FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology

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Vol 14, No 3 (2021)


281-290 632

Objective: to evaluate the clinical and economic feasibility of opioid therapy based on the analysis of its cost and effectiveness in patients with chronic pain syndrome in pancreatic cancer.

Material and methods. An observational prospective study in parallel groups of patients with chronic pain syndrome associated with pancreatic cancer was carried out. The analysis of cost minimization and cost-effectiveness was applied, as well as pharmacoeconomic modeling, which included the construction of a decision tree in patients receiving morphine sulfate (n=45) and fentanyl TTS (n=45) for pain relief. The sensitivity of the obtained data was assessed using one-way analysis.

Results. It was shown that the treatment of chronic pain syndrome in patients with pancreatic cancer with opioid analgesics as part of combined treatment is the least expensive in the morphine sulfate group (incremental cost-effectiveness ratio 144.93). Based on the results of modeling, the prognostic factors of influence on the cost of analgesic therapy were determined: the cost of combined analgesic therapy, the cost of treatment of adverse reactions, and the cost-effectiveness ratio.

Conclusion. Analgesic therapy of chronic pain syndrome with morphine sulfate in patients with pancreatic cancer is pharmacoeconomically feasible.

291-298 587

Objective: to perform a pharmacoeconomic evaluation of the effectiveness of therapies for metastatic colorectal cancer (mCRC) based on real practical data on medical help for patients with this disease.

Material and methods. The authors performed a comparative cost-effectiveness analysis and the calculation of resource consumption in the application of several options of chemotherapy for mCRC: FOLFOX, FOLFIRI, and FOLFOXIRI; targeted therapy: FOLFOX + bevacizumab, FOLFOX + panitumumab, FOLFIRI + cetuximab, FOLFIRI + aflibercept, regorafenib monotherapy.

Results. The cost-effectiveness parameter, calculated as a ratio of the cost of therapy to the median survival without progression, for chemotherapeutic schemes varied from 108 to 167 thousand rubles and for the targeted therapy schemes – from 223 to 930 thousand rubles. The calculation of resource consumption showed that in the case of a limited budget, 100% of patients can be treated by FOLFOX scheme, or 26% of patients by FOLFOX + panitumumab, or 47% of patients by FOLFOX + bevacizumab; and 100% of patients by FOLFIRI scheme or 11.5% of patients by FOLFIRI + cetuximab (aflibercept). Besides, it was established that in the case of a similar budget, 100% of patients with mCRC can be treated by chemotherapy schemes or a limited number of patients with regorafenib.

Conclusion. The cost of targeted therapy significantly exceeds the cost of chemotherapeutic schemes. Still, considering the gross domestic product per capita in the Russian Federation, they can be an economically feasible investment and the optimum option of therapy

299-310 1648

Background. Spinal muscular atrophies (SMA) are clinically and genetically heterogenous inherited orphan diseases leading to progressive spinal motoneurons degeneration and loss of function. Risdiplam and nusinersen are both authorized in Russia for pathogenic SMA treatment and included in the list of vital and essential drugs.

Objective: health economic evaluation of risdiplam (Evrysdi®) in patients with spinal muscular atrophy.

Material and methods. The health economic analysis was done in accordance with local Russian regulation. Cost-minimization analysis was used. We accounted for direct medical costs of pathogenic treatment of SMA, adverse events correction, and supportive care. Decision tree analysis was used. In budget impact analysis the rise of risdiplam share from 0% to 8.5% during 3 years was modelled. Time horizon was 3 years. Probabilistic sensitivity analysis was done.

Results. Total direct medical costs for risdiplam (53,372,153 rubles for one patient in 3 years) were by 21.1% (14,968,427.82 rubles) lower comparing to nusinersen. The most pronounced difference in favor of risdiplam (41,9%) was during first treatment year. The rise of risdiplam share from 0% to 8.5% during 3 years is associated with lower budget costs by 13.9% in 3 years.

