Научно-практический журнал Медицинские технологии. Оценка и выбор
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Issue № 1 | 2020 (39)

DOI: https://doi.org/10.31556/2219-0678.2020.39.1.080-089 meta

Abstract

The only source of financing for immunoglobulin replacement therapy needed by patients with primary immunodeficiencies (PID) in Russian Federation is the compulsory health insurance system: payment is based on diagnosis-related groups (DRG), including the DRG for immunoglobulin treatment at day care and inpatient setting. PID are not included either into regional program for rare diseases, or into federal program of 12 high-cost diseases. This leads to limited coverage of patients with effective drug treatment. Furthermore, currently in Russian Federation there is no neonatal screening for PID, which could facilitate early detection of the disease and timely start of treatment.

Goal of the study: to conduct the analysis of cost and effectiveness of different scenarios of drug provision for the patients with PID, which differ in coverage of patients with therapy and by presence/absence of neonatal screening.

Materials and methods. The model compared three scenarios of drug provision for patients with PID: a) current practice, when in accordance with available data not all patients get necessary immunoglobulin replacement therapy, b) new scenario 1 – financing of drugs for all registered patients with PID when large-scale neonatal screening for PID is absent; c) new scenario 2 – financing of drugs for all registered patients with PID when large-scale neonatal screening is implemented. In each scenario direct medical costs and number of prevented deaths was calculated. Comparison of scenarios was planned to be made by calculation of additional costs per prevented death due to PID, or by assessment of difference of costs and effectiveness (number of prevented deaths) with identification of a dominant scenario.

Results. Both new scenarios including financing of drugs for all registered patients with PID lead to the prevention of significant number of deaths and also to cost savings if compared with current practice. Total costs for current, 1st new and 2nd new scenario for 15 year was^ 2 285,54, 616,49 and 1 318,61 billions of rubles respectively. Also when comparing 1st and 2nd new scenarios with current practice we expect prevention of 243 and 2076 deaths respectively.

Conclusion. Most effective approach is the introduction of large-scale neonatal screening for PID combined with the new source of financing: this scenario saves less money, but helps to prevent highest number of deaths compared with current practice. This scenario can prevent deaths of patients who would not have been diagnosed with PID in the absence of screening, and also helps to save healthcare system budget by centralization of government procurement of drugs.

Keywords

primary immunodeficiency, PID register, neonatal screening for PID, direct medical costs, cost and effectiveness analysis.

For citation

Teptsova T.S., Fedyaeva V.K., Nikitina A.V. Different Scenarios of Providing Drugs for Patients with Primary Immunodeficiency in Russia: Analysis of Costs and Effectiveness. Medical Technologies. Assessment and Choice. 2020; (1):80–89. DOI: 10.31556/2219-0678.2020.39.1.080-089

Issue № 1 | 2020 (39)

DOI: https://doi.org/10.31556/2219-0678.2020.39.1.070-079 meta

Abstract

Objective: to conduct pharmacoepidemiological analysis and analysis of the costs of pharmacotherapy, taking into account the actual consumption of drugs in the real inpatient clinical practice at the federal center in Russia.

Materials and methods. Data from the medical records of 14 patients with burn injury, who were hospitalized in 2018, was analyzed. Patients’ age was from 23 to 67 years (44,93 ± 14,66). Duration of hospitalization was from 17 to 62 days (35,93 ± 14,17). We calculated rate of prescription foe each drug and its share in general structure of all utilized drug courses (n = 460). We performed frequency analysis of prescription structure, DDD (defined daily doses) analysis, DU90% (Drug Utilization 90%) analysis, ABC-analysis and analysis of average cost of pharmacotherapy.

Results. Most frequently used drugs, prescribed in 75-100% of all hospital cases, included 15 names, e.g. 2 antimicrobial drugs (vancomycin and amikacin), 19 were used commonly, including 4 antimicrobial drugs (co-trimoxazole, cefoperazone/sulbactam, tigecyclin and cefepime). Other drugs were used in less than 25% of cases. 33 drugs made 90% of all consumed NDDD, including 5 antimicrobial drugs (vancomycin, amikacin, co-trimoxazole, cefoperazone/sulbactam and tigecyclin). These drugs comprised 70,24% in the prescription structure. The cost of one DDD in DU90% segments (512,33 rubles) is 1,4 higher than in DU10% segment (649,34 rubles). Average cost of drugs included in DU90% group was 4735,89 rubles vs 4966,80 rubles for drugs from DU10% group. This finding shows positive tendency of burn injuries pharmacological treatment.

Conclusion. We obtained the data, which can be used for comparison of real clinical practice costs with a current payment rates for medical care.

Keywords

burn injury, pharmacotherapy, pharmacoepidemiological analysis, drugs assignment structure, DDD-analysis, DU90% analysis, ABC analysis, drugs consumption, pharmacotherapy costs.

