majority of individuals who have sustained an osteoporosis-related fracture or who are at high risk of fracture are untreated and the number of patients on treatment is declining. The aim of this report was to characterize the burden of osteoporosis in each of the EU27 countries in 2010 and beyond. Methods The data on fracture incidence and costs of fractures in the EU27 were taken from a concurrent publication in this journal (Osteoporosis in the European Union: Medical Management, Epidemiology and Economic Burden) and country specific information extracted. Results The clinical and economic burden of osteoporotic fractures in 2010 is given for each of the 27 countries of the EU. The costs are expected to increase on average by 25 % in 2025. The majority of individuals who have sustained an osteoporosis-related fracture or who are at high risk of fracture are untreated and the number of patients on treatment is declining. Conclusions In spite of the high cost of osteoporosis, a substantial treatment gap and projected increase of the economic burden driven by aging populations, the use of pharmacological prevention of osteoporosis has decreased in recent years, suggesting that a change in healthcare policy concerning the disease is warranted.

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Osteoporosis in the European Union: a compendium of country-specific reports

A. Svedbom 0 1 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 E. Hernlund 0 1 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 M. Ivergrd 0 1 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 J. Compston 0 1 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 C. Cooper 0 1 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 J. Stenmark 0 1 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 E. V. McCloskey 0 1 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 B. Jnsson 0 1 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 J. A. Kanis 0 1 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 the EU review panel of the IOF 0 1 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 0 J. Compston Department of Medicine, Addenbrooke's Hospital, Cambridge University , Cambridge, UK 1 EU review panel of the IOF Austria: HP Dimai; Belgium: M Hiligsmann, S Goemaere, J-Y Reginster; Bulgaria: A-M Borissova, M Boyanov, Z Kolarov, R Kovacheva, R Rachkov, P Popivanov, A Shinkov; Cyprus: GL Georgiades; Czech Republic: M Bayer ; Denmark: B Abrahamsen; Estonia: K Maasalu; Finland: H Krger; Germany: K Dreinhoefer; Greece: GP Lyritis, P Makras; Hungary: P Lakatos, I Marton, L Szekeres, K Zalatnai; Ireland: M O'Brien; Italy: ML Brandi, M Rossini, F Silveri; Latvia: S Berza; I Pavlina, I Rasa; Lithuania: V Alekna, M Tamulaitiene; Luxembourg: M Hirsch; Malta: RP Galea; Netherlands: S Papapoulos; Poland: JE Badurski, E Czerwinski, M Jaworski, R Lorenc; Portugal: J Monteiro; Romania: D Grigorie; Slovakia: P Jackuliak, P Masaryk, J Payer; Slovenia: T Kocjan; Spain: A Diez-Perez; Sweden: K kesson 2 ) WHO Collaborating Centre for Metabolic Bone Diseases, University of Sheffield Medical School , Beech Hill Road, Sheffield S10 2RX, UK 3 B. Jnsson Stockholm School of Economics , Stockholm, Sweden 4 E. V. McCloskey Academic Unit of Bone Metabolism, Northern General Hospital , Sheffield, UK 5 J. Stenmark International Osteoporosis Foundation , Nyon, Switzerland 6 C. Cooper NIHR Musculoskeletal Biomedical Research Unit, Institute of Musculoskeletal Sciences, University of Oxford , Oxford, UK 7 C. Cooper MRC Lifecourse Epidemiology Unit, University of Southampton , Southampton, UK 8 C. Cooper MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton and NIHR Musculoskeletal Biomedical Research Unit, Institute of Musculoskeletal Sciences, University of Oxford , Oxford, UK 9 J. Compston Department of Medicine, Addenbrooke's Hospital, Cambridge University , Cambridge, UK 10 J. A. Kanis WHO Collaborating Centre for Metabolic Bone Diseases, University of Sheffield , Sheffield, UK 11 H. P. Dimai Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Metabolism , Graz, Austria 12 E. V. McCloskey Academic Unit of Bone Metabolism, Northern General Hospital , Sheffield, UK and WHO Collaborating Centre for Metabolic Bone Diseases, University of Sheffield , Sheffield, UK 13 J. Compston Department of Medicine, Addenbrooke's Hospital, Cambridge University , Cambridge, UK 14 J-Y. Reginster Department of Public Health, Epidemiology and Health Economics, University of Lige , Lige, Belgium 15 S. Goemaere Unit for Osteoporosis and Metabolic Bone Diseases, Ghent University Hospital , Ghent, Belgium 16 M. Hiligsmann Department of Public Health, Epidemiology and Health Economics, University of Lige , Lige, Belgium and Department of Health Service Research, CAPHRI School for Public Health and Primary Care, Maastricht University , Maastricht, Netherlands 17 E. V. McCloskey Academic Unit of Bone Metabolism, Northern General Hospital , Sheffield, UK and WHO Collaborating Centre for Metabolic BoneDiseases, University of Sheffield , Sheffield, UK 18 J. Compston Department of Medicine, Addenbrooke's Hospital, Cambridge University , Cambridge, UK 19 P. Popivanov Department of Internal Medicine, Bone Metabolic Unit, University Hospital Alexandrovska, Medical University of Sofia , Sofia, Bulgaria 20 R. Rachkov Department of Internal Medicine, Clinic of Rheumatology, University Hospital Ivan Rilski, Medical University of Sofia , Sofia, Bulgaria 21 J. Compston Department of Medicine, Addenbrooke's Hospital, Cambridge University , Cambridge, UK 22 K. kesson Department of Orthopaedics, Malmo University Hospital , Malmo, Sweden 23 J. Compston Department of Medicine, Addenbrooke's Hospital, Cambridge University , Cambridge, UK Summary This report describes epidemiology, burden, and treatment of osteoporosis in each of the 27 countries of the European Union (EU27). Introduction In 2010, 22 million women and 5.5 million men were estimated to have osteoporosis in the EU; and 3.5 million new fragility fractures were sustained, comprising 620,000 hip fractures, 520,000 vertebral fractures, 560,000 forearm fractures and 1,800,000 other fractures. The economic burden of incident and prior fragility fractures was estimated at 37 billion. Previous and incident fractures also accounted for 1,180,000 quality-adjusted life years lost during 2010. The costs are expected to increase by 25 % in 2025. The majority of individuals who have sustained an osteoporosis-related fracture or who are at high risk of fracture are untreated and the number of patients on treatment is declining. The aim of this report was to characterize the burden of osteoporosis in each of the EU27 countries in 2010 and beyond. Methods The data on fracture incidence and costs of fractures in the EU27 were taken from a concurrent publication in this journal (Osteoporosis in the European Union: - Medical Management, Epidemiology and Economic Burden) and country specific information extracted. Results The clinical and economic burden of osteoporotic fractures in 2010 is given for each of the 27 countries of the EU. The costs are expected to increase on average by 25 % in 2025. The majority of individuals who have sustained an osteoporosis-related fracture or who are at high risk of fracture are untreated and the number of patients on treatment is declining. Conclusions In spite of the high cost of osteoporosis, a substantial treatment gap and projected increase of the economic burden driven by aging populations, the use of pharmacological prevention of osteoporosis has decreased in recent years, suggesting that a change in healthcare policy concerning the disease is warranted. Table of Contents Introduction Epidemiology and economic burden of osteoporosis in 1 Austria 2 Belgium 3 Bulgaria 4 Cyprus 5 Czech Republic 6 Denmark 7 Estonia 8 Finland 9 France Acknowledgements List of abbreviations Defined daily dosage Dual-energy X-ray absorptiometry Refers to the 27 countries of the European Union WHO fracture risk assessment tool Gross domestic product Quality-adjusted life year Standard deviation number of SDs by which BMD in an individual differs from the mean value expected in young healthy women Introduction Osteoporosis, literally porous bone, is a disease characterized by weak bone. It is a major public health problem, affecting hundreds of millions of people worldwide, predominantly postmenopausal women. The main clinical consequence of the disease is bone fractures. It is estimated that one in three women and one in five men over the age of fifty worldwide will sustain an osteoporotic fracture. Hip and spine fractures are the two most serious fracture types, associated with substantial pain and suffering, disability, and even death. As a result, osteoporosis imposes a significant burden on both the individual and society. During the past two decades, a range of medications has become available for the treatment and prevention of osteoporosis. The primary aim of pharmacological therapy is to reduce the risk of osteoporotic fractures. A recent report Osteoporosis in the European Union: Medical Management, Epidemiology and Economic Burden published concurrently with this report described the current burden of osteoporosis in the EU in 2010. Twenty two million women and 5.5 million men were estimated to have osteoporosis; and 3.5 million new fragility fractures were sustained, comprising 620,000 hip fractures, 520,000 vertebral fractures, 560,000 forearm fractures and 1,800,000 other fractures (i.e. fractures of the pelvis, rib, humerus, tibia, fibula, clavicle, scapula, sternum and other femoral fractures). The economic burden of incident and prior fragility fractures was estimated at 37 billion. Incident fractures represented 66 % of this cost, long-term fracture care 29 % and pharmacological prevention 5 %. Previous and incident fractures also accounted for 1,180,000 qualityadjusted life years lost during 2010. The costs are expected to increase by 25 % in 2025. The majority of individuals who have sustained an osteoporosis-related fracture or who are at high risk of fracture are untreated and the number of patients on treatment is declining. The objective of this report is to review and describe the current burden of osteoporosis in each of the EU member states. Epidemiological and health economic aspects of osteoporosis and osteoporotic fractures are summarised for 2010 with projections of the future prevalence of osteoporosis, the number of incident fractures, the direct and total cost of the disease including the value of QALYs lost. The report may serve as a basis for the formulation of healthcare policy concerning osteoporosis in general and the treatment and prevention of osteoporosis in particular. It may also provide guidance regarding the overall healthcare priority of the disease in each member state. Epidemiology and Economic Burden of Osteoporosis in Austria Epidemiology and Economic Burden of Osteoporosis A report prepared in collaboration with the International iOnsteAoporosis Foundation (IOF) and the European ustria FAedreerpaotriotnporefpPahraerdmiancecuotlilcaabloIrnadtuisotnrywAitshsotchiaetiIonntsernational Osteoporosis Foundation (IOF) (EFPIA). and the European Federation of Pharmaceutical Industry Associations (EFPIA) A Svedbom, E Hernlund, M Ivergrd, J Compston, CAxeCloSovpeedrb, oJm S& tEemnmmaarkH,erEnVlunMdc&CMloosakIevye,rBgrJd n&sson, HP Dimai and JA Kanis Juliet Compston & Cyrus Cooper & Judy Stenmark & Eugene V. McCloskey & Bengt Jnsson & Axel Svedbom, OptumInsight, Stockholm, Sweden Hans Peter Dimai & John A. Kanis Abstract Summary This report describes epidemiology, burden, and treatment of osteoporosis in Austria. Introduction Osteoporosis is characterized by reduced bone mass and disruption of bone architecture, resulting in increased A. Svedbom : E. Hernlund : M. Ivergrd OptumInsight, Stockholm, Sweden risks of fragility fractures which represent the main clinical consequence of the disease. Fragility fractures are associated with substantial pain and suffering, disability and even death for the affected patients and substantial costs to society. The aim of this study is to describe the epidemiology and economic burden of fragility fractures as a consequence of osteoporosis in Austria, as a further detailed addition to the report for the entire European Union (EU27): Osteoporosis in the European Union: Medical Management, Epidemiology and Economic Burden. Methods The literature on fracture incidence and costs of