Policy options for strengthening health technology assessment in Iran

Policy options for strengthening health technology assessment in Iran | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Policy options for strengthening health technology assessment in Iran Salman Bashzar, Vahid yazdi-faeizabadi, Mohammad Mohseni, Asma Sabermahani This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7359076/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 9 You are reading this latest preprint version Abstract Since health technology-related issues pose ongoing challenges for health systems, ensuring proper Health Technology Assessment (HTA) and its efficient and effective use for health care is essential. After more than a decade since the start of this system in the Iranian health structure, various and scattered HTA groups have been created, which are not under a single, unified policy, indicating a lack of coordination between the units defined in the structure of the HTA system and the decision-making units, and the specific performance of its components cannot be tracked transparently. We conducted a policy analysis study in 4 phases: comparative study, review study, policy analysis, HTA, relying on qualitative interviews with key informants and document analysis, and finally using a focus group discussion approach. As a result, we introduce policy options including maintaining the status quo by implementing a comprehensive strategy, establishing a higher institution under the direct authority of the Minister with specialized committees in the deputy ministries of the Ministry of Health, and establishing a structure independent of the Ministry of Health and within the country's technology system, with their advantages, disadvantages, and requirements, and finally, important recommendations for the formation of a coherent and responsive system. Health Policy Policy Options Health Technology Assessment Key Message Changing old structures requires studying the context and conditions governing existing structures. Creating systematic change in HTA requires the participation of all stakeholders. Constructive change is not created by changing the political structure of the organization alone; reforming the processes of change is a necessary and very sensitive issue in improving structures. In order to achieve efficient and effective functions, Iran's HTA must be updated and its processes must be reformed with the participation of all stakeholders. Introduction Rare resources, increasing demand for health services, an aging population, and technological advances threaten the financial sustainability of many health care systems and make it difficult to allocate resources equitably and efficiently ( 1 ), where factors such as advances in science and engineering, aging populations, emergence of pathogens and other diseases, unexpected outcomes and physician and patient anxiety, third-party payment, financial incentives for technology companies, prevention of medical errors, competition among providers for the use of technology, and public demand due to increased consumer awareness are driving the demand for health technology ( 2 ). There are numerous examples in the history of medicine of health technologies that not only did not produce the intended benefits, but also caused harm ( 3 ), such as hydralazine for the treatment of chronic heart failure, episiotomy for childbirth, hormone replacement therapy for menopausal women, and thalidomide for sedation of pregnant women, which were found to be ineffective or harmful after widespread distribution ( 4 ), and were more evident in the Covid-19 pandemic, when drugs were marketed to treat the disease that lacked the necessary efficacy, and in one case, the production and distribution of the drug remdesivir in the third quarter of 2020, generated approximately $ 900 million in revenue for the manufacturing company ( 5 ). On the other hand, policymakers cannot judge the values ​​and consequences of technology solely on the basis of complex technical data and, for rational decision-making, they need to understand the broader economic, social, ethical and legal impacts of technologies. Since issues related to health technologies pose ongoing challenges to health systems, it is essential to ensure that health technology is properly assessed and used efficiently and effectively for health care. To make optimal use of available resources, the most effective technologies must be used in the light of organizational, social, ethical and economic considerations. The scarcity of resources in the health sector has led to evidence-based decisions in the selection of expensive technologies and has led to the adoption of mechanisms by countries to, on the one hand, control costs, prevent their excessive increase and allocate them optimally, and, on the other hand, prevent the introduction of technologies whose safety and effectiveness are low ( 3 , 6 ). Health technology assessment is a systematic evaluation of the characteristics, effects and/or consequences of health technologies and interventions, used to inform policy and decision-makers in health care, particularly on how to allocate limited resources to health interventions and technologies ( 7 ), and was designed and developed in pioneering countries before 2000 as a policy solution over several years in the context of institutional structures, committed academia, and a science-based community with stakeholder participation for research and the production and use of evidence. In many cases, of course, the top-down interest of politicians and policymakers merged with existing academic interests, leading to a convergence in the initiation of HTA ( 8 – 12 ). Thus, over the past 5 decades, with the beginning of HTA in the United States and its development in developed countries, there has been a remarkable transformation in health-related decision-making. However, it is a new and rapidly expanding field in developing countries, as can be seen from the growing trend in many countries to allocate healthcare technologies more efficiently with limited budgets. HTA has therefore become a decision-making and prioritization tool in health systems ( 13 – 18 ) and is widely used to improve the efficiency of resource allocation ( 1 , 3 ). Policy Context: Most of the challenges that have significantly targeted quality, efficiency, and equity in the Iranian health system are rooted in decision-making and policies that are more driven by pressures from problems than by evidence-based ones. Therefore, the philosophy and function of HTA have shown that a HTA system in Iran can affect multiple sectors and contribute to the efficiency of the health system ( 19 ). In this regard, Iran has not been left behind, and the national program of the HTA System with the aim of producing quality and evidence-based information for decision-making and selecting appropriate technology at different levels of the health system officially began operating in November 2007 at the HTA Secretariat in the Health Economics Department, Center for Network Development and Health Promotion, Ministry of Health, Treatment and Medical Education. Following structural changes in the Ministry of Health, Treatment and Medical Education and the separation of the Health and Treatment Deputy Offices in 2010, HTA began its activities under the title of the HTA Office in the Office of Technology Assessment and Development of Health Standards and Tariffs, Ministry of Health ( 20 , 21 ). Initially, HTAs mainly assessed capital equipment, but with increasing experience and expanding research capacities in universities and research centers, more general assessments of non-capital equipment as well as new and older technologies were conducted ( 21 ). These assessments are conducted by independent experts and assess the short-term and long-term effects of health technologies on the quality of health services ( 20 ). The cost of conducting HTA projects is also financed by the government budget (from the budget of the Medical Equipment Administration) ( 23 ). The process established for assessing health technology in Iran has not changed much since its inception and continues to exist in the same way. Of course, it should also be noted that, in line with the HTA office in the Deputy Minister of Health, the Drug Review and Formulation Council in the Deputy Minister of Food and Drug Administration has independently conducted HTA issues related to drugs, which in 1400 this council was renamed the Drug Evaluation Council and evaluates drugs needed in the country's health sector. However, after two decades of its establishment in the country's health system, various and scattered HTA groups were created, which are not under a single, unified policy. The lack of coordination between the units defined in the structure of the Iranian HTA system and the decision-making units can be clearly understood from its output ( 22 ), and the specific performance of the HTA units established in different parts of the Iranian health system