Background. Health Technology Assessment (HTA) in the Russian Federation has been performed for drugs, not for other medical technologies, which leads to decision making difficulties today. Aim. This ...study aimed to assess the clinical and economic efficiency of distance education and monitoring of blood glucose levels in patients with diabetes mellitus (DM) of both types. Materials and methods. The HTA was prepared using Markov model with a cost-effectiveness analysis methodology. The number of DM complications depending on glycated hemoglobin level with distance education and blood glucose level and without, that has been used for modeling cost of distance education and blood glucose monitoring as well as cost of drugs’ therapy and hospital admission due to DM complications with methodology and source of Obligatory Medical Insurance Fund on 30-yy horizon of modeling. Results. Distance education and blood glucose monitoring in DM patients leads to decrease in complication level as well as mortality, and acceptable additional financial costs from the 5th year of modeling for DM type 1 and from the 6thyear of modeling for type 2 without insulin dose changing. Conclusion. Clinical-economic reasonability of distance education and DM patients’ monitoring are demonstrated in this work. These results should be considered in the decision-making process for HTA budget financing.
Objevtive
: to identify and systematize the main approaches to planning health care provider network used in foreign countries.
Material and methods
. Preliminary search for countries who had an ...experience of systematical planning of health care provider network and tools that they used for planning was conducted in regular health system reviews made by the European Observatory on Health Systems and Policies. Identified tools became a subject of general Internet search for the official publications about goals, mechanisms and results of their usage. The findings were analysed to reveal the similarities and differences between national health care provider network planning policies as well as the objective preconditions for the formation of such policies.
Results
. Three main approaches to health care provider network planning were identified in the analysis: (1) through establishing state-owned health care providers, (2) through granting the right to deliver guaranteed health care or (3) through granting the right to deliver health care of all categories. A close relationship between the choice of prevailing approach to planning and specific planning tools and the national health care model and structure of health services supply was shown. The typical policy of countries most similar to Russia on these parameters (“young” insurance systems, operating under conditions of predominant state supply of medical services) is the protection of key providers on the basis of minimum activity or income guarantees with the gradual development of a competitive health care market based on the rest of the Compulsory Health Insurance program.
Conclusion.
Current Russian health care provider network planning regulation based on the direct control over the state-owned health care providers does not correspond to the changed health care model and does not allow taking full advantages of the social health insurance. The results of the review can be used to develop new tools for planning health care provider network spanning on non-state providers.
Background
. One of the priorities of health care is the balance between the financial resources and the availability of effective medical care. The current approach of access to cancer medicines ...limits the timeliness and availability of treatment. At the same time, financial support from the government provides great costs on cancer drugs. However, these great costs are not rational.
Objective
: to assess the financing needs of the complete transfer of financial support of medical care in the field of oncology to the Compulsory Health Insurance (CHI) system by means of optimizing the functions of the day hospital.
Material and methods
. The achievement of the goal is planned to be reached by eliminating the unusual functions of oncological day hospital. We analyzed the regulatory legal documents regulating drug care and drug provision in the Russian Federation, data from depersonalized (anonymized) registers of the structure of hospitalizations in a day hospital for 2021. The methods of expert assessments, mathematical modeling, as well as literature data analysis were used. The study developed a model for assessing the need to finance the full transfer of medicine provision to the CHI system, including taking into account the hidden deficit.
Results
. The total amount of funds released from the reduction of irrational hospitalizations in day hospital conditions amounted to 2.08% of the funding level of the analyzed schemes. Taking into account the data of hospitalizations in oncological day hospital for 2021, the number of irrational hospitalizations in case of transfer of selected schemes to the outpatient stage will decrease by 16.1%. The transfer of all the medicine therapy to financing from the CHI funds will require significant additional budget expenditures in the amount of 62.5 billion rubles or 2.65% of the total costs of the State Guarantees Program for Provision of Free Medical Care to Citizens.
Conclusion
. Despite the rationality of the proposed changes in the field of improving access to medicine provision concerning cancer drugs and the identified justifications for changing the distribution of financial resources within the State Guarantees Program, there are difficulties. In order to solve this problem, a coordinated consideration of potential strategies to address the access to cancer medicines is needed.
Aim.
Development of a tool for the evaluation of the therapeutic value of anticancer drugs based on multi-criteria analysis of decision making.
Materials and methods.
The study included 4 main ...stages. At the first stage, based on the results of the publications analysis and the EVIDEM system, a list of therapeutic value criteria was formed. At the second stage, for each criterion, a survey of experts was used to develop a scale and to build a value function using the curve-fitting method. At the third stage, the weighing was carried out using the discrete choice experiment method and the statistical package "support.CEs" in R Studio. At the fourth stage, based on the obtained values of the weight coefficients and value functions, a simple linear additive model was constructed.
