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Abstract. Introduction In Germany, accurate data on the prevalence and treatment of osteoporosis, as well as the cost of this illness, are not available. The aim of ...
Osteoporos Int (2007) 18:77–84 DOI 10.1007/s00198-006-0206-y

ORIGINAL ARTICLE

Epidemiology, treatment and costs of osteoporosis in Germany—the BoneEVA Study B. Häussler & H. Gothe & D. Göl & G. Glaeske & L. Pientka & D. Felsenberg

Received: 3 April 2006 / Accepted: 10 July 2006 / Published online: 19 September 2006 # International Osteoporosis Foundation and National Osteoporosis Foundation 2006

Abstract Introduction In Germany, accurate data on the prevalence and treatment of osteoporosis, as well as the cost of this illness, are not available. The aim of this study is to give a valid estimation of these items for the year 2003. Methods Routine data from a German sickness fund covering 1.5 million beneficiaries and billing data for outpatient visits were used to obtain estimates of prevalence for osteoporosis. Claims data for patients with osteoporosis (M80, M81) or an osteoporosis-related fracture diagnosis (S22, S32, S42, S52, S72, S82) or treatment with antiosteoporosis drugs were examined. Costs were calculated from the perspective of the German health insurance system and the German nursing care insurance system, respectively. Only direct costs of osteoporosis were considered. Results In 2003, 7.8 million Germans (6.5 million women) were affected by osteoporosis. Of them, 4.3% experienced B. Häussler (*) : H. Gothe : D. Göl IGES Institute for Healthcare and Social Research Ltd., Wichmannstraße 5, 10787 Berlin, Germany e-mail: [email protected] G. Glaeske Institute of Public Health and Nursing Research, Faculty 11: Human and Health Sciences, University of Bremen, Bremen, Germany L. Pientka Department of Geriatrics, School of Medicine, University of Bochum, Bochum, Germany D. Felsenberg Centre of Muscle and Bone Research, Campus Benjamin Franklin, Charité—Universitätsmedizin Berlin, Berlin, Germany

at least one clinical fracture. Only 21.7% were treated with an anti-osteoporosis drug. The total direct costs attributable to osteoporosis amounted to €5.4 billion. Conclusion This study confirms that osteoporosis is underdiagnosed, undertreated and imposes a considerable economic burden on the health system in Germany. Effective strategies for the prevention and management of this disease are needed. Keywords Bisphosphonates . Costs . Germany . Osteoporosis . Prevalence

Introduction Osteoporosis is defined as a “systematic skeletal disease characterised by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture” [1]. It is a major cause of morbidity and mortality, due to fractures and their complications. Osteoporotic fracture, which is the major health consequence of this condition, may occur at any skeletal site. The primary sites are the spine, hip (proximal femur), humerus and distal forearm [2]. According to the World Health Organization report (1994), about 30% of postmenopausal women are estimated to have osteoporosis. The prevalence rate of osteoporosis ranges between 13% and 30% for the US and the UK [3–5]. The prevalence in Germany is estimated to be between 4 million and 7 million people [6–8]. Postmenopausal women are at the greatest risk of developing osteoporosis because of the accelerated loss in bone mass associated with menopause. One out of three postmenopausal women and one out of five men over the age of 50 years will experience osteoporotic fractures [9].

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Osteoporosis and fractures due to osteoporosis not only have a major impact on peoples’ health and quality of life, but they also place an enormous economic burden on healthcare systems in Europe and worldwide. The report of the European Commission (1998) estimates an increase in the incidence of hip fractures in Germany until the year 2040, from 117,000 hip fractures in the year 2000 to 240,000 hip fractures in 2040. As the median age of the German population increases, the costs associated with osteoporotic fractures are also likely to increase. Due to its social and economic implications, osteoporosis is a major public health problem. Osteoporosis-related fractures account for more hospital days per year than diabetes, myocardial infarction or breast cancer [10, 11]. It is essential to identify individuals at high risk and take preventive measures in order to reduce the costs associated with osteoporosis. The objective of this study was to collect accurate and recent data on the prevalence, treatment and cost of osteoporosis and osteoporotic fractures in Germany, which are vital for planning the allocation of healthcare resources and for developing effective strategies for the prevention and management of this disease.

Materials and methods

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code (PZN), date of prescription and prescribing physician specialty. The PZN code provided information on substance (ATC), package size and defined daily dose (DDD). The ZI data came from a representative sample of office-based physicians from Nordrhein, a region in the Western part of Germany. The panel contained data on patient visits to 14 specialty groups, including general practitioners, internists, surgeons, orthopaedists and radiologists. The following information on approximately 600,000 patients were provided for the year 2003: patient identification number, patient date of birth and gender, diagnosis (ICD-10), physician specialty, physician services provided, date of service provided and the number of contacts with the physician. The Medical Review Board of the statutory sickness funds provided data on patient age and gender, number of cases in need of the long-term care insurance (stages I to III), type of care (inpatient and outpatient) and diagnosis (ICD-10) in Schleswig-Holstein (Northern Germany) in 2003. This study reports national estimates that were extrapolated from the available data sources according to the age–gender distribution of the German population and distribution of the German physicians’ specialty groups. Data from January 1, 2000 to December 31, 2003 were examined in order to identify patients with osteoporosis or osteoporosis-related fractures. Cost estimates and estimates on the number of patients with fractures were based on the data for the year 2003.