cannot be transparently tracked. Methods The present study is part of a larger study called "Policy Analysis of Iran's HTA System" which was conducted in four phases;1) A comparative study aimed at answering the question "What are the structure, content, and dimensions of HTA systems in the world?", 2) A comprehensive review study aimed at answering the question "Challenges of HTA systems in the world?" and completing the interview guide used in policy analysis,3) A policy analysis of Iran's HTA system using Walt and Gill policy triangle approach ( 23 ), and 4) Providing policy options based on the results of the previous three phases. In the comparative phase, eight countries were selected based on the type of health insurance system: Germany and France (traditional insurance system), Finland and Canada (national health insurance system), Denmark and England (national health system), and the United States and Australia (combined insurance system). In the review phase, in order to examine the challenges of HTA in the world and Iran, the electronic databases Web of Science, PubMed, Scopus were searched for the period 1973 to December 08, 2021, and the internal databases Barakat Knowledge Network System and Iranian Research Institute for Information Science and Technology were searched to access Persian articles. A purposive sample of key informants with significant management and policy experience, or extensive training and research related to the HTA system and its related policies were selected for interviews in the third phase. In order to collect sufficient information to cover all aspects of the HTA system, we tried to identify as many relevant stakeholders as possible. 23 interviews were conducted in person and in-person and transcribed. The transcribed interviews were analyzed by the research team using a thematic analysis approach, following the framework analysis methodology, and using MAXQDA10 software. In addition, 10 related documents were reviewed at this stage to complete the data collection. Policy options were extracted from interviews and document analysis, based on the results of the first and second phases, and using a focus group discussion approach between experts and research team members, the policy options were examined and the advantages and disadvantages of each were extracted. The tools used were note sheets and a full recording of the meeting. It is worth noting that S.B played the role of coordinator/mediator in the meeting and regarding participation in the meeting, the presence of individuals in the meeting was considered as informed consent and they were asked for permission to record and take notes. Two focus group discussion sessions were held with an average duration of 120 minutes. Policy options for strengthening the Iran HTA system: In Iran, there are two offices under the two deputy ministries that carry out HTA activities in parallel, each with its own status and power, and in practice, there is no law or legal article stating that each is accountable to the other. In other words, the office in the Food and Drug Administration is not accountable to the Office of Assessment of the Deputy Ministry of Health. On the other hand, the National Institute of Health has also formed the HTA Council, but their relationship is not clear and their processes are completely opaque and ambiguous. On the other hand, the laws related to HTA and its legal status are not clear, so it is necessary to take more fundamental steps to improve this system in order to achieve the desired goals. Participants believed that most of the challenges related to HTA in Iran are related to the governance and structure of this institution, therefore the proposed policy options target the structure and governance and emphasize first reviewing the structure and laws and then the processes and communications of HTA in order to improve the state of the HTA system. Table 1 provides a summary of the analysis of the policy situation, advantages and disadvantages of policy options for the Iranian HTA system based on focus group discussions, interviews and document review. Option 1: Maintaining the status quo by implementing a comprehensive strategy In the current situation, the HTA Office in the Ministry of Health and the Drug Assessment Council in the Ministry of Food and Drug Safety carry out the HTA process separately and with minimal coordination. Meanwhile, the Drug Assessment Council in the Ministry of Food and Drug Safety carries out its processes based on its own internal criteria and standards, has its own political processes, and considers its own criteria in conducting HTA. For example, the discount rate, willingness-to-pay threshold, method of calculating costs, etc. are some of the things that it has specified, and on the other hand, the method of communication with the HTA Office of the Ministry of Health and the Supreme Insurance Council is unclear and non-transparent. This condition also applies to the HTA Office in the Ministry of Health, and the approaches to prioritizing and selecting topics, how to conduct calls and select researchers, and even how to judge and critique projects and then make decisions about them are not very transparent. It is worth noting that the method of communication with the decision-making level of the Supreme Insurance Council is not transparent, and the method of submitting and judging the results is also completely non-transparent. The General Directorate of Medical Equipment also seems to be coordinating the assessment of the required technologies with the Deputy of Treatment and following its processes. However, in the country, these two offices in two deputy offices at the same level as Food and Drug and Treatment carry out HTA activities, and despite the lack of transparent processes, it is said that its results are used. In this option, it is proposed that the situation remains the same, but the units carry out the main processes in a coherent and connected manner. This option also emphasizes conducting drug evaluation in the Deputy of Food and Drug, procedures in the Deputy of Treatment, and health interventions in the Deputy of Health. Since it will be very difficult to make changes in organizations, especially in organizations that have been established and institutionalized for many years and are in a state of relative inactivity, it will be very difficult. Therefore, without changing the current structure and only with the considerations mentioned in Table 1 , many of the shortcomings of the current situation can be largely eliminated and there is hope for the creation of a more coherent HTA system in Iran. The implementation of this policy option requires the involvement of all stakeholders in the health and health legislation areas in order to provide a legal environment and create intra-sectoral interactions and communications between existing offices. In order to fully establish this policy option, it is necessary for policymakers to seek to identify or enact laws within the framework of which HTA and the HTA system will have legal support and to facilitate further moves towards the establishment, institutionalization, and full implementation of HTA with the support of such laws. Also, the roles of the two existing HTA Offices/Committees should be redefined and in the redesign, the roles of each should be clearly and specifically communicated to them and how they should be implemented and carried out, as well as the manner of interactions with technology stakeholders, so that the manner of interactions of the Health Deputies and the General Directorate of Medical Equipment and their position in the process with the Health Deputies and the National Institute for Health Research are clear. In this option, it is also necessary to establish a mechanism to respond to needs through the establishment of foresight and early warning subcommittees in health technologies in order to take proactive measures. It is necessary to create, design, and redesign processes and mechanisms such as prioritization and selection of topics, calls, monitoring and evaluation, arbitration, and decision-making in order to create transparency and manage potential conflicts of interest, which have been identified as the most important challenges of HTA in Iran. Option 2: Establishing a higher body under the direct authority of the Minister with specialized committees in the deputy ministries of the Ministry of Health The aim is to establish an HTA agency/organization/institution under the direct authority of the Minister of Health with specialized committees, which will also make maximum use of the current existing set. In this policy, each deputy ministry in the Ministry of Health complex will have its own specialized committees that carry out their activities in coordination with the main HTA body under the authority of the Minister. Under this policy, activities will be fully coordinated and under one set. In this form, the budget of this unit will be separate from other units and in addition, they can also