Márta Péntek

Epidemiology of osteoporosis related fractures in Hungary from the nationwide health insurance database, 1999-2003

SummaryThe Hungarian national health insurance database was screened for fractures of patients aged 50–100, 1999–2003. On average, there were 343 hip, 1,579 forearm, 342 proximal humerus, 48 inpatient vertebral and 2,459 other fractures/100,000 inhabitants/year.IntroductionThe incidence of fractures differs among populations. Our aim was to study the incidence of fractures in Hungary, focusing on classical osteoporotic sites and to compare the results with those of other European countries.MethodsThe Hungarian National Health Insurance Fund database, covering 100% of the population, was screened for fractures of patients aged 50–100, 1999–2003. The search of vertebral fractures was restricted to those admitted to hospital. A gender and age-matched comparison was performed with available data from Europe.ResultsThere were mean 343 hip, 1,579 forearm, 342 proximal humerus, 48 inpatient vertebral and 2,459 other fractures/100,000 inhabitants/year; the female/male ratio was between 1.2–2.4. Multiple fractures occurred in 23.1% of the cases. Hip fracture incidence in Hungary lies between the rates of northern and southern countries of Europe.ConclusionsOur study offers nationwide epidemiological data on fractures in Hungary. The incidence of fractures increased by age, regardless of the type of fracture. Incidence of hip fractures in Hungary fits in the previously established geographic trends in Europe. Our results fulfil a need for fracture data from Central Europe.

Adherence to biologic DMARD therapies in rheumatoid arthritis

Importance of the field: The efficacy of the biologic disease-modifying antirheumatic drugs (DMARDs) shown in clinical trials may be jeopardized due to prevalent poor patient adherence. Areas covered in this review: Patient adherence including compliance and persistence with biologic DMARDs in rheumatoid arthritis. What the reader will gain: This is a comprehensive review of the literature. The various definitions and methodologies of measurement used in adherence research are reviewed and data are presented by separating compliance and persistence. Differences in compliance rates were mainly based on numerical trends. There was evidence for and against greater persistence with infliximab versus adalimumab and etanercept. There was a trend in favour of greater compliance and lower persistence with TNF-α inhibitor monotherapy versus in combination therapy with methotrexate. Take home message: The evidence suggests that adherence to biologic DMARDs is suboptimal. When further research is applied in the field, agreed definitions and methodology need to be used to allow for cross-study comparisons. In addition, adherence should be assessed in conjunction with clinical outcomes and not on its own so that it can be better understood what levels of adherence provide the required clinical outcomes.

Delphi approach to select rare diseases for a European representative survey. The BURQOL-RD study

OBJECTIVES The BURQOL-RD project is intended to develop a disease based model capable of quantifying the socio-economic burden and health-related quality of life for patients with rare diseases (RDs) and their caregivers in Europe. We described the methodology used to select a set of 10 RDs to be approached in a pilot study. METHODS BURQOL-RD project includes 23 partners from 8 European countries: Spain, UK, France, Germany, Sweden, Italy, Hungary and Bulgaria. A two-round Delphi panels in combination with Carroll diagram was used to generate consensus in the selection of the 10 RDs among the project participants. RESULTS The two Delphi rounds yielded a prioritised list, to which the Carroll diagram was applied, taking into account three determinants: prevalence, availability of effective treatment and need for carer. The final set of RD to be studied was obtained: cystic fibrosis, Prader-Willi syndrome, haemophilia, duchenne muscular dystrophy, epidermolysis bullosa, fragile X syndrome, scleroderma, mucopolysaccharidosis, juvenile idiopathic arthritis and histiocytosis. CONCLUSIONS This methodology permitted the generation of an equilibrated set of RDs for the pilot study of BURQOL-RD project. The model will be suitable for application in a wide range of RDs.

Biosimilars for the management of rheumatoid arthritis: Economic considerations

Biologic drugs have proved highly effective for the treatment of immune-mediated inflammatory diseases such as rheumatoid arthritis (RA). These drugs are often considered cost-effective for well-defined RA patient populations not responding adequately to conventional treatment, but are used first-line relatively rarely, partly due to high costs. Furthermore, not all clinically eligible patients can access biologics even as second-line therapy. Recently, there has been a rise in interest in ‘biosimilar’ drugs that are highly comparable to the ‘reference medicinal product’ (RMP) in terms of efficacy and safety but may generally be lower in price. This review summarizes the cost burden of RA and considers the potential role of biosimilars in reducing drug costs and increasing patient access to biologics.

