Subjective Well-Being Population Norms and Inequalities in Hungary: A Large Cross-Sectional, Internet-Based Survey.

OBJECTIVES: This study aimed to provide subjective well-being (SWB) population norms in Hungary and explore the contribution of explanatory factors of SWB inequality among the Hungarian adult general population. METHODS: The data originated from a large representative internet-based cross-sectional survey in Hungary, which was conducted in 2020. We applied validated multi-item instruments for measuring SWB, namely Satisfaction With Life Scale (SWLS) and World Health Organization-Five Well-Being Index (WHO-5). Multiple linear regressions were used to examine the relationship between demographic-socioeconomic-health status and both well-being instruments. The concentration index (CI) was used to measure the degree of income-related inequality in well-being. RESULTS: A total of 2001 respondents were enrolled with the means ± SD WHO-5 scores and SWLS scores of 0.51 ± 0.21 and 0.51 ± 0.23, respectively. Higher household income, higher educational level, better general health status, and absence of chronic morbidity were significant positive predictors for both WHO-5 and SWLS scores. The CI of WHO-5 scores was lower than that of SWLS scores in the total sample (0.0480 vs 0.0861) and in subgroups by gender (male, 0.0584 vs 0.1035; female, 0.0302 vs 0.0726). The positive CI values implied a slight pro-rich SWB inequality in this population. The regression analyses showed a positive association of SWB with having a higher household income and a better general health status. CONCLUSIONS: This is the first representative study in Hungary to compare population norm of 2 well-being instruments and analyze well-being inequality. Slight pro-rich inequality was found consistently with both SWB measures. Our findings support the need for health and social policies that effectively tackle inequalities in Hungary.

Financial Toxicity Experiences of Patients With Cancer in Indonesia: An Interpretive Phenomenological Analysis.

OBJECTIVES: Financial toxicity (FT) is an important adverse effect of cancer. Recent systematic reviews have shown that FT may lead to treatment nonadherence and impaired health-related quality of life, both of which may adversely influence the survival rates of patients. However, less is known about how patients endure FT, particularly in low- and middle-income countries. The purpose of this study was to explore how patients with cancer experience and cope with FT in Indonesia. METHODS: Semistructured in-depth interviews were conducted to explore the experiences of Indonesian patients with cancer. Qualitative data were analyzed using interpretive phenomenological analysis approach. We purposefully recruited 8 patients undergoing active treatment (aged 27-69 years) who had been diagnosed of cancer over 5 years before and possessed health insurance at the time of diagnosis. RESULTS: We identified 2 main themes: (1) the experienced financial burden, with subthemes underinsurance, out-of-pocket nonhealthcare cancer-related costs, and negative income effect from employment disruption, and (2) the financial coping strategies, with subthemes reallocating household budget, seeking family support, rationalizing treatment decisions, and topping up insurance for family members. CONCLUSIONS: This is the first interpretive phenomenological study on FT in the literature and the first qualitative FT study in Indonesia. Our findings provide insight into the occurrence of FT and coping strategies used by Indonesian patients with cancer. The subjective experiences of patients may be considered to further improve oncology care, support the need for measurement of FT, and provide mitigation programs for patients.

Societal costs and health related quality of life in adult atopic dermatitis.

BACKGROUND: Cost-of-illness studies are widely used for healthcare decision-making in chronic conditions. Our aim was to assess the cost-of-illness of adult atopic dermatitis (AD) from the societal perspective in Hungary. METHODS: We conducted a multicentre, cross-sectional questionnaire survey between February 2018 and January 2021. Data was collected from consecutive AD patients aged ≥ 18 years and their physicians at dermatology departments in Hungary. We calculated direct and indirect costs, including costs for treatments, outpatient visits, hospital admissions, informal care, travel costs and productivity loss. To assess indirect costs, the Work Productivity and Activity Impairment (WPAI) questionnaire was used to collect data, and costs were estimated with the human capital approach. Generalized linear model was used to analyse predictors of total, direct and indirect costs. RESULTS: Altogether 218 patients completed the survey (57.8% female) with an average age of 31.3 (SD = 11.7). Patients' average Dermatology Life Quality Index (DLQI) score was 13.5 (SD = 8.5). According to Eczema Area and Severity Index (EASI) score, 2.3% (n = 5), 21.2% (n = 46), 54.4% (n = 118) and 22.1% (n = 48) had clear, mild, moderate, and severe AD, respectively. We found that the average total, direct medical, direct non-medical and indirect annual costs per patients were €4,331, €1,136, €747, and €2450, respectively, with absenteeism and presenteeism being the main cost drivers, accounting for 24% and 29% of the total cost of AD. A one-year longer disease duration led to, on average, 1.6%, and 4.2% increase in total and direct non-medical costs, respectively. Patients with worse health-related quality of life (higher DLQI score) had significantly higher total, direct medical, direct non-medical costs, and indirect costs. CONCLUSIONS: Our results indicate a substantial economic burden of AD from a societal perspective, mainly driven by productivity losses.

