ML Brandi ∙ F Silveri ∙ M Rossini ∙ C Willers ∙ N Norton ∙ NC Harvey ∙ T Jacobson ∙ H Johansson ∙ M Lorentzon ∙ EV McCloskey ∙ F Borgström ∙ JA Kanis
Introduction
The scorecard summarises key indicators of the burden of osteoporosis and its management in the 27 member states of the European Union, as well as the UK and Switzerland (termed EU27+2) [1]. This country-specific report summarises the principal results for Italy.
Methods
The information obtained covers four domains: burden of osteoporosis and fractures; policy framework; service provision; and service uptake. Data were collected from numerous sources including previous research and IOF reports, and available registers which were used for additional analysis of resource utilization, costing and HRQoL data. Furthermore, country-specific information on osteoporosis management was obtained from each IOF member state via a questionnaire.
Burden of disease
The direct cost of incident fractures in Italy in 2019 was €5.44 billion. Added to this was the ongoing cost in 2019 from fractures that occurred before 2019, which amounted to €3.75 million (long-term disability). The cost of pharmacological intervention (assessment and treatment) was €259 million. Thus, the total direct cost (excluding the value of QALYs lost) amounted to €9.45 billion in 2019. Key metrics are presented in Table 1.
In 2019, the average direct cost of osteoporotic fractures in Italy was €156.3 per individual in the population, while in 2010 the average was €129.1 (after adjusting for inflation) representing an increase of 21% (€156.3 versus €129.1). The 2019 data ranked Italy in 5th place in terms of highest cost of osteoporotic fractures per capita in the EU27+2.
The cost of osteoporotic fractures in Italy accounted for approximately 6.0% of healthcare spending (i.e. €9.45 billion out of €153.85 billion in 2019), significantly higher than the EU27+2 average of 3.5% and ranked Italy 2nd place in the EU27+2 countries These numbers indicate a substantial impact of fragility fractures on the healthcare budget.
Using World Health Organization diagnostic criteria for osteoporosis based on the measurement of bone mineral density (BMD) [2], there were approximately 4,359,000 individuals with osteoporosis in Italy in 2019, of whom approximately 80% were women. The prevalence of osteoporosis in the total Italian population amounted to 6.3%, somewhat higher than the EU27+2 average (5.6%).
Table 1 Key measures of burden of disease for Italy
Category
|
Measure
|
Estimate
|
Rank
|
---|
Burden of disease
|
Direct cost of incident fracture (€m)
|
5438.79
| |
Long-term disability cost (€m)
|
3749.16
| |
Intervention cost (€m)
|
258.61
| |
Total cost (€m)
|
9446.55
| |
QALYs lost (€m)
|
14980
| |
Cost per capita (€)
|
156.32
|
5
|
Proportion of healthcare spending
|
6.0%
|
2
|
Prevalence of osteoporosis
|
6.3%
|
1
|
There were estimated to be 568,000 new fragility fractures in Italy in 2019, equivalent to 1,560 fractures/day (or 60 per hour). This was a slight increase compared to 2010, equivalent to an increment of 1.0 fractures/1000 individuals, totalling 20.6 fractures/ 1000 individuals in 2019.
Some osteoporotic fractures are associated with premature mortality [3]. In Italy, the annual number of deaths associated with a fracture event was estimated to be 105 per 100,000 individuals of the population aged 50 years or more, compared to the EU27+2 average of 116/100,000. The number of fracture-related deaths is comparable to or exceeds that for some of the most common causes of death such as lung cancer, diabetes, chronic lower respiratory diseases.
The remaining lifetime probability of hip fracture (%) at the ages of 50 years in men and women was 7.7% and 19.2%, respectively, placing Italy in the upper tertile of risk for both men and women.
The population of men and women age 50 years or more is projected to increase by 10.1% in men and women between 2019 and 2034, close to the EU27+2 average of 11.4%. The increases in men and women aged 75 years or more are even more marked and amount to 31.8% and 20.3%, respectively. The annual number of osteoporotic fractures in Italy is expected to increase by 133,000 to 702,000 in 2034.