Biological therapy in inflammatory bowel diseases: access in Central and Eastern Europe.

Biological drugs opened up new horizons in the management of inflammatory bowel diseases (IBD). This study focuses on access to biological therapy in IBD patients across 9 selected Central and Eastern European (CEE) countries, namely Bulgaria, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania and Slovakia. Literature data on the epidemiology and disease burden of IBD in CEE countries was systematically reviewed. Moreover, we provide an estimation on prevalence of IBD as well as biological treatment rates. In all countries with the exception of Romania, lower biological treatment rates were observed in ulcerative colitis (UC) compared to Crohns disease despite the higher prevalence of UC. Great heterogeneity (up to 96-fold) was found in access to biologicals across the CEE countries. Poland, Bulgaria, Romania and the Baltic States are lagging behind Hungary, Slovakia and the Czech Republic in their access to biologicals. Variations of reimbursement policy may be one of the factors explaining the differences to a certain extent in Bulgaria, Latvia, Lithuania, and Poland, but association with other possible determinants (differences in prevalence and incidence, price of biologicals, total expenditure on health, geographical access, and cost-effectiveness results) was not proven. We assume, nevertheless, that health deterioration linked to IBD might be valued differently against other systemic inflammatory conditions in distinct countries and which may contribute to the immense diversity in the utilization of biological drugs for IBD. In conclusion, access to biologicals varies widely among CEE countries and this difference cannot be explained by epidemiological factors, drug prices or total health expenditure. Changes in reimbursement policy could contribute to better access to biologicals in some countries.

Cost-of-illness of patients with systemic sclerosis in a tertiary care centre

OBJECTIVE The aim of our study was to assess the costs of SSc and to analyse cost drivers. METHODS A cross-sectional survey of consecutive patients with SSc was performed in a rheumatology centre in Hungary. Clinical characteristics, the European Scleroderma Study Group activity index, disease severity scale (DSS), scleroderma HAQ (S-HAQ) and health care utilization were recorded. Cost calculation was performed and correlation with clinical variables was analysed. Results were compared with RA and PsA. RESULTS Eighty patients were involved: 72 (90%) women, mean age (s.d.) 57.4 (9.6) years and disease duration of 6.2 (6.6) years and 25% of the cases had dcSSc. Mean total cost was 9619 (s.d. 6444) euros/patient/year with rate of indirect cost being 56%. Disability-related productivity loss (55.2%) and hospitalization (28.3%) were the highest among the cost items. Patients with dcSSc had significantly higher direct costs (P = 0.005) compared with the lcSSc subset. Disease activity showed significant correlation with total costs, DSS and S-HAQ with direct costs. SSc-related costs were higher than in matched RA and PsA cases. CONCLUSIONS The cost-of-illness of SSc is high with a dominance of productivity loss related costs. Moreover, the disease activity is an important cost driver.

Comparison of the Psoriatic Arthritis Quality of Life (PsAQoL) questionnaire, the functional status (HAQ) and utility (EQ-5D) measures in psoriatic arthritis: results from a cross-sectional survey

Objectives: To compare the Psoriatic Arthritis Quality of Life (PsAQoL) instrument, the Health Assessment Questionnaire (HAQ) as a measure of functional status, and the generic health status (utility) measure the EuroQoL (EQ-5D) in terms of ability to assess disease severity in psoriatic arthritis (PsA). Methods: The differences between known groups and correlations of the PsAQoL, the HAQ and the EQ-5D with clinical measures were analysed in a sample of 183 PsA patients. Results: Different severities of PsA determined by known groups were distinguished well by all three questionnaires; more severe disease was associated with significantly worse values of the instruments. The correlations revealed a strong relationship between each of the measures, and with the patients’ pain on the visual analogue scale (VAS), the patient global VAS, and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and a weak relationship with the disease duration and the Psoriasis Area Severity Index (PASI). The PsAQoL also correlated strongly with the 28-joint Disease Activity Score (DAS28). Conclusions: The PsAQoL, the HAQ, and the EQ-5D are able to distinguish well across levels of PsA severity.

