AbstractThere is a global call for action for cervical cancer elimination as a public health problem—WHO Strategy 90-70-90. One of the strategic pillars, alongside vaccination, is cervical cancer ...screening. This aims to assess the economic consequences and cost-effectiveness of primary DNA-HPV testing for cervical cancer screening in Bulgaria. Combined cost-effectiveness (CEA) and cost-benefit (CBA) analysis was performed to evaluate the net benefit of the HPV genotype testing program among women aged 30–54 in Bulgaria and to compare its cost-effectiveness with the current practice. ICER was presented separately for only direct costs and direct + indirect costs. The CBA analysis for the age group 30-54 shows that the benefit/cost ratio of DNA-HPV primary screening is 1.03 and the net present benefit accounts for 373,023 euro thus making the program beneficial for the healthcare system. CEA shows that HPV screening is cost-effective over the current practice of PAP testing with ICER 1634 euro/LYG when considering only direct costs and—8020 euro/LYG for direct and indirect costs. The ICER in terms of the sensitivity rate of the testing methods is 1316 euros. The LYG earned with the HPV testing account for 4989 for the observed women. Primary hrHPVDNA-based screening is an important scientific and clinical advance since it offers better reassurance of low cancer risk compared to cytology-only screening conducted at the same interval. Primary hrHPV screening can be considered as a dominant alternative to current cytology-based cervical cancer screening approaches including cytology alone and contesting and providing better benefit.
The aim of this study was to analyze the therapeutic results and survival of patients with myelofibrosis treated with ruxolitinib in comparison with a group on standard therapy. It is a ...cross-sectional, retrospective, non-interventional, real-life study that was performed between January 2000 and February 2023. Patients treated between 2000 and 2016, before the introduction of ruxolitinib, constituted the control group (n = 45), while those treated after May 2016, after ruxolitinib inclusion, constituted the active group (n = 66). Demographic characteristics, clinical indicators, the severity of the disease, and survival were explored using Kaplan–Meier survival analyses. Spearman’s correlation, linear regression, and other statistical analyses were performed. According to the Kaplan–Meier analysis, there was a 75.33% reduction in the fatality risk in the sample. On a general-population level, the fatality risk in the group treated with ruxolitinib varied between 7.9% and 77.18% compared to that of the risk in the control group. There was a decrease in blood parameters (leukocytes, hemoglobin, and platelets) and spleen size. During the first six months, the spleen size of the patients on ruxolitinib decreased by 6%, and during the second six months, it decreased by another 9%. This study shows that patients in a real-life clinical setting treated with ruxolitinib exhibited improved clinical signs of the disease, had a lower symptom severity, and survived longer than patients on standard therapy before ruxolitinib’s entrance into the national market. The improvements correlate with those reported in randomized clinical trials.
The aim of this study was to review the requirements for the reimbursement of biosimilars and to compare the reimbursement status, market share, and reimbursement costs of biosimilars in selected ...Central and Eastern European (CEE) countries.
A questionnaire-based survey was conducted between November 2016 and January 2017 among experts from the following CEE countries: Bulgaria, Czech Republic, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia, and Romania. The requirements for the pricing and reimbursement of biosimilars were reviewed for each country. Data on the extent of reimbursement of biologic drugs (separately for original products and biosimilars) in the years 2014 and 2015 were also collected for each country, along with data on the total pharmaceutical and total public health care budgets.
Our survey revealed that no specific criteria were applied for the pricing and reimbursement of biosimilars in the selected CEE countries; the price of biosimilars was usually reduced compared with original drugs and specific price discounts were common. Substitution and interchangeability were generally allowed, although in most countries they were at the discretion of the physician after a clinical assessment. Original biologic drugs and the corresponding biosimilars were usually in the same homogeneous group, and internal reference pricing was usually employed. The reimbursement rate of biosimilars in the majority of the countries was the same and amounted to 100%. Generally, the higher shares of expenditures were shown for the reimbursement of original drugs than for biosimilars, except for filgrastim, somatropin, and epoetin (alfa and zeta). The shares of expenditures on the reimbursement of biosimilar products ranged from 8.0% in Estonia in 2014 to 32.4% in Lithuania in 2015, and generally increased in 2015. The share of expenditures on reimbursement of biosimilars in the total pharmaceutical budget differed between the countries, with the highest observed value for Slovakia and Hungary and the lowest-for Croatia.