Comprehensive Score for Financial Toxicity and Health-Related Quality of Life in Patients With Cancer and Survivors: A Systematic Review and Meta-Analysis.

OBJECTIVES: Financial toxicity is recognized as an important adverse effect of cancer treatment that may decrease patients' health-related quality of life (HRQOL). We aim to perform a systematic review and meta-analysis on studies investigating the association of HRQOL and financial toxicity measured with the Comprehensive Score for Financial Toxicity in patients with cancer and survivors. METHODS: A systematic literature search was completed in PubMed, Web of Science, Cumulative Index to Nursing and Allied Health Literature, and PsycInfo (last update April 2022). Methodological quality of included studies was assessed using the Appraisal Tool for Cross-Sectional Studies and the Critical Appraisal Skills Program Cohort Study Checklist. Where possible, study outcomes were pooled by random-effects meta-analysis. RESULTS: Thirty-one studies were included with a combined sample of 13 481 patients and survivors with more than 25 cancer types from 9 countries. Nineteen different validated HRQOL instruments were used in these studies, with the Functional Assessment of Cancer Therapy - General (n = 9), the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (n = 5), and EQ-5D (n = 5) being the most common. All but one included studies reported that higher financial toxicity was significantly associated with worse HRQOL. Ten HRQOL domains were correlated with financial toxicity, including physical health (r = 0.34-0.66), social health (r = 0.16-0.55), mental health (r = 0.21-0.54), and daily functioning (r = 0.23-0.52). The meta-analysis indicated a moderate correlation between financial toxicity and overall HRQOL as measured by the Functional Assessment of Cancer Therapy instruments (r = 0.49, 95% confidence interval 0.44-0.54). CONCLUSIONS: This is the first systematic review and meta-analysis to summarize the literature on the association of financial toxicity and HRQOL in patients with cancer and survivors. Our findings substantiate financial toxicity as a relevant outcome of cancer care that is associated with a decline of HRQOL.

Value Set for the EQ-5D-Y-3L in Hungary.

BACKGROUND: The Hungarian health technology assessment guidelines recommend the use of the EuroQol instrument family in quality-adjusted life-year calculations. However, no national value set exists for the EQ-5D-Y-3L or any other youth-specific instrument. OBJECTIVE: This study aims to develop a national value set of the EQ-5D-Y-3L for Hungary based on preferences of the general adult population. METHODS: This study followed the international valuation protocol for the EQ-5D-Y-3L. Two independent samples, representative of the Hungarian general adult population in terms of age and sex were recruited to complete online discrete choice experiment (DCE) tasks and composite time trade-off (cTTO) tasks by computer-assisted personal interviews. Adults valued hypothetical EQ-5D-Y-3L health states considering the health of a 10-year-old child. DCE data were modelled using a mixed logit model with random-correlated coefficients. Latent DCE utility estimates were mapped onto mean observed cTTO utilities using ordinary least squares regression. RESULTS: Overall, 996 and 200 respondents completed the DCE and cTTO surveys, respectively. For each domain, the value set resulted in larger utility decrements with more severe response levels. The relative importance of domains by level 3 coefficients was as follows: having pain or discomfort > feeling worried, sad or unhappy > mobility > doing usual activities > looking after myself. Overall, 12.3% of all health states had negative utilities in the value set, with the worst health state having the lowest predicted utility of - 0.485. CONCLUSION: This study developed a national value set of the EQ-5D-Y-3L for Hungary. The value set enables to evaluate the cost utility of health technologies for children and adolescents based on societal preferences in Hungary.

Assessment of health state utilities in dermatology: an experimental time trade-off value set for the dermatology life quality index.

