Table 3 The analysis results of reports and articles that had presented the HTA in different countries
Country’s name | Country’s income level | Year of study | What part of the HTA has been addressed? | Method of collecting data from countries | Findings | Suggestions for improving HTA for the future of the country |
|---|---|---|---|---|---|---|
Italy | High | 2000 | Processes Policies Health Technology Assessment Institutions | A descriptive statement of a member of the Italian National Research Council | Describing the health system in Italy Evaluating the control processes in health area technologies (legislations in the pharmaceutical industry, medical services and equipment, and services layout, and the control of personal providers of coverage-related services and policies Review of policies related to specific technologies (screening, remote treatment, resection, and organ and tissue transplantation) Surveying and evaluation of HTA in Italy (activities related to HTA, HTA agents, the impact of HTA) | Despite being a descriptive study, it refers to the almost uncontrolled dissemination of health technologies in different parts of Italy (without coherent policies related to health technology). Another important point mentioned in this research is the increasing sensitivity of the Italian government in the legislation of the HTA despite a passive approach to this issue. |
Malaysia | High | 2019 | Technology assessment institutions | Summarizing the process of HTA by reviewing publicly available documents and reports as well as the experiences of the authors | HTA plays a crucial role in prioritizing treatment in public health centers in Malaysia, especially for the Ministry of Health and Medicine as the reference authority for drugs that are authorized to be prescribed in the facilities of this ministry. There are two organizations in the Ministry of Health performing the HTA as their main activities: Malaysia HTA Division and Drug Formula Management Division as a branch of Pharmacy Development and Application Division. Pharmaceutical evaluation to list the drugs is done in the Ministry of Health and Medicine under the supervision of the Formula Management Branch. The evidence-based evaluation is focused on the safety, efficacy, effectiveness, and impact of drug budgets. The cost-effectiveness is not mandatory at the moment; however, it is a concern to the decision-makers. The assessment results will be considered by the panel reviewing the list of drugs of the Ministry of Health for making decisions related to the formula. | The HTA has supported the formulary-related decisions in the Ministry of Health. The generation of evidence for being cost-effective should progress beyond efficiency or effectiveness, safety, and the budget. The impact of the HTA process is currently unknown and has not been formally evaluated up to now. |
Netherlands | High | 2002 | Policymaking | Aimed at determining the policy relevance of the research proposals, and different methods were defined to classify, score, and weight the policy criteria by examining various classification strategies. | According to the results, different rankings of the research proposals into one of three predefined categories of high, moderate, and low relations to the policy suggest that decision-making on the budget can strongly depend on the method of choice. Also, different rankings of the research proposals using a more explicit method indicate a potential context for further development. | Considering that the budget decision-making method depends on the prioritization categories, it seems that the selection method should reflect the organizational perspective that determines the priorities. |
Canada | High | 2003 | Challenges Policies HTA Institutions | Interviewing with key individuals related to HTA in Canada | The increasing importance and interest in HTA due to the use of economic assessments and evidence will be a significant process. The allocation of resources to HTA in Canada has been much lower than in other similar countries. The cooperation between provincial agencies and the National Coordination Office has been limited and some differences have been found regarding the role contradiction of the two in some cases. The need to allocate more resources (despite doubts about the optimality of this allocation compared to other healthcare sectors) and further efforts in the HTA process in Canada | Investing and allocating more resources to HTA, along with resolving conflicts and disputes on the use of this tool in the healthcare sector may play a role in the process of improving the health system. |
Canada | High | 2009 | The process and challenges of developing and using HTA in the health care decisions in Canada | The decentralized nature of the healthcare system has two consequences: A close relationship with the policy-making environment, enabling to respond the requests of the HTA decision-makers according to the set time intervals. By shifting the focus of decision-making from the national to the local level, certain information needs will change to some extent. | A challenge in the process of developing and using HTA seems to be the lack of information in describing the use of HTA in Canada in the workplace, both locally and nationally. Over the years, several released reports have emphasized the lack of transparency concerning the budget decision-making process and called for greater transparency in such processes. | |
