Burden of cancer in Poland analysed using potential years of life lost.

AIM OF THE STUDY: The aim was to assess the impact of the most frequent cancer-related causes of death in Poland by estimating the years of potential life lost (YPLL) and to compare different measures of the burden of cancer deaths on the population. MATERIAL AND METHODS: Mortality rate, YPLL and mean YPLL were calculated for the 11 most frequently recorded cancer-related causes of death in Poland. YPLL were measured applying the up-to-date reference life tables proposed by the Institute for Health Metrics and Evaluation and used in the Global Burden of Disease study (GBD 2015). Absolute numbers of cancer deaths by site, gender and five-year age groups were obtained from the Polish National Cancer Registry (2015). RESULTS: In 2015 the total YPLL amounted to 1,990,457, with 23.6% from lung and bronchial cancer. Mean YPLL was 19.79 years and varied considerably according to tumour site (26.12 [brain] - 14.3 [prostate]). Three tumour sites (brain, ovarian and kidney) are positioned higher according to mean YPLL than according to YPLL percentage and mortality percentage. CONCLUSIONS: Our results draw attention to the impact of cancer on society and individual patients. Addressing research efforts to prevention and/or treatment of major YPLL causes could result in a substantial impact on general life expectancy.

Analysis of the survival of patients receiving systemic treatment for melanoma of the skin: a retrospective population study with patients treated in Poland in 2011-2015.

INTRODUCTION: In Poland, it is uniquely possible to assess real effects of the introduction of new oncological therapies on the overall survival in patients as such therapies are funded by one payer only - the National Health Fund (NHF). Data collected by the NHF make it possible to analyse the survival of all patients who were diagnosed with melanoma. AIM: The paper presents findings of a retrospective analysis of the efficacy of systemic treatment in patients with malignant melanoma of the skin in Poland with regard to the overall survival. MATERIAL AND METHODS: The analysis of the overall survival was performed with the Kaplan-Meier method in the population receiving systemic treatment. Three groups of patients were analysed. Group 1 included all patients who had started systemic treatment between 1 March 2011 and 1 March 2015: 1,258 patients. The median overall survival was 8.4 months. Group 2 included 444 patients who had started systemic treatment between 1 March 2011 and 28 February 2013. The median overall survival was 6.6 months in this group. Group 3 included 814 patients who had started systemic treatment between 1 March 2013 and 1 March 2015 and included 546 patients who were also treated in drug programmes with ipilimumab and vemurafenib (approx. 67%). The median overall survival was 9.4 months. RESULTS: A difference in the overall survival between group 3 and 2 was statistically significant (p < 0.05). CONCLUSIONS: The introduction of vemurafenib and ipilimumab into systemic treatment in Poland using public funds had a significant effect on the prolongation of the overall survival in patients with malignant melanoma of the skin.

New insights into the burden and costs of multiple sclerosis in Europe: Results for Poland.

BACKGROUND: In order to estimate the value of interventions in multiple sclerosis (MS) - where lifetime costs and outcomes cannot be observed - outcome data have to be combined with costs. This requires that cost data be regularly updated. OBJECTIVE AND METHODS: This study is part of a cross-sectional retrospective study in 16 European countries collecting current data on resource consumption, work capacity, health-related quality of life (HRQoL) and prevalent symptoms for patients with MS. Descriptive analyses are presented by level of severity, from the societal perspective, in 2015 Polish Zloty (PLN). RESULTS: A total of 411 MS patients (mean age = 40 years) participated in Poland; 94% were below retirement age, and of these, 59% were employed. Employment was related to disability, and MS affected productivity for 85% of those working. Overall, 97% and 71% of patients experienced fatigue and cognition as important problems, respectively. Mean utility and total annual costs were 0.686 and 48,700 PLN at Expanded Disability Status Scale (EDSS) 0-3, 0.521 and 59,200 PLN at EDSS 4-6.5 and 0.208 and 81,600 PLN at EDSS 7-9, respectively. The average cost of a relapse was 3,900 PLN. CONCLUSION: This study illustrates the burden of MS on Polish patients and provides current data that are important for developing health policies.