fractures in Austria was reviewed and incorporated into a model estimating the clinical and economic burden of osteoporotic fractures in 2010. Furthermore, data on sales of osteoporosis treatments and the population at high risk were used to estimate treatment uptake and treatment gap. Results It was estimated that approximately 87,000 new fragility fractures were sustained in Austria, comprising 16,000 hip fractures, 13,000 vertebral fractures, 13,000 forearm fractures and 44,000 other fractures (i.e. fractures of the pelvis, rib, humerus, tibia, fibula, clavicle, scapula, sternum and other femoral fractures) in 2010. The economic burden of incident and previous fragility fractures was estimated at 799 million for the same year. Incident fractures represented 68 % of this cost, long-term fracture care 29 % and pharmacological prevention 4 %. Previous and incident fractures also accounted for 27,900 quality-adjusted life years (QALYs) lost during 2010. When accounting for the demographic projections for 2025, the number of incident fractures was estimated at 116,000 in 2025, representing an increase of 30,000 fractures. Hip, clinical vertebral (spine), forearm and other fractures were estimated to increase by 5,700, 4,400, 3,700 and 15,900, respectively. The burden of fractures in Austria in 2025 was estimated to increase by 28 % to 1,025 million. Though the uptake of osteoporosis treatments increased from 2001, the proportion of patients aged 50 or above who received treatment declined in the past few years. The majority of women at high fracture risk did not receive active treatment. Conclusions In spite of the high cost of osteoporosis, a substantial treatment gap and projected increase of the economic burden driven by aging populations, the use of pharmacological prevention of osteoporosis is significantly less than optimal, suggesting that a change in healthcare policy concerning the disease is warranted. Introduction Osteoporosis is characterized by reduced bone mass and disruption of bone architecture, resulting in increased risks of fragility fractures which represent the main clinical consequence of the disease. Fragility fractures are associated with substantial pain and suffering, disability and even death for the affected patients and substantial costs to society. The aim of this report was to characterize the burden of osteoporosis in Austria in 2010 and beyond. The literature on fracture incidence and costs of fractures in Austria was reviewed and incorporated into a model estimating the clinical and economic burden of osteoporotic fractures in 2010. Details of the methods used are found in Chapters 3 and 4 of the report Osteoporosis in the European Union: Medical Management, Epidemiology and Economic Burden, published concurrently in Archives of Osteoporosis. Epidemiology of osteoporosis in Austria For the purpose of this report, the population at risk of osteoporosis was considered to include men and women 50 years. The number of men and women 50 years of age amounted to 1,381,000 and 1,660,000 respectively in Austria in 2010 (Table 1). In the population at risk, the number of individuals with osteoporosisas defined by the WHO diagnostic criteriawas estimated at 460,000 (Table 2). There were 28.7 DXA scan machines per million inhabitants [2] and guidelines for the assessment and treatment of osteoporosis are available [3, 4]. A country specific FRAX model is also available for the assessment of fracture risk (http://www.shef.ac.uk/FRAX/). Data on hip fracture incidence are available for Austria [6]. Given that country specific incidences of vertebral, forearm and, other fractures were not found, these were imputed using the methods described in Chapter 3 of the main report. Fracture incidence is presented in Table 3. Standardized to the EU27 population, hip fracture incidence (per 100,000 person years) in men and women 50 years of age was estimated at 322.9 and 757.2 respectively. The number of incident fractures in 2010 was estimated at 87,000 (Table 4). Incident hip, clinical spine, forearm and other fractures were estimated at 16,000, 13,000, 13,000 and 44,000 respectively. 66 % of fractures occurred in women. These estimates are in close agreement with recently published data for 2008 [7]. A prior fracture was defined as a fracture in an individual who was alive during the index year (i.e. 2010) which had occurred after the age of 50 years and before 2010. In the population 50 years of age, the proportions of individuals who had suffered a fracture prior to 2010 were estimated at 2.44 % for hip and 2.75 % for clinical vertebral fractures. The estimated proportions of men and women with prior hip and vertebral fractures by age are presented in Table 5. In the population over 50 years of age, the number of individuals with hip and vertebral fractures that occurred before 2010 was estimated at 74,000 and 84,000 respectively (Table 6). Note that fractures sustained in 2010 were not included in the estimate. Table 2 Estimated number of women and men with osteoporosis (defined as a T-score 2.5 SD) in Austria by age using femalederived reference ranges at the femoral neck, 2010 [5] Table 1 Population at risk: men and women over the age of 50 in Austria, 2010 [1] Age (years) Age (years) Age (years) Table 3 Incidence per 100,000 person years of hip, clinical vertebral, forearm, and other fractures in Austria by age Table 5 Proportion of men and women (in %) with a prior hip or clinical vertebral fracture in Austria, 2010 Fracture at the vertebra forearm The incidence of causally related deaths (per 100,000) in the first year after fracture by age is presented in Table 7. The number of causally related deaths in 2010 was estimated at 1,018 (Table 8). Hip, vertebral and other fractures accounted for 505, 317 and 195 deaths respectively. Overall, approximately 55 % of deaths occurred in women. Table 4 Estimated number of incident fractures in Austria, 2010 Age (years) Fracture at the vertebra forearm Men and Women 18,713 25,209 43,923 19,857 37,335 57,192 16,751 12,593 29,343 36,608 49,928 86,536 Cost of osteoporosis in Austria including and excluding values of QALYs lost For the purpose of this report, the cost of osteoporosis in 2010 (excluding value of QALYs lost) was considered to consist of three components: (i) cost of fractures that occurred in 2010 (first year costs); (ii) cost of fractures sustained prior to year 2010 but which still incurred costs Table 6 Number of men and women in Austria with a prior hip or clinical vertebral fracture after the age of 50 years, 2010 Age (years) Hip fracture Vertebral fracture 18,865 55,405 74,270 Men and Women 18,815 39,129 57,944 14,331 11,348 25,679 33,146 50,476 83,623 Age (years) Hip fracture Vertebral fracture Age (years) in 2010 (long-term disability cost); and (iii) cost of pharmacological fracture prevention including administration and monitoring costs (pharmacological fracture prevention costs). See Chapter 4 of the main report for further details. Table 8 The number of deaths in men and women in Austria in the first year after fracture attributable to the fracture event (causally related), 2010 Fracture at the vertebra Men and Women Table 7 Incidence (per 100,000) of causally related deaths in Austria within the first year after fracture (adjusted for comorbidities), 2010 Age (years) Clinical vertebral Other fracture Table 9 One year costs for relevant pharmaceuticals in Austria, 2010 [11] Annual drug cost () For Austria, only inpatient costs the first year after hip fracture had been reported at the cut off date [8]. Total first year costs after fracture were imputed by applying the inpatient cost for Austria to the ratio of inpatient cost to total first year costs observed in Sweden, resulting in an estimated total first year hip fracture cost of 13,527. Given that no cost data for the other fracture sites were found, these were imputed as described in Chapter 4 of the main report. A recent publication provides similar estimates [7]. Long-term disability costs were estimated by multiplying the yearly cost of residing in nursing home ( 33,317 [9]) with the simulated number of individuals with prior fractures that had been transferred to nursing homes due to the fracture. Cost of pharmacological fracture prevention including its administration were based on treatment uptake reported by IMS Health [10]. Annual drug cost for individual treatments Table 10 Cost of osteoporosis () in Austria by age in men and women, 2010 102,053,686 251,821,366 353,875,052 100,949,687 84,698,294 185,647,981 203,003,373 336,519,660 539,523,033 Long term disability costs 20,498,662 139,171,528 159,670,190 22,209,312 47,262,010 69,471,322 Women and Men 42,707,973 186,433,538 229,141,511 16,211,264 10,238,872 26,450,136 2,580,748 1,137,709 3,718,456 18,792,012 11,376,581 30,168,592 138,763,611 401,231,767 539,995,378 125,739,747 133,098,012 258,837,759 264,503,358 534,329,779 798,833,136 48,671,702 254,284,487 302,956,189 42,389,664 75,870,194 118,259,858 91,061,365 330,154,681 421,216,047 9,608,786 13,377,107 22,985,893 7,862,829 5,017,929 12,880,758 17,471,615 18,395,036 35,866,651 Women and Men 5,096,281 4,036,070 9,132,351 1,504,074 457,487 1,961,561 6,600,355 4,493,557 11,093,912 59,175,579 119,295,231 178,470,809 71,402,432 50,614,693 122,017,126 130,578,011 169,909,924 300,487,935 122,552,347 390,992,895 513,545,242 123,158,999 131,960,303 255,119,302 245,711,346 522,953,198 768,664,544 Table 12 Number of QALYs lost due to fractures during 2010 in men and women in Austria according to age Age (years) is shown in Table 9. In addition, it was assumed that patients on treatment made an annual physician visit costing 30 [11] and a DXA scan costing 30 every second year to monitor treatment [11]. The cost of osteoporosis in 2010 was estimated at 799 million (Table 10). These costs are close to recently published estimates for 2008 [7]. First year costs, subsequent year costs and pharmacological fracture prevention costs amounted to 540 million, 229 million and 30 million, respectively. It is notable that pharmacological fracture prevention costs amounted to only 3.8 % of the total cost. When stratifying costs of osteoporosis by fracture type, hip fractures were most costly ( 421 million) followed by other ( 300 million), spine ( 36 Incident hip fractures Incident vertebral fractures Incident forearm fractures Incident other fractures Prior hip fractures Prior vertebral fractures Total Incident hip fractures Incident vertebral fractures Incident forearm fractures Incident other fractures Prior hip fractures Prior vertebral fractures Total Incident hip fractures Incident vertebral fractures Incident forearm fractures Incident other fractures Prior hip fractures Prior vertebral fractures Total Men and Women million) and forearm fractures ( 11 million) (Table 11 and Fig. 1). Please note that costs for pharmacological fracture prevention were not included given that they cannot be allocated to specific fracture sites. The results are generally consistent with a recent cost of illness study undertaken for the year 2008 [7]. The number of quality adjusted life years (QALYs) lost due to osteoporosis in 2010 was estimated at 27,900 (Table 12). 