have separate financing within the deputy ministries. In this option, it is proposed that the existing offices be specialized under the titles of the Office of Pharmaceutical Technology Assessment, the Office of Non-pharmaceutical Therapeutic Methods and Interventions Assessment, the Office of Medical Equipment and Devices Assessment, and the Office of Public Health Interventions Assessment in the deputy ministries of Food and Drugs, Treatment, General Directorate of Medical Equipment, and the Deputy Ministry of Health, respectively. Prioritizing and selecting HTA topics after the requests of each deputy are sent to the main institution, then by a knowledge intermediary institution such as the National Institute of Health, the plans are carried out scientifically and in defined processes. Then, in the evaluation phase, the main institution judges and sends its recommendations and advice after the judgment to the decision-making institution and even the results are published in the database for the use of other stakeholders. Establishing a specialized health technology horizon mapping unit can activate the proactive approach of this system and pursue the prioritization and selection of HTA topics with greater sensitivity in order to prevent waste of resources. In addition, we will also design and redesign transparency and accountability processes here. Establishing a specialized monitoring and evaluation committee in the institution created for the purpose of critically evaluating and judging projects as well as supervising the implementation of processes in the deputy institutions will be formed. This will create a separation between the supervisor and the project implementer and will create a barrier in the path of potential conflicts of interest. Given that HTA is a multidisciplinary skill and employing many experts in this institution will be a very difficult and costly task, this institution should form temporary specialized committees with the participation of relevant experts, patient representatives, and other relevant stakeholders for its assessment projects, and the processes related to it and how to select the members of this committee should be completely clear and transparent. To create such an institution, organizational stakeholders, including the Food and Drug Administration, the Deputy Minister of Treatment, the General Directorate of Medical Equipment, the Deputy Minister of Health, and the Deputy Minister of Research, must participate in the creation of the upstream institution and try to establish and maintain the necessary communications, coordination, and interactions with each other and even other stakeholders. This institution should also specify that the decision-making, monitoring, and evaluation processes should be designed with greater care and sophistication so that, in addition to transparency and prevention of potential conflicts of interest, it can provide appropriate accountability to stakeholders and society. In direct governance under the supervision of the Minister of Health, it means that the Minister directly supervises and also finances it more appropriately. Also, specialized committees should be formed, such as what we see in NICE or CADTH. In this option, it is suggested that the existing offices be specialized under the titles of the Office of Drug Technology Assessment, the Office of Non-Drug Treatment Methods and Interventions Assessment, the Office of Medical Equipment and Devices Assessment, and the Office of Public Health Interventions Assessment in the Food and Drug Administration, the Treatment, the General Administration of Medical Equipment, and the Health Administration, respectively. Prioritizing and selecting HTA topics should be sent to the main institution after the requests of each of the departments, then the plans should be carried out scientifically and in defined processes by a knowledge intermediary institution such as the National Institute for Health Research, and then the main institution should judge in its own evaluation phase and send its recommendations and advice to the decision-making institution after the judgment, and the results should be published in the database for the use of other stakeholders. Creating a specialized health technology foresight unit can activate the proactive approach of this system and pursue more sensitive prioritization and selection of HTA topics to prevent waste of resources. Option 3: Creating an independent structure from the Ministry of Health and within the country’s technology system This option suggests that an independent structure of the country’s technology system be formed and a HTA system be established under this structure. It seems that an independent complex outside the ministries, such as under the Islamic Consultative Assembly or the presidential institution, can partially solve the challenges of technology assessment, especially in the health sector. Under the establishment of such an institution, the HTA Agency can be placed, and under it, specialized committees that can be formed temporarily and conduct relevant and specific assessments. Shaping the process and creating influence, as well as legislation at this level of decision-making, can give more legitimacy to the HTA Agency in terms of law and regulation. To create an independent structure from the Ministry of Health, cross-sectoral interactions and cooperation are needed between the complexes managed by the Ministry of Health, the Ministry of Science, Research and Technology, and the entire government. In this structure, the technological perspective should not be limited to technologies in a specific field, and under this set of HTA systems, health and environmental attachments of other technologies should also be seen. The most important requirement of this policy is to pay attention to inter-sectoral cooperation and the obligation of the Ministry of Health and the managed entities to cooperate and respond to this institution and vice versa. Also, in this structure, evidence-based decision-making processes should be drawn and formulated in order to prevent person-centered and silo-based decision-making. Table 1 Policy options, considerations, advantages and disadvantages Policy option Option 1: Maintaining the status quo by implementing a comprehensive strategy Option 2: Establishing a higher body under the direct authority of the Minister with specialized committees in the deputy ministries of the Ministry of Health Option 3: Creating an independent structure from the Ministry of Health and within the country’s technology system Consideration - Defining and redefining legal roles for HTA in the health system - Defining and redefining the role of existing offices in HTA - Designing a mechanism for HTA to respond to needs - Creating transparency by designing and redesigning processes and mechanisms for conducting HTA - Creation and establishment of an institution/agency under the direct supervision of the Minister of Health - Establishment of specialized committees in the deputy ministries of the Ministry of Health - Establishment of a specialized monitoring and evaluation committee - Establishment of temporary advisory committees - Designing processes for cross-sectoral collaboration Given that in this option, the HTA area will be separated from the Ministry of Health, specific processes should be designed for cross-sectoral collaboration between organizations involved outside the Ministry of Health and the Ministry of Health so that the Ministry, as the end user of HTA, does not experience new challenges. Advantages - Involving the two main areas of treatment and food and medicine in HTA - Conducting drug HTA in a specialized manner at the Food and Drug Administration - Compliance with these processes by many stakeholders - Acceptability for the Food and Drug Administration and also the Deputy Minister of Treatment - The presence of people with experience in this process in the current situation - Good and appropriate communication with the National Institute of Health Research as a knowledge intermediary institution - The HTA system will operate more coherently. - Needs will be better met. - Roles are clearly defined. - Transparency in processes will be easily accessible to stakeholders. - Mechanisms for preventing conflicts of interest will be deepened. - The existence of an independent body with a clearly defined context and structure - Resolving many conflicts of interest - Creating transparency in HTA processes - The existence of specialized committees in the structure of the independent body - Only one decision-making body is accountable to higher levels - Avoiding duplication of work - Accepting the independence of the HTA Agency from the Ministry of Health and Medical Education - Transparency of processes, of course, by designing assessment mechanisms and processes - Creating an environmental and health continuum for all technologies - Creating an independent institution with government governance and a stable budget - Accountability of an institution/agency