BACKGROUND: Dermatology Life Quality Index (DLQI) scores are used in many countries as access and reimbursement criteria for costly dermatological treatments. In this study we examined how time trade-off (TTO) utility valuations made by individuals from the general population are related to combinations of DLQI severity levels characterizing dermatologically relevant health states, with the ultimate purpose of developing a value set for the DLQI. METHODS: We used data from an online cross-sectional survey conducted in Hungary in 2020 (n = 842 after sample exclusions). Respondents were assigned to one of 18 random blocks and were asked to provide 10-year TTO valuations for the corresponding five hypothetical health states. To analyze the relationship between DLQI severity levels and utility valuations, we estimated linear, censored, ordinal, and beta regression models, complemented by two-part scalable models accommodating heterogeneity effects in respondents' valuation scale usage. Successive severity levels (0-3) of each DLQI item were represented by dummy variables. We used cross-validation methods to reduce the initial set of 30 dummy variables and improve model robustness. RESULTS: Our final, censored linear regression model with 13 dummy variables had R2 = 0.136, thus accounting for 36.9% of the incremental explanatory power of a maximal (full-information) benchmark model (R2 = 0.148) over the uni-dimensional model (R2 = 0.129). Each DLQI item was found to have a negative effect on the valuation of health states, yet this effect was largely heterogeneous across DLQI items, and the relative contribution of distinctive severity levels also varied substantially. Overall, we found that the social/interpersonal consequences of skin conditions (in the areas of social and leisure activities, work and school, close personal relationships, and sexuality) had roughly twice as large disutility impact as the physical/practical aspects. CONCLUSIONS: We have developed an experimental value set for the DLQI, which could prospectively be used for quantifying the quality-adjusted life years impact of dermatological treatments and serve as a basis for cost-effectiveness analyses. We suggest that, after validation of our main results through confirmatory studies, population-specific DLQI value sets could be developed and used for conducting cost-effectiveness analyses and developing financing guidelines in dermatological care.

Resource utilization, work productivity and costs in patients with hidradenitis suppurativa: a cost-of-illness study.

BACKGROUND: Hidradenitis suppurativa (HS) is a, chronic skin disease affecting up to 1% of the population in Europe. This study aims to assess the cost-of-illness of HS from a societal perspective in Hungary and to analyze the predictors of costs. METHODS: A multicentre, cross-sectional cost-of-illness study was performed among 200 adult HS patients. We evaluated direct medical (physician consultations, inpatient admissions, medical, and surgeries), direct non-medical (transportation and caregiving), and indirect costs (productivity loss). RESULTS: The mean annual cost-of-illness of HS was €6,791 per patient. The main cost components were productivity loss (53.3%), biological treatment (21.5%), and informal care (9.2%). Patients missed, on average, 26 and 63 days from work annually due to absenteeism and presenteeism, respectively. Male sex, more severe disease, gluteal involvement, and coexisting inflammatory bowel disease were associated with higher direct medical costs, while lower education level and worse quality-of-life outcomes predicted higher indirect costs. CONCLUSION: This is the first study to assess both direct and indirect costs in HS patients. HS imposes a substantial burden on patients and society, predominantly arising from productivity loss and biological therapy. Resource utilization data and cost-of-illness estimates provide valuable inputs into cost-effectiveness analyses of health interventions in HS.

Health utility measurement by time trade-off method in Hungary / Egészséghasznosság-mérés idoalku módszerrel Magyarországon.