ANALYSIS OF TRENDS IN LIFE EXPECTANCIES AND PER CAPITA GROSS DOMESTIC PRODUCT AS WELL AS PHARMACEUTICAL AND NON-PHARMACEUTICAL HEALTHCARE EXPENDITURES.

Life expectancy is a common measure of population health. Macro-perspective based on aggregated data makes it possible to approximate the impact of different levels of pharmaceutical expenditure on general population health status and is often used in cross-country comparisons. The aim of the study was to determine whether there are long-run relations between life expectancy, total healthcare expenditures, and pharmaceutical expenditures in OECD countries. Common trends in per capita gross domestic products (GDPs) (excluding healthcare expenditures), per capita healthcare expenditures (excluding pharmaceutical expenditures), per capita pharmaceutical expenditures, and life expectancies of women and men aged 60 and 65 were analyzed across OECD countries. Short-term effect of pharmaceutical expenditure onto life expectancy was also estimated by regressing the deviations of life expectancies from their long-term trends onto the deviations of pharmaceutical and non-pharmaceutical health expenditures, as well as GDP from their trends. The dataset was created on the basis of OECD Health Data for 34 countries and the years 1991-2010. Life expectancy variables were used as proxies for the health outcomes, whereas the pharmaceutical and healthcare expenditures represented drug and healthcare consumption, respectively. In general, both expenditures and life expectancies tended to increase in all of the analyzed countries; however, the growth rates differed across the countries. The analysis of common trends indicated the existence of common long-term trends in life expectancies and per capita GDP as well as pharmaceutical and non-pharmaceutical healthcare expenditures. However, there was no evidence that pharmaceutical expenditures provided additional information about the long-term trends in life expectancies beyond that contained in the GDP series. The analysis based on the deviations of variables from their long-term trends allowed concluding that pharmaceutical expenditures significantly influenced life expectancies in the short run. Non-pharmaceutical healthcare expenditures were found to be significant in one out of four models (for life expectancy of women aged 65), while GDPs were found to be insignificant in all four models. The results of the study indicate that there are common long-term trends in life expectancies and per capita GDP as well as pharmaceutical and non-pharmaceutical healthcare expenditures. The available data did not reveal any cause- effect relationship. Other factors, for which the systematic data were not available, may have determined the increase in life expectancy in OECD countries. Significant positive short-term relations between pharmaceutical expenditures and life expectancies in OECD countries were found. The significant short-term effect of pharmaceutical expenditures onto life expectancy means that an increase of pharmaceutical expenditures above long-term trends would lead to a temporary increase in life expectancy above its corresponding long-term trend. However, this effect would not persist as pharmaceutical expenditures and life expectancy would converge to levels determined by the long-term trends.

Budget impact analysis-principles of good practice: report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force.

