Osteoporosis in German men: a cost-of-illness study.

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Original Research

Osteoporosis in German men: a cost-of-illness study Expert Rev. Pharmacoecon. Outcomes Res. Early online, 1–7 (2014)

Sabine Berghaus*1‡, Dirk Mu¨ller1‡, Afschin Gandjour2, Daniele Civello1, Stephanie Stock1 1 Institute of Health Economics and Clinical Epidemiology, The University Hospital of Cologne (Ao¨R), Cologne, Germany 2 Frankfurt School of Finance and Management, Frankfurt, Germany *Author for correspondence: Tel.: +49 152 3389 6229 Fax: +41 022 1430 2304 [email protected] ‡

Authors contributed equally

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Costs of male osteoporosis may have increased due to population aging and change of treatment patterns. This cost-of-illness study provides a current estimate of the economic burden of male osteoporosis in Germany. Routine claims data from six German sickness funds were analyzed and extrapolated to the German statutory health insurance (SHI). For men above the age of 50 with at least one ICD-10 osteoporosis-related diagnosis or osteoporosis-related fracture in 2010, direct costs related to osteoporosis were considered based on a payer’s perspective. Total direct costs attributable to osteoporosis amounted to e728 million in 2010. The majority of these costs (71%) resulted from inpatient treatment due to fractures. Patients aged 75 and older caused approximately 63% of costs. Male osteoporosis represents a non-negligible economic burden for the German health care system. Targeted prevention and promotion measures should be offered both to men and women. KEYWORDS: costs . German statutory health insurance . Germany . men . osteoporosis

Osteoporosis is the most common bone disease in the elderly and a major cause for morbidity and mortality in this population [1,2]. Fractures and their complications are the main cost drivers of osteoporosis. Only 4.3% of German patients with osteoporosis experience a fracture but these patients account for 61.3% of the total costs of osteoporosis [2]. According to reports of the German Federal Statistical Office, total cost of osteoporosis-related diseases (i.e., the codes M80–M82 of the International Classification of Diseases) in both women and men amounted to almost e1.9 billion in 2008. This corresponds to almost 7% of all costs spent for treatment of musculoskeletal diseases [3]. Although osteoporosis mainly affects postmenopausal women, a considerable proportion of osteoporosis-attributable fractures occur in men. According to the review of the Global Burden of Disease 2000 project, 30% of hip fractures and 39% of spine fractures worldwide occurred in men [4]. Men below the age of 60 were 2.9-times more likely to incur an osteoporotic fracture compared with women [5]. In addition to these high rates of fracture incidence and prevalence, men had higher mortality rates than women at all ages with a mortality of 22.3 per 100 person years 5 years after occurrence of a fracture [6]. To prevent osteoporotic fractures in men, medical interventions such as bisphosphonates are available [1]. 10.1586/14737167.2015.990885

According to a German demographic simulation model, the number of osteoporosisattributable fractures in men will be approximately 1.8 million fractures for the period between 2010 and 2050 [7], resulting in a growing demand for both hospital care and long-term care. A detailed knowledge about the cost structure of male osteoporosis would provide decision makers with the opportunity to prioritize healthcare resources and improve the efficiency of care for male osteoporosis. In recent years, three studies evaluated costs of hip fractures in Germany from a societal and third-party-payer perspective for both men and women [4,8–10]. Because of the different approaches in these studies, costs estimated for prevention and treatment of hip fractures differed markedly. Similarly, cost estimates of male osteoporosis in Germany differ to a large extent. A recent incident (fracture)-based modeling approach estimated the direct costs of male osteoporosis to be e174 million (7, adjusted to 2013). In contrast, a prevalencebased approach analyzing claims data (1.5 million insured with 54% of them male) from 2003 yielded e1.04 billion (adjusted to 2013) [2]. In the latter study, more fracture types were included. In another study [10] using German claims data on hospitalizations for hip fractures from 2003/04, the economic burden of osteoporosis in males was estimated