Összefoglaló. Bevezetés: Az idoalku (time trade-off) egy nemzetközileg széles körben alkalmazott életminoség- és egészséghasznosság-mérési módszer. Az idoalkuval mért hasznosságértékek az egészségügyi technológiák költséghatékonysági vizsgálatakor az életminoséggel korrigált életév (quality-adjusted life year, QALY) mutatószám számítására használhatók. Kevés ismerettel rendelkezünk arról, hogy Magyarországon milyen betegségekben állnak rendelkezésre idoalkuval mért hasznosságértékek. Célkituzés: Célunk szisztematikus irodalmi áttekintés keretében összefoglalni és katalogizálni az idoalku módszerrel mért hasznosságértékeket közlo publikációkat Magyarországon. Módszer: 2020 januárjában szisztematikus folyóirat-keresést végeztünk a PubMed, Web of Science és Matarka elektronikus adatbázisokban. Beválogatási kritériumaink a következok voltak: (1) eredeti közlemények, melyek (2) idoalku módszerrel mértek hasznosságértéket, és (3) magyarországi mintán mért adatokat közöltek. Eredmények: 9 eredeti közleményt válogattunk be, amelyek összesen 7 krónikus betegségben (Crohn-betegség, idoskori maculadegeneratio, krónikus migrén, pemphigus, psoriasis, primer dysmenorrhoea és rheumatoid arthritis) 23 egészségi állapot hasznosságát határozták meg. A kutatások mintanagysága 108 és 1996 fo között alakult. Két kutatás betegcsoportokat vizsgált, ketto az általános populációt, és három vizsgálatban szerepelt mindketto. Hat kutatás használta a hagyományos idoalku valamelyik formáját, egy pedig az összetett idoalku módszert. Egy kutatásban szerepelt 'rosszabb a halálnál' válaszlehetoség. A leggyakrabban alkalmazott idotáv a standard 10 év volt (71%). Az egyes állapotok hasznosságának átlaga 0,34 (kezeletlen pemphigus vulgaris) és 0,94 (enyhe primer dysmenorrhoea) között változott. A 'non-traderek' aránya az egyes kutatásokban 0 és 29% között változott. Következtetések: Egyre több krónikus betegségben elérhetok a magyar társadalom vagy betegek preferenciáin alapuló egészséghasznosság-értékek. A hazai idoalku-vizsgálatok többsége megfelel a nemzetközi minoségi követelményeknek. Az idoalku módszer alkalmazása javasolt más krónikus állapotokban is, a felmért hasznosságértékek segíthetik az egészségügyi technológiákkal kapcsolatos finanszírozói döntéshozatalt. Orv Hetil. 2021; 162(14): 542-554. INTRODUCTION: Time trade-off (TTO) is a widely used method to assess health-related quality of life and health utilities for economic evaluations of health technologies. Little is known about the use of TTO in the Hungarian context. OBJECTIVE: To systematically summarize the existing literature on the method in Hungary. METHOD: In January 2020, we conducted a systematic literature search in three electronic databases (MEDLINE, Web of Science and the Hungarian Periodicals Table of Contents Database). Our inclusion criteria were: (1) original publications, which (2) measured utilities by using TTO, (3) from a Hungarian sample. RESULTS: Nine publications containing seven original studies were included that reported utilities for 23 different health states in seven chronic diseases (age-related macular degeneration, chronic migraine, Crohn's disease, pemphigus, primary dysmenorrhoea, psoriasis and rheumatoid arthritis). Sample sizes ranged from 108 to 1996 respondents. Two studies used general population samples, another two used patient groups and three studies used both. Six studies used a form of conventional TTO and one used composite TTO method. The most frequent timeframe was 10 years (71%). The lowest mean utility was 0.34 (uncontrolled pemphigus vulgaris), while the highest was 0.94 (mild primary dysmenorrhoea). The overall proportion of non-traders ranged between 0 and 29% across studies. CONCLUSIONS: A growing number of studies are using TTO to assess utilities for chronic conditions from the general population or patients in Hungary. The majority of Hungarian TTO studies have met international quality standards. The assessment of TTO utilities is recommended also in other chronic conditions to assist health technology assessment. Orv Hetil. 2021; 162(14): 542-554.

Long-term efficacy and cost-effectiveness of infliximab as first-line treatment in rheumatoid arthritis: systematic review and meta-analysis.

Introduction: Early biological treatment of rheumatoid arthritis (RA) may reverse the autoimmune response in some patients resulting in favorable long-term outcomes. Although the cost-effectiveness of this strategy has been questioned, biosimilar entries warrant the revision of clinical and pharmaco-economic evidence. Areas covered: We conducted a systematic review of randomized controlled trials (RCTs) published up to 24 May 2018 in Pubmed, EMBASE and Cochrane CENTRAL, comparing infliximab with non-biological therapy in patients with RA naïve to methotrexate. We performed meta-analyses for efficacy outcomes at month 6 and years 1 and 2. Six RCTs were identified, involving 1832 patients. At month 6 ACR70 response and remission, and at year 1 ACR20/ACR70 responses and remission were improved significantly with first-line infliximab versus control. The differences were not significant at year 2. We reviewed cost-utility studies, up to 31 October 2018 in PubMed, Cochrane CENTRAL and the CRD HTA databases. Four studies indicated that first-line use of originator infliximab calculated at 2005-2008 prices was not cost-effective. Expert opinion: We demonstrated the efficacy benefits of first-line infliximab therapy up to 1 year in methotrexate-naïve RA. We highlighted the need for standardized reporting of outcomes and conducting cost-effectiveness analyses of first-line biosimilar therapy in RA.