BACKGROUND: Budget impact analyses (BIAs) are an essential part of a comprehensive economic assessment of a health care intervention and are increasingly required by reimbursement authorities as part of a listing or reimbursement submission. OBJECTIVES: The objective of this report was to present updated guidance on methods for those undertaking such analyses or for those reviewing the results of such analyses. This update was needed, in part, because of developments in BIA methods as well as a growing interest, particularly in emerging markets, in matters related to affordability and population health impacts of health care interventions. METHODS: The Task Force was approved by the International Society for Pharmacoeconomics and Outcomes Research Health Sciences Policy Council and appointed by its Board of Directors. Members were experienced developers or users of BIAs; worked in academia and industry and as advisors to governments; and came from several countries in North America and South America, Oceania, Asia, and Europe. The Task Force solicited comments on the drafts from a core group of external reviewers and, more broadly, from the membership of the International Society for Pharmacoeconomics and Outcomes Research. RESULTS: The Task Force recommends that the design of a BIA for a new health care intervention should take into account relevant features of the health care system, possible access restrictions, the anticipated uptake of the new intervention, and the use and effects of the current and new interventions. The key elements of a BIA include estimating the size of the eligible population, the current mix of treatments and the expected mix after the introduction of the new intervention, the cost of the treatment mixes, and any changes expected in condition-related costs. Where possible, the BIA calculations should be performed by using a simple cost calculator approach because of its ease of use for budget holders. In instances, however, in which the changes in eligible population size, disease severity mix, or treatment patterns cannot be credibly captured by using the cost calculator approach, a cohort or patient-level condition-specific model may be used to estimate the budget impact of the new intervention, accounting appropriately for those entering and leaving the eligible population over time. In either case, the BIA should use data that reflect values specific to a particular decision maker's population. Sensitivity analysis should be of alternative scenarios chosen from the perspective of the decision maker. The validation of the model should include at least face validity with decision makers and verification of the calculations. Data sources for the BIA should include published clinical trial estimates and comparator studies for the efficacy and safety of the current and new interventions as well as the decision maker's own population for the other parameter estimates, where possible. Other data sources include the use of published data, well-recognized local or national statistical information, and, in special circumstances, expert opinion. Reporting of the BIA should provide detailed information about the input parameter values and calculations at a level of detail that would allow another modeler to replicate the analysis. The outcomes of the BIA should be presented in the format of interest to health care decision makers. In a computer program, options should be provided for different categories of costs to be included or excluded from the analysis. CONCLUSIONS: We recommend a framework for the BIA, provide guidance on the acquisition and use of data, and offer a common reporting format that will promote standardization and transparency. Adherence to these good research practice principles would not necessarily supersede jurisdiction-specific BIA guidelines but may support and enhance local recommendations or serve as a starting point for payers wishing to promulgate methodology guidelines.

LanroNET, a non-interventional, prospective study to assess the resource utilization and cost of lanreotide autogel 120 mg in Polish patients with neuroendocrine tumors - results of interim analysis.

AIM OF THE STUDY: To examine characteristics and treatment patterns of symptomatic neuroendocrine tumors (NETs) patients who received lanreotide Autogel 120 mg (ATG120) administered as part of routine clinical practice. MATERIAL AND METHODS: Lanro-NET is a national, multicenter, non-interventional, observational study in the population of adult patients with symptomatic NETs treated with ATG120 for at least three months before inclusion. Data on demographic and clinical characteristics of the population, dosing interval regimen and aspects of administration were collected prospectively during 12 months. Costs were calculated from the perspective of public payer for the year 2014. RESULTS: Fifty-two patients were enrolled in the study. Primary tumors were located predominantly in gastrointestinal tract (51.2%), all tumors were metastatic. The most commonly reported disease symptoms were flushing and diarrhea (55.8% of patients). 86% of patients had undergone surgery, chemotherapy and radioisotope therapy were used in 11.6% and 46.5% of patients, respectively. During the 12-months observation 12 (28%) patients received ATG120 at an extended dosing interval (> 4 weeks), the mean number of days between injections was 31.75 (SD 6.74). The cost of ATG12 was estimated at 4273.17 PLN patient/month. In all patients ATG120 was administered by nurse, 51.6% of injections in out-patient setting, 48.4% - in hospital. CONCLUSIONS: This study presents the current use of ATG120 in the population of Polish NETs patients in a realistic clinical settings. Finding that 28% of patients could be treated with extended dose intervals supports the potential for ATG120 of reducing treatment burden.

Assessment of the dynamics of inpatient health care delivery in Poland before and throughout the COVID-19 pandemic.

A situation of emergency involving the whole population introduces changes in the dynamics of the health services that are provided. The magnitude of these shifts should be also linked to the medical speciality within which the health benefits are delivered. The aim of the paper was to identify changes in tendencies in inpatient medical service delivery during the COVID-19 pandemic by medical specialties. On the basis of a database extracted for in-patient treatment received from the public payer, a retrospective analysis was carried out. Comparing the values of the dynamics of the services provided in each medical speciality, the period before the COVID-19 pandemic was collated to the years of the pandemic (2020-2021). In the period before COVID-19, positive patient dynamics were observed in more than half of the specialities. Between 2020 and 2021, virtually all specialties reversed the trend and negative dynamics were recorded. The dynamics in 2021 indicate a process of return to the values from 2015 to 2019. Emergency situation has affected the dynamics of healthcare provision in different specialities to various extent. The most resistant to the negative impulses of the state of emergency were the areas that are strictly organisationally and financially defined (e.g. the group of "therapeutic and drug programmes").

