99 research outputs found

    Hospital-based health technology assessment in Russian Federation: opportunities and prospects

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    The problem of rational consumption of resources in situation of limited budgets is extremely relevant for modern health care. Currently, at the state level, there is a procedure for making decisions on the inclusion of new medicines in the restrictive lists (primarily in the List of vital and essential medicines (VED)). It is important to understand that, on the one hand, medicines are not the only medical technology used in the provision of medical care, on the other hand, the existing guidelines are a view of the health system, the State and society on their appearance in real clinical practice. At the same time, conducting clinical and economic research in the hospital allows to take into account the current strategic, organizational, financial, personnel aspects of a particular medical institution. The developed organizational and methodological model of the hospital assessment of health technologies describes the organizational aspects of health technologies assessment in the hospital, as well as the actual methodology of its implementation. The created methodology adapts the world experience of hospital assessment of health care technologies to the existing legislative, administrative, and personnel aspects of the work of medical institutions in the Russian Federation. Testing of the model in hospitals St. Petersburg demonstrated the possibilities and prospects of hospital assessment of health care technologies in Russian institutions, related to information support of management decisions on the introduction of new medical technologies (medicines, medical equipment, medical devices, etc.), taking into account the current strategic, organizational, financial, personnel aspects of a particular medical institution

    Clinical-economic analysis of the target therapy in severe atopic dermatitidis in adults

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    Target therapy of severe atopic dermatitidis (AD) is actual because AD has a high prevalence and social-economic burden. Target therapy consists of monoclonal antibodies (dupilumab) as well as janus kinase inhibitors (upadacitinib and baricitinib). Aim. Health technology assessment of the severe AD target therapy in adults. Мaterials and methods. EASI-75 has been chosen as efficacy criterion in the clinical trial of dupilumab 300 mg every 2 weeks and upadacitinib 30 mg od during 24 weeks, indirect treatment comparison for dupilumab and baricitinib 4 mg od with odds ratio (OR) during 16 weeks has been performed. Modelling with “Tree of decision” method was made for comparable efficacy evaluation on 52-d week of the treatment. Direct medical cost has been calculated for: target and topic therapy, complications, prophylaxis of janus kinase inhibitors side effects. Budget impact analysis for janus kinase inhibitors substitution with dupilumab during 3-years horizon on 100 pts was performed. Multilateral sensitivity analyses were made for results validation. Results. Efficacy of dupilumab and upadacitinib on point 24 w were equal (EASI-75 59,5 % [95 % CI: 54,4; 64,7] and 64,2 % [95 % CI: 59,1; 69,2] accordingly) and on 52 w (65,0 % and 69,0 %, OR vs dupilumab 1,1 [95 % CI: 0,68; 2,1]). Dupilumab has more efficacy than baricitinib on 16 w of therapy (EASI75 65,7 % and 48,0 % accordingly, OR 2,09 [95 % CI: 1,31; 3,35]) and on 52 w (65,0 % and 55,7%, OR vs dupilumab 0,75 [95% CI: 0,47; 0,96]). Dupilumab had economic advantages on 21 % vs upadacitinib during year (993 495 Rub. and 1 253 164 Rub. per patient accordingly based on cost-minimization analysis). Dupilumab was on 11,8 % more economic vs baricitinib based on cost-effective analysis during one year of therapy also. Substitution of janus kinase inhibitors on dupilumab can lead to budget saving on 18,1–44,9 % during 3 years. Results were confirmed by sensitivity analyses. Conclusion. Health Technology of the severe AD treatment in adults with dupilumab is an economic proved

    Cystic fibrosis as a social-economic burden

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    Cystic fibrosis (CF) is a chronic genetic disease with social significant weight because it influences on social humanitarian part of health and on sources of health care system as well. Materials and methods. Data of CF Register and treatment methodology based on clinical guidelines were used for analysis. Direct and indirect medical costs as well as indirect costs have been calculated per one patient per year. Direct costs included diagnostic costs and treatment based on Obligatory medical Insurance fund tariffs, costs of drugs and medical devices, rehabilitation, payments due to disability; indirect costs included loss of GDP. Results. Total expenditures were calculated as 3,1 mln RUR for one patient annually, direct medical costs were 71 % of total. Main part of expenditures was allocated for out-patient stage of treatment — 1,57 mln RUR. Exacerbations costs were estimated as 399,4 thousand RUR. Indirect medical cost was 314,6 thousand RUR, and indirect cost as 582,9 thousand RUR as well annually. Total economic burden of CF for Russian Federation was calculated as 10,37 bln RUR/year, main part was a direct medical expenditures — 73 %. Conclusion. CF is a big social-economic burden in the Russian conditions. Reducing the number of exacerbations and improving lung function, as well as increasing the life expectancy of patients with CF due to introduction of new technologies in health care (targeted therapy) is aimed at reducing the social burden of the disease, which will require increasing the availability of effective (targeted) drugs in the future

