Michał Marczak

Liver Cell Carcinoma in Poland: Data Reported to the National Health Fundin the Years 2008-2012

Introduction: Liver cell carcinoma includes primary malignant liver neoplasms originating from epithelial cells. Liver cell carcinoma is one of the most common cancers and is the 3rd leading cause of cancer-related mortality worldwide. However, the epidemiology and the various available treatment options have not been sufficiently studied in Poland. The aim of the present study was to assess the frequency of use of various liver cell carcinoma treatments in Poland based on data reported by service providers to the National Health Fund in the years 2008-2012. Patients and methods: Data concerning patients with liver cell carcinoma were obtained by querying the National Health Fund databases. The data were collected from the databases using SQL tools and a filter in accordance with the accepted scope of ICD-10 diagnoses. The analysis was conducted using Excel and Statistica 10. The demographic data were collected from the Central Statistical Office’s website. Results: Data on the number of patients and the type of medical services available for patients with a diagnosis of liver cell carcinoma financed by NFZ in the years 2008-2012 are described. Conclusions: The health care system in Poland does not provide liver cell carcinoma patients with rapid access to required health care services, which decreases patient survival. Treatment of advanced stage liver cell carcinoma with Sorafenib, with public payer financing, represents a real and accessible alternative treatment option for this group of patients.

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.

Regional differences in the frequency of diabetes occurrence and its treatment costs during the years 2008–2013, based on the NFZ (National Health Fund) database

In the European region in 2013 the International Diabetes Federation (IDF) estimated the number of patients with diabetes at 56 million [1]. The costs of treatment in Europe were estimated at 140 million Euro. Recently Tamayo et al., when presenting the data for Poland in the updated IDF Diabetes Atlas report, estimated the morbidity at approx. 6.5% [2]. This number was estimated based on the “Wieloośrodkowe Ogolnopolskie Badanie Stanu Zdrowia (WOBASZ)” project of 2003–2005 and earlier analyses from 1998–2001 [3]. Other studies include: Screen-Pol, Polish Multicenter Study on Diabetes Epidemiology (PMSDE) and “Nadciśnienie Tetnicze w Polsce Plus Zaburzenia Lipidowe i Cukrzyca (NATPOL-PLUS)” [4–6]. These analyses were partially local or were based on relatively small groups of patients. In 2004 the total cost of diabetes treatment in Poland was estimated at approx. PLN 6 billion [7]. High social costs of diabetes necessitate uninterrupted preventive activities, enabling the restriction of morbidity and public expenses for its treatment. The studies dedicated to regional variability of diabetes prevalence may help to identify specific risk factors and differences in management. In the region of Europe the differences of morbidity are very high, within the range from 2.4% in Moldavia up to 14.9% in Turkey [2]. In addition to the actual differences in the frequency of occurrence, they certainly are related to uneven and not fully reliable method of data calculation in individual countries [2]. Within Poland, the regional data concerning the frequency of diabetes occurrence in the years 2003–2005 ranged from 4.2% in women in Malopolska province up to 9.0% in men in Wielkopolska province [3]. Current data on regional differences may form the basis for future more detailed analyses on social, epidemiological and economic reasons for the variability of diabetes occurrence frequency in Poland.

Analysis of survival of patients treated with vemurafenib, ipilimumab and dabrafenib for advanced skin melanoma in daily clinical practice (Real-World Data): retrospective analysis of patients treated under drug/reimbursement programmes in Poland in 2013–2016

