ASSESSING SALIVARY CORTISOL IN RESEARCH OF SHIFT WORK RISKS AMONG CASINO EMPLOYEES IN BULGARIA

Although the effects of shift work on casino employees have been documented, no data exists describing the effect of stress on the hormone secretion. The present quantitative study evaluates the use of salivary cortisol concentration as a biomarker of the stress level among casino employees in Bulgaria. This new data emphasize the need to examine the circadian rhythm of cortisol in a casino environment

Pilot Study on the Cost of Some Oncohematology Diseases in Bulgaria

The goal of the current study is to perform a pilot study of the cost of some oncohematology diseases in Bulgaria. This is a pilot broader burden of disease research. The official report of the National health insurance fund provided information about the total expenditures paid for medicines, ambulatory services, and hospitalizations in 2015 and 2016. To evaluate the costs from a patient perspective, an internet inquiry was organized with the support of the patient organization. The inquiry contained questions regarding the patients' demography, type of oncohematology disease, year of diagnosis, quality of life (EuroQol v5D), and additional out of pocket expenditures. Quality of Life data were statistically analyzed and Kruskal-Wallis analysis of variance was performed. From 2015 to 2016 the number of patients with oncohematological diseases decreased by approximately 3000 people. Less than 30% were hospitalized and the hospitalization cost decreased, but the cost for medicines increased by nearly 1.5 million Euros. Cost for medicines almost tripled the hospitalization cost. The reported mean quality of life was 0.749 (SD 0.203). There was positive correlation between QoL and current disease state (p = 0.008) and age (p = 0.025). 42% reported to have additional expenditures related to their oncohematology disease, 22% reported other expenditures (diet, change of everyday habits etc.) and 42% reported to have productivity loses due to loss of employment or change of work, 44% of the respondents reported additional payment for medicines for concomitant diseases. Thus, the total cost (public funds and patients) accounted for 37,708,764 Euro. Despite the high public expenditures, the indirect costs due to productivity loses are higher. Costs for medicines are higher than costs of inpatient treatment, but this tendency is observed in all European countries. The increases in the costs of medicines are compensated by reduced costs of hospitalization. Despite their higher costs, newer medicines are an effective and reasonable investment from a societal perspective. Currently the higher levels of copayment increase the burden on the patients

The health related quality of life for kidney transplant patients in Bulgaria - A pilot study

The aim of the present study was to analyze the pharmacotherapy cost and quality of life of patents after kidney transplantation compared to those with chronic kidney disease in Bulgaria. This retrospective pharmacotherapy cost study and prospective health related quality of life (QoL) study was performed during 2010 - 2011 at the biggest Sofia hospital serving all transplant patients. The cost of pharmacotherapy was analyzed after reviewing patients' records. The health related quality of life was evaluated with the multi-attributable questionnaire SF-36, which measures 9 health domains. Forty-two percent of the patients with chronic kidney disease, and 26% of those with kidney transplant were female. The average age of the transplanted patients was 39.7 for male patients and 42.2 for female ones, while in the group suffering from chronic kidney disease the average male age was 48.3 and that of female patients, 51.2. No statistically significant difference was observed among the mean monthly cost of therapy per patient during the two-year period. The QoL was with lower values in the role limitations domain for patients with chronic kidney diseases and this difference was statistically significant. We found a correlation among the mean cost of pharmacotherapy and mean QoL in both groups of patients. In the group of patients with kidney transplantation the place of living and general health state were positively correlated. The cost of pharmacotherapy and the health state in comparison with the previous year were also positively correlated. This is the first Bulgarian study of the quality of life of kidney transplant patients. It shows that the SF-36 could be successfully used in this group of patients as well as for comparison with the QoL of patients with chronic kidney disease

Cost-effectiveness of short COH protocols with GnRH antagonists using different types of gonadotropins for in vitro fertilization

