Noncommunicable diseases provide a significant impact on global health. Information about the factors influencing the noncommunicable morbidity and the need for medical care is important for forecasting need and distribution of healthcare resources. The article presents the results of a study dealing with the relationship between social determinants of health and acute conditions requiring medical care in women. Social determinants including the standard hierarchy of values and the level of education (high school) influence on individual self-assessment of health and are associated with lower need for medical care due to acute non-communicable diseases. The graph method was used for the study and can be proposed for further investigation of the influence of social determinants on the need for medical care.

Background: From October 2018, adalimumab biosimilars could enter the European market. However, in some countries, such as Netherlands, high discounts reported for the originator product may have influenced biosimilar entry.Objectives: The aim of this paper is to provide a European overview of (list) prices of originator adalimumab, before and after loss of exclusivity; to report changes in the reimbursement status of adalimumab products; and discuss relevant policy measures.Methods: Experts in European countries received a survey consisting of three parts: 1) general financing/co-payment of medicines, 2) reimbursement status and prices of originator adalimumab, and availability of biosimilars, and 3) policy measures related to the use of adalimumab.Results: In May 2019, adalimumab biosimilars were available in 24 of the 30 countries surveyed. Following introduction of adalimumab biosimilars, a number of countries have made changes in relation to the reimbursement status of adalimumab products. Originator adalimumab list prices varied between countries by a factor of 2.8 before and 4.1 after loss of exclusivity. Overall, list prices of originator adalimumab decreased after loss of exclusivity, although for 13 countries list prices were unchanged. When reported, discounts/rebates on originator adalimumab after loss of exclusivity ranged from 0% to approximately 26% (Romania), 60% (Poland), 80% (Denmark, Italy, Norway), and 80–90% (Netherlands), leading to actual prices per pen or syringe between €412 (Finland) and €50 – €99 (Netherlands). To leverage competition following entry of biosimilar adalimumab, only a few countries adopted measures specifically for adalimumab in addition to general policies regarding biosimilars. In some countries, a strategy was implemented even before loss of exclusivity (Denmark, Scotland), while others did not report specific measures.Conclusion: Even though originator adalimumab is the highest selling product in the world, few countries have implemented specific policies and practices for (biosimilar) adalimumab. Countries with biosimilars on the market seem to have competition lowering list or actual prices. Reported discounts varied widely between countries.

Evelien Moorkens, Brian Godman, Isabelle Huys, Iris Hoxha, Admir Malaj , Simon Keuerleber, Silvia Stockinger, Sarah Mörtenhuber, Maria Dimitrova, Konstantin Tachkov, Luka Vončina, Vera Vlahović Palčevski , Gnosia Achniotou, Juraj Slabý, Leona Popelková, Kateřina Kohoutová, Dorthe Bartels, Ott Laius, Jaana E. Martikainen, Gisbert W. Selke, Vasileios Kourafalos, Einar Magnússon, Rannveig Einarsdóttir , Roisín Adams, Roberta Joppi, Eleonora Allocati , Arianit Jakupi, Anita Viksna, Ieva Greiči utė-Kuprijanov, Patricia Vella Bonanno, Vincent Suttorp, Øyvind Melien, Robert Plisko, Ileana Mardare, Dmitry Meshkov, Tanja Novakovic, Jurij Fürst, Corinne Zara, Vanda Marković-Peković , Nataša Grubiša, Gustaf Befrits, Robert Puckett and Arnold G. Vulto*