for decisions made disadvantages - Broken structure of the HTA system - Lack of proper communication and coordination between existing structures - Lack of transparency in existing processes - Conflict of interest in HTA - Lack of definition of communication system between existing structures - Lack of participation of the Health Deputy in HTA processes - Lack of transparency regarding results and recommendations and whether it is mandatory to consider them - Lack of sustainable financing - Lack of independence of both offices - Lack of coordination of processes and possibility of conducting two similar projects in two offices - Lack of proactive approach to technologies - Coordination between departments will continue to be difficult. - Individuals will be indifferent to and resistant to changes. - Processes will continue to be incompletely implemented due to the lack of an upper organizational unit to create uniformity between the processes of the departments. - Communication between the units involved will remain incomplete due to the lack of commitment. - Lack of independence and lack of sustainable financing will continue to be major challenges. - Silo-based decision-making not resolved - Conflicts of interest and lack of transparency still remain to some extent. - Resistance of the Health and Food and Drug Administrations to be accountable to an independent scientific body - Difficulty in coordinating between the agencies - Difficulty in finding scientific and HTA-aware individuals to sit on expert committees - Resistance in downstream institutions to implement laws - Uncertainty about the responsiveness of such a structure to the country's health sector - Creation of a centralized structure and a vertical structure in the decision-making area - Uncertainty and trust in the processes created in the created structure - Difficulty in networking and interactions - Difficulty and challenges related to data flow - Employing and hiring skilled individuals and increasing the volume of government human resources - Lack of trained and skilled individuals in the field of health technology decision-making - Lack of responsiveness of downstream areas to higher areas - Difficulty in coordination between departments (other departments with the Ministry of Health) - Creating more opportunities for silo-based decision-making - Cultural problems, fear of being separated from the Ministry of Health and the problems arising from it - Unresolved conflicts of interest problems in the HTA system and the likelihood of more conflicts Discussion Three policy options, each with their requirements, advantages, and disadvantages, were introduced to strengthen Iran’s HTA system. Since most of the challenges related to Iran’s HTA are related to the governance and structure of this institution, the proposed policy options target the structure and governance, and the options proposed to improve the status of the HTA system emphasize first reviewing the structure and laws, and then HTA processes and communications. The shift from traditional decision-making to a decision-making process that follows modern principles of evidence-based medicine, cost-effectiveness and patient-centred services is a major challenge for health systems with multiple stakeholders ( 24 , 25 ), so moving towards a formal and systematic HTA programme requires a high and strong commitment from government officials and a dedicated and motivated team of experts responsible for the HTA development plan. Accordingly, when aiming to establish or enhance national HTA capacity, the establishment of a formal HTA agency should not necessarily be the sole focus of decision-makers. According to Lehoux, the establishment of a structured HTA network that integrates existing national institutions and is guided by an HTA coordinating body or board is a more appropriate solution ( 26 ), and it is therefore more logical to target policy options to the HTA body/agency. Building HTA capacity requires advocacy and discussion among relevant stakeholders, and the objectives, potential benefits and needs should be clearly stated in the documents, as this will help lobby for public political support and obtain funding. Targeted advocacy and consensus building should be undertaken among identified stakeholders, potential funding bodies, potential users of policy advice and research institutions interested in HTA-related positions. In the first option, it is proposed that the existing structures remain subject to the definition and redefinition of their roles and responsibilities in a way that forms a proper relationship between the existing units. The second option refers to the establishment and establishment of an institution or body above the deputy levels, in which the agency will be independent from the deputy areas and will have greater power to establish communications and interactions among the interested and involved areas at lower levels. In this agency, specialized committees will be formed at the deputy levels and activities will move towards specialization, and the monitoring and evaluation areas will become independent of each other. This agency will also have funding from the Ministry of Health in planning. To establish such an institution, organizational stakeholders, including the Food and Drug Administration, the Deputy for Treatment, the General Directorate of Medical Equipment, the Deputy for Health, and the Deputy for Research, should participate in the establishment of the upstream institution and try to establish and maintain the necessary communications, coordination, and interactions with each other and even other stakeholders. This body should also specify that decision-making, monitoring, and evaluation processes should be designed with greater care and sophistication to ensure transparency and prevent potential conflicts of interest, and to provide appropriate accountability to stakeholders and society. The third option suggests that an independent structure for the country’s technology system be established under the Islamic Consultative Assembly or the presidential institution, and within this structure, a HTA system be formed that assesses all health technologies and adapts them to the country’s context. Shaping the process and creating impact, as well as legislation, at this level of decision-making could give greater legal and regulatory legitimacy to the HTA agency. What is more important are the implementation considerations that are necessary for each of these options. Defining and redefining the legal roles for HTA is a key priority in the health system, given its unclear legal and regulatory status. Health systems and HTA do not operate in a legal vacuum and the law surrounds them. Therefore, the relevant mandatory or optional laws should be placed within the scope of the organization and regulation of health as a public service, which is public law. Since HTA eliminates the need for government authorities to set criteria and analyses for making decisions on the reimbursement of technologies, HTA should essentially be in the nature of public law and subject to mandatory government laws ( 27 ). Therefore, it is necessary to establish HTA in the legal system of the country in order to move forward in the legal and regulatory system of the country. For this reason, policymakers should seek to identify or enact laws within the framework of which HTA and the HTA system will have legal support and facilitate further moves towards the establishment, institutionalization, and full implementation of HTA with the support of such laws. Also, in defining and redefining the role of existing offices in HTA in Iran, the roles, relationships, and how to carry out the processes of each of the existing offices and structures should be clearly defined. In the case of agencies with multiple sub-companies, the Australian HTA ( 28 – 30 ) can be considered as a successful model. In this regard, it is necessary for all offices to work in line with each other and with completely transparent and specific processes for carrying out the assigned activities. In such a way that the processes related to the evaluation of drugs in the Food and Drug Administration, the evaluation of procedures and treatment methods, and diagnostic tests are carried out in the Health Administration. Of course, how they are implemented and carried out, as well as how they interact with the stakeholders of such technologies, should be clearly defined. Also, how the health ministries and the General Directorate of Medical Equipment interact and their position in the process with the treatment ministry should be explained. Therefore, based on studies on obtaining legal support, a specific policy or legal statement to establish a new institution or grant HTA tasks to an existing organization is an important step in formalizing HTA activities ( 18 ). Designing a mechanism to respond to needs is one of the necessities of HTA in Iran, and this requires the ability to anticipate issues, contextualize information, and ensure