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Original Research

Berghaus, Mu ¨ ller, Gandjour, Civello & Stock

to be e2.9 billion. Yet, this analysis was limited by estimating the incidence of other fractures from the incidence of hip fractures based on Swedish data. The proportion of the population with prior fractures was modeled as well [10]. Although these analyses provide valuable information for decision makers, there are two reasons for an update: first, the number of osteoporotic fractures may have increased as a result of population aging and, second, some variables such as treatment patterns may have changed since 2003. For example, augmentation techniques such as kyphoplasty and vertebroplasty have increasingly been used to treat osteoporotic compression fractures of the vertebrae over the past decade compared with less expensive conservative treatment [11]. Because the total number of vertebral fractures (including lumbar and thoracic fractures) is only superseded by hip and wrist fractures [2], vertebral fractures may have a considerable impact on total costs of male osteoporosis. For decision makers, it is important to have knowledge about the current cost structure of osteoporosis, which also reflects changes of treatment patterns. The main objective of this cost-of-illness study was to estimate the cost of osteoporosis and osteoporotic fractures in German men aged 50 years and older from the third-party payer perspective of the German statutory health insurance (SHI) and the statutory nursing insurance system. In Germany, nursing care in long-term care facilities is covered by the statutory nursing insurance since the middle of 1996. With the introduction of this new insurance scheme, Germany is among the first countries that have established an independent statutory insurance for the risk of becoming dependent on permanent nursing care. Materials & methods

This cost-of-illness study aims to estimate the financial burden of male osteoporosis in Germany. Based on unique access to real world data, micro-level utilization and claims data from 2010 were analyzed and cost drivers were identified. Study design

For this cost-of-illness study, a bottom-up, prevalence-based approach was used. The study was based on administrative claims data of 2,919,272 insured population of six large sickness funds of the SHI and the statutory nursing insurance (geographically well distributed in Germany). Our study sample thus represents 4.3% of the SHI or 3.6% of the total German population. Patients who died in 2010 were not included in the analysis. Data sources

The analysis included costs for hospital and outpatient care, medication, nursing care, rehabilitation care, remedies and aids, as well as additional care such as physiotherapy (Heil- und Hilfsmittel). Data was provided by BAHN-BKK, BKK der SIEMAG, BKK vor Ort, Deutsche BKK, Die Schwenninger Krankenkasse and the hkk Erste Gesundheit and included

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1,423,272 men (11.2% of insured in the SHI aged 50 years or older) and 1,496,000 women. Compared with the total SHI, which covers 70 million (around 87%) of the German population [12], this sample differs slightly in the proportion of men (49% in this sample compared with 47% in the SHI) [13] and tends to be younger (study sample: 45.8 years, SHI: 47.9 years) [12,13]. Because cost data on specific subcategories could not be obtained from all insurances, estimates were based on different numbers of insured persons: aids and additional care costs: 1,108,848 male enrollees (representing 8.7% of male insured in the SHI aged 50 or older); physical therapy costs: 700,031 enrollees (5.5%); and rehabilitation and nursing care: 555,587 enrollees (4.4%). The available information in the routine SHI data includes hospital diagnoses (ICD-10), hospital care, drug prescription, aids and additional care and socio-demographic data. Drug prescriptions are coded according to the Anatomical Therapeutic Chemical Classification System (ATC code, SUPPLEMENTARY TABLE 4 in the appendix [supplementary material can be found online at www.informahealthcare.com/suppl/10.1586/ 14737167.2015.990885]). Information on long-term care was obtained from the long-term care insurance, data for rehabilitation from the German pension fund. To ensure data quality, non-answered fields in the dataset were excluded. Data safety was confirmed by physician who completed the table. Study population

Only male individuals were included in this study. They had to be insured during the period from 1 January 2010 to 31 December 2010 by one of the six sickness funds, have an osteoporosis-related diagnosis or fractures and had to be aged 50 or older (i.e., date of birth in 1960 or earlier). Insured men were identified as having osteoporosis if they had one of the ICD-10 diagnoses listed in TABLE 1. Individuals were included in the analysis if either a confirmed or a suspected diagnosis (as primary or secondary diagnosis) was coded [14]. Because some of the fractures may have occurred to reasons other than osteoporosis, the numbers of fractures attributed to osteoporosis were corrected with ageand sex-specific attribution weights derived from Bleibler et al. [15]. Note that the German version of the ICD-10 does not allow a simultaneous use of the codes Sxx and Mxx. Therefore, double counting is technically not possible. Costs