Vemurafenib, ipilimumab and dabrafenib were registered for the treatment of advanced skin melanoma pursuant to the results of randomized phase III clinical trials. Real-world data on survival time for patients treated with those drugs in daily clinical practice are so far limited. Patients with advanced skin melanoma treated under reimbursement programmes (drug programmes), for which they were qualified pursuant to uniform inclusion criteria in force in all oncology centres in Poland. Data were obtained from the electronic databases of the national payer (NFZ) responsible for the implementation and monitoring of reimbursement (drug) programmes. The analysis included all patients included for treatment with vemurafenib (since March of 2013), ipilimumab (since March of 2014) and dabrafenib (since July of 2015) until December 2016. The end date of the observation was set to 31 December 2016. The total survival analysis was performed using the Kaplan–Meier estimator. Until 31 December 2016, 759 patients were treated with vemurafenib, 370 with ipilimumab and 181 with dabrafenib. The overall survival (OS) median was 9.8 months for patients treated with vemurafenib (95% confidence interval: 8.8–10.6) and 6.9 months for patients treated with ipilimumab (95% confidence interval: 5.7–9.2). For patients treated with dabrafenib, the OS median was not reached because of an overly short observation period. The probability of surviving 12 months in the group of patients treated with vemurafenib was 40.5%, ipilimumab was 35.1% and dabrafenib was 60.7%. The probability of surviving 24 and 36 months in the group of patients treated with vemurafenib or ipilimumab amounted to, respectively, 20.1, 15.4 and 21, 18.8%. OS of patients with advanced melanoma treated in daily clinical practice may be comparable to the ones achieved in registration trials. The use of appropriate treatment inclusion criteria may affect the obtained OS.

The prevalence and direct costs of multiple sclerosis therapy in Poland from 2008 to 2016

Aim of the research: Analysis of prevalence of multiple sclerosis (MS) and direct healthcare costs of patients with MS in Poland between 2008 and 2016. Material and methods: Retrospective analysis of data on healthcare services related to the treatment of patients with MS covered by National Health Fund (NHF) in 2008-2016. The Number of patients with MS, utilization of resources, and direct medical cost were analyzed for each year in 9-year time horizon. Costs were calculated from public payer perspective and reported in EuroPPP (adjusted for purchasing power parity). Results: According to data from the NHF, the prevalence of MS in Poland was 103,06 and 113,06 per 100,000 population in 2008 and 2016, respectively. The annual growth rate of spending’s on MS (+14%) was higher than the growth rate of patients (+1.3%). In the years 2008-2016, the average expenditure per patient increased from 2,800 to 6,900 EuroPPP. The largest group of patients was treated the out-patient setting (36% specialized, 29.3% primary care); however, 84% of funds were spent on hospital care. The main drivers for hospital costs were therapeutic/drug programs, which increased from 59 million in 2008 to 233 million EuroPPP in 2016. Currently, 25% of the MS population has access to publicly funded drug programs. Conclusions: The situation of patients with MS in Poland is systematically improving. Over the past 9 years, both the public payer’s expenditure on treatment of MS patients and the number of patients participating in drug programs funded by NHF have tripled. Streszczenie Cel pracy: Ocena częstości występowania stwardnienia rozsianego (SM) oraz bezpośrednich kosztów leczenia pacjentów z SM w Polsce w latach 2008–2016. Materiał i metody: Analiza retrospektywna danych dotyczących świadczeń opieki zdrowotnej związanych z leczeniem pacjentów z SM, finansowanych przez Narodowy Fundusz Zdrowia (NFZ) w latach 2008–2016. Dynamika liczby pacjenAndrzej Jacyna, Andrzej Śliwczyński, Jarosław Stachurski et al. 10 Medical Studies/Studia Medyczne 2018; 34/

The assessment of overall survival (OS) after adjuvant chemotherapy for patients with malignant endometrial cancer in Poland