communication. The predictive capacity of HTA organizations is assessed through activities such as early warning and foresight. Also, responding to needs requires background knowledge, factors of change, barriers to using HTA, and the availability of resources to use outputs and implement changes. Therefore, it is necessary to establish a committee for foresight and early warning in health technologies in order to take proactive measures. Also, since Iran's HTA lacks appropriate transparency processes in all stages of HTA, it is necessary to create a more suitable situation for its transparency by designing and redesigning the processes and mechanisms for conducting HTA. Since transparency is a key element of fair and reliable processes, the link between HTA findings and decision-making processes should be made clear and explicit. Therefore, those involved in the assessment and critical evaluation process should be aware of the issues under consideration and the content of the deliberations, and the processes, deliberations, decisions, and reasoning of the decision-making body should be made available to stakeholders ( 31 ). In practice, transparency is believed to improve the usefulness, consistency, and generalizability of HTA reports. Furthermore, participatory transparency demonstrates the democratic capacity to participate in the evaluation ( 32 ). Brown argues that the demonstration of transparency by an HTA body will always depend on the contexts in which it is initiated and practiced. It will vary according to the form of disclosure sought, the means by which disclosure is made, and any number of other limiting circumstances. Acknowledging this fact protects against the “naïve” assumption that a state of absolute transparency is achievable ( 32 ). Redesigning the development of the human resources required for HTA systems is a policy that should be given special attention at the academic and national levels, given that international organizations have identified the lack of skilled human resources as the most important obstacle to the establishment of HTA capacities ( 17 ). The literature emphasizes that human resources for health are arguably the most important part of health systems ( 33 ). HRH brings together all the other elements of health systems. They link health technologies, infrastructure, knowledge, and financing ( 34 ). Therefore, when HRH is low, inefficient, or ineffective, the entire health system is weakened. Vujicic has identified inadequate HRH capacity as one of the most important constraints in health systems. He also states that many global health initiatives fail to achieve their goals due to the lack of sufficient health workers ( 35 ). Given that in our country, four medical universities are engaged in training HTA specialists, the interdisciplinary nature of HTA should be emphasized at the outset in the development of the agency’s mission statement or charter ( 26 , 36 ). Therefore, in designing and redesigning human resource development, it is important not only to consider training, but also to deploy trained individuals in positions where they can bring the greatest benefit to the HTA system. When countries begin to institutionalize HTA, they are constrained by limited resources, especially skilled professionals and budgets. While many competing health technologies await assessment for potential integration or reimbursement from public resources, it is not possible to assess all of them. In practice, HTA institutions (even in affluent settings) must prioritize internal capacity and resources to meet the growing demand for assessment. When considering the costs of producing HTA, newly established agencies should prioritize their internal resource allocation during the development phase, starting with a limited scope of activities and growing gradually. The production costs for HTA vary based on the type and complexity of the analysis and the internal labor costs to perform such an analysis. Complex and time-consuming analyses have a higher opportunity cost than rapid reviews, which countries should consider when budgeting for HTA activities ( 37 ). In Iran, one of the challenges of Iranian HTA is the lack of sustainable funding, as it is financially dependent on ministries. Therefore, such systems, which can have a significant impact on decision-making areas, should be designed and their processes clearly defined in order to prevent conflicts of interest and maintain financial independence. Conducting assessments in developed countries involves high costs ( 38 – 40 ), and when building an HTA organization, no one size fits all given the potential financial resources. However, it is clear that funding is essential for the sustainability of these institutions. Globally, most government-led HTA agencies are funded from public sources (e.g., annual budgets, earmarked taxes, levies on insurers). In other cases, private funding (project-based or through cost-recovery payments) may supplement the main public budget. Most HTA units are affiliated with academic institutions on a project-based or grant basis, or are the result of targeted funding from central institutions that commission collaborating centers or networks to conduct HTA ( 37 ). One of the criteria for a HTA system is accessibility, as well as transparency in the processes by which the system is implemented. Therefore, designing and redesigning the HTA system database/bank to make the details of HTA and its processes accessible to the public, especially to stakeholders, is a requirement and one of the policies that should be considered in the redesign of the HTA system. If HTA organizations are to successfully achieve their goals, they must be aware that the knowledge produced must be public and visible, and disseminated using various strategies. Effective communication, together with appropriate dissemination of HTA products, are essential elements to increase the visibility of HTA organizations. There is no denying that a high level of visibility can be achieved when HTA results are useful and influence decision-making. HTA researchers have found that dissemination activities are a key process that needs to be intensified. Why and how specific approaches should be adopted is still under debate ( 41 , 42 ). Conclusion The proposed policy options and recommendations target the structure more because most participants have pointed to reforming the structure and communications as well as infrastructure processes as the most important reform solutions. Of course, it should not be overlooked that the Iranian HTA has taken many steps and has traveled many paths. However, this does not mean that this institution has the right conditions. Given the results and findings of this study, researchers believe that very detailed structural and legal reforms should be applied to the HTA and its communications and processes in order to provide a way out of the challenges that have scarred this relatively new institution. However, it should be noted that creating change in organizations, especially in organizations that have been established and institutionalized for many years and are in a state of relative inactivity, will be very difficult. For this reason, changing the current structure requires the support of policymakers and major decision-makers in the country, and the need to change the current system involves involving all stakeholders in the field of health and health legislation in order to provide a legal environment and create intra- and inter-sectoral interactions and communications. Declarations Ethics approval and consent to participate: Ethical approval was received by Kerman university of medical sciences ethics committee (approval number: IR.KMU.REC.1398.644.). this study was conducted in accordance with the Declaration of Helsinki, including the requirement of informed consent from participants (Informed consent was obtained from all individual participants included in the study). Consent for publication: The authors confirm that they have read the journal’s policies and that this manuscript is submitted in accordance with those policies. Competing interests: The authors declare no competing interests, financial or non-financial. Funding: This study is part of a Ph.D dissertation "The Analysis of Iran Health Technology Assessment System and the Presentation of Policy Options" supported financially by Kerman University of Medical Sciences. Grant number: [98000894]. Author Contribution S.B. and V.Y-F. and A.S. contributed to the study design, S.B. and A.S. contributed to data collection, S.B. and V.Y-F. and M.M. contributed to data analysis and all authors wrote the main manuscript text. Authors have read and approved the manuscript. Acknowledgement We express our gratitude to all the experts and researchers who took part in this study. Availability of data and materials: No, I do not have any research data outside the submitted manuscript file. References Angelis A, Kanavos P. Multiple Criteria Decision Analysis (MCDA) for evaluating new medicines in Health Technology Assessment and beyond: The Advance Value Framework. Social science & medicine (1982). 