Data sources Study population Claims data from a statutory German sickness fund and billing data for outpatient visits from the Scientific Institute of the National Association of Statutory Health Insurance Physicians (Zentralinstitut für die Kassenärztliche Versorgung in der Bundesrepublik Deutschland, ZI) were used to obtain estimates of healthcare utilisation for osteoporosis. The information on long-term care (nursing) was collected from the Medical Review Board of the statutory sickness funds (Medizinischer Dienst der Krankenkassen, MDK). The cooperating German sickness fund had information on 1.5 million patients. In comparison to the average of the whole population of all insurants of German statutory sickness funds, insurants of this health insurance company tend to be younger (mean age 37 years) and males are slightly over-represented (54% in comparison to 47% within the whole German statutory sickness fund) [12]. The database covered prescription data, hospitalisation data including diagnoses (ICD-10), admission and discharge dates, sick leave data including diagnoses (ICD-10) and the related number of days absent from work, a selection of demographic variables (age and gender), date of enrollment, rehabilitation, physical therapy and medical aids (assistive devices). The prescription data contained national drug

Individuals were eligible for inclusion in this study if they were consecutively enrolled in the health plan for at least 360 days in the period from January 1, 2000 to December 31, 2003 and aged 50 years or above in 2000 (i.e. date of birth in 1950 or earlier). The following set of criteria was used to identify those included in the study as being osteoporotic: – –



At least one mention of osteoporosis (hospitalisation or sick-leave diagnosis) in the years 2000 to 2003 according to ICD-10 diagnostic code1 (M80, M81); and/or At least one mention of a potentially osteoporosisrelated fracture (hospitalisation or sick-leave diagnosis) in the years 2000 to 2003 according to ICD-10 diagnostic code (Table 1); and/or At least one prescription of a potentially osteoporosisrelated medication (calcium or calcium and vitamin D, hormone therapy, bisphosphonates, raloxifene, teriparatide, fluoride, nandrolone) in the years 2000 to 2003.

1 Patients with an encounter due to Morbus Paget (ICD10: M88) and/ or hypercalcaemia (ICD10: E83.5*) and/or tumour induced osteoporosis (ICD10: M90.7*) were excluded from the analysis.

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Table 1 Attribution of relevant ICD-10 diagnoses to osteoporosis by age group and gender (% of fractures for the given age groups) 50–64 (%)

65–74 (%)

75+ (%)

ICD-10

Description of ICD-10 code

Men

Women

Men

Women

Men

Women

S22 S32 S42 S52 S72 S82

Fracture Fracture Fracture Fracture Fracture Fracture

63 62 34 63 47 10

73 72 44 73 57 12

65 65 40 68 59 11

75 75 50 78 69 14

65 68 60 74 79 14

75 78 70 84 89 17

of of of of of of

rib(s), sternum and thoracic spine lumbar spine and pelvis shoulder and upper arm forearm femur lower leg, including ankle

Source: IGES according to Brecht and Schädlich [13]

Because some of the fractures may have an underlying cause other than osteoporosis, the number of fractures attributed to osteoporosis were estimated according to age– gender-specific attribution weights derived from the literature [13]. The reported weights in Brecht and Schädlich were modified according to the age and diagnosis groups used in this study (Table 1). Medication In this study, seven osteoporosis-related medication categories were defined: calcium or calcium and vitamin D, hormone therapy, bisphosphonates, calcitonins, selective oestrogen receptor modulators (SERMs), fluoride and anabolics. The hormone therapy group included both oestrogen alone and oestrogen–progesterone combination therapies. As these products are not recommended only for osteoporosis therapy, at least one prescription of calcium or calcium and vitamin D, as well as one prescription of a hormone therapy was required in the years surveyed to consider a patient as an osteoporosis patient. Non-specific treatment of osteoporosis involves pharmacologic agents used for the alleviation of pain (especially in the event of an osteoporotic fracture). Therefore, analgesic usage among osteoporosis patients was also examined, but the usage was not considered to be exclusively for osteoporosis. Economic evaluation Costs associated with osteoporosis were estimated. The perspective for the cost calculation was the German statutory health insurance (SHI) system and the German nursing care insurance system. Data from the privately insured patients were not available. It was assumed that there were no cost differences in SHI and privately insured patients. Only direct costs of osteoporosis, expressed in Euro (€) at the prices of 2003, were considered. Only costs attributable to osteoporosis were estimated. Expenditures due to co-morbidities were not incorporated. Costs were calculated according to a bottom-up approach. The allocated annual utilisation of each type of healthcare service was