Psychometric properties of the Hungarian version of the eHealth Literacy Scale.

BACKGROUND: We adapted the eHealth Literacy Scale (eHEALS) for Hungary and tested its psychometric properties on a large representative online sample of the general population. METHODS: The Hungarian version of eHEALS was developed using forward-backward translation. For the valuation study, 1000 respondents were recruited in early 2019 from a large online panel by a survey company. We tested internal consistency, test-retest reliability and construct and criterion validity using classical test theory, as well as item characteristics using an item-response theory (IRT) graded response model (GRM). RESULTS: 55% of respondents were female, and 22.1% were ≥ 65 years old. Mean eHEALS score was 29.2 (SD: 5.18). Internal consistency was good (Cronbach's α = 0.90), and test-retest reliability was moderate (intraclass correlation r = 0.64). We identified a single-factor structure by exploratory factor analysis, explaining 85% of test variance. Essential criteria for GRM analysis were met. Items 3 and 4 (search of health resources) were the least difficult, followed by items 5 and 8 (utilisation of health information), and then items 1 and 2 (awareness of health resources). Items 6 and 7 (appraisal of health resources) were most difficult. The measurement properties of eHEALS were not affected by gender, age, education or income levels. Female gender, older age, intensity of health information seeking, formal health education and visit at the electronic health-record website were associated with higher eHEALS scores, as well as best and worst self-perceived health states, BMI < 25 and participation at health screenings over the past year. CONCLUSIONS: The Hungarian eHEALS is a useful and valid tool for measuring subjective eHealth literacy.

Is the trend of increasing use of patient-reported outcome measures in medical device studies the sign of shift towards value-based purchasing in Europe?

BACKGROUND: The recent update of the European Union's (EU) regulation on public procurement has created new opportunity for progress in the purchasing of medical devices by shifting towards focus on value from one purely on price. Patient-reported outcome measures (PROMs) may serve as additional tools for manufacturers to demonstrate value beyond traditional metrics of safety and performance and to differentiate their products in a market of increasing competition. The aim of our study was to investigate the extent to which PROMs are included in registered device studies in the EU and interpret the results in the context of the purchasing of medical devices. METHODS: Twelve device groups were searched in clinical trial registries to determine the frequency distribution of PROMs in related studies. RESULTS: Results indicate that clinical studies of the selected device categories are done predominately in the western EU nations and are increasingly including PROMs. In the United Kingdom 121 (65%) study, out of 186 included PROMs, and in Germany, 92 (52%) out of 178 between 1998 and 2018. Few device studies were done in the Central and Eastern European region, and out of 76 studies 27 (35%) included PROMs. Since there is no requirement to include PROMs in device studies for regulatory purposes, it seems probable that their increasing use is driven by competitive market pressures. CONCLUSION: The trend of increasing use of PROMs might be driven by the demand of purchasers to demonstrate value of devices, but is manifested at different levels in various regions of the EU.

Cost-of-illness studies in nine Central and Eastern European countries.

BACKGROUND: To date, a multi-country review evaluating the cost-of-illness (COI) studies from the Central and Eastern European (CEE) region has not yet been published. Our main objective was to provide a general description about published COI studies from CEE. METHODS: A systematic search was performed between 1 January 2006 and 1 June 2017 in Medline, EMBASE, The Cochrane Library, CINAHL, and Web of Science to identify all relevant COI studies from nine CEE countries. COI studies reporting costs without any restrictions by age, co-morbidities, or treatment were included. Methodology, publication standards, and cost results were analysed. RESULTS: We identified 58 studies providing 83 country-specific COI results: Austria (n = 9), Bulgaria (n = 16), Croatia (n = 3), the Czech Republic (n = 10), Hungary (n = 24), Poland (n = 11), Romania (n = 3), Slovakia (n = 3), and Slovenia (n = 4). Endocrine, nutritional, and metabolic diseases (18%), neoplasms (12%), infections (11%), and neurological disorders (11%) were the most frequently studied clinical areas, and multiple sclerosis was the most commonly studied disease. Overall, 57 (98%) of the studies explicitly stated the source of resource use data, 45 (78%) the study perspective, 34 (64%) the costing method, and 24 (58%) reported at least one unit costs. Regardless of methodological differences, a positive relationship was observed between costs of diseases and countries' per capita GDP. CONCLUSIONS: Cost-of-illness studies varied considerably in terms of methodology, publication practice, and clinical areas. Due to these heterogeneities, transferability of the COI results is limited across Central and Eastern European countries.