NOS2 Polymorphism in Aspect of Left and Right-Sided Colorectal Cancer.

Background: The NOS2 gene polymorphism rs2297518 is associated with an increased level of NO, which could contribute to colorectal cancer (CRC) development. We hypothesized that the potential influence of the NOS2 gene polymorphism on cancer development may vary between right-sided and left-sided colon cancers, and rectal cancers. The aim of this study was to determine the rs2297518 polymorphism influence on colorectal cancer development with regard to tumor localization. Methods: This case-control study included 199 patients with CRC and 120 controls. The qPCR endpoint genotyping was conducted using the TaqMan® genotyping assay. Results: This study revealed significant differences in tumor characteristic and in the minor alelle A frequency in the NOS2 genotype between colorectal cancers with different localizations. The mucinous adenocarcinoma was diagnosed significantly more often in right-sided cancers than in left-sided (30.6% vs. 10.9%, p = 0.009) and rectal cancers (30.6% vs. 7.1%, p = 0.0003). The minor allele A of the NOS2 genotype was observed more frequently in right-sided cancers than in left-sided cancers (44.9% vs. 23.1%, p = 0.0137) and more frequently in rectal cancers than in left-sided cancers (40.0% vs. 23.1%, p = 0.0285). Conclusions: In conclusion, the results support the hypothesis that the SNP rs2297518 of the NOS2 gene influences colorectal cancer development with regard to tumor localization.

Assessment of real-world usage of lanreotide AUTOGEL 120 in Polish acromegalic patients - results from the prospective 12-month phase of Lanro-Study.

AIM OF THE STUDY: To assess resource utilization and costs of treatment with lanreotide AUTOGEL 120 mg (ATG120) administered as part of routine acromegaly care in Poland. MATERIAL AND METHODS: A multicentre, non-interventional, observational study on resource utilization in Polish acromegalic patients treated with ATG120 at 4 weeks or extended (> 4 weeks) dosing interval. The study recruited adult acromegalic patients treated medically for ≥ 1 year including at least 3 injections of ATG120. Data on dosing interval, aspects of administration, and resource utilization were collected prospectively during 12 months. Costs were calculated in PLN from the public health-care payer perspective for the year 2013. RESULTS: 139 patients were included in the analysis. Changes in dosing regimen were reported in 14 (9.4%) patients. Combined treatment was used in 11 (8%) patients. Seventy patients (50%) received ATG120 at an extended dosing interval; the mean number of days between injections was 35.56 (SD 8.4). ATG120 was predominantly administered in an out-patient setting (77%), by health-care professionals (94%). Mean time needed for preparation and administration was 4.33 and 1.58 min, respectively, mean product wastage - 0.13 mg. Patients were predominantly treated in an out-patient setting with 7.06 physician visits/patient/year. The most common control examinations were magnetic resonance imaging of brain and brain stem (1.36/patient/year), ultrasound of the neck (1.35/patient/year), GH (1.69/patient/year), glycaemia (1.12/patient/year), IGF-1 (0.84/patient/year), pituitary-thyroid axis hormone levels assessment (TSH-0.58/patient/year, T4-0.78/patient/year). There were 0.43 hospitalizations/patient/year. For direct medical costs estimated at PLN 50 692/patient/year the main item was the costs of ATG120 (PLN 4103.87/patient/month; 97%). The mean medical cost, excluding pharmacotherapy, was PLN 1445/patient/year (out-patient care - 49%, hospitalization - 23%, diagnostics/laboratory tests - 28%). CONCLUSIONS: These results represent the current use of ATG120 in the population of Polish acromegalic patients in a realistic clinical setting. Findings that 50% of patients could be treated with dose intervals of longer than 28 days support the potential of ATG120 to reduce the treatment burden.

Glutathione S-Transferase P1 Genetic Variant's Influence on the HbA1c Level in Type Two Diabetic Patients.

