Fanni Rencz

Health technology assessment in Poland, the Czech Republic, Hungary, Romania and Bulgaria

This paper describes and discusses the development and use of health technology assessment (HTA) in five Central and Eastern European countries (CEE): Poland, the Czech Republic, Hungary, Romania and Bulgaria. It provides a general snapshot of HTA policies in the selected CEE countries to date by focusing on country case-studies based on document analysis and expert opinion. It offers an overview of similarities and differences between the individual CEE countries and discusses in detail the role of HTA by assessing its formalization and institutionalization, standardization of methodology, the use of HTA in practice and the degree of professionalization of HTA in the region. It finds that HTA has been to some extent implemented in all five countries studied, with methodologies in accordance with international standards, but that challenges remain when it comes to the role of HTA in health care decision-making as well as to human resource capacities of the countries. This paper suggests that coming years will show whether CEE countries develop adequate national analytical capacity to assess and appraise technologies in the context of local need and affordability, instead of using HTA as a mere administrative procedure to fulfill (inter)national requirements. Finally, suggestions are provided to strengthen HTA in CEE countries through cooperation, mutual learning, a common accreditation of HTA bodies and increased network building among CEE HTA experts.

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.

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.

Treatment preferences of originator versus biosimilar drugs in Crohn’s disease; discrete choice experiment among gastroenterologists

Abstract Objective. To explore preferences of gastroenterologists for biosimilar drugs in Crohn’s disease. Material and methods. Discrete choice experiment was carried out involving 51 Hungarian gastroenterologists in May 2014. The following attributes were used to describe hypothetical choice sets: 1) type of the treatment (biosimilar/originator), 2) severity of disease, 3) availability of continuous medicine supply, 4) frequency of the efficacy check-ups. Multinomial logit model was used to differentiate between three attitude types: 1) always opting for the originator, 2) willing to consider biosimilar for biological-naïve patients only, 3) willing to consider biosimilar treatment for both types of patients. Conditional logit model was used to estimate the probabilities of choosing a given profile. Results. Men, senior consultants, working in inflammatory bowel disease center and treating more patients were more likely willing to consider biosimilar for biological-naïve patients only. Treatment type (originator/biosimilar) was the most important determinant of choice for patients already treated with biologicals, and the availability of continuous medicine supply in case of biological-naïve patients. The probabilities of choosing the biosimilar with all the benefits offered over the originator under current reimbursement conditions are 89% versus 11% for new patients, and 44% versus 56% for patients already treated with biological. Conclusions. For gastroenterologist, the continuous medical supply would be one of the major benefits of biosimilars. However, benefits offered in the scenarios do not compensate for the change from the originator to the biosimilar treatment of patients already treated with biologicals.

Use of biologics for psoriasis in Central and Eastern European countries.

To evaluate the use of biological agents for the treatment of psoriasis and to explore country‐specific differences within six Central and Eastern European (CEE) countries, namely Bulgaria, Croatia, the Czech Republic, Hungary, Poland and Romania.

Alopecia areata and health-related quality of life: a systematic review and meta-analysis

No systematic review has yet evaluated the available evidence on health‐related quality of life (HRQOL) in alopecia areata (AA).

Patients’ access to biological therapy in chronic inflammatory conditions; per capita GDP does not explain the intercountry differences

Biological agents revolutionised the treatment of chronic inflammatory diseases such as rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA) as well as Crohns disease (CD), ulcerative colitis (UC) and psoriasis. RA studies highlighted that uptake of biologic drugs varies strongly across Europe and the income of a country is considered as a major determinant factor for usage.1–3 Putrik et al 4 ,5 found that access to biologics in RA—expressed as a composite score of availability, affordability and acceptability—showed a strong positive correlation with gross domestic product (GDP)/capita (r=0.86) in Europe. Much less is known on this topic in AS, PsA and the other three inflammatory diseases. We analysed real-world biologic usage data and their relationships with GDP/capita in the six inflammatory conditions in Bulgaria, the Czech Republic, Hungary, Poland, Romania and Slovakia. According to our previous literature search, there is no precise and comparable country-specific prevalence data in this region.6–8 Therefore, we estimated the biologic treatment rates per 100 000 inhabitants. Considering the total of six diagnoses, …

The Rituximab Biosimilar CT-P10 in Rheumatology and Cancer: A Budget Impact Analysis in 28 European Countries

AbstractIntroductionNew biosimilars of monoclonal antibodies are anticipated to bring significant cost savings and increase access to treatment. The rituximab biosimilar CT-P10 has recently been approved in Europe in all indications held by reference rituximab (RTX), including rheumatoid arthritis, non-Hodgkin’s lymphoma, and chronic lymphocytic leukemia. We analyzed the budgetary impact of the introduction of CT-P10 into the European Union (EU) for use in patients with rheumatoid arthritis and cancer diagnoses, using a budget impact analysis model.MethodsThe model used a base case scenario in which the 1-year uptake of CT-P10 was estimated at 30%, and the cost of CT-P10 was assumed to be 70% of the cost of RTX. A second 1-year scenario was also modeled, in which the market share of CT-P10 was assumed to be 50% (scenario 2). Finally, 3-year time horizon outcomes were calculated, in which the market share of CT-P10 was assumed to be 30%, 40%, and 50% in the first, second, and third years, respectively.ResultsIn the base case scenario, the introduction of CT-P10 was associated with projected savings of €90.04 million in the first year, which would allow 7531 additional patients to access rituximab treatment. This was equivalent to a 6.4% increase in the number of rituximab-treated patients. In scenario 2, budget savings were €150.10 million, with a total of 12,551 additional patients able to access rituximab, equivalent to a 10.7% increase. Over a 3-year time horizon, projected budget savings were approximately €570 million, equating to 47,695 additional patients able to access rituximab.ConclusionsThe model predicted that the introduction of CT-P10 in the EU will be associated with significant budget savings, the reallocation of which will enable many more patients to access rituximab treatment. This is likely to have a significant impact on health gains at patient and societal levels. Funding: CELLTRION Healthcare Co., Ltd. sponsored the development and analysis of the budget impact analysis model.