Data related to 19 countries | – | 2019 | Challenges | An extensive review of searchable documents related to the policy and publications available in English literature. The data were selected, collected, and characterized using the Arksey and O’Malley framework. | Despite discrete policies in the 19 surveyed countries, (16 African, one Central American and two Asian).2 most integrated community cases management programs relied largely on executors and the donors’ budget. Parallel implementation systems are often used to provide and supply drugs for integrated community cases management programs. These practices sometimes violate some of the basic principles of the healthcare system. The drug inventory depletion was still prominent in several countries and the integrated community cases management indices were sometimes not integrated into the National Health Management Information System. There were no specific incentive packages for workers with salary and wage and those without salary, associated with several regulatory challenges. Some promising measures to improve the iCCM institutionalization included community-based performance financing, use of technology with mobile devices (mHealth), small procedural improvements, and targeted and non-global service provision. | Sustainable integrated management of community affairs requires improved ownership by stakeholders and local and central governments. The government commitment should be evident in budgeting processes and executive strategies. |
Tanzania | Middle | 2019 | Technology Assessment Institutions/Challenges | The HTA concept was examined by revising a list of national essential medicines in Tanzania by identifying a process to use HTA criteria and evidence-based decision-making in Tanzania. The use of economic evidence to make decisions was trained in the country. Then, these trainings were practically implemented to select drugs for the list of national essential drugs in Tanzania. During the revision process, capacity-building workshops were held to strengthen the HTA process. | Lessons learned from creating and strengthening processes based on transparent prioritization, especially in sub-Saharan Africa countries The HTA process was established in Tanzania from 2014 to 2018 with the establishment of the official Health Technology Assessment Committee. The committee performed successfully in the revision of the national drugs list in Tanzania. The country is institutionalizing HTA for decision-making and prioritization. | Although the use and implementation of HTA vary from country to country, some lessons have been learned that can facilitate the implementation and prioritization process based on HTA in low- and middle-income countries. |
Mexico | Middle | 2012 | Optimizing the resources allocated to health technologies – The process of selecting health technologies – The achievements and the process of receiving new technologies | The analysis process of 394 technologies through compliance with the requirement | Implementing strategies to update the table and catalog of essential healthcare supplies (CBCISS) as a supervisory tool and ensuring sufficient and necessary criteria for safety, effectiveness, and of course, the efficiency Establishing a resource coding system, standardizing the technology purchasing policies, and optimizing the government resources | The CBCISS is some tools used by Mexico to optimize the resources allocated to the health technologies. The CBCISS goal is to help optimize the public resources through the use of technology equipment, with proven safety, therapeutic effect, and efficacy. The importance of CBCISS lies in the fact that all public institutions in the national health system should use only the technologies contained therein. |
Switzerland | High | 2017 | The review of one of the institutions related to HTA | Analysis and evaluation of technologies in terms of suitability, cost-effectiveness, and efficiency | Developing an important program to involve all participant institutions and their cooperation to provide an optimal treatment through HTA Advising policy-makers to pay attention to the professionals abroad | |
United States, Canada, France, and Germany | High | 2013 | Policymaking | Different views were considered on the value. The patient’s health is mostly considered at the center of value. The judgment remains concerning the important decisions and is not replaced by mathematical approaches. | 1. Developing a general framework to define and assess the value; developing by covered institutions/HTA and regulators 2. Disease-specific guidelines 3. Further common scientific advice to the industry regarding the proof of value 4. Developing a framework for licensing, use, and gradual repayment 5. Promoting work for a better adaptation of HTA, coverage, and procurement approaches of medical equipment | |
China | Middle | 2009 | Policies Challenges | The review of the literature and searching websites to track the growth trend of HTA in China | Initially, the transfer of HTA knowledge and the establishment of HTA units appeared to be effective methods for HTA development in China. In the late 1990s, Ministry of Health policymakers tried to integrate HTA with policy-making, aiming at improving the quality and efficiency of healthcare measures. The main government officials related to health technology include the Food and Drug Administration, the Ministry of Labor and Social Security, and the Ministry of Health, with diverse involvements in HTA. The China healthcare system has two problems: Significant waste and inefficiency as well as a serious shortage of budget (9) | An HTA-based technology license-issuing mechanism, including the license to use technology, enterprise license, and workforce license, is gradually implemented by the Ministry of Health in China. Moreover, HTA can play a crucial role in entering the technology market, insurance coverage benefits, formulation, clinical path, reimbursement, etc. A great opportunity seems for HTA to serve as a pivotal part in the healthcare reform, especially to help health sector policymakers making difficult decisions. |
Finland | High | 2009 | Ottanen Database | The previous approach was based on intuition and results, which makes the voluntary cooperation successful and admires them with a review of the process of HTA formation in Finland since 1990, as well as the description of the network, actions, and tasks of HTA in this country. | It suggests the development of training courses for the staff of these institutions for HTA. | |
