scholarly journals Health Technology Assessment Challenges for Orphan Medicinal Products in Low- and Middle-Income Countries in Europe

2021 ◽  
Vol 70 (1) ◽  
Author(s):  
Anna Mateva ◽  
Konstantin Tachkov ◽  
Antoniya Yanakieva ◽  
Petya Milushewa
Keyword(s):  
Health Care ◽  
Health Technology Assessment ◽  
Health Care System ◽  
Technology Assessment ◽  
Health Technology ◽  
Medicinal Products ◽  
Middle Income ◽  
Middle Income Countries ◽  
Orphan Medicinal Products ◽  
Low And Middle Income

The purpose of this research is to provide a short overview of the differences in access to and health technology assessment of OMPs in selected low- and middle-income countries in Europe and discuss these in terms of some challenges in the face of HTA comparing with high-income countries. This is a retrospective, desktop study of already published official inquiries of national or international institutions, scientific publications, and reports from national governing bodies who regulate and monitor HTA in low- and middleincome economies in Europe, with further regards to HTA of orphan medicinal products. Among all selected low- and middle-income countries in Europe - Bulgaria, Serbia, North Macedonia, Moldova, Ukraine, and Georgia, have available and up-to-date information regarding their health care legislation. During 2000-2019 EMA approves 164 orphan medicines and out of them from 23 to 133 were found in the selected countries. We found that Bulgaria has a special HTA body. Since 2015 in Ukraine the health care system is experienced dynamic reform. In particular, a legislative framework has been adopted that regulates pharmaceutical pricing and reimbursement policies, the introduction of health technology assessment (HTA), etc. Despite the fact that Serbia is not part of the European Union there is an HTA commission established by the Ministry of Health where members of the HTA committee have 5- year mandates. According to our research, Georgia and North Macedonia do not use HTA. Meanwhile, United Kingdom is well known to show a strong interest in evidence health care. system. On the other hand, ?he Statutory health insurance system (SHI reform), since 2000, established a federally funded HTA program with a database of relevant HTA results. Even though that the high-income countries have more developed HTA guidelines and stronger and more secure health systems, all the countries mentioned in this work are facing similar challenges. All the countries have limite

scholarly journals Adaptive health technology assessment to facilitate priority setting in low- and middle-income countries

2021 ◽  
Vol 6 (4) ◽  
pp. e004549
Author(s):  
Cassandra Nemzoff ◽  
Francis Ruiz ◽  
Kalipso Chalkidou ◽  
Abha Mehndiratta ◽  
Lorna Guinness ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Priority Setting ◽  
Technology Assessment ◽  
Health Technology ◽  
Middle Income ◽  
Middle Income Countries ◽  
Low And Middle Income

Health technology assessment in low- and middle-income countries: a landscape assessment

2016 ◽  
Vol 7 (1) ◽  
pp. 37-42 ◽  
Author(s):  
Joseph B. Babigumira ◽  
Alisa M. Jenny ◽  
Rebecca Bartlein ◽  
Andy Stergachis ◽  
Louis P. Garrison
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Landscape Assessment ◽  
Middle Income ◽  
Middle Income Countries ◽  
Low And Middle Income

scholarly journals Health Technology Assessment capacity development in low- and middle-income countries: Experiences from the international units of HITAP and NICE

F1000Research ◽  
2017 ◽  
Vol 6 ◽  
pp. 2119 ◽  
Author(s):  
Sripen Tantivess ◽  
Kalipso Chalkidou ◽  
Nattha Tritasavit ◽  
Yot Teerawattananon
Keyword(s):  
Health Technology Assessment ◽  
Priority Setting ◽  
Technology Assessment ◽  
Policy Research ◽  
Health Technology ◽  
The Philippines ◽  
Health Coverage ◽  
Middle Income ◽  
Middle Income Countries ◽  
Low And Middle Income

Health Technology Assessment (HTA) is policy research that aims to inform priority setting and resource allocation. HTA is increasingly recognized as a useful policy tool in low- and middle-income countries (LMICs), where there is a substantial need for evidence to guide Universal Health Coverage policies, such as benefit coverage, quality improvement interventions and quality standards, all of which aim at improving the efficiency and equity of the healthcare system. The Health Intervention and Technology Assessment Program (HITAP), Thailand, and the National Institute for Health and Care Excellence (NICE), UK, are national HTA organizations providing technical support to governments in LMICs to build up their priority setting capacity. This paper draws lessons from their capacity building programs in India, Colombia, Myanmar, the Philippines, and Vietnam. Such experiences suggest that it is not only technical capacity, for example analytical techniques for conducting economic evaluation, but also management, coordination and communication capacity that support the generation and use of HTA evidence in the respective settings. The learned lessons may help guide the development of HTA capacity in other LMICs.