multiplied by its unit price to yield the total cost of service in 2003. Unit costs were derived from different official statistics (e.g. Association of German Hospitals, Association of Physicians, Association of Statutory Health Insurance Companies). In Germany, bone mineral density (BMD) measurement (using dual-energy X-ray absorptiometry [DXA] scan) is only reimbursed if a patient has already sustained a fracture which may be related to osteoporosis. Only in case of reimbursement were costs according to densitometry considered for the analysis. Patients’ out-of-pocket payments for densitometry were ignored. In the data provided by the statutory health insurance, information on long-term institutional care was not included. A sample of the utilisation data was obtained separately from the Medical Review Board of the statutory sickness funds. To assess the cost of medical therapy, the number of packages prescribed for patients with osteoporosis was combined with the listed pharmacy prices in the Drug Compendium for Germany [14]. Since data on patient copayments was not available, it was not taken into account in these calculations. In reality, expenditures of sickness funds are reduced by these patient out-of-pocket payments. Annual direct medical costs included the treatment of osteoporosis and its complications, i.e. the treatment of fractures attributable to osteoporosis. Costs were stratified by cost component (inpatient, outpatient, rehabilitation, medication, physical therapy, medical aids and nursing), by age group (ages 50 to 64, 65 to 74, 75 and older) and by gender. The incremental cost of osteoporosis was estimated by using a matched-pairs approach, i.e. by comparing the healthcare costs for patients with osteoporosis to a group of otherwise similar (according to age, sex, comorbidities) patients without osteoporosis. The differences in the total costs between the groups were considered to be an estimate of the costs associated with managing the osteoporosis event.

Results In 2003, 7.8 million individuals, 50 years of age and above, were affected by osteoporosis, equalling a prevalence rate

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Table 2 Distribution of the population and the estimated prevalence of osteoporosis in Germany in 2003 Gender

Age group

German population (n)

Persons with osteoporosis (n)

Estimated prevalence (%)

Men

50–64 65–74 75+ Total (men) 50–64 65–74 75+ Total (women)

7,658,928 3,928,276 2,043,080 13,630,284 7,759,628 4,537,484 4,316,049 16,613,161 30,243,445

543,642 448,962 329,068 1,321,672 1,809,571 2,119,505 2,553,010 6,482,086 7,803,758

7.1 11.4 16.1 9.7 23.3 46.7 59.2 39.0 25.8

Women

All

Source: IGES estimation based on the algorithms described in the Materials and methods section.

of 26%. Prevalence was significantly higher among women (39%) than among men (9.7%). Of all persons estimated to have osteoporosis, 83% (6.5 million) were women. The prevalence of osteoporosis increased with age. Thirty-seven percent of patients were 75 years and older. Up to 6 out of 10 women over the age of 75 were estimated to have osteoporosis. Table 2 shows the distribution of the population and the estimated prevalence of osteoporosis in Germany in 2003. Fractures attributable to osteoporosis An estimated 333,322 of all osteoporosis patients experienced at least one fracture in 2003, equalling a rate of 4.3%. Among these, hip fractures (99,973 patients), wrist fractures (42,242 patients) and clinical vertebral fractures (40,741 patients with thoracic or lumbar spine fractures) were the most common fracture types. Table 3 shows the distribution of osteoporosis patients with fractures by fracture location. Although it had been stated above that at least 60% of all hip and spine fractures among women and men 45 years of age and older (85% of women and men aged 85 and older) should be attributed to osteoporosis [9], the present data show that, in the outpatient setting, the recognition of osteoporosis as an underlying cause of fractures was low. Of all patients of orthopaedists, only 9.7% received an osteoporosis diagnosis. When comparing different fracture locations, physicians were more likely to diagnose osteoporosis in the presence of lumbar spine and pelvis fractures (ICD-10: S32) (37%) or multiple different fractures (34%). Treatment A total of 21.7% of the osteoporotic patients received osteoporosis-specific therapy, representing 12% and 24% for men and women, respectively. For female patients, the treatment prevalence decreased significantly by age (31% in the lowest age group vs. 19% in the highest age group). As shown in Fig. 1, calcium or calcium and vitamin D was the most common treatment choice, followed by

bisphosphonates in accordance with the recent treatment guidelines for osteoporosis [15, 16]. Since patients were on different medications simultaneously, the percentages add up to more than 100%. Analgesics were the most widely prescribed drug for osteoporosis patients. Nine out of ten osteoporosis patients received a prescription for an analgesic. In comparison to non-osteoporotic patients, patients with osteoporosis received three times more prescriptions for these drugs. A sub-analysis of the data indicated that osteoporosis patients taking non-steroidal anti-inflammatory drugs (NSAIDs) were hospitalised more often for peptic ulcer disease than those not taking NSAIDs (3.2% and 2.3% of patients, respectively [p