Conclusion. Risdiplam is economically more effective comparing to nusinersen, because having equal effectiveness, it’s use is associated with lower direct medical costs.

311-323 463

Objective: to analyse of medicines prescriptions for federal beneficiaries with circulatory system diseases and to identify the main trends in the implementation of the federal program for the provision of necessary medicines in the Samara Region in 2014–2017.

Material and methods. The authors reviewed the nomenclature of medicines used to treat circulatory system diseases (CSDs) and distributed to the population of the Samara Region as part of the federal program for the provision of necessary medicines for the period from 2014 to 2017. The methods of comparative, retrospective, logical, graphical and content analysis, the method of data grouping according to Anatomical Therapeutic Chemical classification and methods of descriptive statistics were used.

Results. In 2014–2017 the share of financial costs for the purchase of medicines in the total budget of the federal program for the provision of necessary medicines in the Samara Region did not exceed 6%. Still, in physical terms (in terms of the number of packages) the share of medicines of this pharmacotherapeutic group in the federal program for the provision of necessary medicines averaged about 25%. Nomenclature of medicines of the analyzed group prescribed to federal beneficiaries in 2014–2017 ranged from 90 to 107 nomenclature items. The number of international nonproprietary names (INN) decreased from 51 in 2014 to 36 in 2017. During the period under review, there was a decrease in the acquisition cost of medicines for the treatment of circulatory system diseases and the weighted average cost of one package (by 63% and 53%, respectively).

Conclusion. Perindopril-containing medicines occupied the maximum consumption volumes in monetary terms. There was a decrease in the average cost of one package in 2017, which may be associated with the replacement of original medicines with generics and a concomitant reduction in the number of INN within the subgroup.

324-333 419

Objective: to evaluate behavioral risk factors (BRF) in patients with arterial hypertension (AH) and to determine the ways of improvement of the approaches to preventive consulting targeted to increase medico-economic efficiency of the prevention of cardiovascular diseases (CVDs).

Material and methods. A total of 107 patients aged 40–60 years old that attended health-promoting schools for patients with AH at the institutions of primary medical help in Moscow in 2017–2019 were surveyed. The authors used diagnostic criteria of the risk factors for noncommunicable diseases that have behavioral character according to the classification of the World Health Organization (WHO). Along with that, the authors reviewed the opinion of 128 top managers of the institutions of primary medical help that attended the courses of their qualification improvement “Organization of public healthcare” in 2019. The course was dedicated to the possible ways of improvement of preventive consulting of patients with AH and BRF. The methods of content analysis, synthesis, statistical analysis, comparison, etc. were applied. The authors analyzed the documentation on the prevention of CVDs, scientific publications on the subject from eLibrary, Cochrane Library, PubMed, Scopus databases, and official sites of biomedical journals.

Results. The sociological survey revealed data on the presence of BRF of non-communicable diseases in patients aged 40–60 years old with verified AH based on scientifically proven criteria and WHO classification. These criteria allowed to evaluate the degree of the proneness of patients with AH to the influence of harmful risk factors (smoking, alcohol consumption, lack of physical activity, unhealthy eating habits) and their combinations. The sociological survey data obtained from the top management of institutions of primary medical help indicated the necessity of the improvement of approaches to group preventive consulting of patients with AH and BRF.

Conclusion. The results of the study revealed the main areas of the systemic mistakes in the preventive consulting of patients with AH that have BRF, associated with the evaluation of individual-psychological peculiarities of a personality, and in the organizational aspects of preventive counseling.

334-341 421

Objective: to assess the expenditure of financial resources allocated for drug provision to the rheumatology department of the state clinical hospital.

Material and methods. The materials of the study are statistical reporting data on the expenditure of financial resources for the purchase of drugs for the Rheumatologic Department of Semashko Republican Clinical Hospital (Simferopol) for the period from June 2018 to May 2020. Based on the obtained results, a pharmacoeconomic assessment of the budgetary funds expenditure was carried out using ABC/VEN analysis.