2017;188:137 – 56. Iseli C, Buchman CA. Management of Children with Severe, Severe-profound, and Profound Sensorineural Hearing Loss. Otolaryngologic clinics of North America. 2015;48(6):995–1010. Garrido M V KFNCPBR. Health technology assessment and health policy-making in Europe: current status, challenges and potential2008. Goodman CSJTLGvUSA. Introduction to health technology assessment. 2004. WHO. Remdesivir and three other drugs for hospitalised patients with COVID-19: final results of the WHO Solidarity randomised trial and updated meta-analyses. The Lancet. 2022;399(10339):1941–53. Sacchini D, Virdis A, Refolo P, Pennacchini M, de Paula IC. Health technology assessment (HTA): ethical aspects. Medicine, health care, and philosophy. 2009;12(4):453–7. Bertram M, Dhaene G, Tan-Torres Edejer T, Organization WH. Institutionalizing health technology assessment mechanisms: a how to guide. 2021. Banta D, Jonsson E. History of HTA: introduction. International journal of technology assessment in health care. 2009;25(S1):1–6. Castro HE. Advancing HTA in Latin America: The Policy Process of Setting up an HTA Agency in Colombia. Global Policy. 2017;8:97–102. Bulfone L, Younie S, Carter R. Health technology assessment: reflections from the Antipodes. Value in health. 2009;12:S28-S38. Rajan A, Gutierrez-Ibarluzea I, Moharra M. Addressing issues in health technology assessment promotion: Motives, enablers, and barriers. International journal of technology assessment in health care. 2011;27(1):55–63. Jonsson E. History of health technology assessment in Sweden. International journal of technology assessment in health care. 2009;25(S1):42–52. Sivalal S. History of health technology assessment: A commentary. International journal of technology assessment in health care. 2009;25(S1):285–7. Banta D, Kristensen FB, Jonsson E. A history of health technology assessment at the European level. International journal of technology assessment in health care. 2009;25(S1):68–73. Sivalal S. Health technology assessment in the Asia Pacific region. International Journal of Technology Assessment in Health Care. 2009;25(S1):196–201. Facey K, Topfer L-A, Chan L. Health technology assessment (HTA) glossary. INAHTA–International Network of Agencies for Health Technology Assessment. 2006. Moharra M. EUnetHTA work package 8. EUnetHTA Handbook on health technology assessment capacity building. 2008. Vondeling H. Handbook on Health Technology Assessment Capacity Building. Handbook on HTA Capacity Building: European Network for Health Technology Assessment Work Package 82008. p. 1–90. Davari M, Walley T, Haycox A. Health Technology Assessment Programme for Iran; A Luxury or Real Need? Health Information Management. 2014;10(6):887–900. Doaee S, Oliyaeemanesh A, Nejati M, Mobinizadeh M, Aboee P, Emami RSH. Establishment of health technology assessment in Iran. 2012. Arab-Zozani M, Sokhanvar M, Kakemam E, Didehban T, Hassanipour S. History of Health Technology Assessment in Iran. International journal of technology assessment in health care. 2020;36(1):34–9. Sabermahani A, Yazdi-Feyzabadi V, Bashzar S. Evaluating the quality of health technology assessment reports in a developing country. Eastern Mediterranean health journal = La revue de sante de la Mediterranee orientale = al-Majallah al-sihhiyah li-sharq al-mutawassit. 2023;29(7):554–61. Walt G. Health policy: an introduction to process and power. 1994. Battista RN, Banta HD, Jonnson E, Hodge M, Gelband H. Lessons from the eight countries. Health Policy. 1994;30(1–3):397–421. Cookson R, Maynard A. Health technology assessment in Europe - Improving clarity and performance. International Journal of Technology Assessment in Health Care. 2000;16(2):639–50. Lehoux P, Denis J-L, Tailliez S, Hivon M. Dissemination of health technology assessments: identifying the visions guiding an evolving policy innovation in Canada. Journal of Health Politics, Policy and Law. 2005;30(4):603–42. Organization WH. Institutionalizing health technology assessment mechanisms: A how to guide. WHO Licence: CC BY-NC-SA. 2021;3. Australian Government, Department of Health,TGA and PBAC parallel process and requirements 2020 [Available from: http://www.pbs.gov.au/info/publication/factsheets/shared/tga-pbac-parallel-process . Australian Government, Department of Health,Procedure guidance for listing medicines on the Pharmaceutical Benefits Scheme 2020 [Available from: http://www.pbs.gov.au/industry/listing/procedure-guidance/files/Procedure-Guidance-Listing-Medicines-on-the-PBS-v1-6.pdf . Australian Government, Department of Health,Pharmaceutical Benefits Advisory Committee (PBAC) membership 2020 [Available from: http://www.pbs.gov.au/info/industry/listing/participants/pbac . Martin DK, Giacomini M, Singer PA. Fairness, accountability for reasonableness, and the views of priority setting decision-makers. Health policy. 2002;61(3):279–90. Brown N, Michael M. From authority to authenticity: The performance of transparency in biotechnology. Health, Risk and Society. 2002;4(3):259–73. Hongoro C, McPake B. How to bridge the gap in human resources for health. The Lancet. 2004;364(9443):1451–6. Phiri M. Investing in human resources for health to attain the health MDGs. African Health Monitor. 2007;7(1):15–21. Vujicic M. Macroeconomic and fiscal issues in scaling up human resources for health in low-income countries. Background paper prepared for the World Health Report 2006. 2005. Giacomini MK. The which-hunt: Assembling health technologies for assessment and rationing. Journal of Health Politics, Policy and Law. 1999;24(4):715–58. Castro H, Suharlim C. A roadmap for systematic priority setting and health technology. Assessment (HTA). Arlington, VA: USAID/MSH. 2020. ten Have A, Oortwijn W, Broos P, Nelissen E. European cooperation on health technology assessment. Economic and governance analysis of the establishment of a permanent secretariat ECORYS. 2013. McIntosh B. Fee Schedule for CADTH Pharmaceutical Reviews-April 2022. 2022. Barham L. Research gaps and Health Technology Assessment. Farmeconomia Health economics and therapeutic pathways. 2014;15(2):35–7. Granados A, Jonsson E, Banta HD, Bero L, Bonair A, Cochet MC, et al. EUR-ASSESS project subgroup report on dissemination and impact. International Journal of Technology Assessment in Health Care. 1997;13(2):220–86. Moharra M, Kubesch N, Estrada M, Parada A, Cortés M, Espallargues M. Survey report on HTA organisations. Barcelona: Catalan Agency for Health Technology Assessment and Research. 2008. Additional Declarations No competing interests reported. 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context and conditions governing existing structures.\u003c/li\u003e\n \u003cli\u003eCreating systematic change in HTA requires the participation of all stakeholders.\u003c/li\u003e\n \u003cli\u003eConstructive change is not created by changing the political structure of the organization alone; reforming the processes of change is a necessary and very sensitive issue in improving structures.\u003c/li\u003e\n \u003cli\u003eIn order to achieve efficient and effective functions, Iran\u0026apos;s HTA must be updated and its processes must be reformed with the participation of all stakeholders.\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Introduction","content":"\u003cp\u003eRare resources, increasing demand for health services, an aging population, and technological advances threaten the financial sustainability of many health care systems and make it difficult to allocate resources equitably and efficiently (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e), where factors such as advances in science and engineering, aging populations, emergence of pathogens and other diseases, unexpected outcomes and physician and patient anxiety, third-party payment, financial incentives for technology companies, prevention of medical errors, competition among providers for the use of technology, and public demand due to increased consumer awareness are driving the demand for health technology (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). There are numerous examples in the history of medicine of health technologies that not only did not produce the intended benefits, but also caused harm (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e), such as hydralazine for the treatment of chronic heart failure, episiotomy for childbirth, hormone replacement therapy for menopausal women, and thalidomide for sedation of pregnant women, which were found to be ineffective or harmful after widespread distribution (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e), and were more evident in the Covid-19 pandemic, when drugs were marketed to treat the disease that lacked the necessary efficacy, and in one case, the production and distribution of the drug remdesivir in the third quarter of 2020, generated approximately \u003cspan\u003e$\u003c/span\u003e900\u0026nbsp;million in revenue for the manufacturing