Results.
The authors developed a tool that included 5 criteria for the value of anticancer drugs: efficacy, safety, disease severity, ease of administration, and therapeutic need. For each criterion, a linear value function was built, which allowed the authors to obtain the value of the severity of the criterion in the range from 0 to 1 based on the absolute values of the criterion for a particular drug. As a result of the weighing, two sets of weighting coefficients were obtained by using two different methods of survey results processing. The criterion of efficacy has the most significant contribution to the therapeutic value for the Russian health care system, and the least significant is the severity of the disease. The distribution of the criteria in the intermediate contribution ranks was significantly different between the two sets of weights.
Conclusions.
For practical application and implementation of the proposed tool, it is required to conduct the validation using the example of specific antitumor drugs to select a final set of weighting coefficients, check the stability of the results, and form a scale of therapeutic value levels.
Objective:
development of a unified system and classification of indicators for an integral assessment of performance and effectiveness of the organization of medical care (MC) at the regional level ...in the Russian Federation (RF).
Material and methods.
A systematic search for domestic and foreign scientific publications and a comprehensive analysis of the current regulatory legal acts in the field of health care for the presence of indicators characterizing the effectiveness of MC organization in the RF regions were performed. The search for indicators of effectiveness was carried out in analytical reports based on the results of field events of national medical research centers (NMRC) in the constituent entities of the RF for 2019, 2020 and 2021 in various profiles of MC. In total, 3019 analytical reports on the results of field events and 97 annual public reports on the results of the NMRC activities were analyzed.
Results.
Three options for classifying indicators were formed: according to the method of obtaining (primary, calculated, secondary qualitative); in relation to the final result (resulting, process (surrogate)); classification of parameters that determine the MC system, including in the context of profiles, forms, types, conditions of MC (18 positions). The proposed unified system and classification of indicators has a number of advantages compared with the Organisation for Economic Cooperation and Development, Centers for Medicare & Medicaid Services and Commonwealth Fund indicators adopted in a number of countries. It was established that international systems use mainly resulting indicators, while the domestic health care system uses exclusively process indicators that are not combined into a single system and are monitored by various departments.
Conclusion.
The presented approach to a unified system and classification of indicators for an integrated assessment of performance and effectiveness of MC organization allows to determine the priorities for the development of a monitoring system. At the same time, it should be noted that this approach requires further discussion and improvement.
The article presents the description of structural, organizational and methodological issues of health technology assessment (HTA) of French drugs as well as the state-reimbursable list of drugs. The ...HTA is conducted by an independent public body – French National Authority for Health (HAS). HAS evaluates medical products, procedures, services and technologies from a medical and economic points of view to make cost recovery decisions. HAS consists of two committees providing HTA: Transparency Committee and the Economic and Public Health Assessment Committee. Thus, the French HTA consists of two separate components within the same agency. The result of HAS evaluation of a drug is a conclusion on the level of clinical value and clinical added value, as well as the methodological quality of the studies and the size of the target patient population. Based on the evaluation results, HAS gives recommendations for the National Union of Health Insurance Funds, the Economic Committee for Healthcare Products and Ministry of Health and publishes its opinion on the HAS website. HAS decisions are of a recommendatory nature – the final decision whether to include the drug in reimbursement lists are made by the Ministry of Health and published in the Official Journal of French republic.
Objective
: the development and approbation of the method for comparative analysis of the lists of medicines in different countries and systems of healthcare.
Material and methods
. Based on the ...open-access data on the lists of medicines published on official websites of the authorized regulators, the authors selected the national lists of medicines of Russia, England, and Italy for the development and approbation of the method. It was proposed to use three parameters: the absolute number of medicines by international nonproprietary name (INN); the structure of the lists based on anatomical therapeutic chemical (ATC) classification; and the coverage of the indications based on the International Classification of Diseases, 10th edition (ICD-10). The results of the analysis provided grounds for the review of the approaches to the formation of the lists of medicines required for medical help in Russia, England, and Italy and reimbursed from the state budget.
Results
. The number of medicines by INN in the national lists of England and Italy exceeds the total number of drugs included in the list of vital essential and desirable (VED) in Russia. All the analyzed lists were characterized by an uneven distribution of medicines within the lists by the ATC groups. The lists of medicines in England and Italy significantly exceed the list of VED by the number of the included medicines by all ATC groups excluding groups J and H in comparison with Italy, and groups J and V in comparison with England. At the same time, the list of VED significantly exceeds the list in England by the number of covered indications from the ATC L group. During the approbation, the method showed to be effective and can be used for further comparative studies of the national lists of medicines.
