Cystic fibrosis as a social-economic burden

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

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

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

Socioeconomic and global burden of COVID-19

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

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

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

Эффективность применения алектиниба в сравнении с лорлатинибом у пациентов с ALK-положительным немелкоклеточным раком легкого: фармакоэкономическое исследование

Objective: to evaluate the clinical and economic effectiveness of alectinib in comparison with lorlatinib in adult patients with advanced anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC).Materials and methods. The calculations included the direct costs of the healthcare system: the costs of drug therapy, detecting and relieving adverse events, palliative care. A Markov model consisting of three patient states (“alive without progression”, “alive with progression”, “death”) was constructed, the probabilities of which were obtained from previously conducted clinical studies. Due to the equivalence of strategies regarding overall and non-progressive survival, the cost minimization analysis was applied.Results. The total costs per 1 patient when using lorlatinib were 40.63% higher than for alectinib (12,551,770 and 7,451,522 rubles, respectively). At the same time, the difference was mainly determined by different costs of targeted therapy: in the alectinib group, the cost of drug therapy per 1 patient amounted to 6,646,247 rubles, in lorlatinib group – to 11,922,814 rubles (44% higher).Conclusion. The use of alectinib in the treatment of patients with ALK-positive NSCLC is justified not only from clinical, but also from an economic point of view.Цель: оценить клинико-экономическую эффективность применения алектиниба в сравнении с лорлатинибом у взрослых пациентов с распространенным положительным на киназу анапластической лимфомы (англ. anaplastic lymphoma kinase, ALK) немелкоклеточным раком легкого (НМРЛ).Материал и методы. При расчетах учтены прямые затраты системы здравоохранения: стоимость лекарственной терапии, выявления и купирования нежелательных явлений, паллиативной помощи. Построена марковская модель, состоящая из трех состояний пациента («жив без прогрессии», «жив с прогрессией», «смерть»), вероятности нахождения в каждом из которых получены по данным ранее проведенных клинических исследований. Ввиду равной эффективности стратегий в отношении общей и беcпрогрессивной выживаемости применен анализ минимизации затрат.Результаты. Суммарные затраты в расчете на 1 пациента при использовании лорлатиниба были на 40,63% выше затрат при применении алектиниба (12 551 770 и 7 451 522 руб. соответственно). При этом разница преимущественно определялась различиями в стоимости таргетной терапии: в группе алектиниба затраты на лекарственную терапию в расчете на 1 пациента составили 6 646 247 руб., в группе лорлатиниба – 11 922 814 руб., что на 44% выше.Заключение. Применение алектиниба в терапии пациентов с распространенным ALK-положительным НМРЛ оправданно не только с клинической, но и с экономической точки зрения

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

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

ОПЫТ РАБОТЫ ГОРОДСКОЙ БОЛЬНИЦЫ СВЯТОГО ВЕЛИКОМУЧЕНИКА ГЕОРГИЯ В УСЛОВИЯХ ЭПИДЕМИИ ГРИППА H1N1 2009 ГОДА

The article presents the experience of conversion multi-disciplinary somatic hospitals in the infectious hospital. In November-December 2009, the hospital carried out 602 care to patients with acute respiratory infections and influenza, 61 had confirmed influenza caused by virus H1N1, of which 43 patients were hospitalized in serious and critical condition and needed resuscitative benefits. Arising from the conversion to ensure that the complexity of medical-diagnostic process and the observance of sanitary-epidemiological rules for patients suffering from the flu, demanded the mobilization of all forces and resources of the hospital, additional equipment, purchases of non-core drugs. We obtained the experience can be a great help in such situations with re-profiling of general somatic hospitals in infection.В связи с превышением эпидемического порога по гриппу и острым респираторным заболеваниям в ноябре 2009 г. в Санкт-Петербурге было осуществлено перепрофилирование многопрофильного стационара СПб ГУЗ «Городская больница Святого Великомученика Георгия» в инфекционный. В ноябре – декабре 2009 г. стационаром осуществлена помощь 602 пациентам с острыми респираторными заболеваниями и гриппом, у 61 был подтвержден грипп, вызванный вирусом H1N1, из них 43 пациента были госпитализированы в тяжелом и крайне тяжелом состоянии и нуждались в проведении реанимационного пособия. Возникшие в связи с перепрофилированием сложности по обеспечению лечебно-диагностического процесса, соблюдению санитарно-эпидемиологических правил в отношении пациентов, больных гриппом, потребовали мобилизации всех сил и ресурсов больницы, дополнительного оснащения, закупки непрофильных лекарственных средств. Полученный опыт может стать хорошим подспорьем в подобных ситуациях при перепрофилировании общесоматических стационаров в инфекционные