Determinants of the acceptability of health problems in different ages: exploring a new application of the EQ VAS.

BACKGROUND: We aimed to determine the acceptability of non-perfect health states with age using the EQ VAS and analyse the influencing factors. METHODS: We conducted a cross-sectional survey on a convenience sample from the general population (N = 200). Respondents were asked to indicate on the EQ VAS the health states that are still acceptable for ages between 30 and 80 years in 10-year intervals (VAS acceptable health curve, AHCvas). We recorded respondents' current health, health-related lifestyle, demographic background and explored the reference person they imagined when evaluating acceptable health states. We evaluated the AHCvas by estimating linear multilevel models including a random intercept (estimated at age 30) and a random slope for age. RESULTS: AHCvas scores were available for 194 respondents (mean age = 42.8 years, range 19-93, 58% female). For ages of 30, 40, 50, 60, 70 and 80 years, mean AHCvas scores were 93, 87, 80, 73, 65 and 57, respectively. The decline of AHCvas was linear with age. Respondents' age, health status, lifestyle and health-related experiences, as well as their reference point taken (e.g. imagining themselves, others or both during the valuation task) influenced significantly the acceptability of health problems. CONCLUSIONS: When measured with the EQ VAS, health problems were increasingly acceptable with age. Capturing well the individual variability in the assessment of acceptable health states at different ages, the EQ VAS is a useful addition to EQ-5D-3L descriptive system-based measures of acceptable health.

Validity and reliability of the 9-item Shared Decision Making Questionnaire (SDM-Q-9) in a national survey in Hungary.

BACKGROUND: The nine-item Shared Decision Making Questionnaire (SDM-Q-9) is one of the most frequently applied instruments for assessing patients' involvement in medical decision-making. Our objectives were to develop a Hungarian version of SDM-Q-9, to evaluate its psychometric properties and to compare its performance between primary and specialised care settings. METHODS: In 2019, a sample of adults (n = 537) representative of the Hungarian general population in terms of age, gender and geographic region completed an online survey with respect to a recent health-related decision. Outcome measures included SDM-Q-9 and Control Preferences Scale-post (CPSpost). Item characteristics, internal consistency reliability and the factor structure of SDM-Q-9 were determined. RESULTS: The overall ceiling and floor effects for SDM-Q-9 total scores were 12.3% and 2.2%, respectively. An excellent internal consistency reliability (Cronbach's alpha 0.925) was demonstrated. Exploratory factor analysis resulted in a one-factor model explaining 63.5% of the variance of SDM-Q-9. A confirmatory factor analysis supported the acceptability of this model. Known-groups validity was confirmed with CPSpost categories; mean SDM-Q-9 total scores were higher in the 'Shared decision' category (72.6) compared to both 'Physician decided' (55.1, p = 0.0002) and 'Patient decided' (57.2, p = 0.0086) categories. In most aspects of validity and reliability, there was no statistically significant difference between primary and specialised care. CONCLUSIONS: The overall good measurement properties of the Hungarian SDM-Q-9 make the questionnaire suitable for use in both primary and specialised care settings. SDM-Q-9 may be useful for health policies targeting the implementation of shared decision-making and aiming to improve efficiency and quality of care in Hungary.

Subjective expectations regarding ageing: a cross-sectional online population survey in Hungary.

BACKGROUND: We aimed to investigate individuals' subjective expectations regarding health and happiness alongside their provisions on life circumstances for older ages. METHODS: A cross-sectional online survey was performed involving a representative sample (N = 1000; mean age 50.9, SD = 15.4; female 54.5%) in Hungary. Subjective expectations on health status (EQ-5D-3L/-5L, GALI, WHO-5), happiness (0-10 VAS), employment status, care time, and forms of care for ages 60, 70, 80, and 90 were surveyed. RESULTS: Current mean EQ-5D-5L was 0.869 (SD = 0.164) and happiness was 6.7 (SD = 2.4). Subjective life expectancy was 80.9 (SD = 11.1), and median expected retirement age was 65. Mean expected EQ-5D-5L for ages 60/70/80/90 was 0.761/0.684/0.554/0.402, and no activity limitations (GALI) were expected by 64%/40%/18%/14%, respectively. Expected happiness score was 6.8/6.7/6.2/5.7, and a decrease in mental well-being (WHO-5) was provisioned. A substantial increase in drug expenses and care time was anticipated, but only 52% thought to have extra income besides pension. The great majority expected to be helped by the family (77%/72%/53%/40%) if needed. Educational level, GALI, and longevity expectations were significant predictors of EQ-5D-5L expectations using a standard 5% significance level of decision. Current happiness was major determinant of expected future happiness. CONCLUSIONS: Individuals expect a significant deterioration of health with age but only a moderate decrease in happiness. Overestimation of future activity limitations suggests a gap between statistical and subjective healthy life expectancy. The majority expects to rely on informal care in the elderly. Raise in retirement age is underestimated. Our results can be used as inputs for economic modelling of labor force participation and ageing.

