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.

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.

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.

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.

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.

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.

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.

LanroNET - A Non-Interventional Prospective Study to Assess the Resource Utilisation and Cost of Lanreotide Autogel 120 mg in the Population of Polish Patients with Symptomatic Neuroendocrine Tumours.

Wstep: Celem badania LanroNET byla ocena wykorzystania zasobów medycznych oraz kosztów objawowego leczenia polskich chorych na nowotwory neuroendokrynne z zastosowaniem lanreotydu autogel 120 mg. Material i metody: LanroNET to wieloosrodkowe, nieinterwencyjne, obserwacyjne, prospektywne badanie przeprowadzone w 12 osrod-kach w Polsce. W badaniu uczestniczyli dorosli chorzy na wydzielajace nowotwory neuroendokrynne leczeni lanreotydem autogel 120 mg od przynajmniej 3 miesiecy przed wlaczeniem do badania. Podczas 24-miesiecznej obserwacji rzeczywistej praktyki klinicznej zbierano dane dotyczace wykorzystania zasobów medycznych oraz przebiegu terapii chorych z wydzielajacymi nowotworami neuroendokrynnymi. WYNIKI: W badaniu uczestniczylo 54 chorych na wydzielajace nowotwory neuroendokrynne. Przecietny czas stosowania lanreotydu wynosil 1,7 roku (zakres 0,0-2,2 lata). Badanie ukonczylo 33 pacjentów, najczestsza przyczyna przedwczesnego zakonczenia leczenia (8/16) byla progresja choroby. Calkowity sredni koszt wykorzystanych zasobów bez kosztów farmakoterapii oszacowano na 26 307 zl/EUR 6.030,35 na pacjenta/rok. W czasie badania sredni odstep miedzy wstrzyknieciami lanreotydu wynosil 31,7 dni (6,7). Pod koniec obserwacji, po 24 miesiacach od follow-up, 7 pacjentów stosowalo 42-dniowe odstepy miedzy dawkami. Sredni rzeczywisty koszt lanreotydu autogel 120 mg wyniósl 4216,30 zl/966,49 EUR na pacjenta/28 dni we wspólnej perspektywie platnika i pacjenta i byl nizszy o 554,16 zl/127,02 EUR niz koszt stosowania standardowych 28-dniowych odstepów miedzy dawkami. WNIOSKI: Badanie LanroNET jest pierwszym w Polsce obserwacyjnym dwuletnim badaniem chorych na czynne hormonalnie nowotwo-ry neuroendokrynne zoladkowo-jelitowo-trzustkowe oceniajacym koszty codziennej praktyki klinicznej i koszty leczenia lanreotydem autogel.

An ecological study of the link between the risk of most frequent types of cancer in Poland and socioeconomic variables.

OBJECTIVES: To assess the link between the risks of most frequent cancer sites in Poland and selected socioeconomic variables that potentially affect health outcomes throughout the life course. METHODS: This is a cross-sectional ecological study. Incidence of lung, breast, and colon cancer by voivodeships in 2014 was calculated based on Polish National Cancer Registry. Socioeconomic variables in individual voivodeships were assessed based on Polish Social Cohesion Survey for 2015. Spearman's rank correlation coefficient was used to test the association of incidence rates and socioeconomic variables. The significance level was set at p < 0.05 (two-tailed tests). RESULTS: Statistically significant negative correlation exists between: (1) friend-/neighbour-based social capital and colon and breast cancer, (2) association-based social capital and lung cancer, (3) high religiousness and lung and breast cancer, and (4) income poverty and breast cancer. Statistically significant positive correlation exists between: (1) social isolation, living conditions poverty, poverty resulting from the lack of budget balance, and lung cancer; (2) low/no involvement in religious activity and lung and breast cancer. CONCLUSIONS: Our findings support public health concerns over the implication of socioeconomic environment for cancer.

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.

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.

Drug-class-specific changes in the volume and cost of antidiabetic medications in Poland between 2012 and 2015.

AIM: to investigate the drug-class-specific changes in the volume and cost of antidiabetic medications in Poland in 2012-2015. METHODS: This retrospective analysis was conducted based on the National Health Fund database covering an entire Polish population. The volume of antidiabetic medications is reported according to ATC/DDD methodology, costs-in current international dollars, based on purchasing power parity. RESULTS: During a 4-year observational period the number of patients, consumption of antidiabetic drugs and costs increased by 17%, 21% and 20%, respectively. Biguanides are the basic diabetes medication with a 39% market share. The insulin market is still dominated by human insulins, new antidiabetics (incretins, thiazolidinediones) are practically absent. Insulins had the largest share in diabetes medications expenditures (67% in 2015). The increase in antidiabetic medications costs over the analysed period of time was mainly caused by the increased use of insulin analogues. CONCLUSIONS: The observed tendencies correspond to the evidence-based HTA recommendations. The reimbursement status, the ratio of cost to clinical outcomes and data on the long-term safety have a deciding impact on how a drug is used.