Систематический обзор данных реальной клинической практики при COVID-19: неинтервенционные исследования

Introduction. As defined by the Food and Drug Administration, real-world data (RWD) is data related to a patient's health and/or health care delivery, usually collected from various sources as part of real-world clinical practice research.Objective: to describe the feasible and the most sought-after designs of non-interventional real-world clinical practice trials that provide evidence for the efficacy and safety of drug administration in the therapy of novel coronavirus infection.Material and methods. A search strategy for the terms “COVID-19 AND real-life”, “COVID-19 AND real-data”, “COVID-19 AND real-world” was developed to extract articles published between December 1, 2020 and March 12, 2021 from the databases: PubMed/MEDLINE, the Cochrane Database of Systematic Reviews, and the ClinicalTrials.gov database.Results. The search yielded 137 non-repetitive articles, 32 of them were included in the review. All randomized clinical trials (pragmatic and simplified large ones), studies of the effectiveness of laboratory diagnostic methods, medical triage, social distancing and other sanitary and epidemiological measures to cope with the epidemic were excluded.Conclusion. High-quality, non-randomized RWD studies can enhance the external validity of registration randomized clinical trials by complementing them with a broader range of indicators, which is essential in supporting medical and public health decision-making in the COVID-19 pandemic. Введение. По определению, данному Food and Drug Administration, данные реального мира (англ. real-world data, RWD) – это данные, относящиеся к состоянию здоровья пациента и/или оказанию медицинской помощи, обычно собираемые из различных источников в рамках исследований реальной клинической практики.Цель: описание возможных и наиболее востребованных дизайнов неинтервенционных исследований реальной клинической практики, которые позволяют получить сведения об эффективности и безопасности применения лекарственных средств в терапии новой коронавирусной инфекции.Материал и методы. Для извлечения статей, опубликованных с 1 декабря 2020 г., по 12 марта 2021 г., в рамках литературного обзора разработана стратегия поиска по терминам “COVID-19 AND real-life”, “COVID-19 AND real-data”, “COVID-19 AND real-world” в базе данных медицинских публикаций PubMed/MEDLINE, Кокрейновской базе данных систематических обзоров, а также базе данных клинических исследований СlinicalТrials.gov.Результаты. Было найдено 137 публикаций, из них 32 статьи вошли в обзор. Исключены все рандомизированные клинические испытания (прагматические и упрощенные большие), исследования эффективности методов лабораторной диагностики, медицинской сортировки, социального дистанцирования и других санитарно-эпидемиологических мер по сдерживанию эпидемии.Заключение. Высококачественные нерандомизированные исследования в рамках RWD способны усилить внешнюю валидность регистрационных рандомизированных клинических испытаний, дополнив их более широким спектром показателей, что имеет существенное значение при поддержке принятия решений в области медицины и общественного здравоохранения в условиях пандемии COVID-19.

Клинико-экономическая оценка эффективности и безопасности существующей практики проведения периоперационной антибиотикопрофилактики на оcнове фармакоэпидемиологического исследования в многопрофильных стационарах Санкт-Петербурга