The aim of this study was to explore the cost-effectiveness of short protocols including different types of gonadotropins for controlled ovarian hyperstimulation (COH) for in vitro fertilization (IVF). A retrospective, observational study of the real-life practice in a specialized IVF gynaecology clinic in 2009-2013 was carried out. All women on short COH protocols were recruited into three groups: COH including recombinant follicle stimulating hormone (rFSH) and urinary-FSH (urFSH) (n = 173); including urFSH alone (n = 289); and including rFSH alone (n = 212). The cost-effectiveness of the COH protocols was explored in two different case scenarios for possible outcomes. The first case scenario took into consideration a successful live birth, and the second one, the women to achieve pregnancy with live birth. Decision modelling was done using the TreeAge 2014 Software. According to the results in the first case scenario, the rFSH plus urFSH COH approach showed the highest weighted probability (p = 0.38) of live birth, but the urFSH alternative was cost-effective. The results in the second case scenario demonstrated that the urFSH protocol was again the cost-effective alternative. These results suggest that the strategy with urFSH should be preferred in both cases, but rFSH could also be considered as a cost-effective alternative for successful live birth and achieving pregnancy and delivery, since the incremental cost-effectiveness ratio in comparison with the urFSH protocol is below the gross domestic product per capita. The combined approach of rFSH and urFSH was shown not to be cost-effective in both explored scenarios

A health-related quality of life and pharmacotherapy costs study for patients with cystic fybrosis, gaucher disease and chronic myeloid leukemia in Bulgaria

The aim of the present study was to analyze the cost of pharmacotherapy and quality of life of patients with cystic fibrosis (CF), Gaucher disease (GD) and chronic myeloid leukemia (CML) in Bulgaria. Data for the pharmacotherapy cost were compiled retrospectively. The second part of the study included a prospective quality-of-life survey (conducted at the Medical University Hospital "Alexandrovska" in 2010 and 2011). We estimated the average monthly pharmacotherapy costs according to data from the hospital registries. The quality-of-life survey was done through interviews based on the short form of SF-36, which measures 9 health domains. The total number of patients was 18, of which 10 were with CML, 5 with cystic fibrosis and 3 with Gaucher disease. The average age of the male and female patients with CML was 49.1 years and 48.3 years, respectively; 25 and 24 years in the group with GD, respectively; and 29.5 and 35.3 years in CF group, respectively. No statistical difference between the average monthly pharmacotherapy costs for the observed period was revealed In all patients the quality of life was below the maximum possible value, which is equal to 100 points. The lowest values for the different indicators of quality of life were observed in the CF patients, most likely due to the chronic progression of this particular rare disease. The average range of quality of life for this group was 53.75. We found a statistical correlation between the pharmacotherapy costs and the quality of life. The Spearman correlation analysis revealed a correlation between the drug therapy costs and some quality-of-life indicators only in the patients with CIVIL. The correlation between the pharmacotherapy costs and physiological functions in patients with CIVIL was positive, i.e. higher costs improved this indicator The pharmacotherapy costs were high, the average values for the three groups of patients being: BGN 9221.61 for 2010 and BGN 8254.64 for January March 2011 for patients with CF, BGN 32954.08 for those with GD, and BGN 6389.38 for 2010 and BGN 6591.19 for the second period for the CML patients. The quality of life was significantly reduced for the observed patients: the average value for quality of life were 53.75, 65.03 and 67, respectively, from a maximum of 100

Incretins and SGLT-2i Therapy of Type 2 Diabetes – Real Life Study of Their Therapeutic and Economic Effects