For this analysis, only direct costs (e2010) were considered. This includes hospital costs, costs for outpatient care, drug costs, costs for aids and physical therapy, nursing care and rehabilitation. Co-payments of patients and transfer costs were not included in the analysis. Costs were classified according to age groups (50–64, 65–74, 75+). After adjustment for age, costs calculated for the study sample were extrapolated to the total number of men insured in the German SHI (about 33 million of the German population in 2010).

Expert Rev. Pharmacoecon. Outcomes Res.

Osteoporosis in German men


Inpatient costs

Inpatient costs for surgical and nonsurgical procedures were based on diagnosis-related groups (DRGs) [16]. For the calculation, the web browser for DRGs was used (G-DRG V2011 Browser 2010), which is available from the Institute for the Hospital Remuneration System [16]. Costs were calculated by multiplying the number of patients discharged from hospital with the appropriate DRG rate (base rate 2010 with the cost weights for each DRG group). Additional nationwide and individual hospital fees (e.g., fees for psychological or psychosomatic treatments) or day-care hospital stays were this analysis.

Original Research

Table 1. Overview of all relevant ICD-10 codes. Criteria

ICD-10

Description

At least one fracture associated with osteoporosis in 2010, according to ICD-10-GM 2010

S22 S32 S42 S52 S62 S72 S82 S92

Fracture Fracture Fracture Fracture Fracture Fracture Fracture Fracture

At least one osteoporosis diagnosis in 2010 according to ICD-10-GM 2010

M80 M81 M82

Osteoporosis with pathological fracture Osteoporosis without pathological fracture Osteoporosis in diseases classified elsewhere

of rib(s), sternum and thoracic spine of lumbar spine and pelvis of shoulder and upper arm of forearm at wrist and hand level of femur of lower leg, including ankle of foot, except ankle

GM: German modification.

not considered for

Outpatient costs

Costs for outpatient treatment, medical drugs, aids and physical therapy were obtained from the SHI routine data according to the ICD codes listed in TABLE 1. Whereas costs for outpatient nursing care were obtained from the long-term care insurance, outpatient rehabilitation costs were supplied by the German Pension Fund.

Cost of nursing care

Long-term care insurance benefits include domestic and inpatient nursing (in kind and cash benefits as well as other benefits that are paid either to those needing care or to their caregivers). For the calculation of costs of nursing care, we included only costs incurred within the first 3 months after discharge from hospital as information about costs incurred later was not available. Costs were separated into the categories: cash, in kind and combined compensations (i.e., both in cash and in kind).

Physician costs

Physician costs were estimated by multiplying the number of patient visits per quarter with a lump sum payment physicians receive for a case per quarter. The lump sum payment was based on the German reimbursement schedule for the SHI (Einheitlicher Bewertungsmaßstab, EBM). In addition, for specific measures, the number of points was multiplied with the unit price of the year 2010 (e0.053).

Costs of rehabilitation

Because a SHI perspective was used for this analysis, rehabilitation costs were included only for persons above the age of 65. Below this age, rehabilitation costs are covered by the German pension fund. Rehabilitation costs were obtained from the SHI routine data and were included for the first 3 months after hospital discharge with an osteoporosis-related fracture.