GST (glutathione S-transferases) are capable of influencing glucose homeostasis, probably through regulation of the response to oxidant stress. The aim of our study was to investigate the relationship between GSTP1 gene polymorphism and glycated hemoglobin (HbA1c) levels in type two diabetic (T2D) patients. A total of 307 T2D patients were included. Analysis of the GSTP1 gene polymorphism (rs1695) was conducted using the TaqMan qPCR method endpoint genotyping. HbA1c was determined using a COBAS 6000 autoanalyzer. A univariable linear regression and multivariable linear regression model were used to investigate the association between mean HbA1c level and GSTP1 gene polymorphism, age at T2D diagnosis, T2D duration, therapy with insulin, gender, BMI, smoking status. GSTP1 Val/Val genotype, age at T2D diagnosis, T2D duration and therapy with insulin were statistically significant contributors to HbA1c levels (p < 0.05). Multivariable regression analysis revealed that GSTP1 (Val/Val vs. Ile/Ile) was associated with higher HbA1c even after adjustment for variables that showed a statistically significant relationship with HbA1c in univariable analyses (p = 0.024). The results suggest that GSTP polymorphism may be one of the risk factors for higher HbA1c in T2D patients. Our study is limited by the relatively small sample size, cross-sectional design, and lack of inclusion of other oxidative stress-related genetic variants.

Association between Glutathione S-Transferases Gene Variants and COVID-19 Severity in Previously Vaccinated and Unvaccinated Polish Patients with Confirmed SARS-CoV-2 Infection.

As the outcome of COVID-19 is associated with oxidative stress, it is highly probable that polymorphisms of genes related to oxidative stress were associated with susceptibility and severity of COVID-19. The aim of the study was to assess the association of glutathione S-transferases (GSTs) gene polymorphisms with COVID-19 severity in previously vaccinated and unvaccinated Polish patients with confirmed SARS-CoV-2 infection. A total of 92 not vaccinated and 84 vaccinated patients hospitalized due to COVID-19 were included. The WHO COVID-19 Clinical Progression Scale was used to assess COVID-19 severity. GSTs genetic polymorphisms were assessed by appropriate PCR methods. Univariable and multivariable analyses were performed, including logistic regression analysis. GSTP1 Ile/Val genotype was found to be associated with a higher risk of developing a severe form of the disease in the population of vaccinated patients with COVID-19 (OR: 2.75; p = 0.0398). No significant association was observed for any of the assessed GST genotypes with COVID-19 disease severity in unvaccinated patients with COVID-19. In this group of patients, BMI > 25 and serum glucose level > 99 mg% statistically significantly increased the odds towards more severe COVID-19. Our results may contribute to further understanding of risk factors of severe COVID-19 and selecting patients in need of strategies focusing on oxidative stress.

[Health related quality of life and disease burden of patients with schizophrenia in Hungary]. / A szkizofreniaval elo betegek egeszseggel osszefuggo eletminosege es betegseg-terhe Magyarorszagon.

INTRODUCTION: According to the international literature disease burden of schizophrenia is substantial, however data from Eastern Central Europe is scarce. Our aim was to assess the quality of life and costs of patients with schizophrenia in Hungary. METHODS: A cross sectional questionnaire survey was performed in 3 hospital based psychiatry centres involving patients with schizophrenia. Demographics, disease severity (Clinical Global Impression, CGI), functional ability (Global Assessment of Functioning, GAF) and general health status (EQ-5D) was assessed. Health care utilisation and aids were surveyed for the past 12 months. Costing was performed from the societal perspective and human capital approach was applied. RESULTS: Altogether 78 patients (female 43.6%) were involved with a mean age of 44.2 (SD=13.1) years, disease duration was >10 years at 49 (62.8%) cases, 66 (84.6%) patients were disability pensioners. Distribution between CGI 3-4-5-6 levels were 12 (16%), 33 (43%), 21 (28%), 10 (13%) patients, respectively, mean GAF was 52.6 (SD=13.9). The average EQ-5D score was 0.64 (SD=0.3) and it was significantly worse than the age-matched general population's score in Hungary (p < 0.01). Mean yearly cost was 13 878 Euros/patient (conversion 1 Euro=280.6 HUF), the rate of direct medical,direct non-medical and indirect costs was 28.5%, 5.4% and 66.1%, respectively. Among direct costs hospitalisation and drug costs were dominant. Total cost correlates with disease severity (CGI). CONCLUSION: Schizophrenia leads to notable deterioration in health related quality of life and induce high costs to society, mainly due to the productivity loss of the patients. Nevertheless disease related costs in Hungary are lower than in economically more developed European countries. Our study offers basic data about disease burden of schizophrenia in Hungary to support clinical and health policy decision making.