The purpose of the study based on the data of an anonymous survey is to assess the level of costs for purchasing medicines among the population aged 60 years and older and to analyze the interdependence between the level of material well-being and the level of costs for purchasing medicines. The study was conducted on the basis of a survey of 927 people aged 60 years and older living in Moscow. The questionnaire included questions about the amount of expenses for the purchase of medicines, expressed as a share of the monthly income of a family that was spent on the purchase of medicines. The term «family» is understood as a group of people who lead a common household, regardless of their degree of kinship. To study the impact of income on the cost of purchasing medicines, the questionnaire included a question about the amount of a family's monthly income per member. When analyzing dependencies, such characteristic properties as the Association coefficient (CA), information content (INF), and the Chi-square criterion were calculated. The study revealed that the relationship between the level of material well-being and the level of expenditure on the purchase of medicines is very complex and ambiguous, with pronounced gender differences. In the course of this study, no correlation between the level of disposable income and the share of the total monthly income of a family that is spent on the purchase of medicines was observed. However, there is a correlation between the share of the total monthly income of a family that is spent on food and the share that is spent on the purchase of medicines. The degree of the dependence increases with ageing, which indicates the possibility of purchasing a drug as the main factor in making a decision. The degree of dependence is less pronounced in men below 70 and older and is stronger in women starting from the age of 65 years. The strongest dependence was registered in women of the age group of 70 years and older.

Purpose of research: to study the system of providing medical assistance to patients with oncology diseases in terms of esophageal cancer. Materials and methods: experts survey among oncologists and healthcare specialists with a specialized questionnaire developed with the Delphi method, using mathematical, statistical, analytical methods, as well as the method of logical generalization for data processing. In terms of the research, the following groups of indicators were evaluated: the level of awareness and perception of modern treatment options both among the specialists and the patients; the availability of a complex of medical technologies; characteristics of the technological infrastructure; economic accessibility; the presence of organizational and administrative barriers. On the whole, experts register positive dynamics for the studied indicators, with the exception of certain administrative barriers. The questionnaire developed can be used to study the features of the organization of medical care to patients with oncology diseases.

The Delphi investigation made possible to create and present a model of data flows and expertise for decision - making in healthcare. The model structures and visualizes data flows including population health risks assessment and healthcare interventions value. Most elements of this model are used in practice and are regulated by international or local documents. The investigation also indicates the need for the creation and utilization of additional level of expertise including integrated analysis and modeling of the results of management decisions. Structuring of data management in accordance with this model provides an opportunity to implement proactive risk management in healthcare there to increase healthcare effectiveness significantly.

INTRODUCTION:In January 2018 the European Commission published a Proposal for a Regulation on Health Technology Assessment (HTA): 'Proposal for a Regulation on health technology assessment and amending Directive 2011/24/EU'. A number of stakeholders, including some Member States, welcomed this initiative as it was considered to improve collaboration, reduce duplication and improve efficiency. There were however a number of concerns including its legal basis, the establishment of a single managing authority, the preservation of national jurisdiction over HTA decision-making and the voluntary/mandatory uptake of joint assessments by Member States. Areas covered: This paper presents the consolidated views and considerations on the original Proposal as set by the European Commission of a number of policy makers, payers, experts from pricing and reimbursement authorities and academics from across Europe. Expert commentary: The Proposal has since been extensively discussed at Council and while good progress has been achieved, there are still divergent positions. The European Parliament gave a number of recommendations for amendments. If the Proposal is approved, it is important that a balanced, improved outcome is achieved for all stakeholders. If not approved, the extensive contribution and progress attained should be sustained and preserved, and the best alternative solutions found.

The number of drugs registered on the medicinal drugs market is constantly growing. At that, an analysis of the clinical effectiveness has shown that only a small share of the innovative medicinal drugs that have appeared at the international market have qualitative advantages compared with those being in use already. The purpose of the work: to develop an effective tool to test the working hypothesis, which is based on the assumption that the effectiveness of treatment largely depends on overcoming the barriers and ensuring the availability of medical technology. Materials and methods: the article uses an analytical method and a logical generalization method for creating a questionnaire. Also, it uses the Delphi method as the main research method, the essence of which is joint stage-by-stage work of experts in the field of oncology and public health organization. At the first stage, the paper identifies the main analyzed groups of oncological diseases and the most significant influencing factors that are systematized in the final version of the questionnaire. Results: the questionnaire consists of 33 questions reflecting various aspects of changes in issue of access to medical aid during the last 10 years. The expert evaluated each aspect in relation to 14 groups of oncological diseases identified according to the World Health Organization's X Classification of Diseases X revision. Conclusion: The Delphi method is an effective tool for obtaining an independent expert assessment of healthcare organization and public health issues.