Policy framework (Table 2)
Documentation of the burden of disease is an essential prerequisite to determine the resources that should be allocated to the diagnosis and treatment of the disorder. High quality national data on hip fracture rates have been identified in 18 of 29 countries, of which Italy is one. Data are collected on a national basis and include more than only hip fracture data.
Given that osteoporosis and fragility fractures are common and that effective treatments are widely available, the vast majority of patients with osteoporosis are preferably managed at the primary health care level by general practitioners (GPs), with specialist referral reserved for difficult complex cases. Primary care was the principal provider of the medical care for osteoporosis in Italy, as for 13 of the 28 countries where data were available.
Osteoporosis and metabolic bone disease is not a recognised specialty in most countries including Italy. Specialty care of osteoporosis in Italy is managed via other specialties including rheumatology, endocrinology, internal medicine, rehabilitation medicine and orthopaedics. Osteoporosis is however recognized as a component of specialty training. Although it is possible that these specialties educate their trainees adequately, the wide variation may reflect inconsistencies in patient care, training of primary care physicians and a suboptimal voice to “defend” the interests of those who work within the field of osteoporosis.
Table 2 Policy framework for osteoporosis in Italy
Category
|
Measure
|
Estimate
|
---|
Policy framework
|
National fracture data availability
|
Yes
|
OP recognized as a specialty
|
No
|
OP primarily managed in primary care
|
Yes
|
Other specialties involved
|
Rheumatology, Endocrinology, Internal medicine, Rehabilitation medicine, Orthopaedics
|
Advocacy areas covered by patient organisation
|
Policy, capacity, peer support, research and development
|
The role of national patient organisations is to improve the care of patients and increase awareness and prevention of osteoporosis and related fractures among the general public. Advocacy by patient organisations can fall into four categories: policy, capacity building and education, peer support, research and development. For Italy, all four of the advocacy areas were covered by a patient organisation, which was the case for only 10 out of the 26 countries with at least one patient organisation.
Service provision (Table 3)
A wide variety of approved drug treatments is available for the management of osteoporosis [4]. Potential limitations of their use in member states relate to reimbursement policies which may impair the delivery of health care. Italy is one of the 12 (out of 27) countries that offer full reimbursement.
The assessment of bone mineral density forms a key component for the general management of osteoporosis, being used for diagnosis, risk prediction, selection of patients for treatment and monitoring of patients on treatment. In Italy, the number of DXA units expressed per million of the general population amounted to 23.5 which puts the country in 9th place among the EU27+2.
The average waiting time for DXA ranged from 0 to 180 days across countries, and there was no clear relation between waiting times and the availability of DXA. In Italy, the estimated average waiting time for DXA amounted to 90 days. 23 countries reported shorter average waiting times.
Table 3 Service provision for osteoporosis in Italy
Category
|
Measure
|
Estimate
|
Rank
|
---|
Service provision
|
Reimbursement of OP medications
|
100%
| |
DXA units/million inhabitants
|
23.5
|
9
|
DXA cost (€)
|
90
|
7
|
FRAX risk assessment model available
|
Yes
| |
Fracture liaison service density
|
1-10%
| |
Reimbursement for DXA scans varied between member states both in terms of the criteria required and level of reimbursement awarded. In Italy, the reimbursement was conditional and varied depending on the patient’s condition.
The effective targeting of treatment to those at highest risk of fracture requires an assessment of fracture risk. Risk assessment models for fractures, most usually based on FRAX, were available in 24 out of 29 countries, of which Italy was one. An additional risk assessment model, DeFRA, was also used in Italy. For Italy, guidance on the use of risk assessment within national guidelines was available, as in only 14 of the other countries.
Guidelines for the management of osteoporosis were available in Italy (as in 27 out of 29 countries). The guidelines in Italy included postmenopausal women specifically, as well as osteoporosis in men and secondary osteoporosis including glucocorticoid-induced osteoporosis.