Burden of COVID-19 Mortality and Morbidity in Poland in 2020.

In 2020 COVID-19 caused 41,442 deaths in Poland. We aimed to estimate the burden of COVID-19 using years of potential life lost (YPLL) and quality-adjusted years of life lost (QALYL). YPLL were calculated by multiplying the number of deaths due to COVID-19 in the analyzed age/sex group by the residual life expectancy for that group. Standard and country-specific (local) life tables were used to calculate SPYLL and LPYLL, respectively. QALYL were calculated adjusting LPYLL due to COVID-19 death by age/sex specific utility values. Deaths from COVID-19 in Poland in 2020 caused loss of 630,027 SPYLL, 436,361 LPYLL, and 270,572 QALYL. The loss was greater among men and rose with age reaching the maximum among men aged 65-69 and among women aged 70-74. Burden of COVID-19 in terms of YPLL is proportionate to external-cause deaths and was higher than the burden of disease in the respiratory system. Differential effects by sex and age indicate important heterogeneities in the mortality effects of COVID-19 and justifies policies based not only on age, but also on sex. Comparison with YPLL due to other diseases showed that mortality from COVID-19 represents a substantial burden on both society and on individuals in Poland.

Access to biologic treatment for rheumatoid arthritis in Central and Eastern European (CEE) countries.

BACKGROUND: The aim of this study was to assess and compare patients' access to biologic anti-RA drugs in selected Central and Eastern European (CEE) countries and to analyze the determinants of differences between countries. MATERIAL/METHODS: This is a multi-country survey study, based on a combination of desk research and direct contact with national RA stakeholders. Data was collected using a pre-defined questionnaire. Affordability was measured using an affordability index, calculated comparing the index of health care expenditures to the price index, using Poland as an index of 1. RESULTS: The percentage of patients on biologic treatment in 2009 was highest in Hungary (5% RA patients on biologic treatment), followed by Slovenia (4.5%), Slovakia (3.5%), Czech Republic (2.92%), Romania (2.2%), Estonia (1.8%), and Croatia, Serbia, Poland (below 1.5%). Infliximab, etanercept, adalimumab and rituximab were included in the reimbursement system in all countries, but abatacept and tocilizumab were included only in Slovakia. In Slovenia, public payer covered 75% of the price, and 25% is covered by supplementary health insurance; in Bulgaria public payer covered 50% of etanercept and adalimumab costs, and 75% of rituximab cost. In other countries, biologic drugs are reimbursed at 100%. Affordability index for biologic drugs was the lowest in Slovenia (0.4). In each country national guidelines define which patients are eligible for biologic treatment. Disease Activity Score (DAS28) of over 5.1 and failure of 2 or more disease-modifying anti-RA drugs, including methotrexate, are commonly used criteria. CONCLUSIONS: The most important factors limiting access to biologic anti-RA treatment in the CEE region are macroeconomic conditions and restrictive treatment guidelines.

Challenges in economic evaluation of new drugs: experience with rituximab in Hungary.