Medical drug costs

Drug costs were calculated from the prescription of osteoporosis-related drugs and included the following ATCcodes: calcium/vitamin D, bisphosphonates, hormone therapy and analgesics [2]. Analgesic prescription for male osteoporosis patients was included as it is often used for the alleviation of pain, particularly when a fracture occurs. Medications at the expense of private health insurance obtained in hospitals or purchased by patient themselves in local pharmacies were not included. ATC codes were based on the official German ATC classification of 2010 [16]. Aids & physical therapy costs

Costs for aids and physical therapy were derived from the classification system of the National Association of the SHI. Aids were included when they were related to osteoporotic treatment as judged by experts. Costs were calculated using selection filters, which refer to the site of fracture and type of treatment due to osteoporosis. Physiotherapy costs were obtained from the SHI routine data. informahealthcare.com

Results

In 2010, a total of 40,540 men insured by the German SHI experienced at least one fracture or osteoporosis-related diagnosis. The total number of coded diagnoses for these patients amounted to 118,424 ICD codes including 56,006 fractures (TABLE 1). Whereas 48% of all coded osteoporotic diagnoses were recorded as osteoporosis with or without a pathologic fracture, 52% of diagnoses were recorded as fractures of specific sites resulting from falls or non-fall-related reasons. Most fractures were those of rib(s), sternum and the thoracic spine (16% of all coded diagnoses with a fracture) (TABLE 2). Extrapolating total direct costs for male osteoporosis to the German SHI amounted to e728 million in the year 2010. The majority of costs (71%) were due to hospital treatment. In terms of outpatient care, physician treatment costs had the largest impact (43% of all outpatient costs). Treatments for patients aged 75 and older caused approximately 63% of the total direct costs linked to osteoporosis. doi: 10.1586/14737167.2015.990885

Original Research



Table 2. Number of male patients by ICD-10 code (2010) based on six German sickness funds. ICD-10

Description

Number of patients receiving at least one osteoporotic diagnosis or osteoporotic fracture (%)

Age- and sex-specific weights for extrapolation†

S22

Fracture of rib(s), sternum and thoracic spine

4709 (11.62)

16.5 (8.8–28.0)

S32

Fracture of lumbar spine and pelvis

2539 (6.26)

18.95 (6.75–37.4)

S42

Fracture of shoulder and upper arm

2174 (5.36)

14.9 (7.8–24.85)

S52

Fracture of forearm

2328 (5.74)

10.8 (4.7–20.1)

S62

Fracture at wrist and hand level

2190 (5.40)

6.3 (2.5–12.03)

S72

Fracture of femur

2120 (5.23)

28.1 (15.75–44.3)

S82

Fracture of lower leg, including ankle

2786 (6.87)

17.2 (8.2–29.2)

S92

Fracture of foot, except ankle

1968 (4.85)

5.0 (0.84–11.4)

M80

Osteoporosis with pathological fracture

2956 (7.29)

–

M81

Osteoporosis without pathological fracture

16,605 (40.96)

–

M82

Osteoporosis in diseases classified elsewhere

165 (0.41)

–

Total

40,540 (100)

†

Estimates of fractures attributable to osteoporosis according to [14]. SHI: Statutory health insurance.

Inpatient costs

In 2010, the total inpatient costs caused by osteoporotic fractures in men amounted to e420 million (TABLE 3). The majority of inpatient costs were caused by fractures of the lower leg (including the ankle) and the femur, which caused approximately 34–50% of all fracture costs, respectively. Other costs

Whereas physician costs of osteoporotic fractures in all male enrollees amounted to e132 million, costs of drugs, aids and physical therapy amounted to e83.3 million, e16.2 million and e20.7 million, respectively (TABLE 3). In addition, costs of nursing care and rehabilitation of male enrollees incurred were e47.2 million and e8.7 million, respectively (TABLE 3). Discussion

The purpose of this study was to calculate the overall costs of osteoporosis in men enrolled in the German SHI. They amounted to e728 million in the year 2010. In total, 40,540 male insured (3% of all male insured older than 50 years) were either diagnosed with osteoporosis or experienced at least one osteoporotic fracture (assuming the same risk profile for males insured by private companies, the total number in Germany would be 46,600). The vast majority of these costs result from inpatient treatment due to fractures. The