Japan | High | 2020 | Based on a review of publications and commentaries from April 2019, associated with the opinions of a group of experts on the studied major topics | It provides economic requirements for price adjustment of the list of presenting cost-effective documents to the Central Social Insurance Medical Council (Chuikyo) as a part of the Japan Ministry of Health, Labor, and Welfare for selected drugs and medical devices as well as the latest developments in HTA and the key challenges still to be resolved. Japan is the first country to adopt an algorithmic method for ICER-based pricing. There are some concerns that the implementation of HTA may reduce innovation, help increase drug delays, and ultimately negatively affects the global health system of Japan. Unlike many other countries, where HTA is designed to help with coverage or repayment decisions, HTA has been designed in Japan to help determine or adjust pricing. Based on ICER, in Japan, it can be matched to Farmacoki’s economic theory to regulate or allow the price to reflect the value. Secondly, a broader approach to value-based pricing may be considered since value measurement by merely using ICER is not enough to obtain a large drug value. Thus, the need for evidence to prove the value and support for changes in the health care system should respectively provide incentives for innovation without being evaluated commensurate with the need to produce evidence or be evaluated by suppliers or users of evidence, respectively. | Improving the HTA literacy level and ability among health professionals, universities, government, and industry should be a priority. | |
Asia and Oceania | Middle (Australia and New Zealand: High) | 2009 | Sending questionnaires to countries through the HTA Association | In the Asia-Pacific region, Australia was one of the first countries to implement official HTA programs followed by Singapore, Malaysia, and New Zealand. Other countries have also followed this program and HTA programs are currently available in China, Iran, Japan, Korea, the Philippines, Thailand, and Taiwan. HTA activities are also available in Pakistan and Indonesia, while evaluation research activities are done in India. Naturally, further efforts are required to launch HTA in countries with no such a program and to strengthen existing programs in other countries. | ||
International reports | Eight databases of articles and reports | Challenges that the health system should address in responsible health innovation. | For policy-makers: The justice and sustainability challenges of health systems need to be addressed preventively. Health policymakers have to turn the system-level demand “signals” into opportunities to develop innovation. Innovation policymakers need to reward the technology-based entrepreneurial activities that closely overlap with the challenges of health systems. International policy-oriented forums should share the lessons learned about innovation that better respond to the system-level challenges. For the general public: People need to know about the challenges of justice and sustainability while helping the system by articulating needs and challenges. | |||
Asia (China, South Korea, Japan) | Middle (Japan: High) | 2020 | Health systems of Asian countries HTA structure and evaluation processes HTA test program and its subsequent institutionalization | Case Study of Three Country | Three case studies presented here - South Korea, Japan, and China (Table 1) – indicate the common and specific challenges of the country for the integration of HTA in existing coverage, repayment, and pricing schemes. First, developing a clear, coherent, and standardized HTA framework that explicitly defines the goals, criteria, quality standards, and the best evaluation methods and guidelines seems to be highly important. Second, the generation of country-specific real-world data should be encouraged for use in the HTAs and national databases need to be created or developed accordingly. Finally, demonstrating and measuring the useful impact of HTA on healthcare delivery, clinical outcomes, and the quality of life matters to continue the acceptance and maturity of HTA both nationally and internationally. | Challenges in China: The use of HTA is fragmented and no HTA agency is currently operating nationally to supervise and coordinate all HTA activities. HTA research is scattered throughout government, academia, and industry-based centers. The decision-making process still relies mostly on the experts’ opinions and experiences rather than on evidence-based data. HTA should be fully and formally integrated into existing pricing and refund processes. Challenges of Japan: Some of the unique features of the Japanese pricing and refund system, such as the fixed cost program, will undoubtedly make the integration of HTA into existing methods challenging for the government and manufacturers. It seems that some sort of cooperation should occur between the government and drug manufacturers. There is a need to increase internal capabilities and expertise. The key to HTA success in Japan will be the ability to produce evidence based on the national real-world data. Challenges in South Korea: The lack of specific guidelines, which initially lead to disputes between manufacturers and healthcare providers. The development of specialized staff with pharmaceutical economics expertise appears to be one of the major remaining challenges. |
Latin America | Middle | 2020 | An overview of organizations and HTA processes in Latin America (LA) HTA schedule in Latin America | This article summarizes the discussions of participants in the 40th panel of the International Council of Pharmacy and the results of the research (ISPOR) of the panel discussion of the HTA Council for LA. An additional literature review was done to support some of the existing concepts. | This article includes a brief description of the implementation of HTA over the past 30 years and then a conceptual analysis using some examples of the broader use of HTA to support purchasing decisions and risk-sharing agreements, which may play a crucial role in determining healthcare and treatment priorities in LA in the future. | The HTA processes and methods were important in the past, although they often had separate roles (License or drug refund as examples of these cases). Having more innovative technologies and by creating value frameworks to support healthcare prioritization, HTA nowadays reveals a promising prospect for the sustainability of health systems. |