66 % of the total QALY loss was incurred in women. Prior fractures accounted for 53 % of the total QALY loss. The monetary value of a QALY was varied between 1 to 3 times the gross domestic product (GDP) per capita (Table 13). Assuming a QALY is valued at 2 times GDP/capita, the total cost of the QALYs lost was estimated at 1.90 billion. When the cost of osteoporosis was combined with the value for QALYs lost (valued at 2 GDP), the cost of osteoporosis amounted to 2.70 billion in Austria in 2010. Incident fracture, prior fracture, pharmacological fracture prevention, and value of QALYs lost accounted for 20 %, 8 %, 1 %, 70 % respectively. Burden of osteoporosis up to 2025 The population above 50 years of age is expected to increase from 3.0 million in 2010 to 3.8 million in 2025, corresponding to an increase of 26 % (Table 14). The total number of fractures was estimated to rise from 87,000 in 2010 to 116,000 in 2025 (Table 15), corresponding to an increase of 34 %. Hip, clinical spine, forearm and other fractures increased by 5,700, 4,400, 3,700 and 15,900 respectively. The increase in the number of fractures ranged from 28 % to 36 %, depending on fracture site. The increase was estimated to be particularly marked in men (49 %) compared to women Table 13 Value of lost QALYs () in men and women in Austria in 2010 Incident hip fractures Incident vertebral fractures Incident forearm fractures Incident other fractures Prior hip fractures Prior vertebral fractures Total 1 GDP/ capita 2 GDP/ capita 360,280,447 147,816,230 720,560,893 295,632,461 3 GDP/ capita 1,080,841,340 443,448,691 1,902,577,766 2,853,866,649 556,000 477,000 351,000 238,000 38,000 545,000 435,000 275,000 116,000 10,000 646,000 481,000 402,000 220,000 59,000 642,979 443,000 324,000 129,000 17,000 689,000 536,000 425,000 235,000 66,000 688,000 501,000 350,000 151,000 24,000 642,000 624,000 433,000 275,000 66,000 633,000 597,000 362,000 185,000 28,000 Table 14 Population projections in Austria by age and sex [12] (27 %). Note that the calculations assume no change in the age- and sex-specific incidence of fracture. In the case of hip fracture, there is evidence that age specific rates have been decreasing in recent years [13]. The cost of osteoporosis (excluding values of QALYs lost) was estimated to rise from 799 million in 2010 to 1,025 million in 2025, corresponding to an increase of 28 % (Table 16). Costs incurred in women and men increased by 21 % and 43 % respectively. The total number of QALYs lost due to fracture was estimated to rise from 27,900 in 2010 to 34,600 in 2025, corresponding to an increase of 24 % (Table 17). The increase was estimated to be particularly marked in men (38 %) compared to women (17 %). Incident and prior fractures accounted for 67 % and 33 % of the increase respectively. The cost of osteoporosis including value of QALYs lost was estimated to increase from approximately 2.7 billion in 2010 to 3.4 billion in 2025. The increase was estimated to be particularly marked in men (+39 %) compared to women (+18 %) (Table 18). Treatment uptake To estimate uptake of individual osteoporosis treatments, sales data from IMS Health (20012011) were used to 18,713 25,209 43,923 10,061 23,076 33,136 13,631 13,031 26,662 23,691 36,107 59,798 Women and Men 10,255 17,642 27,897 12,202 22,427 34,628 Women and Men derive the number of defined daily doses (DDDs) sold per 100,000 persons aged 50 years or above (Fig. 2). Adjusting the sales data for compliance allowed for an estimation of the proportion of population aged 50 years or above who received any osteoporosis treatment (see Chapter 5 of the report on Osteoporosis in the European Union: Medical Management, Epidemiology and Economic Burden for further details). The proportion of persons over the age of 50 years who were treated increased from 3.06 % in 2001 to 6.1 % in 2006 but subsequently decreased to 5.17 % in 2011. Table 16 Current and future cost ( 000,000) of osteoporosis (excluding values of QALYs lost) by age and calendar year in men and women in Austria Treatment gap In order to assess the potential treatment gap, the numbers of men and women eligible for treatment in Austria were defined as individuals with a 10-year fracture probability exceeding that of a woman with a prior fragility fracture derived from FRAX, equivalent to a fracture threshold (See Chapter 5 of the main report for further details). Subsequently, these estimates were compared to the number individuals who received osteoporosis treatment obtained from the analysis of IMS Health data. The treatment gaps in men and women were Table 17 Projected QALYs lost due to incident and prior fractures for the years 2010 and 2025 by age in men and women in Austria Incident fractures Prior fractures All fractures Women and Men Table 18 Present and future cost ( 000,000) of fracture (direct cost and cost of QALYs) by age and calendar year in men and women in Austria assuming the uptake of treatment remains unchanged Women and Men Table 19 Number of men and women eligible for treatment, treated and treatment gap in 2010 Number potentially treated (1000 s) Number eligible for treatment (1000 s) Difference (1000 s) Treatment gap (%) estimated at 52 % and 51 % respectively (Table 19). Note that the estimate of the treatment gap is conservative given that it assumes that current use of osteoporosis treatments are only directed to men and women at high risk. Acknowledgements This report has been sponsored by an unrestricted educational grant from the European Federation of Pharmaceutical Industry Associations (EFPIA) and the International Osteoporosis Foundation (IOF). The data in this report have been used to populate a more detailed report on Osteoporosis in the European Union: Medical Management, Epidemiology and Economic Burden. We acknowledge the help of Helena Johansson and Prof Anders Odn for their help in the calculations of fracture probability. We thank Oskar Strm and Fredrik Borgstrm who were prominent authors of an earlier report covering a similar topic in a sample of EU countries and provided the template for the present report. We also thank Dr Dominique Pierroz, Carey Kyer and Ageeth Van Leersum of the IOF for their help in editing the report. The report has been reviewed by the members of the IOF EU Osteoporosis Consultation Panel and the IOF European Parliament Osteoporosis Interest Group, and we are grateful for their local insights on the management of osteoporosis in each country. References Epidemiology and Economic Burden of Osteoporosis in Belgium Epidemiology and Economic Burden of Osteoporosis A report prepared in collaboration with the International in Belgium Osteoporosis Foundation (IOF) and the European A Svedbom, E Hernlund, M Ivergrd, J Compston, Eugene V. McCloskey & Bengt Jnsson & AMxiceklaSvleHdbiloigms,mOapntnu m&SIntesifgahnt,GSotoecmkaheorlem&, Sweden Jean-Yves Reginster & John A. Kanis Emma Hernlund, OptumInsight, Stockholm, Sweden Abstract Summary This report describes epidemiology, burden, and treatment of osteoporosis in Belgium. Introduction Osteoporosis is characterized by reduced bone mass and disruption of bone architecture, resulting in increased risks of fragility fractures which represent the main clinical consequence of the disease. Fragility fractures are associated with substantial pain and suffering, disability and even death for the affected patients and substantial costs to society. The aim of this study is to describe the epidemiology and economic burden of fragility fractures as a consequence of osteoporosis in Belgium, as a further detailed addition to the report for the entire European Union (EU27): Osteoporosis in the European Union: Medical Management, Epidemiology and Economic Burden. Methods The literature on fracture incidence and costs of fractures in Belgium were reviewed and incorporated into a model estimating the clinical and economic burden of osteoporotic fractures in 2010. Furthermore, data on sales of osteoporosis treatments and the population at high risk were used to estimate treatment uptake and treatment gap. A. Svedbom : E. Hernlund : M. Ivergrd OptumInsight, Stockholm, Sweden Results It was estimated that approximately 80,000 new fragility fractures were sustained in Belgium, comprising 15,000 hip fractures, 12,000 vertebral fractures, 12,000 forearm fractures and 41,000 other fractures (i.e. fractures of the pelvis, rib, humerus, tibia, fibula, clavicle, scapula, sternum and other femoral fractures) in 2010. The economic burden of incident and previous fragility fractures was estimated at 606 million for the same year. Incident fractures represented 69 % of this cost, long-term fracture care 26 % and pharmacological prevention 5 %. Previous and incident fractures also accounted for 26,800 quality-adjusted life years (QALYs) lost during 2010. When accounting for the demographic projections for 2025, the number of incident fractures was estimated at 99,000 in 2025, representing an increase of 19,000 fractures. Hip, clinical spine, forearm and other fractures was estimated to increase by 3,900, 2,900, 2,300 and 10,300, respectively. The burden of fractures in Belgium in 2025 was estimated to increase by 21 % to 733 million. Though the uptake of osteoporosis treatments increased from 2001, the proportion of patients aged 50 or above who received treatment declined in the past few years. A substantial proportion of women at high fracture risk did not receive active treatment. Conclusions In spite of the high cost of osteoporosis, a substantial treatment gap and projected increase of the economic burden driven by aging populations, the use of pharmacological prevention of osteoporosis is significantly less than optimal, suggesting that a change in healthcare policy concerning the disease is warranted. Introduction Osteoporosis is characterized by reduced bone mass and disruption of bone architecture, resulting in increased risks of fragility fractures which represent the main clinical consequence of the disease. Fragility fractures are associated with substantial pain and suffering, disability and even death for the affected patients and substantial costs to society. The aim of this report was to characterize the burden of osteoporosis in Belgium in 2010 and beyond. The literature on fracture incidence and costs of fractures in Belgium was reviewed and incorporated into a model estimating the clinical and economic burden of osteoporotic fractures in 2010. Details of the methods used are found in Chapters 3 and 4 of the report Osteoporosis in the European Union: Medical Management, Epidemiology and Economic Burden, published concurrently in Archives of Osteoporosis. Table 1 Population at risk: men and women over the age of 50 in Belgium, 2010 [1] Age (years) Epidemiology of osteoporosis in Belgium For the purpose of this report, the population at risk of osteoporosis was considered to include men and women 50 years. The number of men and women 50 years of age amounted to 1,829,000 and 2,130,000 respectively in Belgium in 2010 (Table 1). The number of individuals with osteoporosisas defined by the WHO diagnostic criteriawas estimated at 600,000 (Table 2), similar to an earlier estimate in 2008 [2]. There are 53 DXA scan machines per million inhabitants [3], and guidelines for the assessment and treatment of osteoporosis are available [48]. A country specific FRAX model is also available for the assessment of fracture risk (http:// www.shef.ac.uk/FRAX/). Data on hip fracture incidence are available for Belgium and we used a mean estimate for 20057 [10]. The incidence of hip fractures was determined using the national hospital database, which fully covers the annual hospital stays in Belgium (source: INAMI-RIZIV [Institut National dAssurance Maladie InvaliditRijksinstituut voor Ziekte en Invaliditeitsverzekering] and SPF Public Health). Given that country specific incidence of vertebral, forearm and, other fractures were not found, these were imputed using the methods described in Chapter 3 of the main report. Fracture incidence is presented in Table 3. Standardized to the EU27 population, hip fracture incidence (per 100,000 person years) in men and women 50 years of age was estimated at 228.5 and 538.7 respectively. Table 2 Estimated number of women and men with osteoporosis (defined as a T-score -2.5 SD) in Belgium by age using femalederived reference ranges at the femoral neck, 2010 [9] Age (years) Fracture at the vertebra forearm Fracture at the vertebra forearm Men and Women Age (years) Table 3 Incidence per 100,000 person years of hip, clinical vertebral, forearm, and other fractures in Belgium by age Table 5 Proportion of men and women (in %) with a prior hip or clinical vertebral fracture in Belgium, 2010 The number of incident fractures in 2010 was estimated at 80,000 (Table 4). Incident hip, clinical vertebral, forearm and other fractures were estimated at 15,000, 12,000, 12,000 and 41,000 respectively. 