A budget impact model for biosimilar infliximab in Crohn’s disease in Bulgaria, the Czech Republic, Hungary, Poland, Romania, and Slovakia

Objectives: To estimate the budget impact of the introduction of biosimilar infliximab for the treatment of Crohn’s disease (CD) in Bulgaria, the Czech Republic, Hungary, Poland, Romania and Slovakia. Methods: A 3-year, prevalence-based budget impact analysis for biosimilar infliximab to treat CD was developed from third-party payers’ perspective. The model included various scenarios depending on whether interchanging originator infliximab with biosimilar infliximab was allowed or not. Results: Total cost savings achieved in biosimilar scenario 1 (interchanging not allowed) and BSc2 (interchanging allowed in 80% of the patients) were estimated to €8.0 million and €16.9 million in the six countries. Budget savings may cover the biosimilar infliximab therapy for 722–1530 additional CD patients. Conclusions: Introduction of biosimilar infliximab to treat CD may offset the inequity in access to biological therapy for CD between Central and Eastern European countries.

Health economics and health technology assessment in Central and Eastern Europe: a dose of reality

It is an opinion widely shared, at least among health economics (HE) and health technology assessment (HTA) experts, that the need for HE and HTA is increasing due to two main factors. One is the more and more serious budget constraints of the recession, the other increasingly demanding policy makers and funders who require greater evidence for new and existing therapies. But is this really the case? Are policy makers and funders aware of the potentials and limitations of HE and HTA? If they are convinced and committed to use HE and HTA results, is there sufficient capacity at national level to provide the required HE and HTA evaluations both in terms of quantity and quality? Are these methodologies and results recognised or valued during the decision making process? More than 20 years ago, in the early 1990s when the political systems in Central and Eastern European countries changed from socialism to democracy, many of us believed that HE and HTA would spread quickly around the region. We thought HE and HTA institutions and university departments would be established and that this development would be boosted further by the pure fact of EU enlargement incorporating all new member states. We had a dream that more and more resource allocation decisions related to drug reimbursement and public health would be based on results, provided nationally, from HTA and HE. At that time we had no doubt that, due to sustainable economic growth, fresh money would be allocated to different parts of health care systems under the title of ‘‘resource allocation’’. Our methodology was set to assist decisions under this economic condition. Various projects funded by the European Commission, and worldwide (INAHTA) and European networks (EunetHTA) pushed things further. However, this dream is still sluggish in coming to fruition. Still today, the role of HE and HTA is very limited in the new member states. Only two countries, Poland and Hungary, have established HTA offices and some university departments of HE. In the following, we will see what has been achieved so far, look at possible explanations for this slow development, and discuss the main issues still waiting to be resolved.

Patients' preferences for healthcare system reforms in Hungary: A conjoint analysis

AbstractObjectives: To illustrate how conjoint analysis can be used to identify patient preferences for healthcare policies, and to measure preferences for healthcare reforms in Hungary. Data source/study setting: Data was collected via a mail-based survey and a direct survey administered in a rheumatology out-patient centre in Flór Ferenc County Hospital, Budapest, Hungary (n = 86). Study design: We designed and administered a conjoint analysis to the study population. Attributes and attribute levels were developed on the basis of key informant interviews and a literature review. Additional demographic, occupation and healthcare utilisation data were also collected using surveys. A mixed effects linear probability model was estimated holding respondent characteristics constant and correcting for clustering. Data collection: Conjoint analysis questionnaires were administered by a physician to 50 consecutive rheumatology patients in a clinic and an additional 36 were mailed by post. Principal findings: The response rate for the physician-administered survey was 98% (but 18% of these were excluded for inconsistent preferences) and 53% for the mail survey, leaving a final sample of 59. Regression results (R2 = 56.8%) indicated that patients preferred a health system that was not cost constrained (p = 0.003), was based on solidarity (p < 0.001) and where patients were empowered (p = 0.024). Further, they would choose a system with no choice of provider to avoid co-payments (p = 0.005). Conclusions: This study demonstrates that patients have clear preferences for healthcare system policy. In order to develop evidence-based healthcare policy and to empower patients in the healthcare system, methods such as conjoint analysis offer a simple yet theoretically grounded basis for policy making.