AimIncretins [dipeptidyl peptidase-4 inhibitors (DPP-4i) and glucagon-like peptide 1 RA (GLP-1 RA)] and sodium-glucose cotransporter-2 inhibitors (SGLT-2i) groups are now routinely used for type 2 diabetes therapy and comprise a large number of medicinal products. The long term therapeutic and economic effect of the incretins’ and SGLT-2i in real life setting is not well documented. The goal of the current study is to analyze the cost and results of incretins and SGLT-2i based therapy for type 2 diabetes in Bulgaria.MethodsThe study uses information about the changes in glycated hemoglobin (HbA1c) level from the National diabetes register for 6122 patients and cost paid by the National Health Insurance Fund (NHIF) for diabetes complications, and medicine prices.ResultsThe results show that after the therapy patients achieved excellent diabetes control. There were no HbA1c values less than 6% before treatment. After the therapy, 3356 people showed values less than 7% HbA1c. It is considered very good diabetic control. The number of people with HbA1c above 8% is decreasing significantly. The number of people with values above 9% is decreasing by almost four times. HbA1c level decreases with the highest percentage for the patients treated with GLP-1 RA, followed by those treated with DPP-4i and SGLT-2i. For a year NHIF reimbursed 5.25 million BGN for incretins and SGLT-2i therapy. NHIF can save between 306 and 510 thousand BGN from incidents that have not occurred as a result of 5 years of therapy.ConclusionIncretins [dipeptidyl peptidase-4 inhibitors (DPP-4i) and glucagon-like peptide 1 receptor agonists (GLP-1 RA)] and sodium-glucose linked transporter-2 inhibitors (SGLT-2i) therapy steadily decreases the HbA1c level, and risk of developing diabetic incidents is reduced to between 333 and 465 cases among 6122 treated patients. Avoided cost for therapy of diabetes incidents account for between 305 and 510 thousand BGN

Comparative Analysis of Legislative Requirements About Patients' Access to Biotechnological Drugs for Rare Diseases in Central and Eastern European Countries

Objectives: The aim of the study was to compare the access of patients with rare diseases (RDs) to biotechnological drugs in several Central and Eastern European countries (CEECs). We focused on the legislative pricing and reimbursement requirements, availability of biotechnological orphan medicinal products (BOMPs) for RDs, and reimbursement expenditures. Methods: A questionnaire-based survey was conducted among experts from 10 CEECs: Bulgaria, Croatia, Estonia, Greece, Hungary, Poland, Romania, Slovakia, Serbia, and Macedonia. The legal requirements for reimbursement and pricing of BOMPs were collected. All BOMPs and medicines without prior orphan designations were extracted from the European list of orphan medicinal products, 2017. The reimbursement status of these medicinal products in 2017 in the public coverage of the included CEECs as well as the share of their costs in relation to the total public pharmaceutical spending for the period from 2014 to 2016 were defined. Results: Our survey revealed that some differences in the legal requirements for pricing and reimbursement of BOMPs amongst the countries included in the study. All European Union countries have developed and implemented pharmacoeconomic guidelines with or without some specific reimbursement requirements for orphan medicinal products. Cost-effectiveness analysis, cost-utility analysis, Markov models, meta-analysis, and discount levels of costs and results were required only in Bulgaria, Poland and Hungary. The number of reimbursed BOMPs and biotechnological medicinal products for RDs without prior orphan designation was the highest in Hungary (17 and 40, respectively). Patient-based reimbursement schemes were available only in Hungary for 11 out of 17 BOMPs. Poland and Greece have the highest pharmaceutical expenditure of reimbursed BOMPs with are similar to 214 million and 180 million EUR, respectively in the observed period from 2014 to 2016. High proportion of the pharmaceutical expenditure on the reimbursed biotechnological medicinal products for RDs for the observed period 2014-2016 is presented in Bulgaria and Slovakia. Conclusions: The non-European Union CEECs face a significant delay in the legal implementation of pharmacoeconomic guideline for assessment of BOMPs. The access to BOMPs is similar among the observed CEECs and the countries with the best access are Hungary and Greece. The influence of BOMP expenditures on the budget in the individual countries is significant

Predicting the outcomes and costs for a cohort of 426 patients with Chronic Obstructive Pulmonary Disease (COPD) in Bulgaria through a Markov model

