Научно-практический журнал Медицинские технологии. Оценка и выбор
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Issue № 1 | 2019 (35)

DOI: https://doi.org/10.31556/2219-0678.2019.35.1.087-102 meta

Abstract

Aim. To assess the economic outcomes of using vinflunine in combination with the best supportive therapy (BST) in the treatment of patients with urothelial transitional cell carcinoma (UTCC) and ineffectiveness of chemotherapy with a cisplatin-containing combination of drugs and the inability to use immuno-oncological drugs.

Methods. The economic impact assessment was carried out using cost-effectiveness analysis and budget impact analysis. Cost-effectiveness and budget impact analyses were performed in Microsoft Excel models.

Results. The use of vinflunine in combination with BST in the second-line chemotherapy of UTCC, compared with using BST only, increases the life expectancy of patients – overall survival (OS) with vinflunine + BST was 6.9 months, only with BST was 4.3 months. The amount of additional costs to achieve one unit of efficiency (ICER) when using vinflunine in combination with BST amounted to 190 920 rubles for one added month of life, which is 61.7% lower compared to the reference ICER for pembrolizumab (the drug is included in the drug list). As a result of the analysis of the “impact on the budget”, it was shown that the use of therapy with vinflunine requires additional financial costs for a course of treatment in the amount of 49 639 191 руб. (57,76%) for the first year, 138 516 980 руб. (80,03%) for the second year and 263 841 866 руб. (88,91%) for the third year of the analyzed introduction of vinflunine into the structure of drug provision for patients with UTCC in the Russian Federation, based on the calculation of the need for 586 patients per year.

Conclusion. Based on the analysis, it was shown that therapy with vinflunine combination with BST is a cost-effective and preferred alternative compared to BST for treating patients with urothelial transitional cell carcinoma and ineffectiveness of chemotherapy with a cisplatin-containing combination of drugs and the inability to use immuno-oncological drugs.

Keywords

urothelial transitional cell carcinoma, vinflunin, chemotherapy, maintenance therapy, budget impact analysis, cost-effectiveness analysis.

For citations

Nedogoda S.V., Rogov V.A., Salasyuk A.S., Frolov M.Yu. Pharmacoeconomic Analysis of Vinflunine in Patients With Urothelial Transitional Cell Carcinoma Resistant to Platinum-Based Regimens. Medical Technologies. Assessment and Choice. 2019; 1(35): 87–102.

Issue № 1 | 2019 (35)

DOI: https://doi.org/10.31556/2219-0678.2019.35.1.074-085 meta

Abstract

Objective: Based on the cost-effectiveness analysis (CEA) to determine economic and clinical consequences of using mepolizumab instead of omalizumab in adults with severe eosinophilic asthma, when omalizumab is administered once every 2 weeks or mepolizumab is administered once every 4 weeks.

Methods: Effectiveness and safety analysis was conducted based on the published network meta-analysis, because head-to-head clinical trials of omalizumab versus mepolizumab were not identified during targeted scientific literature search. Direct medical costs were calculated using information from the register of manufacturers` maximum selling prices for vital and essential drugs (VED), instructions for medical use, the unit cost of healthcare services.

Results: Effectiveness and safety of the compared drugs were determined based on the results of the network meta-analysis. Frequency of clinically significant asthma exacerbations (risk ratio = 0,19; 95% CI: 0,02–2,32) and withdrawals due to adverse events (risk ratio = 0,05; 95% CI: 0,002–0,95). Therefore, despite the tendency to mepolisumab benefits, it was concluded that there are no statistically significant differences in the effectiveness and safety of the compared drugs due to the insufficient statistical power of the result. Direct medical costs were 870130 rubles and 1852063 rubles for mepolizumab and omalizumab respectively. Saving of direct medical costs for mepolizumab treatment was 959170 rubles per patient per year or 52%.

Conclusion: treatment with mepolizumab versus omalizumab in patients with severe eosinophilic asthma, when omalizumab is administered once every 2 weeks or mepolizumab is administered once every 4 weeks, leads to saving of direct medical costs for drug treatment.

Keywords

cost-effectiveness analysis, pharmacoeconomic analysis, budget impact analysis, cost-effectiveness, omalizumab, mepolizumab, severe asthma.

For citations

Tolkushin A.G., Pogudina N.L., Ivanov D.A., Demko I.V. Cost-Effectiveness Analysis of Treatment for Severe Eosinophilic Asthma in Adults: Mepolizumab and Omalizumab. Medical Technologies. Assessment and Choice. 2019; 1(35): 74–85.