66 % of fractures occurred in women. A prior fracture was defined as a fracture in an individual who was alive during the index year (i.e. 2010) which had occurred after the age of 50 years and before 2010. In the population 50 years of age, the proportions of individuals who had suffered a fracture prior to 2010 were estimated at 1.88 % for hip and 2.04 % for clinical vertebral fractures. The estimated proportions of men and women with prior hip and vertebral fractures by age are presented in Table 5. In the population over 50 years of age, the number of individuals with hip and vertebral fractures that occurred before 2010 was Table 4 Estimated number of incident fractures in Belgium, 2010 Age (years) Table 6 Number of men and women in Belgium with a prior hip or clinical vertebral fracture fracture after the age of 50 years, 2010 Age (years) Hip fracture Vertebral fracture 15,802 24,727 40,529 17,511 34,888 52,399 13,634 13,860 27,493 31,144 48,748 79,892 16,393 58,093 74,485 Men and Women Age (years) Hip fracture Vertebral fracture 18,168 38,957 57,124 11,396 12,186 23,582 29,563 51,143 80,706 Table 7 Incidence (per 100,000) of causally related deaths in Belgium within the first year after fracture (adjusted for comorbidities), 2010 Age (years) Hip Clinical vertebral Other fracture Table 9 One year costs for relevant pharmaceuticals in Belgium, 2010 [15] estimated at 74,000 and 81,000 respectively (Table 6). Note that fractures sustained in 2010 were not included in the estimate. The incidence of causally related deaths (per 100,000) in the first year after fracture by age is presented in Table 7. These comprise approximately 30 % of deaths associated with Table 8 The number of deaths in men and women in Belgium in the first year after fracture attributable to the fracture event (causally related), 2010 Fracture at the vertebra Age (years) Men and Women Annual drug cost () fracture [11]. The number of causally related deaths in 2010 was estimated at 979 (Table 8). Hip, vertebral and other fractures accounted for 492, 310 and 177 deaths respectively. Overall, approximately 51 % of deaths occurred in women. Cost of osteoporosis in Belgium including and excluding values of QALYs lost For the purpose of this report, the cost of osteoporosis in 2010 (excluding value of QALYs lost) was considered to consist of three components: (i) cost of fractures that occurred in 2010 (first year costs); (ii) cost of fractures sustained prior to year 2010 but which still incurred costs in 2010 (long-term disability cost); and (iii) cost of pharmacological fracture prevention including administration and monitoring costs (pharmacological fracture prevention costs). See Chapter 4 of the main report for further details. Table 10 Cost of osteoporosis () in Belgium by age in men and women, 2010 73,267,761 199,531,556 272,799,317 67,907,494 78,540,769 146,448,264 141,175,255 278,072,325 419,247,581 12,842,111 97,521,075 110,363,186 11,998,486 35,072,065 47,070,551 Women and Men 24,840,597 132,593,139 157,433,737 15,118,387 10,688,414 25,806,802 2,395,596 1,229,492 3,625,088 17,513,983 11,917,906 29,431,890 101,228,259 307,741,045 408,969,304 82,301,576 114,842,326 197,143,903 183,529,836 422,583,371 606,113,207 Table 11 Total cost () in 2010 by fracture site in men and women in Belgium. Note that costs for fracture prevention therapy and monitoring are not included Women and Men 32,930,499 7,022,947 3,883,014 42,273,412 86,109,872 188,200,459 10,747,124 3,281,739 94,823,308 297,052,631 221,130,958 17,770,070 7,164,754 137,096,720 383,162,503 25,561,846 61,536,698 87,098,543 5,384,963 1,039,942 4,607,182 422,622 9,992,145 1,462,564 47,919,230 79,905,981 47,046,332 113,612,834 94,965,562 193,518,815 58,492,345 12,407,909 4,922,956 90,192,643 166,015,853 249,737,157 15,354,306 3,704,361 141,869,640 410,665,465 308,229,502 27,762,216 8,627,318 232,062,283 576,681,318 The cost of a hip fracture has been estimated at 11,426 in Belgium [12] comparable to a more recent estimate [13]. Given that no cost data for the other fracture sites were found, these were imputed as described in Chapter 4 of the main report. Long-term disability costs were estimated by multiplying the yearly cost of residing in nursing home ( 22,608 [14]) with the simulated number of individuals with prior fractures that had been transferred to nursing homes due to the fracture. Annual drug costs () for individual treatments are shown in Table 9. In addition, it was assumed that patients on treatment made an annual physician visit costing 19 and a DXA scan at 34 every second year to monitor treatment [15]. Spine 5% Fig 1 Share (%) of fracture cost by fracture site in Belgium. Note that costs for fracture prevention therapy and monitoring are not included Table 12 Number of QALYs lost due to fractures during 2010 in men and women in Belgium according to age Age (years) Incident hip fractures Incident vertebral fractures Incident forearm fractures Incident other fractures Prior hip fractures Prior vertebral fractures Total Incident hip fractures Incident vertebral fractures Incident forearm fractures Incident other fractures Prior hip fractures Prior vertebral fractures Total Incident hip fractures Incident vertebral fractures Incident forearm fractures Incident other fractures Prior hip fractures Prior vertebral fractures Total Men and Women The cost of osteoporosis in 2010 was estimated at 606 million (Table 10). First year costs, subsequent year costs and pharmacological fracture prevention costs Table 13 Value of lost QALYs () in men and women in Belgium in 2010 1 GDP/ capita 2 GDP/ capita 3 GDP/ capita 342,179,611 135,438,142 684,359,221 270,876,285 1,026,538,832 406,314,427 1,734,269,594 2,601,404,391 Table 14 Population projections in Belgium by age and sex [16] 770,000 652,000 454,000 319,000 68,000 769,358 622,000 372,000 187,000 23,000 775,000 696,000 506,000 316,000 83,000 778,000 664,000 430,000 194,000 29,000 747,000 738,000 583,000 305,000 92,000 747,000 707,000 499,000 195,000 36,000 1,494,000 1,445,000 1,082,000 500,000 128,000 amounted to 419 million, 157 million and 29 million, respectively. It is notable that pharmacological fracture prevention costs amounted to only 4.8 % of the total cost. This cost is very likely overinflated since reimbursement for DXA only came into effect in Table 16 Current and future cost ( 000,000) of osteoporosis (excluding value of QALYs lost) by age and calendar year in men and women in Belgium Women and Men August of 2010 and repeat DXA is only reimbursed at 5 years. When stratifying costs of osteoporosis by fracture type, hip fractures were most costly ( 308 million) followed by other ( 232 million), spine ( 28 million) and forearm fractures ( 9 million) (Table 11 and Fig. 1). Please note that costs for pharmacological fracture prevention were not included given that they cannot be allocated to specific fracture sites. The number of quality adjusted life years (QALYs) lost due to osteoporosis in 2010 was estimated at 26,800 (Table 12). 67 % of the total QALY loss was incurred in women. Prior fractures accounted for 55 % Table 17 Projected QALYs lost due to incident and prior fractures for the years 2010 and 2025 by age in men and women in Belgium Incident fractures 2010 2025 Prior fractures 2010 2025 All fractures 2010 2025 10,357 20,946 31,303 of the total QALY loss. The monetary value of a QALY was varied between 1 to 3 times the gross domestic product (GDP) per capita (Table 13). Assuming a QALY is valued at 2 times GDP/capita, the total cost of the QALYs lost was estimated at 1.73 billion. When the cost of osteoporosis was combined with the value for QALYs lost (valued at 2 GDP), the cost of osteoporosis amounted to 2.34 billion in Belgium in 2010. Incident fracture, prior fracture, pharmacological fracture prevention, and value of QALYs lost accounted for 18 %, 7 %, 1 %, 74 % respectively. Table 18 Present and future cost ( 000,000) of fracture (direct cost and cost of QALYs) by age and calendar year in men and women in Belgium assuming the uptake of treatment remains unchanged Women and Men Burden of osteoporosis up to 2025 The population above 50 years of age is expected to increase from 4.0 million in 2010 to 4.6 million in 2025, corresponding to an increase of 17 % (Table 14). The total number of fractures was estimated to rise from 80,000 in 2010 to 99,000 in 2025 (Table 15), corresponding to an increase of 24 %. Hip, clinical vertebral, forearm and other fractures increased by 3,900, 2,900, 2,300 and 10,300 respectively. The increase in the number of fractures ranged from 19 % to 26 %, depending on fracture site. The increase was estimated to be particularly marked in men (32 %) compared to women (20 %). Note that no change in the age and sex specific incidence was assumed over this period. The cost of osteoporosis (excluding values of QALYs lost) was estimated to rise from 606 million in 2010 to 733 million in 2025, corresponding to an increase of 21 % (Table 16). Costs incurred in women and men increased by 17 % and 29 % respectively. The total number of QALYs lost due to fracture was estimated to rise from 26,800 in 2010 to 31,300 in 2025, corresponding to an increase of 17 % (Table 17). The increase was estimated to be particularly marked in men (25 %) compared to women (13 %). Incident and prior fractures accounted for 65 % and 35 % of the increase respectively. The cost of osteoporosis including value of QALYs lost was estimated to increase from approximately 2.3 billion in 2010 to 2.8 billion in 2025. The increase was estimated Table 19 Number of men and women eligible for treatment, treated and treatment gap in 2010 Number potentially treated (1000 s) Number eligible for treatment (1000 s) Difference (1000 s) Treatment gap (%) to be particularly marked in men (+26 %) compared to women (+14 %) (Table 18). Treatment uptake To estimate uptake of individual osteoporosis treatments, sales data from IMS Health (20012011) were used to derive the number of defined daily doses (DDDs) sold per 100,000 persons aged 50 years or above (Fig. 2). Adjusting the sales data for compliance allowed for an estimation of the proportion of population aged 50 years or above who received any osteoporosis treatment (see Chapter 5 of the report on Osteoporosis in the European Union: Medical Management, Epidemiology and Economic Burden for further details). The proportion of persons over the age of 50 years who were treated increased from 2 % in 2001 to 6.3 % in 2011 and thereafter decreased. Treatment gap In order to assess the potential treatment gap, the numbers of men and women eligible for treatment in Belgium were defined as individuals with a 10-year fracture probability exceeding that of a woman with a prior fragility fracture derived from FRAX, equivalent to a fracture threshold (See Chapter 5 of the main report for further details). Subsequently, these estimates were compared to the number individuals who received osteoporosis treatment obtained from the analysis of IMS Health data. The treatment gaps in men and women were estimated at 45 % and 47 % respectively (Table 19). Note that the estimate of the treatment gap is conservative given that it assumes that current use of osteoporosis treatments are only directed to men and women at high risk. Not all individuals at high risk as assessed by FRAX are eligible for reimbursement with the present reimbursement criteria. Acknowledgements This report has been sponsored by an unrestricted educational grant from the European Federation of Pharmaceutical Industry Associations (EFPIA) and the International Osteoporosis Foundation (IOF). The data in this report have been used to populate a more detailed report on Osteoporosis in the European Union: Medical Management, Epidemiology and Economic Burden. We acknowledge the help of Helena Johansson and Prof Anders Odn for their help in the calculations of fracture probability. We thank Oskar Strm and Fredrik Borgstrm who were prominent authors of an earlier report covering a similar topic in a sample of EU countries and provided the template for the present report. We also thank Dr Dominique Pierroz, Carey Kyer and Ageeth Van Leersum of the IOF for their help in editing the report. The report has been reviewed by the members of the IOF EU Osteoporosis Consultation Panel and the IOF European Parliament Osteoporosis Interest Group, and we are grateful for their local insights on the management of osteoporosis in each country. References Epidemiology and Economic Burden of Osteoporosis in Bulgaria Epidemiology and Economic Burden of Osteoporosis A report prepared in collaboration with the Internationin al OBsteuoplogroasirsiFaoundation (IOF) and the European FAedreerpaotriotnporefpPahraerdmiancecuotlilcaabloIrnadtuisotnrywAitshsotchiaetiIonntsernational Osteoporosis Foundation (IOF) (aEnFdPItAh)e. European Federation of Pharmaceutical Industry Associations (EFPIA) Abstract Summary This report describes epidemiology, burden, and treatment of osteoporosis in Bulgaria. Introduction Osteoporosis is characterized by reduced bone mass and disruption of bone architecture, resulting in increased risks of fragility fractures which represent the main clinical consequence of the disease. Fragility fractures are associated with substantial pain and suffering, disability and even death for the affected patients and substantial costs to society. The aim of this study is to describe the epidemiology and economic burden of fragility fractures as a consequence of osteoporosis in A. Svedbom : E. Hernlund : M. Ivergrd OptumInsight, Stockholm, Sweden Bulgaria, as a further detailed addition to the report for the entire European Union (EU27): Osteoporosis in the European Union: Medical Management, Epidemiology and Economic Burden. Methods The literature on fracture incidence and costs of fractures in Bulgaria was reviewed and incorporated into a model estimating the clinical and economic burden of osteoporotic fractures in 2010. Furthermore, data on sales of osteoporosis treatments and the population at high risk were used to estimate treatment uptake and treatment gap. Results It was estimated that approximately 38,000 new fragility fractures were sustained in Bulgaria, comprising population, hip fracture incidence (per 100,000 person years) in men and women 50 years of age was estimated at 125.9 and 353.0 respectively. The number of incident fractures in 2010 was estimated at 204,000 (Table 4). Incident hip, clinical spine, forearm and other fractures were estimated at 40,000, 30,000, 30,000 and 104,000 respectively. 