The aim was to estimate the economic burden, as well as rate of progression of COPD for a cohort of 426 patients for a 10-year period. A total of 426 patients from 19 regions with Chronic Obstructive Pulmonary Disease were enrolled in a representative, ambispective, national study for Bulgaria. Patients were recorded on disease stage, occupation, smoking habits and medication. Cost of treatment was calculated and a 10-year one-way Markov model was used by employing transition probabilities and quality of life data from available literature. Costs and outcomes were recorded and a cost-effectiveness acceptability curve (CEAC) was established. Out of all patients included in the study 288 were non-smokers with a mortality percentage after 10 years of 42.7%. Smokers showed faster transition rate with 139 of them transitioning to more severe states and mortality was 54.6%. The incremental cost-effectiveness ratio (ICER) was 863.75 BGN. Patients who smoked had a lower quality of life – cumulatively for the 10-year period QALY = 623.51 for smokers vs. 1557.51 for non-smokers, but also lower costs for treatment (538 007.52 BGN vs. 1 344 757.95 BGN) accounted by the high transition rate and mortality amongst that group. Relatively few non-smokers transitioned from a less severe to a more severe state (6%), while most of the very severe stage patients experienced a lethal outcome within 10 years (81%). Despite the higher costs associated with the disease, the Quality of Life and lower transition probability would enable patients to live a normal life. The ICER was well below the WHO threshold

Predicting the outcomes and costs for a cohort of 426 patients with Chronic Obstructive Pulmonary Disease (COPD) in Bulgaria through a Markov model

The aim was to estimate the economic burden, as well as rate of progression of COPD for a cohort of 426 patients for a 10-year period. A total of 426 patients from 19 regions with Chronic Obstructive Pulmonary Disease were enrolled in a representative, ambispective, national study for Bulgaria. Patients were recorded on disease stage, occupation, smoking habits and medication. Cost of treatment was calculated and a 10-year one-way Markov model was used by employing transition probabilities and quality of life data from available literature. Costs and outcomes were recorded and a cost-effectiveness acceptability curve (CEAC) was established. Out of all patients included in the study 288 were non-smokers with a mortality percentage after 10 years of 42.7%. Smokers showed faster transition rate with 139 of them transitioning to more severe states and mortality was 54.6%. The incremental cost-effectiveness ratio (ICER) was 863.75 BGN. Patients who smoked had a lower quality of life – cumulatively for the 10-year period QALY = 623.51 for smokers vs. 1557.51 for non-smokers, but also lower costs for treatment (538 007.52 BGN vs. 1 344 757.95 BGN) accounted by the high transition rate and mortality amongst that group. Relatively few non-smokers transitioned from a less severe to a more severe state (6%), while most of the very severe stage patients experienced a lethal outcome within 10 years (81%). Despite the higher costs associated with the disease, the Quality of Life and lower transition probability would enable patients to live a normal life. The ICER was well below the WHO threshold

Evaluation of the economic and social burden of chronic obstructive pulmonary disease (COPD)

The aim of this study was to calculate the economic and social burden of chronic obstructive pulmonary disease (COPD) in Bulgaria generated from the loss of productivity due to absence from work (absenteeism), due to premature retirement, due to reduced productivity (presenteeism), and the disability adjusted life years (DALY). An observational study among 426 Bulgarian COPD patients was conducted for the period 2014–2015. Human capital approach was used to calculate the productivity losses and the DALY methodology of the World Health Organization was applied. The patients with moderate (50%) and severe (48%) disease were absent from work more frequently than those with mild COPD (2%) and generated productivity losses of 521.45€ per patient per year. The average indirect costs per patient for the remaining working ages due to premature retirement account for 25,000€ (6250 per patient on average), while those due to presenteeism, for about 3750.64€ per year. Accordingly, the DALYs in the group of patients with mild severity were lowest due to the low disutility index and number of patients in this sample group. On average, a patient with mild COPD spends 0.62 years of his life in disability due to the disease, while those with moderate and severe disease spend 6.00 and 9.00 years, respectively. This amounted to the following indirect costs experienced by patients: 3596.52€; 34,204.01€; 51,332.20€, respectively. We demonstrated a significant indirect financial and societal burden of COPD in Bulgaria, which is in correlation with the severity of the disease