Issue № 1 | 2019 (35)

DOI: https://doi.org/10.31556/2219-0678.2019.35.1.066-073 meta

Abstract

Introduction. In 2018 the Federal Order of 03.08.2018 No. 299-FO was adopted, whereby the provision of drugs for the treatment of systemic juvenile idiopathic arthritis (sJA) was delegated to the federal level.

Aim. In accordance with the requirements for the development of formularies of medicines, approved by Decree of the Government of the Russian Federation No. 871, the budget impact analysis of inclusion in the expensive drugs list of canakinumab for the treatment of sJA was conducted.

Material and methods. The drug costs were calculated based on the manufacture`s maximum selling price inclusive of all taxes and additional charges according to the legislation of the Russian Federation. Characteristics and the size of the target population of patients diagnosed with sJA were determined based on the data from different sources – clinical trials, registries, standards, of medical care, experts` judgment. The time horizon of the analysis is 1 year and 3 years. The sensitivity analysis was performed to test how results affected by changes in key assumptions such as drug price and size of the target population.

Results. The budget impact analysis revealed that provision for the target population of canakinumab for the treatment of sJA does not require a significant increase in the programme budgeting of costly diseases. The insignificant increase is required for the programme budgeting equal to the amount of 1,588 billion per year, which is 4% less than the 2018 budget.

Conclusions. Assurance of centralized purchasing of canakinumab from federal budget resources is in harmony with the financing capacity of costly diseases programme, extended from 2019, to cover canakinumab reimbursement for patients with sJA.

Keywords

systemic onset juvenile arthritis (sJA), canakinumab, costly diseases programme, budget impact analysis.

For citations

Derkach E.V. Budget Impact Analysis of Inclusion in the Expensive Drugs List of Canakinumab for Treatment of Systemic Onset Juvenile Arthritis. Medical Technologies. Assessment and Choice. 2019; 1(35): 66–73.

Issue № 1 | 2019 (35)

DOI: https://doi.org/10.31556/2219-0678.2019.35.1.056-065 meta

Abstract

The authors have developed and formed a holistic “Quality management and patient safety in surgery program” (Program) structural components and technological elements of a systematic approach to the safety of surgical patients. The Program is based on the coordinated implementation of a wide range of modern sections of the health care system: from the introduction of the principle of standardization, the use of advances in evidence-based medicine, the use of advanced surgical technologies, the development of innovative forms of management and informatization, to issues of efficiency and high social efficiency. The Program is designed to be the base for ensuring the proper quality and the highest possible level of safety in the treatment of surgical patients in any health facilities with surgical services, by optimizing the quality management process.

Keywords

patient safety, quality management, surgery, program.

For citations

Karsanov A.M., Polunina N.V., Gogichaev T.K. Patient Safety in Surgery. Part 2: Surgical Treatment Quality Management Program. Medical Technologies. Assessment and Choice. 2019; 1(35): 56–65.

Issue № 4 | 2018 (34)

DOI: https://doi.org/10.31556/2219-0678.2018.34.4.083-086 meta

Abstract

Modern data on cicatricial pathology of the skin is presented. Scar classifications, features of clinical manifestations of their pathomorphological aspects are analyzed in detail. The problem of correctly assessing the outcome of cicatricial deformities of the skin at an early stage of its formation is relevant, since in most cases patients with cicatricial deformities need surgical or conservative treatment at the early stages of its formation. A new version of the classification with a qualitative and quantitative assessment of the scar tissue should be developed using the study of its microcirculation and endogenous fluorescence at different periods of scar tissue formation to select clear indications and scar correction time.

Keywords

scar, classification, hypertrophic scar deformation, keloid cicatrix, pathogenesis of cicatrix.

For citations

Andreeva V. V., Kuzmina E. N. Modern View on Classification of Cicatricial Skin Deformations. Medical Technologies. Assessment and Choice. 2018; 4(34): 83–86.

Issue № 4 | 2018 (34)

DOI: https://doi.org/10.31556/2219-0678.2018.34.4.063-075 meta

Abstract

The aim of this study was to estimate the socio-economic burden of lung cancer (LC) in the Russian Federation.