    Principles of clinical and economic analysis of antimicrobial drugs

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    In light of rising costs in the health care system and the introduction of innovative but expensive technologies, decision makers are looking for reliable methods to assess their cost-effectiveness. To this end, a comprehensive assessment of medical technology is carried out, including the analysis of information on its comparative clinical efficacy and safety, as well as an assessment of the economic consequences of its implementation. One of the most important features of clinical and economic studies of antimicrobials is the ability of infectious agents to acquire resistance to therapy, which fundamentally changes their effectiveness, and, consequently, the clinical and economic feasibility of use over time. Taking into account the risks of resistance as a criterion of effectiveness in pharmacoeconomical studies of antimicrobial drugs is an important factor affecting the feasibility of inclusion of drugs in the restrictive lists. At the same time, this criterion remains underutilized

    Factors associated with adverse outcome among hospitalized patients with moderate to severe COVID-19

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    Aims. To consider factors associated with adverse outcome among hospitalized patients with moderate and severe COVID-19.Materials and methods. Data from 345 case histories of adult patients hospitalized with moderate to severe COVID-19 were analyzed in a single-center retrospective study. Characteristics by sex, age, number of days from disease onset to admission to hospital, duration of hospitalization, duration of disease, population characteristics by medical history of comorbidities and self-medication, outcome of hospitalization and medical technologies used in hospital conditions were given for the whole cohort of patients. All parameters were analyzed using descriptive statistics methods. Qualitative variables are given in absolute (n) and relative (%) values with 95% confidence interval. Continuous variables were presented as median and quartiles. Risk factors for mortality were determined across groups using the χ2  criterion and odds ratio.Results. There was no demonstrated effect of gender, degree of pulmonary tissue lesions on computed tomography data, or time of initiation of respiratory support on disease outcome. At the same time, the age older than 65 years as well as neoplasms, type 2 diabetes mellitus, dementia, Stage 3 arterial hypertension, chronic heart failure, coronary heart disease, myocardial infarction and stroke history, chronic obstructive pulmonary disease, bronchiectatic disease, urogenital diseases were the predictors of unfavorable outcome in patients with moderate and severe COVID-19 form. Prehospital use of antiplatelet agents, direct and indirect oral anticoagulants, drugs affecting the renin-angiotensin system, systemic glucocorticosteroids, antibiotics, antiviral drugs, and analgesics was associated with a decrease in the mortality rate in patients with moderate-to-severe COVID-19, as well as timely use of pronposition and transfer to intensive care unit.Conclusions. Our findings are partially consistent with previous reports on the effect of risk factors on COVID-19 outcomes

    Socio-economic burden of COVID-19 in the Russian Federation

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    Purpose. Assessment of the socio-economic burden of COVID-19 in the Russian Federation (RF). Materials and methods. Identification and assessment of direct medical, direct non-medical costs, as well as indirect costs associated with the development of the coronavirus infection epidemic. When calculating the socio-economic burden, the prevalence-based calculation approach was chosen. The sources of data on the epidemiology of the disease were data from the Ministry of Health and data from the Government of the Russian Federation. Results. The socio-economic burden of COVID-19 in the Russian Federation will amount to 4.6 trillion rubles ($71.1 billion) or 4 % from GDP. In the cost structure, more than half of the costs are direct non-medical expenses (58.62 %), indirect expenses due to GDP losses are 40.65 %, direct medical expenses are only less than 1 % (0.74 %). The results of the sensitivity analysis showed that the extension of the self-isolation period from 1 month to 1.5 and 2 months will lead to an increase in the share of indirect expenses from 40.65 % (1 month) to 56.08 (1.5 months) and 67.76 % (2 months) for all expenses in connection with the COVID-19 epidemic. At the same time, the socio-economic burden of COVID-19 will amount to 6.2 and 8.5 trillion rubles, respectively. Conclusions. The epidemic of a novel coronavirus infection will lead to great economic losses in the Russian society