Biosimilars for the Management of Inflammatory Bowel Diseases: Economic Considerations.

Biological drugs revolutionized the treatment of inflammatory bowel diseases (IBD) such as Crohn's disease and ulcerative colitis. However, not all clinically eligible patients have access to biologicals due to significant costs and budget impact. Biosimilars are highly comparable to their originator product in terms of clinical efficacy and safety. Biosimilars are priced 15-75% lower than their reference product, which makes them a less costly alternative and is expected to offer better patients access to biologicals. The total projected cost savings are significant. If the achieved budget savings were used to cover more biological therapy, several additional IBD patients could be treated. Currently, the main barriers to the increasing uptake of biosimilars are the few incentives of the key stakeholders, while physicians' and patients' skepticism towards biosimilars seems to be changing. Over the coming years, biosimilars are expected to gain a growing importance in the treatment of IBD, contributing to a better access to treatment, improving population-level health gain and sustainability of health systems. This review summarizes the results of the literature on the economic considerations of biosimilars in IBD and the role of biosimilar infliximab in the treatment of IBD.

[Assessment of health-related quality of life in psoriasis patients in Hungary]. / Psoriasisban szenvedo betegek életminoségének vizsgálata Magyarországon.

INTRODUCTION: The health status and health-related quality of life (HRQoL) of patients with psoriasis in Hungary are understudied. AIM: To assess HRQoL in psoriasis patients, to compare HRQoL of psoriasis patients to that of the general public in Hungary and to identify predictors of HRQoL. METHOD: Between 2012 and 2016, two cross-sectional surveys were carried out among psoriasis patients at two academic dermatology departments. HRQoL was assessed by EQ-5D-3L, EQ Visual Analogue Scale (EQ VAS) and Dermatology Life Quality Index (DLQI). Predictors of HRQoL were analysed by multivariate linear regression. RESULTS: 434 patients were enrolled (mean age 49 years, 65% male, 81% moderate-to-severe psoriasis, 43% treated with biologics). Mean EQ-5D-3L, EQ VAS and DLQI scores were 0.74 ± 0.28, 69.06 ± 20.98 and 6.78 ± 7.38, respectively. Overall, 54%, 43%, 40%, 32% and 15% of patients indicated at least some problems in pain/discomfort, anxiety/depression, mobility, usual activities and self-care. EQ-5D-3L index scores in patients were lower compared to the age- and gender-matched general population in Hungary. The difference was statistically significant for the age groups 25-34 and 45-64 in males, and 18-64 in females (p<0.05). Female gender (p = 0.042), psoriatic arthritis (p<0.001) and palmoplantar psoriasis (p = 0.031) were associated with lower EQ-5D-3L index scores. On the contrary, employed and highly educated patients reported higher EQ-5D-3L index scores (p<0.001). CONCLUSIONS: We were the first to assess HRQoL in psoriasis patients by using EQ-5D questionnaire in Hungary, and more broadly in Central and Eastern Europe. Our findings are useful for cost-effectiveness modelling of psoriasis treatments and decision-making in healthcare. Orv Hetil. 2018; 159(21): 837-846.

Cost-effectiveness of biological treatment sequences for fistulising Crohn's disease across Europe.