Methodology: the social burden of LC is defined as the number of patients newly diagnosed with LC in 2016, those who are followed-up in oncology clinics, disabled and deceased persons. The economic burden consists of total direct and indirect costs associated with LC and estimated from a government perspective. Direct medical costs include costs for diagnosis, inpatient and outpatient treatment, palliative care, follow-up costs, and expenditures for the subsidized drug coverage. Direct non-medical costs include payments for sickness and disability caused by LC. Indirect costs were calculated as a loss of a gross domestic product due to LC morbidity and mortality. Calculations were based on the methods described in Ignatieva V. I. et al. (2014) and adapted by the authors of this study to new methods of inpatient medical care payment. Indirect costs were calculated by the friction cost method. The sensitivity analysis was conducted to estimate the impact of initial parameters` variations, as well as the impact of indirect costs estimation with the human capital methods, on the results.

Results. In 2016, medical care was provided to 185,631 patients with LC, of whom 51,768 (27.9%) were newly diagnosed during the year. Direct medical costs were about 6.83 billion rubles. Most costs were incurred in inpatient care (4.09 billion rubles, 60.0%) and for the subsidized drug coverage (1.49 billion rubles, 21.8%). Direct non-medical expenses were about 5.76 billion rubles, 5.16 billion (89.7%) were disability-related payments. Indirect costs were about 14.77 billion rubles (friction cost method).

Keywords

socio-economic burden, lung cancer, cost of illness, direct medical costs, direct non-medical costs, indirect costs, subsidized drug coverage.

For citations

Avxentyeva M. V., Gorkavenko F. V., Nikitina A. V., Savilova A. G., Gerasimova К. V., Musina N. Z., Omelyanovskiy V. V. Estimation of Socioeconomic Burden of Lung Cancer in the Russian Federation. Medical Technologies. Assessment and Choice. 2018; 4(34): 63–75.

Issue № 4 | 2018 (34)

DOI: https://doi.org/10.31556/2219-0678.2018.34.4.056-062 meta

Abstract

To improve the management of patients with diabetes mellitus (DM), a change to the current system of reimbursement for completed case treatment of this group of patients, followed-up in the outpatient departments of the hospitals, based upon obligatory health insurance fund was introduced. A new Diagnosis-Related Group (DRG) «Follow-up of patients» was proposed and proved to be listed in the medical register. Calculations based on the model of a patient with DM, who needs to be followed up and potentially has been diagnosed with complications of the disease. The model includes a patient’s stay in an outpatient department of the hospital for three days to be diagnosed and treated.

Keywords

diabetes mellitus, management and follow-up of patients, medical register, reimbursement for completed case treatment, diagnosis-related group.

For citations

Shestakova M. V., Zelenova O. V., Yarek-Martynova I. Ya., Abramov S. I., Vikulova O. K., Karpov O. I. Modelling of Healthcare Expenditures on Management of Patients with Diabetes Mellitus for Reimbursement under Diagnosis-Related Groups. Medical Technologies. Assessment and Choice. 2018; 4(34): 56–62.

Issue № 4 | 2018 (34)

DOI: https://doi.org/10.31556/2219-0678.2018.34.4.047-055 meta

Abstract

The article is devoted to the search for the fundamental bases for the effective solution of the problem of the safety of surgical patients (SSP), which becomes a key direction in improving the surgical services of each medical organization. The definition of SSP is proposed as a complex concept combining progressive educational, clinical and managerial technologies aimed at preventing the negative consequences of surgical treatment, based on their internal connections and general development prospects. This allowed to justify the implementation of an integrated approach to its solution in practice.
Obligatory components of the organizational structure of such an approach are: informational-legal, educational-motivational, surgical (perioperative), control-administrative and organizational. The necessary technological processes for this are considered by the authors: standardization, creation of a single legal and educational platform for all subjects of medical law, personnel management, the process principle of technology implementation, risk management, improvement of information support. The unity of the components and elements of the SSP program is harmonized with the principle of mutual potentiation of their specific requirements, which are consistent with the main goal – the restoration of the patient’s health.

Keywords

patient safety, surgery, conceptual framework, integrated approach, system organization, program.

For citations

Karsanov A. M., Polunina N. V., Gogichaev T. K. The Safety of Patients in Surgery. Part 1: Conceptual Basis of the Problem. Medical Technologies. Assessment and Choice. 2018; 4(34): 47–55.

Issue № 4 | 2018 (34)

DOI: https://doi.org/10.31556/2219-0678.2018.34.4.039-046 meta

Abstract

Aim. To measure comprehensive indicators of consumption in order to assess their correlation with the level of resistance of S. aureus, K. pneumoniae, E. coli in multidisciplinary hospitals of St. Petersburg in 2014–2016.

