Научно-практический журнал Медицинские технологии. Оценка и выбор
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Issue № 2 | 2019 (36)

DOI: https://doi.org/10.31556/2219-0678.2019.36.2.010-015 meta

Abstract

Three-dimensional printing has several significant advantages over traditional methods of production: simplification and acceleration of the production process, versatility, low cost and a few others. As a result, additive technologies have quickly become a highly promising area with great potential in many areas of human activity, finding more and more points of application. Medicine is no exception. The development of three-dimensional printing in the field of medicine can not only solve a few pressing health problems, but also stimulate the progress of technology. To date, three-dimensional medical printing is used in the following areas: individual prostheses both temporary and permanent wear, surgical instruments, simulation manuals for training medical students and preoperative training of surgeons. Of interest is the joint application of additive technologies with cellular technologies – bioprinting. Despite its great potential, this activity is not sufficiently regulated, which is a serious obstacle to its development. The introduction into practice of the principles proposed in this work of the device and functioning of a specialized service – laboratory of additive medical production – should solve this problem and contribute to the rapid development of medical three-dimensional printing in the Russian Federation.

Keywords

additive technologies, medical production, 3D printing, healthcare organization, import substitution.

For citations

Prikhodko A.A., Vinogradov R.A., Vakhrushev S.G. Measures for the Development of Medical Additive Technologies in the Russian Federation. Medical Technologies. Assessment and Choice. 2019; 2 (36): 10–15.

Issue № 1 | 2019 (35)

DOI: https://doi.org/10.31556/2219-0678.2019.35.1.008-017 meta

Abstract

Results of the assessment of methodological quality of economic evaluations (EE), submitted to justify the inclusion/exclusion of drugs in the lists of drugs for medical use (list of vital and essential drugs, additional medication supply list and expensive drug list), are given in the article. The study was conducted in 2018 in the FSBI “Center for healthcare quality assessment and control” of the Ministry of Health of the Russian Federation. Assessment was performed based on 12 criteria in accordance with the requirements to the methodological quality of economic evaluations, described in the draft Order of the Government of the Russian Federation, No. 871, and then were approved in the Order of the Government of the Russian Federation, No. 871, state on 20.11.2018. The distribution of EE based on the number of criteria they did not meet, and also the frequency of made mistakes for each criterion are presented. Main reasons for EE not meeting the requirements to methodological quality, prescribed by the Order of the Government of the Russian Federation, No. 871, are analyzed.

Keywords

comprehensive assessment, Order of the Government of the Russian Federation, No. 871, lists of drugs, economic evaluations, methodological quality.

For citations

Khachatryan G.R., Ivakhnenko О.I., Sura M.V., Avxentyeva М.V. Assessment of the Methodological Quality of Economic Evaluations: Main Mistakes. Medical Technologies. Assessment and Choice. 2019; 1(35): 8–17.

Issue № 4 | 2018 (34)

DOI: https://doi.org/10.31556/2219-0678.2018.34.4.011-018 meta

Abstract

The article provides the results of the assessment of methodological quality of budget impact analysis (BIA) submitted as a justification for the inclusion/exclusion of drugs into the drugs lists for medical use (Vital and Essential Drug list, List of Drugs for Certain Categories of Citizens, List of High-Cost Drugs) in 2018.The assessment was performed by the Center of Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation according to the requirements, described in the Order of the Government of the Russian Federation, № 871 (version from 29.10.2018), which consist of 11 criteria. The information on distribution of BIA studies in regards to the number of criteria not meeting the requirements and proportion of mistakes on every criterion is presented. Besides, the authors analyzed main causes of non-meeting the requirements for methodological quality of BIA studies described in the Order of the Government of the Russian Federation, № 871.

Keywords

comprehensive assessment, Order of the Government of the Russian Federation № 871, drug list, budget impact analysis, methodological quality.

For citations

Ivakhnenko O. I., Khachatryan G. R., Sura M. V., Avxentyeva M. V., Omelyanovskiy V. V. Results of Methodological Quality Assessment of Budget Impact Analysis: Main Mistakes. Medical Technologies. Assessment and Choice. 2018; 4(34): 11–18.