68 % of fractures occurred in women. A prior fracture was defined as a fracture in an individual who was alive during the index year (i.e. 2010) which had occurred after the age of 50 years and before 2010. In the population 50 years of age, the proportion of individuals who had suffered a fracture prior to 2010 was estimated at 1.32 % for hip and 1.34 % for clinical vertebral fractures. The estimated proportions of men and women with prior hip and vertebral fractures by age are presented in Table 5. In the population over 50 years of age, the number of individuals with hip and vertebral fractures that occurred before 2010 was estimated at 211,000 and 212,000 respectively (Table 6). Note that fractures sustained in 2010 were not included in the estimate. The incidence of causally related deaths (per 100,000) in the first year after fracture by age is presented in Table 7. The number of causally related deaths in 2010 was estimated at 2,550 (Table 8). Hip, vertebral and other fractures accounted for 1,289, 719 and 542 deaths respectively. Overall, approximately 53 % of deaths occurred in women. Cost of osteoporosis in Spain including and excluding values of QALYs lost For the purpose of this report, the cost of osteoporosis in 2010 (excluding value of QALYs lost) was considered to Table 4 Estimated number of incident fractures in Spain, 2010 Age (years) Fracture at the vertebra forearm 10,850 18,839 29,689 11,626 13,529 25,155 14,572 15,147 29,719 Men and Women 15,596 49,483 65,079 17,304 21,889 39,193 37,450 101,969 139,419 27,667 37,066 64,733 65,117 139,035 204,152 Table 5 Proportion of men and women (in %) with a prior hip or clinical vertebral fracture in Spain, 2010 Age (years) Hip fracture Vertebral fracture consist of three components: (i) cost of fractures that occurred in 2010 (first year costs); (ii) cost of fractures sustained prior to year 2010 but which still incurred costs in 2010 (long-term disability cost); and (iii) cost of pharmacological fracture prevention including administration and monitoring costs (pharmacological fracture prevention costs). See Chapter 4 of the main report for further details. Table 6 Number of men and women in Spain with a prior hip or clinical vertebral fracture after the age of 50 years, 2010 Age (years) Hip fracture Vertebral fracture 40,224 113,704 153,927 23,972 34,529 58,501 64,196 148,233 212,428 22,185 134,852 157,037 13,297 40,226 53,523 35,482 175,078 210,560 Men and Women The cost of a hip fracture has been estimated at 9,421 in Spain, imputed from the UK data [9,10] by adjusting for differences in health care price levels. Given that no cost data for the other fracture sites were Table 8 The number of deaths in men and women in Spain in the first year after fracture attributable to the fracture event (causally related), 2010 Age (years) Fracture at the vertebra Men and Women Table 7 Incidence (per 100,000) of causally related deaths in Spain within the first year after fracture (adjusted for comorbidities), 2010 Age (years) Hip Clinical vertebral Other fracture Table 9 One year costs for relevant pharmaceuticals in Spain, 2010 [12] Annual drug cost () found, these were imputed as described in Chapter 4 of the main report. Long-term disability costs were estimated by multiplying the yearly cost of residing in nursing home ( 51,786 [11]) with the simulated number of individuals with prior fractures that had been transferred to nursing homes due to the fracture. Annual drug cost () for individual treatments is shown in Table 9 for 2010. For the purposes of this report drug costs were used for 2010 [12]. In addition, it was assumed that patients on treatment made an annual physician visit costing 109 [13] and a DXA scan costing 79 [14] every second year to monitor treatment. The cost of osteoporosis in 2010 was estimated at 2,842 million (Table 10). First year costs, subsequent year costs and pharmacological fracture prevention costs amounted to 1,372 million, 1,055 million and 414 Table 10 Cost of osteoporosis () in Spain by age in men and women, 2010 Age First year (years) fracture cost Long term disability costs Total cost million respectively. It is notable that pharmacological fracture prevention costs amounted to only 14.6 % of the total cost. When stratifying costs of osteoporosis by fracture type, hip fractures were most costly ( 1,591 million) followed by other ( 742 million), spine ( 63 million) and forearm fractures ( 32 milllion) (Table 11 and Fig. 1). Please note that costs for pharmacological fracture prevention were not included given that they cannot be allocated to specific fracture sites. The number of quality adjusted life years (QALYs) lost due to osteoporosis in 2010 was estimated at 70,800 (Table 12). Prior fractures accounted for 57 % of the total loss and 69 % of the loss occurred in women. The monetary value of a QALY was varied between 1 to 3 times the gross domestic product Fig. 1 Share (%) of fracture cost by fracture site in Spain. Note that costs for fracture prevention therapy and monitoring are not included Incident hip fractures Incident vertebral fractures Incident forearm fractures Incident other fractures Prior hip fractures Prior vertebral fractures Total Incident hip fractures Incident vertebral fractures Incident forearm fractures Incident other fractures Prior hip fractures Prior vertebral fractures Total Incident hip fractures Incident vertebral fractures Incident forearm fractures Incident other fractures Prior hip fractures Prior vertebral fractures Total Men and Women Table 12 Number of QALYs lost due to fractures during 2010 in men and women in Spain according to age Age (years) Table 14 Population projections in Spain by age and sex [15] 3,276,000 2,569,000 1,945,000 1,387,000 288,000 3,212,585 2,352,000 1,568,000 865,000 125,000 6,488,585 4,921,000 3,513,000 2,252,000 413,000 3,619,000 2,824,000 2,178,000 1,384,000 375,000 3,632,000 2,622,000 1,790,000 889,000 174,000 7,251,000 5,446,000 3,968,000 2,273,000 549,000 3,859,000 3,234,000 2,387,000 1,412,000 444,000 3,987,000 3,054,000 1,989,000 946,000 219,000 7,846,000 6,288,000 4,376,000 2,358,000 663,000 (GDP) per capita (Table 13). Assuming a QALY is valued at 2 times GDP/capita, the total cost of the QALYs lost was estimated at 3.27 billion. When the cost of osteoporosis was combined with the value for QALYs lost (valued at 2 GDP), the cost of osteoporosis amounted to 6.11 billion in Spain in 2010. Incident fracture, prior fracture, pharmacological fracture prevention, and value of QALYs lost accounted for 22 %, 17 %, 7 %, 54 % respectively. Burden of osteoporosis up to 2025 The population above 50 years of age is expected to increase from 15.9 million in 2010 to 21.5 million in 2025, corresponding to an increase of 35 % (Table 14). The total number of fractures was estimated to rise from 204,000 in 2010 to 286,000 in 2025 (Table 15), corresponding to an increase of 40 %. Hip, clinical spine, forearm and other fractures increased by 16,700, 11,500, 10,000 and 43,500 respectively. The increase in the number of fractures ranged from 34 % to 42 %, depending on fracture site. The increase was estimated to be particularly marked in men (49 %) compared to women (36 %). The cost of osteoporosis (excluding value of QALYs lost) was estimated to rise from 2.8 billion in 2010 to 3.7 billion in 2025, corresponding to an increase of 30 % (Table 16). Costs incurred in women and men increased by 26 % and 39 % respectively. The total number of QALYs lost due to fracture was estimated to rise from 70,800 in 2010 to 89,000 in 2025, corresponding to an increase of 26 % (Table 17). The increase was estimated to be particularly marked in men (37 %) compared to women (21 %). Incident and prior 1 GDP/ capita 2 GDP/ capita 3 GDP/ capita 204,496,899 210,643,500 408,993,798 421,286,999 613,490,697 631,930,499 681,493,449 1,362,986,897 2,044,480,346 251,189,028 502,378,055 753,567,083 1,635,611,014 3,271,222,028 4,906,833,042 Table 13 Value of lost QALYs () in men and women in Spain in 2010 Treatment uptake 2,859,000 2,351,000 1,961,000 1,234,000 223,000 5,633,000 4,492,000 3,504,000 1,969,000 307,000 fractures accounted for 66 % and 34 % of the increase respectively. The cost of osteoporosis including value of QALYs lost was estimated to increase from approximately 6.1 billion in 2010 to 7.8 billion in 2025. The increase was estimated to be particularly marked in men (+38 %) compared to women (+23 %) (Table 18). To estimate uptake of individual osteoporosis treatments, sales data from IMS Health (20012011) were used to derive the number of defined daily doses (DDDs) sold per 100,000 persons aged 50 years or above (Fig. 2). Adjusting the sales data for compliance allowed for an estimation of the proportion of population aged 50 years or above who received any osteoporosis treatment (see Chapter 5 of the report on Osteoporosis in the European Union: Medical Management, Epidemiology and Economic Burden for further details). The proportion of persons over the age of 50 years who were treated increased from 2.74 % in 2001 to 9.56 % in 2009 but subsequently decreased to 8.51 % in 2011. Treatment gap In order to assess the potential treatment gap, the numbers of men and women eligible for treatment in Spain were defined as individuals with a 10-year fracture probability exceeding that of a woman with a prior fragility fracture derived from Table 16 Current and future cost ( 000, 000) of osteoporosis (excluding value of QALYs lost) by age and calendar year in men and women in Spain Women and Men FRAX, equivalent to a fracture threshold (See Chapter 5 of the main report for further details). Subsequently, these estimates were compared to the number of individuals who received osteoporosis treatment obtained from the analysis of IMS Health data. The treatment gaps in men and women were estimated at 20 % and 25 % respectively (Table 19). Note that the estimate of the treatment gap is conservative given that it assumes that current use of osteoporosis treatments are only directed to men and women at high risk. Table 17 Projected QALYs lost due to incident and prior fractures for the years 2010 and 2025 by age in men and women in Spain Incident fractures 2010 2025 Prior fractures 2010 2025 All fractures 2010 2025 13,236 29,272 42,508 Women and Men 10,273 36,189 46,462 10,970 38,102 49,073 18,731 52,075 70,806 13,259 46,007 59,267 10,249 19,454 29,703 23,509 65,461 88,970 Women and Men References Table 19 Number of men and women eligible for treatment, treated and treatment gap in 2010 Number potentially treated (1000 s) Number eligible for treatment (1000 s) Difference (1000 s) Treatment gap (%) Table 18 Present and future cost ( 000,000) of fracture (direct cost and cost of QALYs) by age and calendar year in men and women in Spain assuming the uptake of treatment remains unchanged Acknowledgements This report has been sponsored by an unrestricted educational grant from the European Federation of Pharmaceutical Industry Associations (EFPIA) and the International Osteoporosis Foundation (IOF). The data in this report have been used to populate a more detailed report on Osteoporosis in the European Union: Medical Management, Epidemiology and Economic Burden. We acknowledge the help