    Approaches to Assessing the Safety of Medicines during the COVID-19 Pandemic Using the Example of Azithromycin

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    Most of the medicines used to treat the novel coronavirus infection (COVID-19) are either approved under an accelerated procedure or not approved for the indication. Consequently, their safety requires special attention.The aim of the study was to review methodological approaches to collecting data on the safety of medicines, using COVID-19 treatment regimens involving azithromycin as a case study.Materials and methods: PubMed® (MEDLINE), Scopus, eLIBRARY, and Cyberleninka databases were searched for publications on azithromycin as part of combination therapy for COVID-19 in 2020–2021. Search queries included names of the medicinal product or its pharmacotherapeutic group and words describing adverse drug reactions (ADRs) during treatment.Results: the analysis included 7 publications presenting the results of studies covering the use of azithromycin as part of COVID-19 combination therapy in more than 4000 patients. Most commonly, the patients receiving COVID-19 therapy including azithromycin developed cardiovascular ADRs (up to 30% of azithromycin prescription cases). In 3 of the analysed publications, safety information was collected through spontaneous reporting and active identification based on the findings of laboratory and instrumental investigations performed during the clinical studies; in other 3, only spontaneous reports were used; and in the last one, ADR database information was studied.Conclusion: currently, information on ADRs associated with the use of medicines is mainly gathered via spontaneous reporting. Direct sourcing of information on personal experiences with a certain product from patients, among other means through social media analysis, opens a promising direction towards the improvement of existing approaches to collecting safety data

    Pharmacoeconomics modes of antibiotic therapy of uncomplicated community-acquired acute pyelonephritis in a multidisciplinary hospital

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    Introduction. Despite the high level of resistance of E.coli as the main causative agent of urinary tract infections, fluoroquinolones are among the most frequently used antimicrobial agents in empirical therapy of uroinfections.Aim. Clinical and economic evaluation of the effectiveness of different antibacterial strategies of community-acquired uncomplicated acute pyelonephritis with the predicted dynamics of resistance of E.coli as the main causative agent of uroinfections.Materials and methods. Te calculations take into account the literature data on the effectiveness and safety of the starting regime of antibacterial therapy of uncomplicated pyelonephritis with cephalosporins of the 3rd generation, fluoroquinolones, aminoglycosides and carbapenems in terms of hospital specialized medical care. Te model of «decision tree» is constructed. A list of direct and indirect costs was compiled, on the basis of which the cost of 1 case of acute uncomplicated pyelonephritis therapy for each strategy of antibacterial therapy was calculated. Te «cost-effectiveness analysis» and budget impact analysis were performed.Results. Te cost of 1 case of therapy with acute uncomplicated pyelonephritis gentamicin was the lowest in comparison with alternative strategies (33 679,89 rubles). Cost-effectiveness analysis showed that the strategy of antibacterial therapy of acute uncomplicated pyelonephritis with gentamicin dominated alternative strategies: at lower costs, it was also more effective.Summary. For a more accurate calculation of clinical and economic efciency of antimicrobial agents it is necessary to monitor the dynamics of the resistance level in the territory of the Russian Federation

    Socioeconomic and global burden of COVID-19

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    Relevance. Assessment of the burden of disease provides information on the economic consequences of the disease, allows you to assess the social significance, identify areas that require additional clinical and economic research, changes in methodological approaches to the organization of measures for the prevention, early detection and treatment of diseases.The aim. Assessment of the socioeconomic and global burden of COVID-19 in the Russian Federation (RF).Materials and methods. Identification and assessment of direct medical, direct non-medical, and indirect costs associated with the development of the coronavirus epidemic. When calculating the socioeconomic burden, the variant of calculations was chosen taking into account the prevalence of the disease. The sources of data on the epidemiology of the disease were data from the Ministry of Health and data from the Government of the RF.Results. The socioeconomic burden of COVID-19 in 2020 in the RF amounted to about 5.4 trillion rubles (5 % of nominal GDP in 2020) and was largely due to indirect costs due to GDP losses due to a 1.5-month period of self-isolation. The estimated global burden of disease is more than 4 million YLLs globally, of which in the RF 2,486.30 among men and 1,378.22 YLL among women.Conclusion. The epidemic of the new coronavirus infection has led to colossal economic losses in Russian society. The data presented underscore not only the clinical, but also the economic importance of investing in the development of strategies for the treatment and prevention of new coronavirus infection
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