Precision medicine for managing chronic diseases.

Precision medicine (PM) is an important modern paradigm for combining new types of metrics with big medical datasets to create prediction models for prevention, diagnosis, and specific therapy of chronic diseases. The aim of this paper was to differentiate PM from personalized medicine, to show potential benefits of PM for managing chronic diseases, and to define problems with implementation of PM into clinical practice. PM strategies in chronic airway diseases, diabetes, and cardiovascular diseases show that the key to developing PM is the addition of big datasets to the course of individually profiling diseases and patients. Integration of PM into clinical practice requires the reengineering of the health care infrastructure by incorporating necessary tools for clinicians and patients to enable data collection and analysis, interpretation of the results, as well as to facilitate treatment choices based on new understanding of biological pathways. The size of datasets and their large variability pose a considerable technical and statistical challenge. The potential benefits of using PM are as follows: 1) broader possibilities for physicians to use the achievements of genomics, proteomics, metabolomics, and other "omics" disciplines in routine clinical practice; 2) better understanding of the pathogenesis and epidemiology of diseases; 3) a revised approach to prevention, diagnosis, and treatment of chronic diseases; 4) better integration of electronic medical records as well as data from sensors and software applications in an interactive network of knowledge aimed at improving the modelling and testing of therapeutic and preventative strategies, stimulating further research, and spreading information to the general public.

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.

Effects of genetic polymorphisms of glutathione S-transferase genes (GSTM1, GSTT1, GSTP1) on the risk of diabetic nephropathy: a meta-analysis.

INTRODUCTION: Glutathione S-transferases (GSTs) belong to a family of ubiquitous and multifunctional enzymes that protect the cells against oxidative stress. OBJECTIVES: The aim of the study was to evaluate the association between the polymorphisms of glutathione-S-transferase (GST) genes and diabetic nephropathy (DN). PATIENTS AND METHODS: PubMed, EMBASE, and Google Scholar databases were systematically searched to identify relevant studies. The odds ratio (OR) for the association was determined using a fixed or random effects model. Tests for heterogeneity of the results and sensitivity analyses were performed. RESULTS: A total of 9 publications (874 patients in the study group, 966 controls) were included. With the exception of 1 study, GSTT1 and GSTM1 genotypes were not assessed by methods that measure a gene copy number. A significantly increased risk of DN was found for the GSTM1(-) genotype (OR, 1.27; 95% CI, 1.02-1.58) and the combination of GSTT1(-)/GSTM1(-) (OR,2.02; 95% CI, 1.22-3.36). We did not observe a correlation between DN and the GSTT1(-) genotype or the presence of Val alleles. In a subgroup analysis, an association between DN and the GSTM1(-) genotype was significant in Asians but not in Caucasians. CONCLUSIONS: Our results indicate that the GSTM1(-) genotype and the combination of GSTT1(-)/GSTM1(-) increase the risk of DN. The combination of the GST polymorphisms rather than individual polymorphismshould be investigated. Genotyping allowing a trimodular determination of the GST copy number variations may better describe an association between the risk of disease and a given genotype.

Dosage and costs of lanreotide Autogel 120 mg administered as part of routine acromegaly care in Poland - two years of data from Lanro-Study.

INTRODUCTION: To evaluate, over 24 months of prospective follow-up, the dosage and costs of lanreotide AUTOGEL 120 mg (ATG120) administered as part of routine acromegaly care in Poland. MATERIAL AND METHODS: A multicentre, non-interventional, observational prospective study on resource utilisation in Polish acromegalic patients treated with ATG120 at 4-week or extended (> 4 weeks) dosing interval. The study population consisted of adult acromegalic patients treated for at least 3 injections of ATG120. The endpoints were: percentage of patients treated with ATG120 at an extended dosing interval (> 4 weeks), mean time between injections, and the cost of ATG120 during a 24-month prospective observation. Costs were calculated in PLN from the public health-care payer and patient perspective for the year 2014. RESULTS: 143 patients were enrolled in, and 132 completed (70% women, 81% macroadenoma, 75% previous surgery) the analysis. During two years, changes in the treatment pattern were reported in 41 patients: 17% of them had increased injection interval and 10% switched to octreotide LAR and then returned to ATG120. Sixty-three patients (48%) received ATG120 at an extended dosing interval. ATG120 was predominantly administered in an out-patient setting (84%) by a health care professional (97%). CONCLUSIONS: The results demonstrated that extended dosing interval of ATG120 is used in a substantial proportion of patients in routine clinical practice in Poland. Such findings support the potential for ATG120 in reducing treatment burden in the real-world clinical environment.

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.