Issue № 33 | 2018 (3)

DOI: https://doi.org/10.31556/2219-0678.2018.33.3.009-017 meta

Abstract

The paper discusses the issues of normative and legal regulation for creation of drug lists (List of Vital and Essential Medicines, List of Medical Drugs for Certain Categories of Citizens, List of High-Cost Medical Drugs (Seven Nosologies list). It also considers historical aspects, current state and planned changes of these rules. The stages of expertise, evaluation criteria, and rules of decision making in the process of inclusion of medical drugs (MD) into the lists according to the RF Government Decree no. 871 on 28 August 2014 and the project on the amendment of this decree are thoroughly considered. The proposed changes address the terms of submission of proposals for the inclusion and exclusion of MDs into the lists, and the terms of expert procedures. Changes in expert procedures (complex evaluation) of MD are proposed; a new stage (analysis of methodological quality of pharmacoeconomic studies and budget impact analysis) is introduced. Integral scales of clinical and pharmacoeconomic evaluation of MD are substituted with complex evaluation scales. The requirements for methodological quality of pharmacoeconomic studies and budget impact analysis are created. A further stage of the development of the rules for creating the lists can be the performance of complex evaluation within a single expert body with the participation of expert organizations and leading specialists.

Keywords

drug list, FR Government Decree no. 871 on 28 August 2014, complex evaluation, complex evaluation scale.

For citations

Omelyanovskiy V. V., Sura M. V., Avxentyeva M. V., Khachatryan G. R. The Rules for Creation of Federal Drug Lists: Current State and
Development Prospects. Medical Technologies. Assessment and Choice. 2018; 2(32): 9–17.

Issue № 32 | 2018 (2)

DOI: https://doi.org/10.31556/2219-0678.2018.32.2.008-022 meta

Abstract

The article explains the prerequisites, principles and steps of the developing in 2018 new diagnostic related groups (DRG) for inpatient cancer pharmacotherapy in Russian healthcare. New DRGs were developed in 5 steps: 1) most prevalent malignant tumors were revealed based on statistical data on the cancer incidence rate in 2016; 2) all recommended schemes of drug therapy for the most prevalent tumors were extracted from clinical guidelines made by Russian Oncology Association; 3) standards of medical care were created for the cases of hospital treatment with the use of each scheme of drug therapy; 4) the costs of hospital treatment with the use of each scheme were calculated; 5) cases with similar costs were combined into DRGs. 10 DRGs were formed for inpatient treatment and 8 – for treatment in the day hospitals. The cost-based relative weights were determined for each DRG. The system for coding drug regimens was developed for computerized assignment of cases to the DRGs in the Russian regions. The new DRGs are more homogeneous than previous ones in terms of clinical and economic characteristics, thus the main principle of DRG development is followed to a greater extent than before. Authors underline the necessity to monitor the results of the new DRGs implementation at the regions for minimizing the risks of imbalance in the payment system.

Keywords

provider-payment method in healthcare; diagnostic related group (DRG), cancer; standard of medical care; clinical guideline.

For citations

Avxentyeva M. V., Omelyanovskiy V. V., Petrovskiy A. V. et al. New Approaches to the Development of Diagnostic Related Groups for Cancer Pharmacotherapy in Russian Federation. Medical Technologies. Assessment and Choice. 2018; 2(32): 8–22.

Issue № 32 | 2018 (2)

DOI: https://doi.org/10.31556/2219-0678.2018.32.2.024-033 meta

Abstract

The classification algorithm is one of the key elements of the provider-payment system based on diagnostic related groups (DRG). Current version of the algorithm in Russian DRG system is described in a manual approved by the Federal Fund of Compulsory Medical Insurance. The algorithm determines the steps of computerized assignment of each hospital case to the DRG. Each region of Russia creates its own information system for classification of cases based on the approved algorithm. The article provides a brief analysis of the case-mix classification criteria and the classification algorithms in the Russian DRG model. The problems of the current algorithm are underlined and illustrated by the examples. Finally, the authors propose the ways for improving the algorithm.

Keywords

provider-payment methods in healthcare, diagnostic related groups (DRG), classification algorithm.

For citations

Fedyaev D. V., Akimov O. V., Zuev A. V. Algorithm of Hospital Cases Classification in the Russian Model of Diagnostic Related Groups: Need for Improvement. Medical Technologies. Assessment and Choice. 2018; 2(32): 24–33.