Introduction: There is continued unmet medical need for new medicines across countries especially for cancer, immunological diseases, and orphan diseases. However, there are growing challenges with funding new medicines at ever increasing prices along with funding increased medicine volumes with the growth in both infectious diseases and non-communicable diseases across countries. This has resulted in the development of new models to better manage the entry of new medicines, new financial models being postulated to finance new medicines as well as strategies to improve prescribing efficiency. However, more needs to be done. Consequently, the primary aim of this paper is to consider potential ways to optimize the use of new medicines balancing rising costs with increasing budgetary pressures to stimulate debate especially from a payer perspective. Methods: A narrative review of pharmaceutical policies and implications, as well as possible developments, based on key publications and initiatives known to the co-authors principally from a health authority perspective. Results: A number of initiatives and approaches have been identified including new models to better manage the entry of new medicines based on three pillars (pre-, peri-, and post-launch activities). Within this, we see the growing role of horizon scanning activities starting up to 36 months before launch, managed entry agreements and post launch follow-up. It is also likely there will be greater scrutiny over the effectiveness and value of new cancer medicines given ever increasing prices. This could include establishing minimum effectiveness targets for premium pricing along with re-evaluating prices as more medicines for cancer lose their patent. There will also be a greater involvement of patients especially with orphan diseases. New initiatives could include a greater role of multicriteria decision analysis, as well as looking at the potential for de-linking research and development from commercial activities to enhance affordability. Conclusion: There are a number of ongoing activities across countries to try and fund new valued medicines whilst attaining or maintaining universal healthcare. Such activities will grow with increasing resource pressures and continued unmet need.

Medicines receiving a conditional marketing authorization through Medicines Adaptive Pathways to Patients (MAPPs) will be a challenge for payers. The “introduction” of MAPPs is already seen by the European Medicines Agency (EMA) as a fait accompli, with payers not consulted or involved. However, once medicines are approved through MAPPs, they will be evaluated for funding by payers through different activities. These include Health Technology Assessment (HTA) with often immature clinical data and high uncertainty, financial considerations, and negotiations through different types of agreements, which can require monitoring post launch. Payers have experience with new medicines approved through conditional approval, and the fact that MAPPs present additional challenges is a concern from their perspective. There may be some activities where payers can collaborate. The final decisions on whether to reimburse a new medicine via MAPPs will have more variation than for medicines licensed via conventional processes. This is due not only to increasing uncertainty associated with medicines authorized through MAPPs but also differences in legal frameworks between member states. Moreover, if the financial and side-effect burden from the period of conditional approval until granting full marketing authorization is shifted to the post-authorization phase, payers may have to bear such burdens. Collection of robust data during routine clinical use is challenging along with high prices for new medicines during data collection. This paper presents the concept of MAPPs and possible challenges. Concerns and potential ways forward are discussed and a number of recommendations are presented from the perspective of payers.

Managed entry agreements (MEAs) are a set of instruments to facilitate access to new medicines. This study surveyed the implementation of MEAs in Central and Eastern Europe (CEE) where limited comparative information is currently available. We conducted a survey on the implementation of MEAs in CEE between January and March 2017. Sixteen countries participated in this study. Across five countries with available data on the number of different MEA instruments implemented, the most common MEAs implemented were confidential discounts (n = 495, 73%), followed by paybacks (n = 92, 14%), price-volume agreements (n = 37, 5%), free doses (n = 25, 4%), bundle and other agreements (n = 19, 3%), and payment by result (n = 10, > 1%). Across seven countries with data on MEAs by therapeutic group, the highest number of brand names associated with one or more MEA instruments belonged to the Anatomical Therapeutic Chemical (ATC)-L group, antineoplastic and immunomodulating agents (n = 201, 31%). The second most frequent therapeutic group for MEA implementation was ATC-A, alimentary tract and metabolism (n = 87, 13%), followed by medicines for neurological conditions (n = 83, 13%). Experience in implementing MEAs varied substantially across the region and there is considerable scope for greater transparency, sharing experiences and mutual learning. European citizens, authorities and industry should ask themselves whether, within publicly funded health systems, confidential discounts can still be tolerated, particularly when it is not clear which country and party they are really benefiting. Furthermore, if MEAs are to improve access, countries should establish clear objectives for their implementation and a monitoring framework to measure their performance, as well as the burden of implementation.