BACKGROUND: Implementation of a new therapy into clinical practice is a complex process. Various countries have different requirements for information but most often focus on economic evaluation, which often plays a stronger role in healthcare decision making than does clinical evidence. MATERIAL/METHODS: To identify all potential challenges in economic evaluation, the case of a new biological drug, rituximab, used to treat rheumatoid arthritis, has been taken as an example. We present methods and results of economic assessment, highlighting the specific issues that should be considered in countries with economic and health care conditions similar to those of Hungary. RESULTS: In principle, economic evaluation requires data on characteristics of target population, disease progression, treatment impact, preferences, resource utilization and unit prices. Treatment effect/relative risk reduction and clinical practice patterns (resource use) may be more generalizable, whereas prices and baseline risk need to be jurisdiction specific. In order to address issues of transferability, investments need to be made in the collection of epidemiological and demographic data, plus data on clinical practice patterns, resource use, costs and health state valuation. In Hungary this problem has been solved through conducting a well designed 255 patient cross-sectional study. CONCLUSIONS: The Hungarian example shows that there should be more investment in data collection for those parameters that are thought to differ most from place to place. Owing to the similarities between Central and Eastern Europe countries in health care systems, clinical practice patterns and economic indicators, they may be able to develop partnerships to develop relevant regional databases and registries.

Glutathione S-transferases gene polymorphism influence on the age of diabetes type 2 onset.

INTRODUCTION: Type 2 diabetes (T2D) is a multifactorial disease affecting mostly adults older than 40 years. The aim of the study was to examine GST gene polymorphism influence on the risk of T2D, especially in young adults. RESEARCH DESIGN AND METHODS: 200 diabetic patients and 221 healthy controls participated in this study. Three GST gene polymorphism have been analyzed: GSTP1 (single-nucleotide polymorphism Ile105Val), homozygous deletion of GSTT1 (null/null) and GSTM1 (null/null), using TaqMan real-time quantitative PCR. RESULTS: The distribution of examined polymorphisms was similar in patient group and control group. Statistically significant differences were demonstrated for the combination of GSTP1 Val/Val and GSTT1 null/null genotypes between patients diagnosed before 40 years of age and healthy people (12.5% vs 0.9%, p=0.016). Moreover, all three examined gene polymorphism together (GSTP1 Val/Val, GSTM1nul/null and GSTT1 null/null genotype) was observed in 12.5% of patients diagnosed before 40 years of age and in 0.5% of healthy individuals (p=0.013). CONCLUSION: In conclusion, the results suggest that GST polymorphism may be one of the risk factors for developing T2D at a younger age than the T2D population average.

Budget-impact analyses: a critical review of published studies.

This article reviews budget-impact analyses (BIAs) published to date in peer-reviewed bio-medical journals with reference to current best practice, and discusses where future research needs to be directed. Published BIAs were identified by conducting a computerized search on PubMed using the search term 'budget impact analysis'. The years covered by the search included January 2000 through November 2008. Only studies (i) named by authors as BIAs and (ii) predicting financial consequences of adoption and diffusion of a new health intervention(s) within a specific healthcare setting were included. Relevant studies were evaluated according to the checklist that focuses on issues unique to BIA, highlighting areas of agreement or dissent between published studies and methodological guidelines. A total of 34 studies met the inclusion criteria, the majority published in 2007-8. Of these, 41% were from the US, 54% were prepared for pharmaceuticals and 65% had BIA as their main aim. The published BIAs were heterogeneous in respect of methods for deriving budget-impact estimates, time horizon and population. There is fairly good agreement between published studies and methodological guidelines within the scope of perspective, comparator, cost included and data sources. Specific issues that need to be addressed and/or improved are reporting format, sensitivity analysis and discounting. The results indicate that, recently, BIAs have appeared more frequently in peer-reviewed journals, providing stimulus to development, validation and dissemination of methods. Many published studies fail to reach the desired quality, but this situation should change with good research practice principles that will help codify and clarify important issues and promote standardization and transparency. Future research needs to be directed to quality assurance of published BIAs and investment in data collection for parameters specific to BIAs.

Cost-effectiveness of somatostatin analogues in the treatment of acromegaly.