Fracture liaison services (FLS), also known as osteoporosis coordinator programmes and care manager programmes, provide a system for the routine assessment and management of postmenopausal women and older men who have sustained a low trauma fracture. Fracture liaison services were reported for 1–10% of hospitals in Italy.
The use of indicators to systematically measure the quality of care provided to people with osteoporosis or associated fractures has expanded as a discipline within the past decade [5]. Italy was one of only few countries with national quality indicators in place.
Service uptake (Table 4)
The web-based usage of FRAX showed considerable heterogeneity in uptake between the countries. The average uptake for the EU27+2 was 1,555 sessions/million/year of the general population with an enormous range of 49 to 41,874 sessions/million. The use of FRAX in Italy amounted to 414 sessions/million in 2019, with a 20 percent decrease since 2011. It is notable, however, that Italy has its own risk assessment tools that are widely used [6, 7].
Many studies have demonstrated that a significant proportion of men and women at high fracture risk do not receive therapy for osteoporosis (the treatment gap) [8]. In the EU27+2 the average treatment gap was 71% but ranged from 32% to 87%. For Italy, the treatment gap amongst women amounted to 71% or 2,055,000 out of 2,889,000 characterised at risk, and it increased significantly compared to 2010. The average treatment gap among EU27+2 increased from 55% in 2010 to 71% in 2019.
Table 4 Service uptake for osteoporosis in Italy
Category
|
Measure
|
Estimate
|
Rank
|
---|
Service uptake
|
Number of FRAX sessions/million people/yer
|
414
|
23
|
Treatment gap for women eligible for treatment (%)
|
71
|
13
|
Proportion surgically managed hip fractures
|
>90%
| |
About 5% of people with a hip fracture die within 1 month of their fracture [9]. A determinant of peri-operative morbidity and mortality is the time a patient takes to get to surgery [10]. For Italy, the average waiting time for hip fracture surgery after hospital admission was reported to be 2–3 days. The proportion of surgically managed hip fractures was reported to be over 90%.
Scores and scorecard
Scores were developed for Burden of disease and the healthcare provision (Policy framework, Service provision and Service uptake) in the EU27+2 countries. Italy scores resulted in a 14th place regarding Burden of disease. The combined healthcare provision scorecard resulted in an 8th place for Italy. Thus, Italy presents as one of the high-burden high-provision countries among the EU27+2.
Fig. 1 Scores by country for metrics related to policy framework, service provision and service uptake. The mean score for each of the 3 domains is given. An asterisk denotes that there was one or more missing metric which decreases the overall score
The first SCOPE was undertaken in 2010, almost 10 years previously. Fifteen of the 16 score card metrics on healthcare provision were used in the two surveys. Scores had improved or markedly improved in 15 countries, remained constant in 8 countries and worsened in 3 countries. For Italy, the scores were markedly improved.
Fig. 2 The scorecard for all the EU27+2 countries illustrating the scores across the four domains. The elements of each domain in each country were scored and coded using a traffic light system (red, orange, green). Black dots signify missing information
The second edition of the Scorecard for Osteoporosis in Europe (SCOPE 2021) allows health and policy professionals to assess key indicators on the healthcare provision for osteoporosis within countries and between countries within the EU 27+2. The scorecard is not intended as a prescriptive template. Thus, it does not set performance targets but may serve as a guide to the performance targets at which to aim in order to deliver the outcomes required.
Acknowledgements
SCOPE was supported by an unrestricted grant from Amgen to the International Osteoporosis Foundation (IOF). Amgen was neither involved in the design nor writing of the report. We are grateful to Anastasia Soulié Mlotek and Dominique Pierroz of the IOF for their help in the administration of SCOPE. We acknowledge the valuable assistance of the Italian Society for Osteoporosis, Mineral Metabolism and Bone Diseases (SIOMMMS). The report has been reviewed by the members of the SCOPE Consultation Panel and the relevant IOF National societies, and we are grateful for their local insights on the management of osteoporosis in each country. The source document has been reviewed and endorsed by the Committee of Scientific Advisors of the IOF and benefitted from their feedback.
References
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