Addressing issues in health technology assessment promotion: Motives, enablers, and barriers

2011 ◽  
Vol 27 (1) ◽  
pp. 55-63 ◽  
Author(s):  
Abinaya Rajan ◽  
Iñaki Gutierrez-Ibarluzea ◽  
Montse Moharra
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Academic Research ◽  
Health Technology ◽  
High Income ◽  
Local Context ◽  
Survey Questionnaire ◽  
Middle Income ◽  
Middle Income Countries ◽  
Low And Middle Income

Objectives: The aim of this study was to analyze the motives, enablers, and barriers to promote or initiate health technology assessment (HTA) in different contexts.Methods: An observational study design was used to address the above question that included a survey questionnaire and a two-phase study. The respondents for the questionnaire and first round of the study were from HTA agencies of high income countries and those low and middle income countries that have managed to establish HTA agencies (n = 50), that are members of International Network of Agencies for Health Technology Assessment (INAHTA), EuroScan, or European network for Health Technology Assessment (EUnetHTA). The second round of the study was exclusively with respondents from low and middle income countries that were manly affiliated to Health Technology Assessment International (HTAi) interest subgroup for low and middle income countries and aimed to initiate HTA activities (n = 34).Results: Forty-one of fifty HTA agencies answered the survey questionnaire. Thirty-three of fifty individuals belonging to HTA agencies from high income countries and sixteen of thirty-four individuals from low and middle income countries answered in the first and second phases of the study, respectively. In the promotion and/or initiation of HTA, the top three motives were the same for both high income and low and middle income countries. The top three enablers were also similar but the prioritization varies. The top three barriers were more context specific.Conclusions: HTA promotion or initiation is influenced by the following: (i) key players that affect the time taken to establish HTA agencies; (ii) three models for HTA promotion and initiation: top-down (political interest), bottom-up (academic/research interest), and converging (political and academic/research interests); and (iii) motives, enablers, and barriers at the local context.

scholarly journals Application of evidence-informed deliberative processes in health technology assessment in low- and middle-income countries

2020 ◽  
Vol 36 (4) ◽  
pp. 440-444
Author(s):  
Wija Oortwijn ◽  
Sanne van Oosterhout ◽  
Lydia Kapiriri
Keyword(s):  
Decision Making ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Contextual Factors ◽  
Health Technology ◽  
Appraisal Committee ◽  
Middle Income ◽  
Middle Income Countries ◽  
Deliberative Processes ◽  
Low And Middle Income

ObjectivesEvidence-informed deliberative processes (EDPs) were introduced to guide health technology assessment (HTA) agencies to improve their processes toward more legitimate decision making. A survey among members of the International Network of Agencies for HTA (INAHTA) showed that EDPs can also be relevant for countries that have not (yet) established such an agency. Therefore, we explored to what extent low- and middle-income countries (LMIC) applied the steps and elements stipulated in the EDP framework and their need for guidance.MethodsThe survey among INAHTA members was slightly adapted to address LMIC context and sent to 416 experts identified through several HTA sources. The questions focused on contextual factors and the EDP steps (installation of an appraisal committee, selecting technologies and criteria, assessment, appraisal, communication and appeal). Data collection took place between 21 May and 1 September 2019. Descriptive statistics and qualitative analyses were used to summarize the findings.ResultsWe received sixty-six meaningful responses from experts in thirty-two LMIC. We found that contextual factors to support HTA development are overall not present or only present to some extent. Respondents indicated that guidance was needed for specific elements related to selecting technologies and criteria, assessment, appraisal, as well as communication and appeal.ConclusionsEDPs have the potential to provide steps for improving HTA processes. The results of this study can serve as a baseline measurement for future monitoring and evaluation of EDP application in the responding LMIC. This could support the countries in improving their processes and enhancing legitimate decision making when using HTA.

scholarly journals Pilot approach to analyzing patient and citizen involvement in health technology assessment in four diverse low- and middle-income countries

2021 ◽  
Vol 37 ◽  
Author(s):  
Anke-Peggy Holtorf ◽  
Debjani Mueller ◽  
M. Sharmila A. Sousa ◽  
Lauren Pretorius ◽  
Kalman Emry Wijaya ◽  
...  
Keyword(s):  
Decision Making ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Citizen Involvement ◽  
Health Coverage ◽  
Middle Income ◽  
Health Technologies ◽  
Middle Income Countries ◽  
Low And Middle Income