of Helena Johansson and Prof Anders Odn for their help in the calculations of fracture probability. We thank Oskar Strm and Fredrik Borgstrm who were prominent authors of an earlier report covering a similar topic in a sample of EU countries and provided the template for the present report. We also thank Dr Dominique Pierroz, Carey Kyer and Ageeth Van Leersum of the IOF for their help in editing the report. The report has been reviewed by the members of the IOF EU Osteoporosis Consultation Panel and the IOF European Parliament Osteoporosis Interest Group, and we are grateful for their local insights on the management of osteoporosis in each country. Abstract Summary This report describes epidemiology, burden, and treatment of osteoporosis in Sweden. Introduction Osteoporosis is characterized by reduced bone mass and disruption of bone architecture, resulting in increased risks of fragility fractures which represent the main M. Ivergrd : A. Svedbom : E. Hernlund OptumInsight, Stockholm, Sweden J. Stenmark International Osteoporosis Foundation, Nyon, Switzerland clinical consequence of the disease. Fragility fractures are associated with substantial pain and suffering, disability and even death for the affected patients and substantial costs to society. The aim of this study is to describe the epidemiology and economic burden of fragility fractures as a consequence of osteoporosis in Sweden, as a further detailed addition to the report for the entire European Union (EU27): Osteoporosis in the European Union: Medical Management, Epidemiology and Economic Burden. Methods The literature on fracture incidence and costs of fractures in the EU27 was reviewed and incorporated into a model estimating the clinical and economic burden of osteoporotic fractures in 2010. Furthermore, data on sales of osteoporosis treatments and the population at high risk were used to estimate treatment uptake and treatment gap. Results It was estimated that approximately 107,000 new fragility fractures were sustained in Sweden, comprising 20,000 hip fractures, 16,000 vertebral fractures, 16,000 forearm fractures and 54,000 other fractures (i.e. fractures of the pelvis, rib, humerus, tibia, fibula, clavicle, scapula, sternum and other femoral fractures) in 2010. The economic burden of incident and previous fragility fractures was estimated at 1,486 million for the same year. Incident fractures represented 62 % of this cost, long-term fracture care 36 % and pharmacological prevention 2 %. Previous and incident fractures also accounted for 36,000 quality-adjusted life years (QALYs) lost during 2010. When accounting for the demographic projections for 2025, the number of incident fractures was estimated at 135,000 in 2025, representing an increase of 28,000 fractures. Hip, clinical vertebral (spine), forearm and other fractures were estimated to increase by 6,100, 4,500, 3,300 and 14,400, respectively. The burden of fractures in Sweden in 2025 was estimated to increase by 23 % to 1,828 million. Though the uptake of osteoporosis treatments increased from 2001, the proportion of patients aged 50 or above who received treatment remained at very low levels in the past few years. The majority of women at high fracture risk did not receive active treatment. Conclusions In spite of the high cost of osteoporosis, a substantial treatment gap and projected increase of the economic burden driven by an aging population, the use of pharmacological prevention of osteoporosis is significantly less than optimal, suggesting that a change in healthcare policy concerning the disease is warranted. Introduction Osteoporosis is characterized by reduced bone mass and disruption of bone architecture, resulting in increased risks of fragility fractures which represent the main clinical consequence of the disease. Fragility fractures are associated with substantial pain and suffering, disability and even death for the affected patients and substantial costs to society. The aim of this report was to characterize the burden of osteoporosis in Sweden in 2010 and beyond. The literature on fracture incidence and costs of fractures in Sweden was reviewed and incorporated into a model estimating the clinical and economic burden of osteoporotic fractures in 2010. Details of the methods used are found in Chapters 3 and 4 of the report Osteoporosis in the European Union: Medical Management, Epidemiology and Economic Burden, published concurrently in Archives of Osteoporosis. Epidemiology of osteoporosis in Sweden For the purpose of this report, the population at risk of osteoporosis was considered to include men and women 50 years. The number of men and women 50 years of age amounted to 1,659,000 and 1,830,000 respectively in Sweden in 2010 (Table 1). Table 1 Population at risk: men and women over the age of 50 in Sweden, 2010 [1] Age (years) Age (years) Age (years) Table 2 Estimated number of women and men with osteoporosis (defined as a T-score 2.5 SD) in Sweden by age using femalederived reference ranges at the femoral neck, 2010 [4] In the population at risk, the number of individuals with osteoporosisas defined by the WHO diagnostic criteriawas estimated at 520,000 (Table 2). There are 10 DXA scan machines per million inhabitants [2], and guidelines for the assessment and treatment of osteoporosis are available [3]. A country specific FRAX model is also available for the assessment of fracture risk (http://www.shef.ac.uk/FRAX/). Data on incidence for all fracture types under consideration are available for Sweden [5,6]. Standardized to the EU27 population, hip fracture incidence (per 100,000 person years) in men and women 50 years of age was estimated at 318.6 and 802.8 respectively. Table 3 Incidence per 100,000 person years of hip, clinical vertebral, forearm, and other fractures in Sweden by age Fracture at the vertebra forearm The number of incident fractures in 2010 was estimated at 107,000 (Table 4). Incident hip, clinical spine, forearm and other fractures were estimated at 20,000, 16,000, 16,000 and 54,000 respectively. 66 % of fractures occurred in women. A prior fracture was defined as a fracture in an individual who was alive during the index year (i.e. 2010) which had occurred after the age of 50 years and before 2010. In the population 50 years of age, the proportion of individuals who had suffered a fracture prior to 2010 was estimated at 2.84 % for hip and 3.19 % for clinical vertebral fractures. The estimated proportions of men and women with prior hip and vertebral fractures by age are presented in Table 5. In the population over 50 years of age, the number of individuals with hip and vertebral fractures that occurred before 2010 was estimated at 99,000 and 111,000 respectively (Table 6). Note that fractures sustained in 2010 were not included in the estimate. The incidence of causally related deaths (per 100,000) in the first year after fracture by age is presented in Table 7. The number of causally related deaths in 2010 was estimated at 1,171 (Table 8). Hip, vertebral and other fractures accounted for 589, 362 and 220 deaths respectively. Overall, approximately 54 % of deaths occurred in women. Cost of osteoporosis in Sweden including and excluding values of QALYs lost For the purpose of this report, the cost of osteoporosis in 2010 (excluding value of QALYs lost) were considered to consist of three components: (i) cost of fractures Table 4 Estimated number of incident fractures in Sweden, 2010 Age (years) Table 6 Number of men and women in Sweden with a prior hip or clinical vertebral fracture after the age of 50 years, 2010 Age (years) Hip fracture Vertebral fracture Table 5 Proportion of men and women (in %) with a prior hip or clinical vertebral fracture in Sweden, 2010 Age (years) Hip fracture Vertebral fracture that occurred in 2010 (first year costs); (ii) cost of fractures sustained prior to year 2010 but which still incurred costs in 2010 (long-term disability cost); and (iii) cost of pharmacological fracture prevention including administration and monitoring costs (pharmacological fracture prevention costs). See Chapter 4 of the main report for further details. 12,784 53,743 66,527 11,741 20,684 32,425 24,525 74,427 98,952 Men and Women 24,433 49,996 74,428 18,741 18,178 36,919 Fracture at the vertebra forearm Men and Women 10,329 21,321 31,650 11,889 10,342 22,231 22,218 31,663 53,881 25,386 45,018 70,403 19,006 17,636 36,643 Men and Women In Sweden, the costs of hip and vertebral fractures have been estimated to range from 12,870 to 19,667, and from 2,048 to 14,219 respectively. The cost of forearm fracture has been estimated at 2,401 [7]. Costs for other Table 8 The number of deaths in men and women in Sweden in the first year after fracture attributable to the fracture event (causally related), 2010 Fracture at the vertebra Age First year (years) fracture cost Table 7 Incidence (per 100,000) of causally related deaths in Sweden within the first year after fracture (adjusted for comorbidities), 2010 Age (years) Hip Clinical vertebral Other fracture Table 9 One year costs for relevant pharmaceuticals in Sweden, 2010 [9] Annual drug cost () Age (years) 164,775,011 459,502,549 624,277,561 129,916,509 172,932,982 302,849,491 294,691,520 632,435,531 927,127,051 Long term disability costs 45,041,829 299,410,779 344,452,608 47,296,421 137,583,421 184,879,842 15,865,811 9,840,865 25,706,677 2,429,058 1,179,974 3,609,032 Total cost 225,682,651 768,754,194 994,436,845 179,641,988 311,696,377 491,338,365 Women and Men 92,338,250 436,994,201 529,332,450 18,294,870 11,020,839 29,315,709 405,324,640 1,080,450,571 1,485,775,210 fractures were imputed as described in Chapter 4 of the main report. Long-term disability costs were estimated by multiplying the yearly cost of residing in nursing home ( 57,247 [7]) with the simulated number of individuals with prior fractures that had been transferred to nursing home due to the fracture. Annual drug cost () for individual treatments is shown in Table 9. In addition, it was assumed that patients on treatment made an annual physician visit costing 130 [8] and a DXA scan costing 152 [8] every second year to monitor treatment. The cost of osteoporosis in 2010 was estimated at 1,486 million (Table 10). First year costs, subsequent year costs and pharmacological fracture prevention costs amounted to 927 million, 529 million and 29 million respectively. It is notable that pharmacological Table 10 Cost of osteoporosis () in Sweden by age in men and women, 2010 fracture prevention costs amounted to only 2.0 % of the total cost. When stratifying costs of osteoporosis by fracture type, hip fractures were most costly ( 823 million) followed by other ( 421 million), spine ( 173 million) and forearm fractures ( 39 million) (Table 11 and Fig. 1). Please note that costs for pharmacological fracture prevention were not included given that they cannot be allocated to specific fracture sites. The number of quality adjusted life years (QALYs) lost due to osteoporosis in 2010 was estimated at 36,000 (Table 12). Prior fractures accounted for 55 % of the total loss and 64 % of the loss occurred in women. The monetary value of a QALY was varied between 1 to 3 times the gross domestic product (GDP) per capita (Table 13). Assuming a QALY is valued at 2 times GDP/capita, the total cost of the QALYs lost was estimated at 2.67 billion. Table 12 Number of QALYs lost due to fractures during 2010 in men and women in Sweden according to age Age (years) Incident hip fractures Incident vertebral fractures Incident forearm fractures Incident other fractures Prior hip fractures Prior vertebral fractures Total Incident hip fractures Incident vertebral fractures Incident forearm fractures Incident other fractures Prior hip fractures Prior vertebral fractures Total Incident hip fractures Incident vertebral fractures Incident forearm fractures Incident other fractures Prior hip fractures Prior vertebral fractures Total Men and Women 1 GDP/ capita 2 GDP/ capita 3 GDP/ capita 165,618,254 189,937,256 331,236,508 379,874,511 496,854,762 569,811,767 521,113,364 1,042,226,728 1,563,340,092 213,567,199 427,134,398 640,701,598 1,332,932,135 2,665,864,269 3,998,796,404 Table 13 Value of lost QALYs () in men and women in Sweden in 2010 Table 14 Population projections in Sweden by age and sex [10] When the cost of osteoporosis was combined with the value for QALYs lost (valued at 2 GDP), the cost of osteoporosis amounted to 4.15 billion in Sweden in 2010. Incident fracture, prior fracture, pharmacological fracture prevention, and value of QALYs l o s t a c c o u n t e d f o r 2 2 % , 1 3 % , 1 % , 6 4 % respectively. Burden of osteoporosis up to 2025 The population above 50 years of age is expected to increase from 3.5 million in 2010 to 4.1 million in 2025, corresponding to an increase of 18 % (Table 14). The total number of fractures was estimated to rise from 107,000 in 2010 to 135,000 in 2025 (Table 15), corresponding to an increase of 26 %. Hip, clinical spine, forearm and other fractures increased by 6,100, 4,500, 3,300 and 14,400 respectively. The increase in the number of fractures ranged from 20 % to 30 %, depending on fracture site. The increase was estimated to be particularly marked in men (33 %) compared to women (23 %). The cost of osteoporosis (excluding value of QALYs lost) was estimated to rise from 1.5 billion in 2010 to 1.8 billion in 2025, corresponding to an increase of 23 % (Table 16). Costs incurred in women and men increased by 19 % and 32 % respectively. The total number of QALYs lost due to fracture was estimated to rise from 36,000 in 2010 to 43,300 in 2025, corresponding to an increase of 20 % (Table 17). The increase was estimated to be particularly marked in men (27 %) compared to women (16 %). Incident and prior fractures accounted for 61 % and 39 % of the increase respectively. 