For citation

Zhukova O.V., Nekaeva E.S., Khoroshavina E.S., Kozlova E.A., Dudukina Y.A., Arefyev I.Y. Pharmacoepidemiological Analysis of Pharmacotherapy for Burn Injuries in Real Clinical Practice. Medical technologies Assessment and Choice. 2020; (1):70–79. DOI: 10.31556/2219-0678.2020.39.1.070-079

Issue № 1 | 2020 (39)

DOI: https://doi.org/10.31556/2219-0678.2020.39.1.061-069 meta

Abstract

Objective: to assess the cost of the severe bronchial asthma (BA) treatment with various biological agents at inpatient and day care setting from the compulsory medical insurance (CMI) system perspective.

Methods. The authors constructed the MS Excel® analytical decision-making model and calculated the CMI system’s costs of severe BA treatment with various biological drugs at inpatient and day care setting. The costs of treatment with benralizumab, dupilumab, omalizumab, reslizumab and mepolizumab were compared. The cost difference between benralizumab and other drugs was identified taking into account the frequency of the drugs’ administration. The first administration was assumed to be inpatient, followed by the administrations in day care ward.

Results. The use of benralizumab reduces the expenses of the CMI system by 0.8 million rubles per patient (–39%) compared with omalizumab, mepolizumab, resizumab and by 2.9 million rubles per patient (–69%) versus dupilumab due to the lowest frequency of administration, therefore less hospitalizations for therapy. With a 5-year modeling horizon, benralizumab therapy allows to reduce the CMI system expenses by 4.5 million rubles (–48%) compared with omalizumab, mepolizumab, reslizumab and by 13.9 million rubles (–74%) compared with dupilumab. The use of benralizumab will release 5–7 cases per patient per year compared to omalizumab, resizumab and mepolizumab and 18–20 cases per patient per year compared to dupilumab.

Conclusion. Benralizumab therapy in patients with severe BA in inpatient and day care settings will lead to the optimization of CMI expenditures and more rational use of budgets allocated to hospitals.

Keywords

bronchial asthma, genetic engineering biological therapy, benralizumab, omalizumab, mepolizumab, reslizumab, dupilumab, cost analysis.

For citation

Nedogoda S.V., Salasyuk A.S., Barykina I.N., Smirnova V.O., Frolov M.Yu. Сost of the Biologacal Therapy for Severe Brochcial Asthma Treatment at Inpatient and Day Care Setting. Medical technologies. Assessment and Choice. 2020; (1):61–69. DOI: 10.31556/2219-0678.2020.39.1.061-069

Issue № 1 | 2020 (39)

DOI: https://doi.org/10.31556/2219-0678.2020.39.1.055-060 meta

Abstract

Existing approaches to the implementation of cost-sharing agreements in the Russian Federation are described. Such agreements are used in practice to limit budget expenditures while improving access to modern drug therapy for patients. Presently, innovative models of drug provision are not directly mentioned in federal legislation and are not covered by special legal regulation; therefore, they are regulated by the general rules of the applicable law. The authors propose approaches to determining the juridical nature of cost-sharing agreements, analyze the organizational schemes used in practice and assess their compliance with different legislative fields: civil law, legislation on the protection of competition, law on the contract system in the procurement of goods and services for state and municipal needs, and the law on obligatory medical insurance. The results of the analysis can be used in the implementation of cost-sharing agreements in the daily activities of medical organizations and public health authorities of the Russian Federation.

Keywords

cost-sharing agreements, co-financing, innovative models, legislation, public procurement.

For citation

Zheleznyakova I.A., Fyodorov A.A. Approaches to Increasing Access to Innovative Drugs Based on Cost-sharing Agreements. Medical Technologies. Assessment and Choice. 2020; (1):55–60. DOI: 10.31556/2219-0678.2020.39.1.055-060

Issue № 1 | 2020 (39)

DOI: https://doi.org/10.31556/2219-0678.2020.39.1.048-054 meta

Abstract

The article is devoted to the development of conceptual approaches to training of personnel for the implementation of lean production technologies in medical organizations – one of the modern directions of optimization of primary health care aimed at intensification of activity processes and elimination of resource losses. Conceptual approaches to the nature of content, structuring of the matrix of competences for application in training and professional activity of organizers of lean production, approaches to the professional basis of design of educational programs have been defined.

Keywords

lean production, lean-technologies, lean production methods and tools, leadership, competence.