Abstract Background In low- and middle-income countries (LMICs) striving to achieve universal health coverage, the involvement of different stakeholders in formal or informal ways in health technology assessment (HTA) must be culturally and socially relevant and acceptable. Challenges may be different from those seen in high-income countries. In this article, we aimed to pilot a questionnaire for uncovering the context-related aspects of patient and citizen involvement (PCI) in LMICs, collecting experiences encountered with PCI, and identifying opportunities for patients and citizens toward contributing to local decision- and policy-making processes related to health technologies. Methods Through a collaborative, international multi-stakeholder initiative, a questionnaire was developed for describing each LMIC's healthcare system context and the emergence of opportunities for PCI relating to HTA. The questionnaire was piloted in the first set of countries (Brazil, Indonesia, Nigeria, and South Africa). Results The questionnaire was successfully applied across four diverse LMICs, which are at different stages of using HTA to inform decision making. Only in Brazil, formal ways of PCI have been defined. In the other countries, there is informal influence that is contingent upon the engagement level of patient and citizen advocacy groups (PCAGs), usually strongest in areas such as HIV/AIDS, TB, oncology, or rare diseases. Conclusions The questionnaire can be used to analyze the options for patients and citizens to participate in HTA or healthcare decision making. It will be rolled out to more LMICs to describe the requirements and opportunities for PCI in the context of LMICs and to identify possible routes and methodologies for devising a more systematic and formalized PCI in LMICs.

scholarly journals The Significance & Need of prioritizing Health Technology Assessment added with economic evaluations of medical interventions in Low & Middle Income countries (LMICs): The Covid-19 experience

2021 ◽  
Author(s):  
Piyush Kumar
Keyword(s):  
Health Care ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Economic Burden ◽  
Cost Effective ◽  
Health Technology ◽  
Economic Evaluations ◽  
Middle Income ◽  
Medical Interventions ◽  
Middle Income Countries

The covid-19 pandemic had disclosed the truth that health care resources are limited and the medical interventions applied to deal with the pandemic such as ventilators are not available to most of the population and there are needs of suitable cheaper alternative to be assessed to be cost effective than the available interventions to reduce the economic burden as well. Only looking at the benefits of intervention avoiding the cost effective analysis will do harm definitely in short as well as long run as the economic burden must need to be addressed in order to make an intervention reach from top to bottom strata of the population. The health technology assessment will help policy makers to achieve the goal of primary health care as well as universal health coverage by making the healthcare system affordable, accessible , available to everyone particularly poor populations. A simple question is: are the ventilators available to all who required it? Of course the answer is no. Limiting the medical interventions only to rich people is not going to solve the problems of nations; the interventions should be available, accessible, and affordable to everyone who needs it. This is the only way and for this we must have HTA (health technology assessment) added with economic evaluations of medical interventions to search alternatives which can be better cost effective than existing one. In this article I am discussing significance of HTA and economic evaluations of medical interventions in Low & Middle Income countries.

IMPLEMENTATION OF LOCAL/HOSPITAL-BASED HEALTH TECHNOLOGY ASSESSMENT INITIATIVES IN LOW- AND MIDDLE-INCOME COUNTRIES

2012 ◽  
Vol 28 (4) ◽  
pp. 445-451 ◽  
Author(s):  
Randa Attieh ◽  
Marie-Pierre Gagnon
Keyword(s):  
Systematic Review ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Local Level ◽  
Health Technology ◽  
Hospital Level ◽  
Local Hospital ◽  
Middle Income ◽  
Middle Income Countries ◽  
Low And Middle Income

Objectives:The objective of this study is to review the implementation of health technology assessment (HTA) at the local and hospital levels in low- and middle-income countries (LMIC). This review will provide a starting point for identifying the conditions for HTA implementation in hospitals in LMIC through the analysis of experiments conducted in these countries.Methods:A systematic review of the literature was conducted to document the local-/hospital-level HTA experiments performed in LMIC.Results:This systematic review showed that few experiments of local HTA in LMIC have been published to date, with only five articles found in our survey. These documents report studies of clinical effectiveness and economic evaluation at the local level in certain Asian and Latin American countries. In addition, pharmaceuticals and medical devices were the most common topics covered by HTA at the local level in these countries.Conclusions:Currently, HTA plays an increasingly important role in healthcare systems in supporting decision making for healthcare policies and practices. This systematic review contributes to identify priorities in the process and methodology of HTA implementation at the local/hospital level in LMIC. The paucity of HTA in LMIC is often assumed to be due to the lack of formally tasked HTA agencies, to politics and to shortage of resources.

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