INTRODUCTION: Somatostatin analogues (SSAs) are the largest contributor to the direct medical cost of acromegaly management worldwide. The aim of this review was to identify and report available evidence on the cost-effectiveness of SSAs in the treatment of acromegaly. AREAS COVERED: A literature search on relevant papers published up to April 2018 was performed. A total of 22 eligible studies (10 full-text articles and 12 conference abstracts) conducted in 14 countries were included in the analysis. In majority of studies, modelling technique was the principal research method. EXPERT COMMENTARY: The results of cost-effectiveness analyses: 1) support published recommendations where SSAs are indicated as first-line medical treatment for patients with persistent disease after surgery or who are not eligible for surgery; 2) suggest that preoperative medical therapy with SSAs may be highly cost-effective in acromegalic patients with macroadenoma, in centres without optimal surgical results 3) indicate that in some countries pasireotide and pegvisomant appeared to be cost-effective or even dominant strategies in comparison to first-generation SSAs. The main limitation of economic evaluations was the lack of high-quality studies designed to directly compare various treatment strategies in acromegaly.

Costs and effects of secondary prevention with perindopril in stable coronary heart disease in Poland: an analysis of the EUROPA study including 1251 Polish patients.

OBJECTIVES: To estimate the long-term impact of treatment with perindopril on costs and health effects in patients with stable coronary artery disease in Poland. METHODS: The cost-effectiveness analysis was based on data from a randomized double-blind, placebo-controlled trial. A decision-tree analysis was employed, including Monte Carlo and bootstrapping techniques. This study was a sub-study of the EUROPA (European Trial on Reduction of Cardiac Events with Perindopril in Stable Coronary Artery Disease) trial (n = 12,218; mean follow-up 4.2 years). Resource use was based on data from Polish EUROPA study patients (n = 1251), while effectiveness was based on the whole EUROPA study. The health gain of perindopril in life-years was based on overall EUROPA study results, and the adapted Polish life expectancy of patients not dying during the trial. Costs were calculated in new Polish zloty (PLN), year 2003 values; euro1 = PLN4.053. Only direct healthcare costs related to cardiovascular events and medication use were studied. RESULTS: When observed mortality was combined with life expectancy beyond the end of the study, perindopril use showed a gain in life expectancy of 0.182 life-years (SD +/- 0.129) at a cost of PLN1983 (SD +/- 103) with discounting of 5% per annum on costs and no discounting on effects. This resulted in an incremental cost-effectiveness ratio (ICER) of PLN10 896 per life-year gained. The probability that the ICER for perindopril was below the threshold of PLN60 000 was 88%. The overall results were insensitive to discount rates for costs and life-years. CONCLUSIONS: Perindopril leads to a reduction in the risk of coronary events among patients with stable heart disease. When the expected improvement in life expectancy is combined with associated medical costs, there is a high probability that perindopril is cost effective, given the threshold of PLN60 000 per life-year gained.

Burden of suicide in Poland in 2012: how could it be measured and how big is it?

OBJECTIVES: The aim of our study was to estimate the health-related and economic burden of suicide in Poland in 2012 and to demonstrate the effects of using different assumptions on the disease burden estimation. METHODS: Years of life lost (YLL) were calculated by multiplying the number of deaths by the remaining life expectancy. Local expected YLL (LEYLL) and standard expected YLL (SEYLL) were computed using Polish life expectancy tables and WHO standards, respectively. In the base case analysis LEYLL and SEYLL were computed with 3.5 and 0% discount rates, respectively, and no age-weighting. Premature mortality costs were calculated using a human capital approach, with discounting at 5%, and are reported in Polish zloty (PLN) (1 euro = 4.3 PLN). The impact of applying different assumptions on base-case estimates was tested in sensitivity analyses. RESULTS: The total LEYLLs and SEYLLs due to suicide were 109,338 and 279,425, respectively, with 88% attributable to male deaths. The cost of male premature mortality (2,808,854,532 PLN) was substantially higher than for females (177,852,804 PLN). Discounting and age-weighting have a large effect on the base case estimates of LEYLLs. The greatest impact on the estimates of suicide-related premature mortality costs was due to the value of the discount rate. CONCLUSIONS: Our findings provide quantitative evidence on the burden of suicide. In our opinion each of the demonstrated methods brings something valuable to the evaluation of the impact of suicide on a given population, but LEYLLs and premature mortality costs estimated according to national guidelines have the potential to be useful for local public health policymakers.