BACKGROUND: In clinical practice, treatment sequences of biologicals are applied for active fistulising Crohn's disease, however underlying health economic analyses are lacking. OBJECTIVE: The purpose of this study was to analyse the cost-effectiveness of different biological sequences including infliximab, biosimilar-infliximab, adalimumab and vedolizumab in nine European countries. METHODS: A Markov model was developed to compare treatment sequences of one, two and three biologicals from the payer's perspective on a five-year time horizon. Data on effectiveness and health state utilities were obtained from the literature. Country-specific costs were considered. Calculations were performed with both official list prices and estimated real prices of biologicals. RESULTS: Biosimilar-infliximab is the most cost-effective treatment against standard care across the countries (with list prices: €34684-€72551/quality adjusted life year; with estimated real prices: €24364-€56086/quality adjusted life year). The most cost-effective two-agent sequence, except for Germany, is the biosimilar-infliximab-adalimumab therapy compared with single biosimilar-infliximab (with list prices: €58533-€133831/quality adjusted life year; with estimated prices: €45513-€105875/quality adjusted life year). The cost-effectiveness of the biosimilar-infliximab-adalimumab-vedolizumab three-agent sequence compared wit biosimilar-infliximab -adalimumab is €87214-€152901/quality adjusted life year. CONCLUSIONS: The suggested first-choice biological treatment is biosimilar-infliximab. In case of treatment failure, switching to adalimumab then to vedolizumab provides meaningful additional health gains but at increased costs. Inter-country differences in cost-effectiveness are remarkable due to significant differences in costs.

Is the DLQI appropriate for medical decision-making in psoriasis patients?

Dermatology Life Quality Index (DLQI) is the most commonly applied measure of health-related quality of life (HRQoL) in psoriasis patients. It is among defining criteria of moderate-to-severe psoriasis and present in treatment guidelines. Our objective was to estimate preference-based HRQoL values (i.e., utilities) for hypothetical health states described by the 10 items of the DLQI in psoriasis patients. Moreover, we compare results to findings of a similar study previously conducted among the general public. A cross-sectional survey was carried out among 238 psoriasis patients. Seven hypothetical DLQI-defined health states with total scores of 6, 11, and 16 (3-3 and 1 states, respectively) were evaluated by time trade-off method. The difference in DLQI scores between hypothetical health states was set at 5 points, as it exceeds the minimal clinically important difference (MCID). Utility scores were found to be homogenous across the seven hypothetical health states (range of means for the 6-point states 0.85-0.91, range of means for the 11-point states 0.83-0.85, and mean of 0.84 for the 16-point state). Overall, mean utilities assessed by psoriasis patients were higher for all seven states compared with the general public (mean difference 0.16-0.28; p < 0.001). In 11 out of the 15 comparisons between health states with DLQI scores differing larger than the MCID, there was no statistically significant difference in utility. Thus, in clinical settings, patients with DLQI scores differing more than the MCID may have identical HRQoL. Improving the definition of moderate-to-severe disease and reconsideration of the DLQI in clinical assessment of psoriasis patients are suggested.

Access to biologicals in Crohn's disease in ten European countries.

AIM: To analyze access (availability, affordability and acceptability) to biologicals for Crohn's disease (CD) in ten European countries and to explore the associations between these dimensions, the uptake of biologicals and economic development. METHODS: A questionnaire-based survey combined with desk research was carried out in May 2016. Gastroenterologists from the Czech Republic, France, Germany, Hungary, Latvia, Poland, Romania, Slovakia, Spain and Sweden were invited to participate and provide data on the availability of biologicals/biosimilars, reimbursement criteria, clinical practice and prices, and use of biologicals. An availability score was developed to evaluate the restrictiveness of eligibility and administrative criteria applied in the countries. Affordability was defined as the annual cost of treatment as a share of gross domestic product (GDP) per capita. Correlations with the uptake of biologicals, dimensions of access and GDP per capita were calculated. RESULTS: At the time of the survey, infliximab and adalimumab were reimbursed in all ten countries, and vedolizumab was reimbursed in five countries (France, Germany, Latvia, Slovakia, Sweden). Reimbursement criteria were the least strict in Sweden and Germany, and the strictest in Hungary, Poland and Slovakia. Between countries, the annual cost of different biological treatments differed 1.6-3.3-fold. Treatments were the most affordable in Sweden (13%-37% of the GDP per capita) and the least affordable in the Central and Eastern European countries, especially in Hungary (87%-124%) and Romania (141%-277%). Biosimilars made treatments more affordable by driving down the annual costs. The number of patients with CD on biologicals per 100000 population was strongly correlated with GDP per capita (0.91), although substantial differences were found in the uptake among countries with similar economic development. Correlation between the number of patients with CD on biologicals per 100000 population and the availability and affordability was also strong (-0.75, -0.69 respectively). CONCLUSION: Substantial inequalities in access to biologicals were largely associated with GDP. To explain differences in access among countries with similar development needs further research on acceptance.