BACKGROUND:Across European countries, differences exist in biosimilar policies, leading to variations in uptake of biosimilars and divergences in savings all over Europe.OBJECTIVES:The aim of this article is to provide an overview of different initiatives and policies that may influence the uptake of biosimilars in different European countries. Recommendations will be formulated on how to create sustainable uptake.METHODS:An overview of policies on biosimilars was obtained via a questionnaire, supplemented with relevant articles. Topics were organized in five themes: availability, pricing, reimbursement, demand-side policies, and recommendations to enhance uptake.RESULTS:In all countries studied, biological medicines are available. Restrictions are mainly dependent on local organization of the healthcare system. Countries are willing to include biosimilars for reimbursement, but for commercial reasons they are not always marketed. In two thirds of countries, originator and biosimilar products may be subjected to internal reference pricing systems. Few countries have implemented specific incentives targeting physicians. Several countries are implementing pharmacist substitution; however, the scope and rules governing such substitution tend to vary between these countries. Reported educational policies tend to target primarily physicians, whereas fewer initiatives were reported for patients. Recommendations as proposed by the different country experts ranged from the need for information and communication on biosimilars to competitive pricing, more support for switching and guidance on substitution.CONCLUSIONS:Most countries have put in place specific supply-side policies for promoting access to biosimilars. To supplement these measures, we propose that investments should be made to clearly communicate on biosimilars and educate stakeholders. Especially physicians need to be informed on the entry and use of biosimilars in order to create trust. When physicians are well-informed on the treatment options, further incentives should be offered to prescribe biosimilars. Gainsharing can be used as an incentive to prescribe, dispense or use biosimilars. This approach, in combination with binding quota, may support a sustainable biosimilar market.

ВЕСТНИК СОВРЕМЕННОЙ КЛИНИЧЕСКОЙ МЕДИЦИНЫ 2016 Том 9, вып. 4 15 ОРИГИНАЛЬНЫЕ ИССЛЕДОВАНИЯ К ачество планирования объемов и структуры медицинской помощи непосредственно связано с достижением высокого уровня доступности медицинской помощи, а также высокой эффек-тивности использования ресурсов [1].В качестве основы планирования традиционно предлагается использовать показатели здоровья населения в целом и отдельных специфических групп [2].Среди

Реферат.Контроль и управление качеством медицинской помощи становятся неотъемлемой частью повседневной работы руководителя территориальной эндокринологической службы.Целью работы явилась разработка инструментов, которые позволяют эффективно, неформально и с разумными трудозатратами проводить оценку качества медицинской помощи в профилактике и лечении специфических поздних осложнений сахарного диабета.Материал и методы.Проведен анализ повседневной клинической практики, эпидемиологических данных и экспертных рекомендаций по диагностике и лечению поздних осложнений сахарного диабета.Результаты и их обсуждение.Авторами разработан набор показателей для оценки качества медицинской помощи в области амбулаторной профилактики и амбулаторного лечения диабетической ретинопатии, нефропатии и синдрома диабетической стопы.Выводы.Несмотря на большую значимость оценки качества медицинской помощи и управления им, имеет место нехватка инструментов для этого в отношении осложнений сахарного диабета.Разработанная нами система позволяет анализировать три аспекта качества диагностики и лечения поздних осложнений сахарного диабета, позволяя планировать действия

Background The access of high-technology medicines in Russia is restricted for such reasons as pricing and reimbursement policy, medical indications and many others. Most difficulties are presented in children because of a lack of clinical data about effectiveness and safety. The objective of the study was to evaluate acceptability, affordability and availability of high technology medicines and provide the practical recommendations for optimization of their access in Russia (e.g.,the biologics in children with juvenile idiopathic arthritis (JIA)).