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main strength of this study is the analysis of a large database that includes data from six insurance funds with more than 1.4 million insured men. Compared with the findings of Haüssler et al. [2], which are also based on claims data (from 2003) and a health insurance perspective, in our analysis, estimates of costs for male osteoporosis were approximately 25% lower (e0,73 billion vs e1 billion). In both analyses, patients aged 75 and older caused approximately three-quarter of the total direct costs linked to osteoporosis and, the vast majority of costs resulted from inpatient treatment (58 vs 62% in the study of Haüssler et al. [2]). Differences can primarily be explained using different weights for estimating the proportion of fractures attributable to osteoporosis. Calculations of Haüssler et al. [2] were based on data from Brecht et al., which were published in 2000 and therefore might not reflect the age- and sex-specific weights of fractures attributable to osteoporosis in the year 2010. Using these weights for our analysis, our results are almost equal to those of Haüssler et al. [2], indicating no change in the burden of osteoporosis. To rely on updated weights, we used recently published empirical data obtained from the national and international literature [15]. Our results could not confirm a cost increase in inpatient treatment due to a change of treatment patterns for vertebral fractures. As shown for the USA, vertebral augmentation



Original Research


Table 3. Costs of male osteoporosis by types and age in Germany in 2010 euros (95% confidence interval in brackets)†. Cost category

50–64

65–74

75 +

total

Inpatient‡

47,337,523 [24,946,090–78,497,080]

40,708,671 [22,006,962–66,533,325]

330,868,537 [171,325,927–543,863,226]

419,719,638 [218,700,344–661,859,093]

Physician

37,810,091

45,594,267

48,691,873

132,096,231

Medication

18,020,008

29,622,585

35,652,625

83,295,218

Aids

5,950,469

4,988,414

5,258,917

16,197,800

Physical therapy

8,234,249

6,637,572

5,801,063

20,672,884

Nursing care§

–

–

–

47,191,651

–

–

–

8,691,624

§

Rehabilitation †

Because some of the fractures may have occurred due to causes other than osteoporosis, the number of fractures attributable to osteoporosis was estimated using ageand sex-specific weights derived from the literature [15]). ‡ Costs were calculated by the Institute for the Hospital Remuneration System [16]. § Data was not available for specific age groups.

procedures have seen a continued increase from 2004 to 2008 [11]. Reasons for this increasing utilization, which are likely to be similar for Germany, include financial incentives, perceived safety of a minimal-invasive surgical procedure and effectiveness of vertebral height restoration [11]. Although the total inpatient costs were about one-quarter lower in our analysis compared with the findings from Haüssler et al., unfortunately, neither in our study nor in the analysis of Haüssler et al., expenses for surgical treatments could be exactly assigned to specific fracture sites [2]. Therefore, a direct comparison of treatment patterns for vertebral fractures is not possible. Compared with the study by Haüssler et al. [2], costs of outpatient treatment were also lower. The main reason for this difference is in the categories for nursing care and medication. Although in our analysis only four drugs were considered for estimating medication costs (calcium/vitamin D, bisphosphonates, hormone therapy, and analgesics), in the analysis of Haüssler et al. [2], a broader spectrum of drugs was considered. In addition, in that study medication costs were based on pharmacy sales prices without regard for sales discounts that were considered in our study. In addition, non-prescription drugs were not considered in our analysis due to the payer’s perspective. In the estimate of long-term costs there were also methodological discrepancies. Although in our analysis, costs of nursing care included only those costs that were incurred within 3 months after discharge from hospital, in the study of Haüssler et al. [2], costs of nursing care beyond this time were included. In contrast to the analysis of Haüssler et al., in our study, minor fractures coded with the ICD S52 (forearm fractures) and M82 (osteoporotic fractures, not specified) were included. The reason is that about one-third of osteoporotic fractures in males are minor fractures [6]. Comparing the costs of osteoporosis for men and women, in previously published analysis for Germany, the absolute direct costs resulting from osteoporotic treatment for women were