company (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eOn the other hand, policymakers cannot judge the values ​​and consequences of technology solely on the basis of complex technical data and, for rational decision-making, they need to understand the broader economic, social, ethical and legal impacts of technologies. Since issues related to health technologies pose ongoing challenges to health systems, it is essential to ensure that health technology is properly assessed and used efficiently and effectively for health care. To make optimal use of available resources, the most effective technologies must be used in the light of organizational, social, ethical and economic considerations. The scarcity of resources in the health sector has led to evidence-based decisions in the selection of expensive technologies and has led to the adoption of mechanisms by countries to, on the one hand, control costs, prevent their excessive increase and allocate them optimally, and, on the other hand, prevent the introduction of technologies whose safety and effectiveness are low (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eHealth technology assessment is a systematic evaluation of the characteristics, effects and/or consequences of health technologies and interventions, used to inform policy and decision-makers in health care, particularly on how to allocate limited resources to health interventions and technologies (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e), and was designed and developed in pioneering countries before 2000 as a policy solution over several years in the context of institutional structures, committed academia, and a science-based community with stakeholder participation for research and the production and use of evidence.\u003c/p\u003e\u003cp\u003eIn many cases, of course, the top-down interest of politicians and policymakers merged with existing academic interests, leading to a convergence in the initiation of HTA (\u003cspan additionalcitationids=\"CR9 CR10 CR11\" citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). Thus, over the past 5 decades, with the beginning of HTA in the United States and its development in developed countries, there has been a remarkable transformation in health-related decision-making. However, it is a new and rapidly expanding field in developing countries, as can be seen from the growing trend in many countries to allocate healthcare technologies more efficiently with limited budgets. HTA has therefore become a decision-making and prioritization tool in health systems (\u003cspan additionalcitationids=\"CR14 CR15 CR16 CR17\" citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e) and is widely used to improve the efficiency of resource allocation (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e\n\u003ch3\u003ePolicy Context:\u003c/h3\u003e\n\u003cp\u003eMost of the challenges that have significantly targeted quality, efficiency, and equity in the Iranian health system are rooted in decision-making and policies that are more driven by pressures from problems than by evidence-based ones.\u003c/p\u003e\u003cp\u003eTherefore, the philosophy and function of HTA have shown that a HTA system in Iran can affect multiple sectors and contribute to the efficiency of the health system (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e). In this regard, Iran has not been left behind, and the national program of the HTA System with the aim of producing quality and evidence-based information for decision-making and selecting appropriate technology at different levels of the health system officially began operating in November 2007 at the HTA Secretariat in the Health Economics Department, Center for Network Development and Health Promotion, Ministry of Health, Treatment and Medical Education. Following structural changes in the Ministry of Health, Treatment and Medical Education and the separation of the Health and Treatment Deputy Offices in 2010, HTA began its activities under the title of the HTA Office in the Office of Technology Assessment and Development of Health Standards and Tariffs, Ministry of Health (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). Initially, HTAs mainly assessed capital equipment, but with increasing experience and expanding research capacities in universities and research centers, more general assessments of non-capital equipment as well as new and older technologies were conducted (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). These assessments are conducted by independent experts and assess the short-term and long-term effects of health technologies on the quality of health services (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eThe cost of conducting HTA projects is also financed by the government budget (from the budget of the Medical Equipment Administration) (\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e). The process established for assessing health technology in Iran has not changed much since its inception and continues to exist in the same way. Of course, it should also be noted that, in line with the HTA office in the Deputy Minister of Health, the Drug Review and Formulation Council in the Deputy Minister of Food and Drug Administration has independently conducted HTA issues related to drugs, which in 1400 this council was renamed the Drug Evaluation Council and evaluates drugs needed in the country's health sector.\u003c/p\u003e\u003cp\u003eHowever, after two decades of its establishment in the country's health system, various and scattered HTA groups were created, which are not under a single, unified policy. The lack of coordination between the units defined in the structure of the Iranian HTA system and the decision-making units can be clearly understood from its output (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e), and the specific performance of the HTA units established in different parts of the Iranian health system cannot be transparently tracked.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003cp\u003eThe present study is part of a larger study called \"Policy Analysis of Iran's HTA System\" which was conducted in four phases;1) A comparative study aimed at answering the question \"What are the structure, content, and dimensions of HTA systems in the world?\", 2) A comprehensive review study aimed at answering the question \"Challenges of HTA systems in the world?\" and completing the interview guide used in policy analysis,3) A policy analysis of Iran's HTA system using Walt and Gill policy triangle approach (\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e), and 4) Providing policy options based on the results of the previous three phases.\u003c/p\u003e\u003cp\u003eIn the comparative phase, eight countries were selected based on the type of health insurance system: Germany and France (traditional insurance system), Finland and Canada (national health insurance system), Denmark and England (national health system), and the United States and Australia (combined insurance system).\u003c/p\u003e\u003cp\u003eIn the review phase, in order to examine the challenges of HTA in the world and Iran, the electronic databases Web of Science, PubMed, Scopus were searched for the period 1973 to December 08, 2021, and the internal databases Barakat Knowledge Network System and Iranian Research Institute for Information Science and Technology were searched to access Persian articles.\u003c/p\u003e\u003cp\u003eA purposive sample of key informants with significant management and policy experience, or extensive training and research related to the HTA system and its related policies were selected for interviews in the third phase. In order to collect sufficient information to cover all aspects of the HTA system, we tried to identify as many relevant stakeholders as possible. 23 interviews were conducted in person and in-person and transcribed.\u003c/p\u003e\u003cp\u003eThe transcribed interviews were analyzed by the research team using a thematic analysis approach, following the framework analysis methodology, and using MAXQDA10 software. In addition, 10 related documents were reviewed at this stage to complete the data collection. Policy options were extracted from interviews and document analysis, based on the results of the first and second phases, and using a focus group discussion approach between experts and research team members, the policy options were examined and the advantages and disadvantages of each were extracted. The tools used were note sheets and a full recording of the meeting. It is worth noting that S.B played the role of coordinator/mediator in the meeting and regarding participation in the meeting, the presence of individuals in the meeting was considered as informed consent and they were asked for permission to record and take notes. Two focus group discussion sessions were held with an average duration of 120 minutes.