Results. The total expenditure on the procurement of drugs for rheumatology department was 5,308,775.23 rubles. The list of medicines for the department included 50 items. The ABC analyses revealed that 80% of the budgetary funds (A class) were spent on 4 drugs included in the standards of pharmacotherapy for rheumatic diseases. According to VEN analysis all of them were classified as V category (vitally important).

Conclusion. The results revealed a high efficiency of the implementation of the state program of drug provision to the Rheumatologic Department of Semashko Republican Clinical Hospital. 

342-356 2754

Background. Prediction of the new coronavirus infection (COVID-19) spread is important to take timely measures and initiate systemic preventive and anti-epidemic actions both at the regional and state levels to reduce morbidity and mortality.

Objective: to develop a model for short-term forecasting of COVID-19 cases and deaths in the Russian Federation.

Material and methods. The data for the model training were collected from the Stopcoronavirus.rf and Johns Hopkins University portals. It included 13 features to assess the infection dynamics and mortality, as well as the rate of morbidity and mortality in different countries and certain regions of the Russian Federation. The model was trained by the CatBoost gradient boosting method and retrained daily with updated data.

Results. The forecast model of COVID-19 cases and deaths for the period of up to 14 days was created. The mean absolute percentage error (MAPE) estimate of the model’s accuracy ranged from 2.3% to 24% for 85 regions of the Russian Federation. The advantage of the CatBoost machine learning method over linear regression was shown using the example of the root mean square error (RMSE) value. The model showed less error for regions with a large population than for less populated ones.

Conclusion. The model can be used not only to predict the pandemic of the novel coronavirus infection but also to control and assess the spread of diseases from the group of new infections at their emergence, peak incidence, and stabilization period.


357-364 1295

The article provides an overview of global trends in various treatment approaches for COVID-19 in terms of pharmacoeconomic effectiveness. Different strategies for managing patients with the new coronavirus infection, separate groups of drugs are considered. The current clinical trials for COVID-19, the main directions, problems and challenges facing the healthcare system are discussed in detail. The aspects of the economic efficiency of various measures to prevent the spread of COVID-19 are presented. A thorough study of the pharmacoeconomic features of the new coronavirus infection will allow to develop effective standards for planning the process of supply for medical organizations in the pandemic.

365-378 590

Objective: to review clinical and economic studies on the pre-dialysis stage of chronic kidney disease (CKD) and the cost-effectiveness of medical interventions used to detect CKD and prevent its progression.

Material and methods. Articles were collected from the bibliographic databases PubMed, Cochrane Library and eLibrary for 2010–2020. Keywords for the search: ‘chronic kidney disease (CKD)’, ‘cost-effectiveness’, ‘economic evaluation’, ‘economic burden’, ‘cost’, ‘healthcare’. After the selection and elimination of the repeated articles, we reviewed 36 Russian and foreign studies on the economic burden of CKD and the clinical and economic effectiveness of various medical interventions of the CKD pre-dialysis stage.

Results. We found 21 studies on the economic burden of CKD. A significant part of them (n=6) was performed in the United States.The methodology for assessing the economic burden varied significantly from study to study. Studies on medical interventions at the CKD predialysis stage can be divided into three groups: Group 1 (n=9) – studies on the clinical and economic effectiveness of screening programs; Group 2 (n=3) – studies on the clinical and economic effectiveness of nephroprotectors and other drugs that slow down the course of CKD; and Group 3 (n=3) – studies on the clinical and economic effectiveness of multidisciplinary care. We concluded on the clinical and economic feasibility of most interventions that were used to detect CKD and prevent its progression.

Conclusion. We did not find any scientific data that could currently serve as a justification for the clinical and economic feasibility of CKD control programs in the Russian Federation. At the same time, studies conducted in foreign countries on the screening for CKD and some interventions aimed at slowing the progression of CKD suggest that in the Russian Federation, such approaches can be justified not only clinically, but also economically. It is necessary to conduct domestic research on the clinical and economic feasibility of interventions aimed at identifying and treating CKD at an early stage.