For citation

Zadvornaya O.L. Conceptual Approaches to the Advanced Training of Lean Production Staff in Medical Organizations Providing Primary Health Care. Medical Technologies Assessment and Choice. 2020; (1):48–54. DOI: 10.31556/2219-0678.2020.39.1.048-054

Issue № 1 | 2020 (39)

DOI: https://doi.org/10.31556/2219-0678.2020.39.1.043-047 meta

For citation

Zheleznyakova I.A., Avxentyeva M.V., Bereznikov A.V., Kamenskaya N.A., Fyodorov A.A., Petrovsky A.V. Practical Problems in Organization and Payment for Medical Care for Patients with Oncological Diseases Within the Frame of Providing Quality and Safety of Medical Care: Expert Opinion. Medical technologies. Assessment and Choice. 2020; (1):43–47. DOI: 10.31556/2219-0678.2020.39.1.043-047

Issue № 1 | 2020 (39)

DOI: https://doi.org/10.31556/2219-0678.2020.39.1.030-042 meta

Abstract

Aim of the study. Analysis of medical tourism’s organizational features based on the example of the large medical organizations in the United Kingdom, South Korea, Italy and China.

Materials and methods. The data were collected by the authors by interviewing the heads of medical organizations and their deputies in the United Kingdom, South Korea, Italy and China (3–4 respondents per medical organization) using the developed questionnaire to identify the main mechanisms and tools for organizing the export of medical services. SWOT-analysis (Strengths; Weaknesses; Opportunities; Threats) was performed in order to comprehensively evaluate the received information.

Results. Along with weaknesses and threats that slow down the development of medical services exports, strengths (internal factors) and opportunities ( external factors) that contribute to the development of medical tourism were also identified: the widespread popularity of the brand of medical organizations abroad which is associated with the provision of premium medical services; versatility and ability to conduct high-tech surgical operations; the presence of a separate premium class building and an international department for working with foreign patients and promoting a medical organization in the world market; well-established business relationships with assistance companies; foreign medical personnel who speak foreign languages and possess necessary skills to treat foreign patients; developed electronic medical care system; developed system of quality control of medical care; the presence of branches in other countries; the presence of a medical visa in the system of legislation; established cooperation with many countries at the embassy level; state licensing and accreditation for the provision of medical services to foreign citzens; the availability of a state website on the provision of medical assistance to foreign citizens; the possibility of the age of value added tax.

Conclusion. We identified main patterns in the organization of export of medical services that can be applied to develop this direction in medical organizations of the Russian Federation during the analysis the strengths and weaknesses of four large medical organizations abroad, as well as external factors that affect the work of these medical organizations.

Keywords

medical tourism, medical services export, medical information system, international department of a medical organization.

For citation

Daykhes A.N., Reshetnikov V.A., Manerova O.A., Mikhailov I.A. Analysis of Current Practices of Organizing the Export of Medical Services in the United Kingdom, Italy, South Korea and China. Medical technologies. Assessment and Choice. 2020; (1):30–42. DOI: 10.31556/2219-0678.2020.39.1.030-042

Issue № 1 | 2020 (39)

DOI: https://doi.org/10.31556/2219-0678.2020.39.1.019-029 meta

Abstract

Since 2013 a diagnosis-related groups (DRG) model has been introduced for the payment of medical care provided in inpatient settings and the day hospitals in Russia at the federal level. The DRG model is improved annually by the increasing of DRG number and specifying the classification criteria for attributing treatment cases to a particular group. In this article, we describe the main changes in the DRG model in 2020 compared with the last year. Main changes include the creation of new classification criteria for the formation of DRG, new DRG in the oncology profile, the changes in the DRG for epilepsy and chronic viral hepatitis C treatment, as well as for the use of genetically engineered biological drugs and selective immunosuppressants. The article also describes the innovations regarding the general approaches to paying for health care with respect to DRG: the rules for applying regional correction factors and for simultaneous payment for two DRG within one treatment case.

Keywords

provider-payment method in healthcare, diagnosis-related groups (DRG), classification criteria.

For citation

Lazareva M.L., Zheleznyakova I.A., Avxentyeva M.V., Fedyaev D.V., Zuev A.V., Ledovskikh Y.A., Semakova E.V., Omelyanovskiy V.V. Main Changes in the Model of Diagnosis-Related Groups in Russia in 2020. Medical Technologies Assessment and Choice. 2020; (1):19–29. DOI: 10.31556/2219-0678.2020.39.1.019-029

Issue № 4 | 2019 (38)

DOI: https://doi.org/10.31556/2219-0678.2019.38.4.087-100 meta

Abstract

Aim: to assess economic consequences of alectinib compared with the recommended therapy schemes for patients with non-small cell lung cancer (NSCLC) with tumor expression of anaplastic lymphoma kinase (ALK+) without previous experience of targeted therapy from the Russian healthcare
system perspective.