571,000 583,000 365,000 253,000 58,000 580,000 579,000 317,000 161,000 22,000 594,000 584,000 433,000 242,000 67,000 605,636 575,000 398,000 162,000 28,000 634,000 551,000 520,000 249,000 72,000 649,000 543,000 482,000 183,000 33,000 1,283,000 1,094,000 1,002,000 432,000 105,000 639,000 574,000 524,000 306,000 75,000 650,000 573,000 483,000 240,000 37,000 1,289,000 1,147,000 1,007,000 546,000 112,000 4,101,000 The cost of osteoporosis including value of QALYs lost was estimated to increase from approximately 4.2 billion in 2010 to 5 billion in 2025. The increase was estimated to be particularly marked in men (+29 %) compared to women (+17 %) (Table 18). Treatment uptake To estimate uptake of individual osteoporosis treatments, sales data from IMS Health (20012011) were used to derive the number of defined daily doses (DDDs) sold per 100,000 persons aged 50 years or above (Fig. 2). Adjusting the sales data for compliance allowed for an estimation of the proportion of population aged 50 years or above who received any osteoporosis treatment (see Chapter 5 of the report on Osteoporosis in the European Union: Medical Management, Epidemiology and Economic Burden for further details). The proportion of persons over the age of 50 years who were treated increased from 1.53 % in 2001 to 3.28 % in 2011. Treatment gap In order to assess the potential treatment gap, the numbers of men and women eligible for treatment in Sweden were defined as individuals with a 10-year fracture probability exceeding that of a woman with a prior fragility fracture derived from FRAX, equivalent to a fracture threshold (See Chapter 5 of the main report for further details). Subsequently, these Table 16 Current and future cost of ( 000, 000) osteoporosis (excluding value of QALYs lost) by age and calendar year in men and women in Sweden Women and Men estimates were compared to the number of individuals who received osteoporosis treatment obtained from the analysis of IMS Health data. The treatment gaps in men and women were estimated at 63 % and 72 % respectively (Table 19). Note that the estimate of the treatment gap is conservative given that it assumes that current use of osteoporosis treatments are only directed to men and women at high risk. Table 17 Projected QALYs lost due to incident and prior fractures for the years 2010 and 2025 by age in men and women in Sweden Incident fractures Prior fractures All fractures Women and Men 12,896 23,130 36,025 14,052 29,222 43,273 Table 18 Present and future cost ( 000,000) of fracture (direct cost and cost of QALYs) by age and calendar year in men and women in Sweden assuming the uptake of treatment remains unchanged Women and Men Table 19 Number of men and women eligible for treatment, treated and treatment gap in 2010 Number potentially treated (1000 s) Number eligible for treatment (1000 s) Treatment gap (%) Acknowledgements This report has been sponsored by an unrestricted educational grant from the European Federation of Pharmaceutical Industry Associations (EFPIA) and the International Osteoporosis Foundation (IOF). The data in this report have been used to populate a more detailed report on Osteoporosis in the European Union: Medical Management, Epidemiology and Economic Burden. We acknowledge the help of Helena Johansson and Prof Anders Odn for their help in the calculations of fracture probability. We thank Oskar Strm and Fredrik Borgstrm who were prominent authors of an earlier report covering a similar topic in a sample of EU countries and provided the template for the present report. We also thank Dr Dominique Pierroz, Carey Kyer and Ageeth Van Leersum of the IOF for their help in editing the report. The report has been reviewed by the members of the IOF EU Osteoporosis Consultation Panel and the IOF European Parliament Osteoporosis Interest Group, and we are grateful for their local insights on the management of osteoporosis in each country. References AA rreeppoortrptrperpeapreadriendcionllacboolrlaatbioonrawtiitohnthwe iItnhtetrhneatIionnt-ernational Osteoporosis Foundation (IOF) aalnOdsttheoepEoruorsiospFeoaunndFaetdioenra(ItOioFn) oafndPhthaermEuarcoepuetaincal Industry Associations (EFPIA) Federation of Pharmaceutical Industry Associations (EFPIA). Moa Ivergrd & Axel Svedbom & Emma Hernlund & JMulIievterCgomrdp,sAtonSv&eCdybroums ,C>ooper & Judy Stenmark & Eugene V. McCloskey & Bengt Jnsson & John A. Kanis Abstract Summary This report describes epidemiology, burden, and treatment of osteoporosis in the UK. Introduction Osteoporosis is characterized by reduced bone mass and disruption of bone architecture, resulting in increased risks of fragility fractures which represent the main clinical consequence of the disease. Fragility fractures are associated with substantial pain and suffering, disability and even death for the affected patients and substantial costs to society. The aim of this study is to describe the epidemiology and economic burden of fragility fractures as a consequence of osteoporosis in the UK, as a further detailed M. Ivergrd : A. Svedbom : E. Hernlund OptumInsight, Stockholm, Sweden C. Cooper MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton and NIHR Musculoskeletal Biomedical Research Unit, Institute of Musculoskeletal Sciences, University of Oxford, Oxford, UK J. Stenmark International Osteoporosis Foundation, Nyon, Switzerland addition to the report for the entire European Union (EU27): Osteoporosis in the European Union: Medical Management, Epidemiology and Economic Burden. Methods The literature on fracture incidence and costs of fractures in the UK was reviewed and incorporated into a model estimating the clinical and economic burden of osteoporotic fractures in 2010. Furthermore, data on sales of osteoporosis treatments and the population at high risk were used to estimate treatment uptake and treatment gap. Costs, calculated in Euros, were converted to for the purpose of this report (1.00 GBP= 1.23; 21st Dec 2012). Results It was estimated that approximately 536,000 new fragility fractures were sustained in the UK, comprising 79,000 hip fractures, 66,000 vertebral fractures, 69,000 forearm fractures and 322,000 other fractures (i.e. fractures of the pelvis, rib, humerus, tibia, fibula, clavicle, scapula, sternum and other femoral fractures) in 2010. The economic burden of incident and previous fragility fractures was estimated at 3,496 ( 5,408) million for the same year. Incident fractures represented 74 % of this cost, long-term fracture care 25 % and pharmacological prevention 2 %. Previous and incident fractures also accounted for 158,700 quality-adjusted life years (QALYs) lost during 2010. When accounting for the demographic projections for 2025, the number of incident fractures was estimated at 682,000 in 2025, representing an increase of 146,000 fractures. Hip, clinical vertebral (spine), forearm and other fractures were estimated to increase by 23,000, 18,000, 15,900 and 89,300, respectively. The burden of fractures in the UK in 2025 was estimated to increase by 24 % to 5,465 ( 6,723) million. Though the uptake of osteoporosis treatments increased from 2001, the proportion of patients aged 50 years or above that received treatment remained at very low levels in the past few years. The majority of women at high fracture risk did not receive active treatment. Conclusions In spite of the high cost of osteoporosis, a substantial treatment gap in women and projected increase of the economic burden driven by an aging population, the use of pharmacological prevention of osteoporosis is significantly less than optimal, suggesting that a change in Introduction healthcare policy concerning the disease is warranted. Osteoporosis is characterized by reduced bone mass and disruption of bone architecture, resulting in increased risks of fragility fractures which represent the main clinical consequence of the disease. Fragility fractures are associated with substantial pain and suffering, disability and even death for the affected patients and substantial costs to society. The aim of this report was to characterize the burden of osteoporosis in the UK in 2010 and beyond. The literature on fracture incidence and costs of fractures in the UK was reviewed and incorporated into a model estimating the clinical and economic burden of osteoporotic fractures in 2010. Details of the methods used are found in Chapters 3 and 4 of the report on Osteoporosis in the European Union: Medical Management, Epidemiology and Economic Burden, published concurrently in Archives of Osteoporosis. Epidemiology of osteoporosis in the UK For the purpose of this report, the population at risk of osteoporosis was considered to include men and women 50 years. The number of men and women 50 years of age amounted to 10,102,000 and 11,534,000 respectively in the UK in 2010 (Table 1). In the population at risk, the number of individuals with osteoporosisas defined by the WHO diagnostic criteriawas estimated at 3.21 million (Table 2). There are 8.2 DXA scan machines per million inhabitants [2], and guidelines for the assessment and treatment of osteoporosis are available [3]. A country specific FRAX model is also available for the assessment of fracture risk (http://www.shef.ac.uk/FRAX/). Table 1 Population at risk: men and women over the age of 50 in the UK, 2010 [1] Age (years) 3,844,000 3,449,000 2,418,000 1,486,000 337,000 11,534,000 Table 2 Estimated number of women and men with osteoporosis (defined as a T-score 2.5 SD) in the UK by age using femalederived reference ranges at the femoral neck, 2010 [4] Age (years) Men and women Incidence data for hip and forearm fractures were retrieved from Singer et al. [5]. Given that country specific incidences of vertebral and other fractures were not found, these were imputed using the methods described in Chapter 3 of the main report. Fracture incidence is presented in Table 3. Standardized to the EU27 population, hip fracture incidence (per 100,000 person years) in men and women 50 years of age was estimated at 186.0 and 523.5 respectively. The number of incident fractures in 2010 was estimated at 536,000 (Table 4). Incident hip, clinical vertebral, forearm and other fractures were estimated at 79,000, 66,000, 69,000 and 322,000 respectively. 