Materials and methods. We extracted data on the public procurement of antimicrobial drugs for systemic use (ATC code J01) in multidisciplinary hospitals of St.-Petersburg in 2014–2015 from IMS Health database. Prevalence of resistant strains was assessed based on the results of bacteriological surveys, St. Petersburg Medical Information-analytical Center (MIAC). The indicators of antimicrobial drugs consumption, drug resistance, drug resistance index were calculated.

Results. The structure of public procurement of antimicrobial drugs does not correlate with the the prevalence of multi-resistant infections in St. Petersburg hospitals as a result of out-dated standards for specialized medical care. Current epidemiological situation requires purchasing of the the expensive antimicrobial drugs of limited access and performing epidemiological control measures that demand additional investments.

Conclusion. The existing standards for specialized medical care should be timely updated with regard to recommendations on antibacterial treatment in accordance with the current epidemiological situation.

Keywords

antimicrobial drug, bacterial resistance, drug resistance index.

For citations

Gomon Y. M., Kolbin A. S., Svetlichnaya Y. S., Proskurin M. A. Comprehensive Assessment of Antimicrobial Drug Consumption at the St. Petersburg Hospitals in 2014-2016. Medical Technologies. Assessment and Choice. 2018; 4(34): 39–46.

Issue № 4 | 2018 (34)

DOI: https://doi.org/10.31556/2219-0678.2018.34.4.025-038 meta

Abstract

Objective. Cost-effectiveness analysis (CEA) of elbasvir in combination with grazoprevir (EBR/GZR) for the treatment of patients with chronic hepatitis C (CHC), infected with genotype 1 subtype b, who previously did not receive antiviral therapy (AVT), without cirrhosis or with compensated cirrhosis, from a Russian healthcare system perspective.

Methods. In a model, developed in MS Office (Microsoft Excel® package), the differences in direct medical costs were determined (using cost minimization analysis) by comparing EBR/GZR and 3D (the combination of ombitasvir, paritaprevir, ritonavir, and dasabuvir), which have comparable effectiveness in patients with chronic hepatitis C (genotype 1b). Besides, changes in costs for the treatment of patients with CHC (genotype 1b), if EBR/GZR are reimbursed, are analysed under the State-guaranteed benefit package (SGBP) for free medical care for the citizens of the Russian Federation (budget impact analysis). Frequencies of long-term consequences of CHC (number of cases of decompensated cirrhosis and hepatocellular carcinoma) were projected in the long run depending on whether AVT is administered or not, for 20 years or lifetime time horizon. For calculations, data from literature and standard financial expenditures in Russian healthcare system in 2018 were used. Univariate (one-way) sensitivity analysis was conducted to assess the impact in the price change of EBR/GZR package on the results of the analysis.

Results. Average cost per patient for therapy with EBR/GZR was 510 142 rubles, or 21% less than for therapy with 3D that was 645 614 rubles. If EBR/GZR are included in Vital and Essential Drugs List (VED), expenditures under SGBP for treatment of CHC (genotype 1b) are expected to decrease by 16,1% in three years: by 9,4% in the first year, 15,7% in the second year and by 21% in the third year.

Conclusions: Using EBR/GZR in clinical practice is efficient and leads to an improvement in the competitiveness in the field. It also allows reducing the additional healthcare system expenditures on direct-acting antiviral agents (DAAA) in AVT of CHC, and provides highly-effective therapeutic regimes under SGBP for patients without increasing the budget. Greater accessibility of DAAA (EBR/GZR and 3D) within the Russian healthcare system and increased availability of these drugs for the patients will lead to a significant decrease in incidence of such severe and costly consequences of hepatitis as decompensated cirrhosis and hepatocellular carcinoma in comparison with no treatment in the long run.

Keywords

chronic hepatitis C, antiviral therapy, direct-acting antiviral agents, elbasvir, grazoprevir, ombitasvir, paritaprevir, ritonavir, dasabuvir, cost-effectiveness analysis.

For citations

Pyadushkina E. A., Derkach E. V., Boyarskaya T. V., Zhdanov K. V., Kozlov K. V. Cost-effectiveness analysis of elbasvir and grazoprevir for treatment of adult patients with chronic hepatitis C (genotype 1b) from Russian Healthcare system perspective. Medical Technologies. Assessment and Choice. 2018; 4(34): 25–38.