Moderate to severe psoriasis patients' subjective future expectations regarding health‐related quality of life and longevity

Unrealistic expectations regarding treatments and clinical outcomes may lead to disappointment about therapy and sub‐optimal compliance; nonetheless, these expectations have not been studied in psoriasis patients yet.

Health-related quality of life and its determinants in pemphigus: a systematic review and meta-analysis

DEAR EDITOR, The growing interest in exploring the impact of pemphigus on health-related quality of life (HRQoL) is reflected in the increasing number of studies in the area. Two reviews can be found in the literature on HRQoL impairment related to pemphigus; however, neither of them applied a systematic search strategy or meta-analysis. Also, the latest study included was published in 2009. Therefore, the objectives of this paper were to perform a systematic review of the literature on HRQoL in pemphigus, to perform a meta-analysis on the most frequently used instruments, and to identify the possible determinants of HRQoL. We searched in Ovid Medline, Embase, Web of Science, CINAHL, PsycINFO and the Cochrane Library up to 6 October 2014. The search strategy included a combination of terms related to pemphigus, general HRQoL and the names of generic and dermatology-specific instruments. No language limits were applied. Eligible studies were screened by two independent reviewers (F.R. and V.B.), and references were also tracked. Inclusion criteria were (i) the study population included adult patients with pemphigus; (ii) the study reported HRQoL of pemphigus assessed by any instrument (not aggregated results for a group of skin diseases); and (iii) publications were original articles. For all studies the following data were extracted: patient characteristics (sample size, pemphigus type, mean age, disease duration, sex ratio, current therapy and geographical location), applied HRQoL instruments and HRQoL scores. Determinants of general or dermatology-specific HRQoL analysed statistically in the studies were retrieved. For meta-analysis, the number of patients and mean HRQoL scores and SDs were extracted, and 95% confidence intervals (CIs) were calculated. Meta-analysis was performed on Dermatology Life Quality Index (DLQI) total scores or individual domains of HRQoL instruments, on which results were reported in at least three separate studies including patients of similar characteristics. Where significant heterogeneity was detected between studies (Cochran’s Q P < 0 01 or I > 50%), random-effects meta-analysis (inverse-variance method) was applied; otherwise the fixed-effects approach was employed. Sixteen studies from eight different countries were identified assessing HRQoL in 1465 patients with pemphigus with eight different instruments (Table 1). Our systematic search strategy yielded nine further papers published since the former reviews, and two additional studies that were not included in the earlier reviews despite being published before 2009. There were 11 cross-sectional studies, four case–control studies and a prospective cohort with a 4-month follow-up period. The patient populations varied between seven and 380, with only five studies enrolling > 100 participants. Four different generic measures were used: Short Form-36 (SF-36), Activities of Daily Living, World Health Organization Quality of Life-BREF and World Health Organization Disability Assessment Schedule 2.0. Four types of dermatologyor oraldisease-specific tools were applied: DLQI, Skindex-29, Skindex-17 and Chronic Oral Mucosal Diseases Questionnaire. The most frequently used measures were SF-36 (eight of 16), DLQI (five of 16) and Skindex-29 (four of 16). The meta-analysis showed the highest deterioration in the role-physical dimension of SF-36 (38 1, 95% CI 20 4–55 9), followed by role-emotional (47 5, 95% CI 21 9–73 2) and vitality (50 7, 95% CI 43 6–57 7) (Fig. 1a). The mean total DLQI score of patients with pemphigus ranged from 4 0 to 13 8. Newly diagnosed or untreated patients scored on average 12 0 (95% CI 11 1–12 9) (Fig. 1b). The greatest impairments were reported in the symptoms and feelings, and daily activities dimensions of DLQI (2 8–3 0 and 1 9–2 2, respectively). The meta-analysis indicated similar mean scores in the symptoms (35 8, 95% CI 32 7–38 9) and emotions (36 5, 95% CI 33 8–39 2) domains of Skindex-29, whereas they were slightly lower for social functioning (32 8, 95% CI 29 9–35 6) (Fig. 1c). Overall, 41 possible determinants of HRQoL were identified (Table S1; see Supporting Information), of which reduced HRQoL was clearly associated with higher disease severity, anxiety and depression in at least two separate studies. However, the impact of several factors on HRQoL, such as age, sex, type of pemphigus, disease duration, mucocutaneous involvement, clinical activity, itching, skin burning or being treated by adjuvant drugs, cannot be clearly stated. This paper provides the first systematic review and metaanalysis of HRQoL studies in pemphigus. The various HRQoL instruments applied, the different sample sizes and the geographical locations hinder the comparison of the 16 studies. Only five studies used both generic and dermatology-specific measures. The eight different tools capture different aspects of HRQoL and yet do not necessarily explore all the