64 % of fractures occurred in women. Table 3 Incidence per 100,000 person years of hip, clinical vertebral, forearm, and other fractures in the UK by age Fracture at the vertebra forearm Age (years) 10,504 45,632 56,136 18,574 60,669 79,243 Fracture at the vertebra forearm 16,482 23,640 40,121 14,485 11,317 25,803 30,967 34,957 65,924 37,567 21,440 59,007 44,238 24,681 68,920 Men and Women 64,277 125,656 189,933 135,688 186,099 321,786 128,830 216,367 345,197 100,637 90,039 190,676 229,467 306,406 535,873 Table 4 Estimated number of incident fractures in the UK, 2010 Age (years) hip Table 5 Proportion of men and women (in %) with a prior hip or clinical vertebral fracture in the UK, 2010 Age (years) Hip fracture Vertebral fracture A prior fracture was defined as a fracture in an individual who was alive during the index year (i.e. 2010) which had occurred after the age of 50 years and before 2010. In the population 50 years of age, the proportion of individuals who had suffered a fracture prior to 2010 was estimated at 1.94 % for hip and 2.02 % for clinical vertebral fractures. The estimated proportions of men and women with prior hip and vertebral fractures by age are presented in Table 5. In the population over 50 years of age, the number of individuals with hip and vertebral fractures that occurred before 2010 was estimated at 419,000 and 437,000 respectively (Table 6). Note that fractures sustained in 2010 were not included in the estimate. The incidence of causally related deaths (per 100,000) in the first year after fracture by age is presented in Table 7. The number of causally related deaths in 2010 was estimated at 6,059 (Table 8). Hip, vertebral and other fractures accounted for 2,764, 1,795 and 1,500 deaths respectively. Overall, approximately 54 % of deaths occurred in women. Cost of osteoporosis in the UK including and excluding values of QALYs lost For the purpose of this report, the cost of osteoporosis in 2010 (excluding value of QALYs lost) was considered to consist of three components: (i) cost of fractures that occurred in 2010 (first year costs); (ii) cost of fractures sustained prior to year 2010 but which still incurred costs in 2010 (long-term disability cost); and (iii) cost of pharmacological fracture prevention including administration and monitoring costs (pharmacological fracture prevention costs). See Chapter 4 of the main report for further details. The cost of hip, vertebral and forearm fractures has been estimated at 9,390 ( 11,055), 2,341 ( 2,756), and 1,073 ( 1,263) respectively [6,7]. Costs for other fractures were imputed as described in Chapter 4 of the main report. Long-term disability costs were estimated by multiplying the yearly cost of residing in nursing home 24,444 ( 33,756) [6]) Table 6 Number of men and women in the UK with a prior hip or clinical vertebral fracture after the age of 50 years, 2010 Age (years) Hip fracture Vertebral fracture 55,026 238,068 293,095 101,286 317,595 418,881 Men and Women 98,018 194,076 292,093 175,879 261,621 437,499 Men and Women Age (years) Table 7 Incidence (per 100,000) of causally related deaths in the UK within the first year after fracture (adjusted for comorbidities), 2010 Age (years) Hip Clinical vertebral Other fracture Table 9 One year costs for relevant pharmaceuticals in the UK, 2010 [9] Annual drug cost Table 8 The number of deaths in men and women in the UK in the first year after fracture attributable to the fracture event (causally related), 2010 Fracture at the vertebra Age First year (years) fracture cost treatment made an annual physician visit costing 41 ( 50) [8] and a DXA scan costing 41 ( 51) [6] every second year to monitor treatment. The cost of osteoporosis in 2010 was estimated at 4,397 ( 5,408) million (Table 10). First year costs, subsequent year costs and pharmacological fracture prevention costs amounted to 3,233 ( 3,977) million, 1,080 ( 1,328) million and 84 ( 103) million, respectively. It is notable that pharmacological fracture prevention costs amounted to only 1.9 % of the total cost. When stratifying costs of osteoporosis by fracture type, other fractures were most costly at 2,069 million ( 2,545 million) followed by hip fractures at 2,039 million ( 2,508 million), vertebral fractures at 134 million ( 165 million) and forearm fractures at Table 10 Cost of osteoporosis () in the UK by age in men and women, 2010 495,992,508 1,624,852,298 2,120,844,806 446,135,385 666,005,143 1,112,140,528 Total cost Long term disability costs 93,791,815 45,809,624 635,593,947 642,093,815 27,826,902 2,294,773,015 735,885,630 73,636,526 2,930,366,962 93,353,413 6,946,167 546,434,965 250,509,467 3,398,496 919,913,106 343,862,880 10,344,663 1,466,348,071 Women and Men 942,127,892 187,145,228 52,755,790 1,182,028,910 2,290,857,441 892,603,281 31,225,398 3,214,686,120 3,232,985,333 1,079,748,509 83,981,188 4,396,715,030 71 million ( 87 million) (Table 11 and Fig. 1). Please note that costs for pharmacological fracture prevention were not included given that they cannot be allocated to specific fracture sites. The number of quality adjusted life years (QALYs) lost due to osteoporosis in 2010 was estimated at 158,700 (Table 12). Prior fractures accounted for 52 % of the total loss and 64 % of the loss occurred in women. The monetary value of a QALY was varied between 1 to 3 times the gross domestic product (GDP) per capita (Table 13). Assuming a QALY is valued at 2 times GDP/capita, the total cost of the QALYs lost was estimated at 7.0 billion ( 8.7 billion). Forearm Spine 2% 3% Fig. 1 Share (%) of fracture cost by fracture site in the UK. Note that costs for fracture prevention therapy and monitoring are not included Table 12 Number of QALYs lost due to fractures during 2010 in men and women in the UK according to age Incident hip fractures Incident vertebral fractures Incident forearm fractures Incident other fractures Prior hip fractures Prior vertebral fractures Total Incident hip fractures Incident vertebral fractures Incident forearm fractures Incident other fractures Prior hip fractures Prior vertebral fractures Total Incident hip fractures Incident vertebral fractures Incident forearm fractures Incident other fractures Prior hip fractures Prior vertebral fractures Total Men and Women Age (years) Incident hip fractures Incident vertebral fractures Incident forearm fractures Incident other fractures Prior hip fractures Prior vertebral fractures Total 1 GDP/ capita 2 GDP/ capita 3 GDP/ capita 785,659,033 1,178,488,549 920,944,314 1,381,416,471 803,258,637 1,606,517,275 2,409,775,912 1,322,480,924 2,644,961,849 505,249,355 1,010,498,711 3,967,442,773 1,515,748,066 3,535,851,862 7,071,703,728 10,607,555,591 Table 13 Value of lost QALYs () in men and women in the UK in 2010 Table 14 Population projections in the UK by age and sex [10] When the cost of osteoporosis was combined with the value for QALYs lost (valued at 2 GDP), the cost of osteoporosis amounted to 11.47 billion ( 14.11 billion) in the UK in 2010. Incident fracture, prior fracture, pharmacological fracture prevention, and value of QALYs lost accounted for 28 %, 9 %, 1 % and 62 %, respectively. Burden of osteoporosis up to 2025 The population above 50 years of age is expected to increase from 21.6 million in 2010 to 26.2 million in 2025, corresponding to an increase of 21 % (Table 14). The total number of fractures was estimated to rise from 536,000 in 2010 to 682,000 in 2025 (Table 15), corresponding to an increase of 27 %. Hip, clinical vertebral, forearm and other fractures increased by 23,000, 18,000, 15,900 and 89,300 respectively. The increase in the number of fractures ranged from 23 % to 29 %, depending on fracture site. The increase was estimated to be particularly marked in men (32 %) compared to women (24 %). The cost of osteoporosis (excluding value of QALYs lost) was estimated to rise from 4.4 billion ( 5.4 billion) in 2010 to 5.5 billion ( 6.7 billion) in 2025, corresponding to an increase of 24 % (Table 16). Costs incurred in women and men increased by 20 % and 32 % respectively. The total number of QALYs lost due to fracture was estimated to rise from 158,700 in 2010 to 190,500 in 2025, corresponding to an increase of 20 % (Table 17). The increase was estimated to be particularly marked in men (27 %) compared to women (16 %). Incident and prior fractures accounted for 67 % and 33 % of the increase respectively. The cost of osteoporosis including value of QALYs lost was estimated to increase from approximately 11.5 billion ( 14.1 billion) in 2010 to 14.0 billion ( 17.2 3,844,000 3,449,000 2,418,000 1,486,000 337,000 3,740,000 3,262,000 2,053,000 925,000 122,000 7,584,000 6,711,000 4,471,000 2,411,000 459,000 4,271,000 3,624,000 2,595,000 1,496,000 391,000 4,140,197 3,423,000 2,253,000 1,014,000 162,000 8,411,197 7,047,000 4,848,000 2,510,000 553,000 4,559,000 3,654,000 3,016,000 1,574,000 439,000 4,423,000 3,450,000 2,649,000 1,125,000 198,000 8,982,000 7,104,000 5,665,000 2,699,000 637,000 4,373,000 4,076,000 3,184,000 1,733,000 474,000 4,268,000 3,842,000 2,791,000 1,271,000 231,000 8,641,000 7,918,000 5,975,000 3,004,000 705,000 billion) in 2025. The increase was estimated to be particularly marked in men (+29 %) compared to women (+18 %) (Table 18). Treatment uptake To estimate uptake of individual osteoporosis treatments, sales data from IMS Health (20012011) were used to derive the number of defined daily doses (DDDs) sold per 100,000 persons aged 50 years or above (Fig. 2). Adjusting the sales data for compliance allowed for an estimation of the proportion of population aged 50 years or above who received any osteoporosis treatment (see Chapter 5 of the report on Osteoporosis in the European Union: Medical Management, Epidemiology and Economic Burden for further details). The proportion of persons over the age of 50 years who were treated increased from 1.11 % in 2001 to 5.5 % in 2011. Treatment gap In order to assess the potential treatment gap, the numbers of men and women eligible for treatment in 14,485 11,317 25,803 Women and Men 37,567 21,440 59,007 44,238 24,681 68,920 52,445 32,417 84,862 64,277 125,656 189,933 135,688 186,099 321,786 76,638 160,668 237,305 161,964 249,091 411,055 the UK were defined as individuals with a 10-year fracture probability exceeding that of a woman with a prior fragility fracture derived from FRAX, equivalent to a fracture threshold (See Chapter 5 of the main report for further details). Subsequently, these estimates were compared to the number of individuals who received osteoporosis treatment obtained from the analysis of IMS Health data. For men, the data indicate that the volume of sold osteoporosis drugs would be sufficient to cover treatment for more patients than the number that fall above the fracture threshold. It should Table 16 Current and future cost ( 000, 000) of osteoporosis (excluding value of QALYs lost) by age and calendar year in men and women in the UK be noted, however, that the results from this analysis should be interpreted with some caution since it has been assumed that the distribution of drug use between genders observed in Sweden is valid for all countries. The treatment gaps in men and women were estimated at 34 % and 54 % respectively (Table 19). Note that the estimate of the treatment gap is conservative given that it assumes that current use of osteoporosis treatments are only directed to men and women at high risk. Table 17 Projected QALYs lost due to incident and prior fractures for the years 2010 and 2025 by age in men and women in the UK 10,504 45,632 56,136 18,574 60,669 79,243 Table 18 Present and future cost ( 000,000) of fracture (direct cost and cost of QALYs) by age and calendar year in men and women in the UK assuming the uptake of treatment remains unchanged Women and Men Number potentially treated (1000 s) Number eligible for treatment (1000 s) Difference (1000 s) Treatment gap (%) Acknowledgements This report has been sponsored by an unrestricted educational grant from the European Federation of Pharmaceutical Industry Associations (EFPIA) and the International Osteoporosis Foundation (IOF). The data in this report have been used to populate a more detailed report on Osteoporosis in the European Union: Medical Management, Epidemiology and Economic Burden. We acknowledge the help of Helena Johansson and Prof Anders Odn for their help in the calculations of fracture probability. We thank Oskar Strm and Fredrik Borgstrm who were prominent authors of an earlier report covering a similar topic in a sample of EU countries and provided the template for the present report. We also thank Dr Dominique Pierroz, Carey Kyer and Ageeth Van Leersum of the IOF for their help in editing the report. The report has been reviewed by the members of the IOF EU Osteoporosis Consultation Panel and the IOF European Parliament Osteoporosis Interest Group, and we are grateful for their local insights on the management of osteoporosis in each country. Open Access This article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited. References


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A. Svedbom, E. Hernlund, M. Ivergård, J. Compston, C. Cooper, J. Stenmark, E. V. McCloskey, B. Jönsson, J. A. Kanis, the EU review panel of the IOF. Osteoporosis in the European Union: a compendium of country-specific reports, Archives of Osteoporosis, 2013, 137, DOI: 10.1007/s11657-013-0137-0