almost five-times as much as those for men [2,15]. Assuming the same relation for our analysis, the costs of treating osteoporosis in women in Germany would amount e3.6 billion. A recent modeling-based comparison about the costs of osteoporosis in the EU revealed that the costs of male osteoporosis in Germany are higher than those of some countries (e.g., Belgium or the Netherlands) but lower than those of others (e.g., Denmark or Sweden) [10]. However, a direct comparison of the present real world data-based analysis – which revealed substantially lower costs of treatment of male osteoporosis in Germany than calculated in the analysis of Svedbom et al. [10] – with analyses from other countries is not possible, as these differ in the selected study population, survey year, cost elements, included diagnoses, survey methodology and data sources. For future research, we recommend longitudinal studies to assess the change of costs of male osteoporosis over time. Our study has some limitations. First, for some variables, the databases of the health insurance companies considered for this analysis had only a limited number of patient records. Therefore, estimates for some costs categories were based on a limited number of cases (i.e., aids and physical therapy costs, nursing care and rehabilitation). In addition, costs of nursing care and rehabilitation that occurred more than 3 months after discharge from hospital could not be included because of a lack of data. Whereas our analysis ensured that these costs were related to osteoporotic fractures or osteoporosis, it omitted long-term costs resulting from nursing care and rehabilitation. Second, men insured in our study sample were little younger than men insured in all sickness funds (study sample: 45.8 years, SHI: 47.9 years), which may affect the representativeness of the results. Third, there are some restrictions on the filters and selection parameters used for the analysis. In this respect, we may have included treatment for unrelated diseases. In particular, there is a risk of overestimating the cost of bone strengthening drugs for the treatment of osteoporosis, because calcium,

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Original Research


vitamin D and hormones are not very specific indicators for osteoporosis. In addition, the use of analgesics cannot be completely attributed to an osteoporotic fracture or diagnosis as they are also used for the treatment of other diseases. To some extent, however, this overestimation might be outweighed by the inclusion of only four drugs in our analysis. In addition, there may be an overestimation of the costs of aids and physical therapy as they may have also been applied to non-osteoporosis indications. Finally, in this cost-of-illness study, the calculated costs of osteoporosis are based on the data of male enrollees who are over 50 years old and have utilized the medical services. The exclusion of younger patients, patients without physician contact and non-reported therapies may have affected the results. Furthermore, misdiagnosis in both directions (i.e., falsepositive and false-negative) cannot be excluded. As shown by Hube et al. [17], only 70% of physicians are moderately confident of the diagnosis and treatment of osteoporosis [17]. By nature, the usage of administrative claims data can result in biased estimates because of misdiagnosis. For example, an analysis of routine hospital data showed that 2% of patients had an operation for a hip fracture but did not have a hip fracture diagnosis (many had a multiple fracture diagnosis) [18]. Although administrative data in general is useful for ascertaining osteoporosis-related fractures, its validity for estimating fracture incidence often depends on the site and features of

the case definition [19]. For this analysis, the likelihood of biased estimates resulting from misdiagnosis was assumed to be low, as non-answered fields in the dataset were excluded and data safety was confirmed by the physician who completed the table. Despite some methodological limitations, this cost-of-illness analysis highlights the socioeconomic impact of male osteoporosis. In accordance with previous study, male osteoporosis represents a significant economic burden for the German health care system. Our study presents an updated estimate using real world data as well as new weights to quantify the true proportion of osteoporotic fractures. It shows that previous estimates overestimated somewhat the still non-negligible burden. To reduce the costs of male osteoporosis in society, it will be important to offer preventive measures. This includes assessing the risk of falls, maintaining mobility and correcting nutritional deficiencies (particularly of calcium, vitamin D and protein) [20]. Financial & competing interest disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending or royalties. No writing assistance was utilized in the production of this manuscript.

Key issues .

Of all insured males older than 50 years, 3% were either diagnosed with osteoporosis or experienced at least one osteoporotic fracture, resulting in costs of e728 million.

.

Compared with previous findings, the costs of in- and outpatient treatment were about 25% lower.

.

Almost two-thirds of all costs were caused by insured males aged 75 and older. Male osteoporosis represents a non-negligible economic burden for the German health care system and targeted prevention and promotion measures should be offered both to men and women.

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