OBJECTIVES In 2013 malignant endometrial cancers have amounted to 7.3% of all cancers diagnosed among women in the report by the Polish National Cancer Registry Raw prevalence rate amounted to 28.7, whereas standardised prevalence rate 15.6 per 100 000 population. Among the causes of death, these cancers amounted to 3% and were ranked ninth on the list of the most common causes of oncologic mortality of women. In the year 2013 a total of 1243 women died of malignant endometrial cancers. A stable increase of malignant endometrial cancer incidence has been observed for 2 decades. Despite that fact, the increase of the mortality incidence is at a much lower level, which demonstrates the much higher effectiveness of the treatment of such cancers. The recording rate of the malignant endometrial cancer mortality amounts to 95%, so the presented absolute numbers are reliable. Examining the clinical stages of malignant endometrial cancers, we can establish that approx. 85% of them are diagnosed at stage I or II according to the FIGO classification. Patients with advanced stages of cancer represent less than 15%. MATERIAL AND METHODS retrospective analysis of endometrial body cancer prevalence data for the entire population of Poland, assessment of malignant endometrial cancer prevalence in the years 2008-2015 and overall survival probability in the population of patients undergoing adjuvant chemotherapy. RESULTS The number of patients with a diagnosed malignant endometrial cancer within the studied period in Poland remains on a stable level (2008 - 30.6 thousand patients, 2015 - 40.2 thousand patients). Among all listed patients with the indica-tion of C54 each year approx. 20% enters hospital treatment. System therapy with chemotherapy drugs was used in approx. 1-2% of patients treated in hospitals. The average age of the patients was 64.9 years, and the median age 65 years. The num-ber of observations was 2085, including 1088 censored observations. The average survival for the sample under study was 30.67 month (SD = ± 0.6); median survival time was 23.93 month. The number of censored observations was 1088 (52.16%). Probable survival of 1 year is achieved by 67.57% of patients, 2 years by 49.73%, 3 years by 40.68%, above 5 years 30.77%. CONCLUSIONS The incidence of endometrial cancer in Poland in the years 2008-2015 continues to grow at 5% upward trend (in Europe 3.4-5.9). In Poland in 2012, crude incidence rate for cancer of the uterus was 29.8 and did not differ significantly from the results in countries such as Finland, Slovakia, Sweden, Belgium and Bulgaria. The overall survival after adjuvant chemotherapy for patients with malignant endometrial cancer in Poland shows considerable differences depending on the region of the country.

Sequentiality of treatment in the rheumatoid arthritis drug programme in the years 2009–2014

Approximately 1% of the population suffers from rheumatoid arthritis (RA) worldwide (0.45% in Poland). The therapy consists of the use of disease-modifying antirheumatic drugs (DMARDs). Biologics are used in the form of the drug programme. Analysis of the NHF database demonstrated the sequence of conversion between drugs and time spent in a single treatment. In 2009, the patients would start the following treatments: adalimumab 5.8%; etanercept 14.4%; infliximab 23.1%; leflunomide 53.6%; rituximab 3%. After the first year 16% of patients changed therapy or abstained, and in the second year this situation affected 65% of patients. The following percentages maintained the same treatment in the last 6 years: infliximab 4%; adalimumab 15%; etanercept 21%; leflunomide on prescription was continued by 70%. Patients remain too long on the same therapy when it is inefficient. Achieving remission or low disease activity (DAS28 < 2.6) should take place within 6 months of starting therapy.

Changes in the morbidity and costs of systemic lupus erythematosus in Poland in the years 2008–2012

Objectives The goal of the article is to present the changes in morbidity and costs of systemic lupus erythematosus (SLE) in Poland in the 2008–2012 period, depending on the province of residence of the patients based on data reported to the public payer – the National Health Fund. Material and methods Based on the ICD-10 code and the patients personal identity number, the number of patients and medical costs (cost of hospitalization, pharmaceutical, medical procedures, dialysis and specialist consultations) were calculated by province (voivodeship) and urban or rural residence. Results Annually on average in the assessed period in Poland approximately 20 000 patients were diagnosed with SLE. The studied group was dominated by women (they were 5.2 times more numerous). The morbidity rate was 52.183 patients per 100 thousand inhabitants. Most patients were in the age range of 48–56 years. Average annual expenses for this group of patients over the examined period were USD 16,327 million. Two times more was expended on patients inhabiting cities, approximately 4 times more on women. Calculated per patient, the average cost of therapy was USD 810.63. Conclusions The population of SLE patients in Poland is highly stable. The results of analysis indicate 1.64 times more frequent occurrence in urban areas, which may be connected with availability of doctors. The SLE treatment costs in Poland are much lower than in other countries, which is related mainly to the fact that therapy with biological drugs is not financed.