Poland | High | 2012 | Evaluation of drugs by relevant institutions and its relationship with the interests and strategies of large multinational drug companies | A total of 109 in-depth semi-structured interviews were performed with a targeted sample of stakeholders involved in the repayment process in Poland, along with analyzing four available document sources, including the recommendations issued by AHTAPol. | Drug manufacturers used strategies on direct and indirect effects. The former included building relationships with a circle of HTA analyzers and medical professionals who were working for the agency. In indirect strategies, they employed intellectual leaders of the society in medical settings, organizations, and even political elites to support the appropriate political positions of pharmaceutical companies. An increasing proportion of drugs evaluated and recommended by AHTAPol was reported to be cost-ineffective (unaffordable) or backed by questionable pharmacological economic evidence. | Some drug evaluation results may outweigh the interests of multinational pharmaceutical companies over general payers. It was suggested that the risks involved in the drug evaluation process could be reduced through the followings: (1) The professionalization of HTA, (2) Restrictions on job search and employment after the payment of public salaries, (3) Disclosure and management of conflicts of interest of experts, (4) Patient institutionalization and public participation, and (5) Increasing the institutional separation of AHTAPol from the political elite. |
Germany | High | 2000 | Describing the status and the development rate of Health technology regulation (HTR) according to measuring the effectiveness of decisions and their applicability | The HTA-related literature was identified by searching the literature and databases through personal contacts. The literature was analyzed according to the different sectors of the healthcare system. A national survey was performed to analyze the current state of HTA in Germany. Moreover, the names of the evaluating subjects were gathered in this study. | The results indicate that the range of HTA decisions in the outpatient ward is much more lawful and regulated than in the inpatient ward. The same is true of the dissemination and use of technology. The separation of hospitals and intensive care units seems to be an obstacle to setting the regulations and the establishment of HTA as an effective tool in Germany. Until recently, the HTA in Germany was focused on technologies such as gene technology. The German Working Group on HTA in the healthcare sector adopted a systematic approach to performing HTAs. It was concluded that the legislation of health technologies in Germany was associated with different inconsistencies, from precise legislation in the outpatient sector to almost the absence of legislation in the rehabilitation sector. | The rise in interest in HTA, along with the high priority set by the newly elected government for HTA will probably improve this situation in the future. |
Europe Region Selected European countries (Group A: Germany, France, and Sweden; Group B: Poland, Bulgaria, Hungary, and Romania) | High | 2018 | An analytical framework between HTA methods | The evaluation criteria used in all countries include effectiveness, safety, relative efficiency, and economic data. In Group A countries, the major goals involve improving the quality of care, ensuring equal access, and efficient use of resources. Group B countries have established HTA organizations with formal guidelines, but often follow the decisions of other developed countries. They considerably emphasize the budget impact of new treatment methods and also use HTA as a tool to estimate the costs for state budgets. | HTA organizations have been developed dynamically not only in high-income countries but also in countries with limited resources. The countries being caught in the storm of its implementation can benefit from the experience and development of these countries. | |
Europe | High | 2017 | Reports of HTA institutions | A systematic approach to identifying entities involved in the HTA and selecting the evaluation reports (93 selected reports) | Clinical evidence in more than half of the studies showed moderate or low quality designed to indicate the efficacy and safety. | This study confirmed the low quality of scientific evidence used in the HTA, and thus, the use of evidence would be improved by meeting stricter quality requirements. |
Switzerland | High | 2017 | Evaluating the effectiveness, appropriateness, economic viability, and cost-effectiveness of the HTA and recommendations to policy decision-makers and health care providers | In the area of development of processes, methods and issues related to the stakeholders’ participation, determining the processes and criteria should be raised for use in selecting the technology. | It is still in the early stages of the HTA and is supposed to continue the HTA program effectively by developing the participation of various stakeholders in this area. | |
India | Middle | 2014 | Examining and understanding the perspectives of stakeholders in the HTA in terms of evidence-based decision-making about healthcare system policy-making to evaluate their knowledge, relevant position, and interest in HTA | Semi-structured interviews with policymakers, academics, and industry experts | Although there was a good understanding of HTA among national policymakers, academics, industry experts, and the community, a lack of knowledge was seen among low-level policymakers. There was a positive perception among stakeholders for decision-making concerning the HTA generation. At the national level, however, institutions preferred to be cautious in using HTA evidence due to the very limited capacity to use evidence-based tools in the Indian health system. The key issue was the manufacturing capacity for the production and use of HTA in decision-making. Employees at the national level had little knowledge and understanding of the subject. | All stakeholders tried to promote HTA as a tool for evidence-based policy-making. |