The requirements for the pricing and reimbursement of biosimilar products as well as the access of patients to biologic treatment do not differ significantly between the considered CEE countries. Biosimilar drugs significantly influence the reimbursement systems of these countries, and the expenditure on the reimbursement of biosimilars is increasing as they are becoming more accessible to patients.
We aimed to explore symptom severity and adherence to therapy for patients with myelofibrosis treated with ruxolitinib in Bulgaria. It is a prospective, non-interventional study performed at the ...specialized hospital for active treatment of hematological diseases in Sofia during 2022-2023. Date of diagnosis, demographic characteristics, clinical indicators, ruxolitinib dose, and other data points were collected. Clinical indicators were assessed at baseline, in the middle, and at the end of observation. Severity of symptoms was measured with MPN-SAF TSS and adherence to therapy with the Morisky 4 questionnaire six times during the observation. The mean age of diagnosis was 58.5 years, with the average duration of disease of 3 years. Patients' laboratory results were within physiological ranges, with spleen size experiencing a constant decrease. The average value for the severity of the symptoms per MPN-SAF TSS results decreased significantly, indicating better disease control. The average adherence to therapy did not change and remained high at around 9 points, except for one patient. In conclusion the treatment of myelofibrosis patients with ruxolitinib decreased symptom severity and spleen size. Patients were adherent to the therapy over the observed period, but as treatment duration increases, the risk of adherence decreases.
To evaluate the expected life expectancy in patients with diabetes in Bulgaria and to compare it to the expected life expectancy of the non-diabetic population in the country.
It is a retrospective ...observational population study on individuals diagnosed with diabetes, compared to the non-diabetic population in Bulgaria for the period 2012-2015. Data from the national diabetes register and national statistical institute were used to construct life-tables with probability of survival with t-test and Chi Square test. Confounder analysis was done by age, sex, and type of diabetes. All-cause mortality and deaths in diabetic patients were analyzed. Kaplan-Meier survival curves were constructed for each age group and a log-rank analysis was conducted.
Average life expectancy in the non-diabetic population, patients with Type 1 DM and with Type 2 DM is 74.8; 70.96 and 75.19 years, respectively. For 2012-2015 the mortality in the non-diabetic population remained constant and lower (average-1.48%) compared to type-1 DM (5.25%) and Type-2 (4.27%). Relative risk of death in diabetics was higher overall (12%), after the age of 70 before which the relative risk was higher for the non-diabetic population. This was observed as a trend in all analyzed years.
Patients with type 2 DM have a longer life-expectancy than patients with type-1 DM and overall Diabetics life expectancy equals that of the non-diabetic population, which could suggest improved disease control and its associated complications in Bulgaria. Male diabetics show slightly longer life expectancy than their counterparts in the non-diabetic population, by a marginal gain of 0.6 years for the entire observed period. Life expectancy in diabetic women increased by 1.3 years, which was not observed in the non-diabetic population. Prevalence of diabetes was higher for women. Improved diabetes control may explain this gain in life; however other studies are needed to confirm this.
Health care systems worldwide are experiencing tremendous financial pressure because of the introduction of new targeted health technologies and medicines. This study aims to analyze and compare ...public and household healthcare expenditures in Bulgaria during the period 2015–2019, as well as present the major cost-containment measures implied by the government and their probable influence on the overall health care cost. Regulatory analysis of the endorsed cost-containment measures, budget analysis of public and household health care expenditures, and their extrapolations were performed. The regulatory analysis reveals that a large number of measures are introduced and valid until January 2021, considering pharmaceuticals, medical devices, and negotiations between the National Health Insurance Fund (NHIF) and Marketing authorization holders (MAHs). NHIF costs due to pharmaceuticals, food supplements, and medical devices are rising from 2015 to 2019. The overall health expenditures average per household and the average per person also grow in this period. The cost extrapolation reveals that an increase in 3-year periods is expected. Despite the implementation of variety of cost-containment measures in Bulgaria, such as HTA, ERP, discounts, and annual negotiations, The National Health Insurance Fund's (NHIF) spending on pharmaceuticals continues to rise in recent years, and further increases are expected in the next 3 years. The average expenditure per household and per person also increased, which confirms the global trend of rising medicine and outpatient services value.