Material and methods. Markov model was developed in Microsoft Excel 2010 software for cost calculation. 5-year costs of alectinib, crizotinib and ceritinib were calculated, taking into account the differences in clinical effectiveness and safety of the compared drugs. Data about clinical effectiveness and safety were derived from the network meta-analysis Steenrod A. et al, 2018, where alectinib showed superior effectiveness in the first line of therapy for ALK+ NSCLC vs crizotinib and ceritinib: relative risk (RR) of progression-free survival (PFS) was 0,50 (95% confidence interval 0,36–0,70) and 0,41 (0,25–0,67) respectively. Safety of alectinib in the first line therapy was superior to the safety of ceritinib – RR of severe adverse events (SAE)3–4 grade 0,36 (95% CI 0,17–0,79), – and was comparable with safety of chemotherapy and crizotinib – RR of SAE 3–4 grade 0,81 (95% CI 0,44–1,52) and 0,65 (95% CI 0,51–1,04) respectively. Cost effectiveness analyses and budget impact analysis were conducted from the Russian healthcare system perspective.

Results. Cost of one year course of alectinib was 3 431 970 rubles, which was comparable with crizotinib (3 435 405 rub.) and 55% higher than the one-year cost of ceritinib. Cost-effectiveness ratio was lower for alectinib compared with crizotinib, incremental cost-effectiveness ratio (ICER) for alectinib vs crizotinib was 2 735 900 rub., which was 66% lower than ICER for ceritinib vs crizotinib. Given the number of patients eligible for alectinib, it’s impact on State Guarantees Program of Free Medical Care is not much. Sensitivity analysis showed that the results of budget impact assessment are stable.

Conclusion. Alectinib is a preferred option for patients with ALK+ NSCLC from economic point of view. It doesn’t have a significant impact on the budget within the State Guarantees Program of Free Medical Care, and also has higher effectiveness compared with crizotinib and ceritinib and better safety when compared with ceritinib.

Keywords

ALK-positive non-small cell lung cancer, alectinib, crizotinib, ceritinib, budget impact analysis, cost-effectiveness analysis.

For citation

Nedogoda S.V., Salasyuk A.S., Barykina I.N., Smirnova V.O., Popova E.A. Assessment of clinical and economic effectiveness of Alectinib for patiens with ALK+ non-small cell lung cancer without previous experience of targeted therapy. Medical Technologies Assessment and Choice. 2019;(4):87–100. DOI: 10.31556/2219-0678.2019.38.4.087-100

Issue № 4 | 2019 (38)

DOI: https://doi.org/10.31556/2219-0678.2019.38.4.076-086 meta

Abstract

Multiple randomised controlled trials (RCTs) have compared the efficacy of targeted therapies for the treatment of moderate-to-severe plaque psoriasis with placebo. However, the relative effectiveness of these treatments is not studied sufficiently.

The aim of this study was to compare the effectiveness and safety of targeted drugs (netakimab, ixekizumab, guselkumab, secukinumab, ustekinumab, certolizumab, infliximab, adalimumab, etanercept, tofacitinib and apremilast) in adult patients with moderate-to-severe plaque psoriasis using such outcomes as PASI 75/90/100, PGA/IGA, DLQI, AEs, SAEs and withdrawals due to AEs.

Material and methods. We performed a systematic literature review in PubMed database and in the CENTRAL section of Cochrane library (Embase filter) to identify relevant RCTs. The primary outcome was Psoriasis Area and Severity Index (PASI) 75 response at week 12 of treatment. Other analyzed outcomes: PASI 90/100, Physician’s Global Assessment (PGA) /IGA, Dermatology Life Quality Index (DLQI), number of patients suffering from at least one adverse event (AE) / severe AE and number of patient withdrawals from the study due to AE during initial 12 weeks of treatment. For each outcome we conducted network meta-analyses (NMAs) and univariate meta-regression analyses to adjust for baseline risk differences and cross-trial differences.

Results. We selected 35 RCTs. We conducted several types of NMAs for each outcome to avoid bias in research. In most cases random effects NMAs adjusted to differences in placebo response rate provided the best model fit statistics and were selected for interpretation. Pairwise indirect comparisons from most NMAs suggested IL-17 inhibitors (netakimab and ixekizumab) along with IL-23 inhibitor guselkumab have superior effectiveness and favorable safety profile compared to other targeted therapies used to treat adults with moderate-to-severe plaque psoriasis during initial 12 weeks of therapy based on PASI 75/90/100, PGA/IGA, and DLQI.

Keywords

plaque psoriasis, systematic review, meta-analysis, meta-regression, targeted therapies, biologics.

For citation

Tolkacheva D.G., Sokolova V.D., Mladov V.V. Effectiveness and safety of targeted drugs for the treatment of adults with moderate-to-severe plaque psoriasis in the Russian Federation. Medical Technologies Assessment and Choice. 2019;(4):76–86. DOI: 10.31556/2219-0678.2019.38.4.076-086