A survey conducted in four hospitals located in the city of St. Petersburg revealed that the commonly used perioperative antibiotic prophylaxis (PAP) did not follow (in 88% of cases) the guidelines approved for national clinical practice.Aim. To perform a cost-effectiveness analysis of the commonly practiced PAP among patients with clean, clean-contaminated and contaminated surgical wounds in a multidisciplinary hospital.Materials and methods. The PAP cost-effectiveness analysis was performed using the data from a multicenter epidemiological survey and previously conducted studies. The Markov model was used to compare the effectiveness and safety of the commonly used PAP with that recommended by the clinical practice guidelines. The rate of surgical site infection (SSI) and antibiotic-associated diarrhea (AAD) were chosen for the endpoints.Results. The costs associated with a single case of PAP according to the clinical practice guidelines was 3.5 times less than that associated with the PAP used in the common practice (RUB 4913,67 and 17837,71 respectively). The present analysis demonstrates that the PAP recommended by the clinical practice guidelines was more cost-effective as compared with the commonly practiced PAP.Conclusion. Regular epidemiological monitoring is required to improve effectiveness and safety of the existing PAP practice. Целью исследования является клинико-экономическая оценка эффективности и безопасности существующей практики назначения периоперационной антибиотикопрофилактики.Материалы и методы. На основании данных фармакоэпидемиологического исследования, проведенного в четырех многопрофильных стационарах г. Санкт-Петербурга, оценена реальная практика проведения периоперационной антибиотикопрофилактики (ПАП) инфекций области хирургического вмешательства (ИОХВ), которая в абсолютном большинстве случаев (88%) не соответствовала клиническим рекомендациям. Построена модель анализа решений относительно эффективности и безопасности ПАП в реальной практике в сравнении с ПАП в соответствии с клиническими рекомендациями. В качестве критериев эффективности выбраны частота ИОХВ и число случаев предотвращенной антибиотик-ассоциированной диареи (ААД). Проведен анализ «затраты-эффективность».Результаты. Стоимость одного случая ПАП, проведенной по протоколу, с учетом прямых и непрямых затрат меньше таковой, используемой в реальной практике, более чем в 3,5 раза (4913,67 руб. и 17837,71 руб., соответственно). Анализ «затраты-эффективность» показал, что стратегия применения ПАП по протоколу доминировала перед стратегией проведения ПАП в реальной практике: при меньших затратах она имела наибольший прирост эффективности.Выводы. Для оптимизации потребления АМП с целью ПАП в каждом стационаре необходим периодический фармакоэпидемиологический мониторинг существующей практики проведения ПАП. Соблюдение основных принципов ПАП наряду с мерами инфекционного контроля является одной из возможностей минимизировать затраты, связанные с ее неэффективностью.

Реальная практика проведения клинико-экономических исследований лекарственных средств, входящих в федеральную программу высокозатратных нозологий

Objective: to assess the compliance of the actual practice of conducting clinical and economic research with the requirements applicable in the Russian Federation (RF) when including drugs in the Federal Program of High-Cost Nosologies (HCN).Material and methods. In the CyberLeninka and eLibrary databases, a search was made for clinical and economic studies of medicines included in the HCN list published in the RF in the period from 2011 to June 2021.Results. Information was obtained on 23 published clinical and economic studies of the effectiveness of drugs, which is less than 30% of all drugs included in the HCN program during the specified period. More than half of the studies of chronic disabling diseases had a modeling horizon of 1 year. The sensitivity analysis of the results in over 1/3 of cases considered only the deviation of the price of the strategies under consideration, and in a quarter of cases it was not carried out at all. Only 4 studies evaluated the increase in quality-adjusted life year, although, for chronic disabling diseases, quality of life is one of the key performance indicators.Conclusion. In the RF, less than 30% of the results of pharmacoeconomical studies of drugs included in the HCN Program are published, which does not allow to make adequate evaluation of pharmacoeconomical approaches to its formation. To analyze the effectiveness of the tools used in assessing the economic efficiency of expensive medical technologies, a further retrospective research of the studies conducted in the RF is required.Цель: оценка соответствия реальной практики проведения клинико-экономических исследований действующим в Российской Федерации (РФ) требованиям, предъявляемым при включении лекарственных средств (ЛС) в федеральную программу высокозатратных нозологий (ВЗН).Материал и методы. В базах данных КиберЛенинка и eLibrary проведен поиск клинико-экономических исследований ЛС, включенных в перечень ВЗН, которые были опубликованы в РФ в период с 2011 г. по июнь 2021 г.Результаты. Получены сведения о 23 клинико-экономических исследованиях эффективности ЛС, что составляет менее 30% от всех ЛС, включенных в указанный период в программу ВЗН. Более половины исследований хронических инвалидизирующих заболеваний имели горизонт моделирования 1 год. Анализ чувствительности результатов более чем в 1/3 случаев учитывал только отклонение цены рассматриваемых стратегий, а в 1/4 случаев такой анализ вообще не проводился. Только в 4 исследованиях оценивали прирост лет качественной жизни, несмотря на то что для хронических инвалидизирующих заболеваний качество жизни – один из ключевых показателей эффективности.Заключение. В РФ публикуется менее 30% результатов фармакоэкономических исследований ЛС, включенных в программу ВЗН, что не позволяет в полной мере оценить фармакоэкономические подходы к ее формированию. Для анализа эффективности инструментов, используемых при оценке экономической эффективности дорогостоящих медицинских технологий, требуется дальнейшее ретроспективное изучение проведенных в РФ исследований.