The aim of this study is to evaluate the effect of the introduction of biosimilars in Bulgaria on the prices and utilization of biologic disease modifying antirheumatic drugs (bDMARD). It is a ...combined qualitative and quantitative analysis of time of entry of biosimilars on the national market and the respective changes in the prices and utilization during 2015-2020. We found 58 biosimilars for 16 reference products authorized for sale on the European market by the end of 2019, but for 2 of the reference products biosimilars were not found on the national market. Only inflammatory joint disease had more than one biosimilar molecule indicated for therapy. Prices of the observed bDMARD decreased by 17% down to 48%. We noted significant price decreases upon biosimilar entrance onto the market. In total, the reimbursed expenditures for the whole therapeutic group steadily increased from 72 to 99 million BGN. Utilization changed from to 0.5868 to 2.7215 defined daily dose (DDD)/1000inh/day. Our study shows that the entrance of biosimilars in the country is relatively slow because only half of the biosimilars authorized in Europe are reimbursed nationally. Introduction of biosimilars decreases the prices and changes the utilization significantly but other factors might also contribute to this.
Medication adherence (MA) is a major problem. On average 50% of chronic disease management medications are not taken as prescribed While digital healthcare tools like mobile apps offer benefits such ...as informative messages and prescription management, they must be personalized and offer support across all medication phases to effectively address individual patient factors and optimize adherence, with room for further improvements. This scoping review examined the impact of digital health technologies on MA in adults with diabetes as well as their benefits and barriers. Using PubMed and Scopus databases, 11 out of 385 studies (2.86%) from January 2017 to August 2023 met the criteria for digital health interventions in diabetes MA, assessed through the Chronic Care Model. The Chronic Care Model (CCM) is a patient-centered, evidence-based framework designed to improve the care and outcomes for chronic illness patients, consisting of six core elements and enhanced by eHealth tools that facilitate self-management and support through digital innovations. The results demonstrate the effectiveness of digital health technology in improving medication adherence among adults with diabetes. Specific digital interventions, including mobile apps like Gather and Medisafe, SMS text messaging, telemonitoring, and tailored care management have demonstrated effectiveness in enhancing MA. These interventions have shown positive outcomes, including enhanced glycemic control and increased patient engagement. Some of the limitations, which these technologies face, are the poor usability, digital illiteracy among the patients, low rates of sustainability and low accessibility among the elderly population. Digital health technology shows promise in enhancing medication adherence among adults with diabetes, as revealed in this scoping review. However, ongoing research is necessary to fine-tune these interventions for improved outcomes and the overall well-being of individuals with diabetes. Additional improvement of the technologies and adaptation to the diverse population might be a good field for exploration.
Provision of the latest innovative and advanced therapies for rare diseases (RDs) patients, following the international therapeutic recommendations, is crucial and necessary for both practitioners ...and patients. The goal is to assess the access of Bulgarian patients with the most cost-consuming RDs to medicines and to compare the pharmacotherapeutic patterns in Bulgaria and the relevant European professional associations. Pharmaco-therapeutic guidelines for treating the most cost-consuming RDs in Bulgaria were analyzed to assess their compliance with the European ones. Market entrance was evaluated through analysis of the availability of medicines in the Positive Drug List (PDL) and their date of inclusion since marketing authorization. Guidelines’ compliance index was calculated and patient access was analyzed through evaluation of the National Health Insurance Fund (NHIF) standards, which provide additional criteria for treatment initiation. The analyzed guidelines follow the adopted recommendations by the relevant European professional associations. NHIF have exclusion and inclusion criteria for initiating treatment with medicines for rare diseases and for continuation. The average time-lag between centralized procedure approval and inclusion in the Bulgarian PDL for orphan medicinal products (MPs) is 6.75 years (SD = 4.96) with the longest time observed for eptacog alfa (20 years) and the shortest for rurioctocog alfa pegol, octocog alfa and simoctocog alfa (1 year). Bulgarian patients with cystic fibrosis with pulmonary manifestation had a wait time of only 1.6 years to get access to innovative, centrally authorized medicines, whereas the period for access to acromegaly treatment was 8.2 years. The main factors influencing market entrance and patient access are the time to inclusion in the PDL and the NHIF criteria.
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