Issue № 31 | 2018 (1)

Abstract

In the last decade, the interest of the Russian and international scientific and medical communities and pharmaceutical companies in the research of routine clinical practice has increased significantly. In addition to the already usual term «non-intervention study», «real world data» and «real world evidence» came; role of health technology assessment is being emphasized more often and more actively, more attention is being paid to patient-oriented approach. The objectives of this article are: updating information in the field of routine clinical practice, discussing new terms for the Russian-language scientific literature and the role of real world data in health technology assessment.

Keywords

non-interventional study, real-world data study, health technology assessment.

For citations

Goldina T. A., Suvorov N. I. Real-World Data Studies: from Data to Health Technology Assessment and Decision-Making in Healthcare. Medical Technologies. Assessment and Choice. 2018; 1(31): 21–29.

Issue № 31 | 2018 (1)

Abstract

An approach is proposed to find reference values of incremental cost-effectiveness ratio (ICER) for the assessment of pharmacoeconomic effectiveness of drugs for lists of vital and essential drugs. The essence is to use a unified simple method of calculation of ICER for drugs within the therapeutic groups already included into the list. The criteria of effectiveness should be separately defined for each area. The method was developed on the example of antineoplastic drugs. The numerator in the formula of ICER is the difference in costs between compared drugs, and the denominator is the difference in saved life years or life years without tumor progression obtained from the overall survival rate or progression-free survival in randomized clinical trials (RCT). RCT that form the basis for ICER calculation should demonstrate statistically significant advantages of the proposed drug compared to the drug already included into the list. The calculation considers the cost of drugs only.

Keywords

incremental cost-effectiveness ratio (ICER), list of vital and essential drugs, antineoplastic drugs.

For citations

Omelyanovsky V. V., Avxentyeva M. V., M. V. Sura M. V., Khachatryan G. R., Savilova A. G. Approaches to the Creation of a Unified Method of Calculation of Incremental Cost-Effectiveness Ratio for the Re-Consideration of Lists of Medical Drugs; an Example of Antineoplastic Drugs. Medical Technologies. Assessment and Choice. 2018; 1(31): 10–20.

Issue № 30 | 2017 (4)

Abstract

The aim of the study was to identify the main directions of improvement of planning and organization of medical care based on the analysis of age and gender composition of the population of the Moscow region, and its special features compared to the national level. The analysis was based on the materials of the Russian Federal State Statistics Service (Rosstat). The dynamics of the number of population was assessed for the period between 2012 and 2016. According to the analysis, the Moscow region was typical in respect of age and gender composition. There was a trend towards the increase of the share of older population and persons under active working age. The decrease of working population increases demographic load and decreases GDP. We found demographic depression under 19 years of age that should lead to the decrease in marriages and in the formation of family structures in the nearest future. The assessment of the trends in demographic factors enables to predict the transformation of demand for medical services and to plan reorganization of health care in Russian regions.

Keywords

age and gender composition, organization of medical care, Moscow region.

For citations

Voynov M. A., Yelchuyeva Z. G. Identification of the Main Directions for the Improvement in Planning and Organization of Medical Care Based on the Analysis of Population Structure by Age and Sex (on the Example of Moscow Region). Medical Technologies. Assessment and Choice. 2017; 4(30): 21–29.

Issue № 30 | 2017 (4)

Abstract

Since 2012, a unified model of payment for hospital care based on diagnosis related groups (DRGs) is being implemented in the Russian system of mandatory health insurance. Today, two mechanisms of the regional adaptation of this model are defined on the federal level. The first one is adjustment coefficients (coefficient for the level of medical care in health care organization, coefficient for the complexity of treatment, management coefficient), and the second one is distinguishing subgroups within standard DRGs. The analysis of tariff agreements in regions revealed significant transregional differences in interpretation and application of the established rules. They vary from strict compliance with the approved algorithms to arbitrary and often distorted interpretation of federal recommendations. The obtained data suggest that tighter restrictions are needed on the federal level in respect of regional adjustment coefficients, including those for day hospitals. The experience of some regions in distinguishing subgroups in standard DRGs including drug treatment schedules may be useful for further subdivision of DRGs on the federal level.

Keywords

diagnosis-related groups (DRG), coefficient for the level of medical care in health care institution (CLC), coefficient for the complexity of treatment of patient (CCT), management coefficient (MC), subgroups of DRG.

For citations

Sura M. V. DRG-based Payment for Medical Care in Mandatory Health Insurance: Regional Adaptation. Medical Technologies. Medical Technologies. Assessment and Choice. 2017; 4(30): 11–20.