Conclusion
. Non-uniform lists of medicines by ATC-codes show that each country has priority areas in their healthcare systems. The list of VED can be shorter by the absolute number of the included medicines in England and Italy but it can exceed them by the coverage of indications due to peculiarities of the procedure of the list formation (reimbursement of medicines by all the registered indications). The results of the study with the proposed method can serve for the optimization of the VED list and the analysis of therapeutic areas that are undercovered.
Objective
: to evaluate cost-effectiveness and budget impact of using single and dual chamber implantable cardioverter-defibrillators (ICD) adjunctive to the standard drug therapy (DT) compared to ...the standard DT alone for the primary and secondary prevention of sudden cardiac death (SCD).
Material and methods
. Original partitioned survival analysis model was developed to assess the cost-effectiveness of using ICD within the modelling horizon of 8 years. The following model outcomes were used: life years and quality-adjusted life years (QALY). Primary prevention model was focused on patients after myocardial infarction with left ventricular ejection fraction (LVEF) ≤30%, whilst secondary prevention model considered cardiac arrest survivors and/or patients diagnosed with ventricular tachycardia or ventricular fibrillation with LVEF ≤35%. The model summarizes treatment effect and costs for ICD and DT specific to the healthcare system of the Russian Federation (RF). The main scenario accounted for ICD implantation cost in accordance with general reimbursement price asserted in the high technology medical care list part 2 (HТMC 2). Additionally, alternative scenario of ICD reimbursement level was developed to account for general tariff split onto singleand dual-chamber ICD implantation reimbursement tariffs which can be financed through high technology medical care list part 1 (HТMC 1). Budget impact analysis compared the costs of using ICD within the current volume of the annual increase in ICD implantations and a threefold increased volume of ICD implantations.
Results
. By the end of the modelling period, additional 34% of patients survived in the ICD group compared to the DT group. Incremental cost-effectiveness ratio (ICER) per 1 QALY constituted 2.8 and 2.2 million rubles for primary and secondary prevention, respectively. ICER values are slightly above or lower than the willingness-to-pay threshold of 2.5 million rubles per 1 QALY in the RF in the segment of primary and secondary SCD prevention, respectively. Additional HТMC 1 scenario incorporating lower ICD implantation prices resulted in an average ICER drop by 13% compared to HTMC 2. Overall patient population requiring SCD prevention comprised of 7,161 and 3,341 patients in primary and secondary prevention, respectively. Budget impact analysis showed that threefold rise in the ICD implantations rate will require additional 648 million rubles for primary prevention cohort to provide additional 573 patients with ICD, and 230 million rubles for secondary prevention cohort with additional 267 patients covered with ICD. ICD reimbursement price drop within the HТMC 1 scenario will save 133 million rubles and allow to provide additional 143 patients with ICDs for a given budget.
Conclusion
. ICD is a cost-effective option of secondary prevention of SCD. Additional analysis of ICD reimbursement price drop drives ICER downwards to a considerable extent which in turn increases the accessibility of ICDs to patients. In scenario of ICD implantation financing within HТMC 1, ICD is established to be a cost-effective option for primary and secondary prevention of SCD in the RF.
Methods of payment to care providers constitute an essential part of the healthcare financing system; these mechanisms determine the motivation of service providers. Throughout the history of public ...health care, the payment methods have been gradually improved so to stimulate the providers to best match the societal demands (greater access to health services, cost reduction, and better quality) and prevent “moral hazards”. As a result, the most advanced healthcare systems have stopped paying simply for service volume and rigorously restraining the costs. Instead, the updated system is based on the integrated payments combining the elements of cost control with the stimuli that promote a high quality and better access to healthcare service. At present, the new payment mechanisms aiming at improving the long-term treatment outcomes (life expectancy and quality of life) are available. The care provider payment system existing in Russia, by large, corresponds to the best international practices as far as the hospital care is concerned. However, the payment arrangements in the primary care network still lag behind the international standards. To improve the situation, quality indicators should be included in payments for primary care services.
In Australia, the federal government is in charge of providing the health care to patients. The government agencies determine the list of reimbursable pharmaceuticals and medical services and also ...define the preferential categories of the population. The states and territories may have their own health care programs in addition to the federal ones. The Pharmaceutical Benefits Advisory Committee (PBAC) is responsible for the health technology assessment (HTA) and decides which technology is eligible for reimbursement by the federal budget. The drug evaluation process includes five stages: a review of general information about the product, assessment of its clinical efficacy, cost-effectiveness analysis, assessment of financial implications of including the drug in the reimbursement list, and consideration of any other factors that may influence the committee decision. In addition to the full reimbursement of pharmaceuticals, the committee may decide to provide funding based on a managed entry agreement.
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