379-406 511

The review of medical literature is devoted to modern data in the field of diagnosis and treatment of osteoarthritis using endo- and phenotyping. It includes the latest data on the epidemiology of osteoarthritis of different localizations, modern definitions and classifications of osteoarthritis endotypes and phenotypes, pathobiochemical patterns and pathomorphological parallels of disease phenotypes, new methodological approaches to the phenotyping of osteoarthritis (prognostic, prescriptive phenotyping, alternative methods), as well as modern advances in pharmacotherapy of the disease based on data from selected randomized controlled trials and meta-analyzes.

407-414 373

Osteoarthritis is considered a peripheral joint disease and is often ignored when discussing the prevalence and treatment of back pain. Traditionally, clinical guidelines from various countries are devoted to the treatment of nonspecific back pain (lower back pain), although this diagnosis is syndromic and is absent in ICD-10. Therefore, in real clinical practice, such diagnoses as osteochondrosis and dorsopathy simultaneously exist. The treatment strategies for back pain do not take into account chronic inflammation directly related to pro-inflammatory cytokines and oxidative stress, which makes drug therapy ineffective. It is advisable from the first days of therapy to choose parenteral forms from the group of symptomatic slow-acting drugs containing chondroitin sulfate (Chondroguard®), which will accelerate the onset of the analgesic effect and increase the effectiveness of pathogenetic therapy.

415-422 465

The article presents a review of current and alternative methods for planning the scope and financing of medical care in the subjects of the Russian Federation. The relevance of the issue is due to the imperfection of the current planning model, which stimulate representatives of the profile bodies and independent experts to develop alternative methods. The current approaches and legal documents regulating the procedure for distributing the scope of medical care and financial resources to pay for this care are discribed. The analysis of alternative methods shows how different demographic and infrastructural features of regions can be used to redistribute the scope of medical care and the corresponding financial support.

423-444 424

The aim of the three-report review is the historical development of clinical trials, controlled trials (CT) and randomized controlled trials (RCT), and the inclusion of these approaches in health-related disciplines (Medicine and Epidemiology). Report 2 provides a description of the wellknown James Lind Library (JLL), as well as a formed database of sources on the theme. JLL was internationalized, although most of the papers belong to authors from the UK. Many studies on the history of CT and RCT are reflected in JLL publications, but remain unclaimed without changing on common milestones and priorities. Besides, the formed base of sources included 9 studies not reflected in the JLL, of which three are principled. Six of them are given in Report 2.

Half of historical milestones on the theme (168 in total) belong to the United Kingdom, 23% to the United States, and 4% to the Italy. The remaining 19 countries, ancient, medieval and modern, contribute 0.6–4% (Russia – 1.2% by the 20th century). The earliest source on the history of CT is J.P. Bull’s dissertation (1951). The formed database as of July 2020 contained more than 260 publications, and only 9 of them were Russian (2005–2018). The base includes 7 western dissertations on the history of CT.

The object of the Report 2 study was CT as such, without any attempts at randomization or even quasi-randomization by alternate allocation. The most comprehensive thematic table on non-randomized CTs has been compiled, including studies from the Chinese emperor Shen Nung (2373 BC) and the prophet Daniel (6th century BC), to BCG vaccination for children of Canadian Indians (1941–1949). PubMed search on ‘non-randomized controlled trial’ was made. For the period of 1990–2020 years, 303 publications were found (up to 32 papers in 2020). Compared to RCT, the number of such studies is small (estimated at 0.08%), but it is important to have an appropriate conjuncture in the modern period. Along with the fact that most of the drugs and therapies currently in use are developed without RCT, the revealed ‘immortality’ of CT, even without quasi-randomization, can have social significance, removing complexes and embarrassment in cases where neither RCT nor even quasi-RCT is possible, but social and public needs require the immediate receipt of at least an approximate answer to hot questions of public health (for example, in 2020).

ISSN 2070-4909 (Print)
ISSN 2070-4933 (Online)