Epidemiology of asthma in Poland in urban and rural areas, based on provided health care services

INTRODUCTION Asthma is a serious health and social problem, also in Poland. The epidemiological data indicate that the problem of asthma concerns approximately 4 million people in Poland, whereas almost approximately 70% of them have no diagnosis and are not aware of their illness, and on the other hand in 39% of persons who declared the diagnosis of asthma in a survey the diagnosis was negatively verified (overdiagnosis of asthma). So far, no detailed comparative studies for asthma incidence rate in urban and rural areas were conducted in Poland. The aim of the study was to analyze patients with asthma in Poland in the years 2008-2012, with regard to province and type of commune (rural/urban). MATERIAL AND METHODS The study used data from National Health Fund (NFZ) - reported by health care providers regarding the patients diagnosed with asthma. Using structured query language (SQL) a set of patients was selected and created, for whom at the same time ICD-10 code: J45.X-bronchial asthma was reported. In order to estimate the number of patients with asthma we used the PESEL social security number as a unique identifier of the patient. Code of the patients commune of residence in conjunction with the Central Statistical Office data formed the basis for the division of municipalities into urban and rural areas. The analysis of asthma incidence trends in Poland was performed on the basis of health services provided to patients. The analysis was performed by using the Statistica 10 software using a negative binomial regression model. RESULTS In 2009 a significant increase in the number of patients with asthma was observed compared with the previous year, whereas after 2009 the number of patients diagnosed with asthma remained relatively constant. A significant increase of predominance of women among asthma patients in recent years can be noticed: from 107% in 2008 to almost 115% in 2012 (F:M ratio). Regardless of the analyzed year and the diagnosis the incidence rate remained constant: approximately 55-57% for urban areas and about 43-45% in rural areas. CONCLUSIONS The average prevalence rate for rural areas is significantly lower than for urban areas. The use of adjusted incidence rate leads to the conclusion that the number of sufferers in urban areas is higher (about 10%) of the number of sufferers in the rural areas. The results of the analysis are consistent with information from previous studies in Poland and in the world.

Juvenile idiopathic arthritis morbidity rate in rural and urban areas of Poland 2008–2012

OBJECTIVE The aim of this study was to investigate the juvenile idiopathic arthritis (JIA) morbidity rate in the Polish population, calculated per 1,000 inhabitants of a given province, taking into account the differences between urban and rural areas, gender and area of residence (province) 2008-2012. METHOD From the NFZ IT systems information was obtained on the treatment of patients who had M08 and M09 juvenile arthritis, diseases classified elsewhere by the ICD-10 diagnosis code in the settlement report of the hospital. The number of patients, their gender and age at individual diagnoses were calculated based on the PESEL number provided in the statistical reports of the patient with the analysed ICD-10 diagnosis. Urban and rural cases were compared using commune zip codes. The basic for classifying the patient as a member of a urban or rural population was the zip code of the declared place of residence. RESULTS In Poland, the number of patients suffering from juvenile idiopathic arthritis has been increasing since 2008 - from 9.2 thousand in 2008 to 11.4 thousand in 2012. The majority were girls (approx. 62%). Most patients were living in urban areas; in 2008, 5.9 thousand: urban areas - 64% of women and 36% of men; 3.2 thousand: rural areas - 62% of women, 38% of men); in 2012, 7.2 thousand - urban areas); 4.2 thousand - rural areas. The morbidity indicators ranged from 0.195 - 0.357 per 1,000 inhabitants, depending on the year, gender and place of residence (province and commune).