\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003ePolicy options for strengthening the Iran HTA system:\u003c/h3\u003e\n\u003cp\u003eIn Iran, there are two offices under the two deputy ministries that carry out HTA activities in parallel, each with its own status and power, and in practice, there is no law or legal article stating that each is accountable to the other. In other words, the office in the Food and Drug Administration is not accountable to the Office of Assessment of the Deputy Ministry of Health. On the other hand, the National Institute of Health has also formed the HTA Council, but their relationship is not clear and their processes are completely opaque and ambiguous. On the other hand, the laws related to HTA and its legal status are not clear, so it is necessary to take more fundamental steps to improve this system in order to achieve the desired goals.\u003c/p\u003e\u003cp\u003eParticipants believed that most of the challenges related to HTA in Iran are related to the governance and structure of this institution, therefore the proposed policy options target the structure and governance and emphasize first reviewing the structure and laws and then the processes and communications of HTA in order to improve the state of the HTA system. Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e provides a summary of the analysis of the policy situation, advantages and disadvantages of policy options for the Iranian HTA system based on focus group discussions, interviews and document review.\u003c/p\u003e\n\u003ch3\u003eOption 1: Maintaining the status quo by implementing a comprehensive strategy\u003c/h3\u003e\n\u003cp\u003eIn the current situation, the HTA Office in the Ministry of Health and the Drug Assessment Council in the Ministry of Food and Drug Safety carry out the HTA process separately and with minimal coordination. Meanwhile, the Drug Assessment Council in the Ministry of Food and Drug Safety carries out its processes based on its own internal criteria and standards, has its own political processes, and considers its own criteria in conducting HTA. For example, the discount rate, willingness-to-pay threshold, method of calculating costs, etc. are some of the things that it has specified, and on the other hand, the method of communication with the HTA Office of the Ministry of Health and the Supreme Insurance Council is unclear and non-transparent.\u003c/p\u003e\u003cp\u003eThis condition also applies to the HTA Office in the Ministry of Health, and the approaches to prioritizing and selecting topics, how to conduct calls and select researchers, and even how to judge and critique projects and then make decisions about them are not very transparent. It is worth noting that the method of communication with the decision-making level of the Supreme Insurance Council is not transparent, and the method of submitting and judging the results is also completely non-transparent. The General Directorate of Medical Equipment also seems to be coordinating the assessment of the required technologies with the Deputy of Treatment and following its processes.\u003c/p\u003e\u003cp\u003eHowever, in the country, these two offices in two deputy offices at the same level as Food and Drug and Treatment carry out HTA activities, and despite the lack of transparent processes, it is said that its results are used. In this option, it is proposed that the situation remains the same, but the units carry out the main processes in a coherent and connected manner. This option also emphasizes conducting drug evaluation in the Deputy of Food and Drug, procedures in the Deputy of Treatment, and health interventions in the Deputy of Health. Since it will be very difficult to make changes in organizations, especially in organizations that have been established and institutionalized for many years and are in a state of relative inactivity, it will be very difficult.\u003c/p\u003e\u003cp\u003eTherefore, without changing the current structure and only with the considerations mentioned in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e, many of the shortcomings of the current situation can be largely eliminated and there is hope for the creation of a more coherent HTA system in Iran. The implementation of this policy option requires the involvement of all stakeholders in the health and health legislation areas in order to provide a legal environment and create intra-sectoral interactions and communications between existing offices. In order to fully establish this policy option, it is necessary for policymakers to seek to identify or enact laws within the framework of which HTA and the HTA system will have legal support and to facilitate further moves towards the establishment, institutionalization, and full implementation of HTA with the support of such laws.\u003c/p\u003e\u003cp\u003eAlso, the roles of the two existing HTA Offices/Committees should be redefined and in the redesign, the roles of each should be clearly and specifically communicated to them and how they should be implemented and carried out, as well as the manner of interactions with technology stakeholders, so that the manner of interactions of the Health Deputies and the General Directorate of Medical Equipment and their position in the process with the Health Deputies and the National Institute for Health Research are clear.\u003c/p\u003e\u003cp\u003eIn this option, it is also necessary to establish a mechanism to respond to needs through the establishment of foresight and early warning subcommittees in health technologies in order to take proactive measures. It is necessary to create, design, and redesign processes and mechanisms such as prioritization and selection of topics, calls, monitoring and evaluation, arbitration, and decision-making in order to create transparency and manage potential conflicts of interest, which have been identified as the most important challenges of HTA in Iran.\u003c/p\u003e\u003cp\u003e\u003cb\u003eOption 2: Establishing a higher body under the direct authority of the Minister with specialized committees in the deputy ministries of the Ministry of Health\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThe aim is to establish an HTA agency/organization/institution under the direct authority of the Minister of Health with specialized committees, which will also make maximum use of the current existing set. In this policy, each deputy ministry in the Ministry of Health complex will have its own specialized committees that carry out their activities in coordination with the main HTA body under the authority of the Minister. Under this policy, activities will be fully coordinated and under one set. In this form, the budget of this unit will be separate from other units and in addition, they can also have separate financing within the deputy ministries.\u003c/p\u003e\u003cp\u003eIn this option, it is proposed that the existing offices be specialized under the titles of the Office of Pharmaceutical Technology Assessment, the Office of Non-pharmaceutical Therapeutic Methods and Interventions Assessment, the Office of Medical Equipment and Devices Assessment, and the Office of Public Health Interventions Assessment in the deputy ministries of Food and Drugs, Treatment, General Directorate of Medical Equipment, and the Deputy Ministry of Health, respectively. Prioritizing and selecting HTA topics after the requests of each deputy are sent to the main institution, then by a knowledge intermediary institution such as the National Institute of Health, the plans are carried out scientifically and in defined processes. Then, in the evaluation phase, the main institution judges and sends its recommendations and advice after the judgment to the decision-making institution and even the results are published in the database for the use of other stakeholders.\u003c/p\u003e\u003cp\u003eEstablishing a specialized health technology horizon mapping unit can activate the proactive approach of this system and pursue the prioritization and selection of HTA topics with greater sensitivity in order to prevent waste of resources. In addition, we will also design and redesign transparency and accountability processes here. Establishing a specialized monitoring and evaluation committee in the institution created for the purpose of critically evaluating and judging projects as well as supervising the implementation of processes in the deputy institutions will be formed.\u003c/p\u003e\u003cp\u003eThis will create a separation between the supervisor and the project implementer and will create a barrier in the path of potential conflicts of interest. Given that HTA is a multidisciplinary skill and employing many experts in this institution will be a very difficult and costly task, this institution should form temporary specialized committees with the participation of relevant experts, patient representatives, and other relevant stakeholders for its assessment projects, and the processes related to it and how to select the members of this committee should be completely clear and transparent.\u003c/p\u003e\u003cp\u003eTo create such an institution, organizational stakeholders, including the Food and Drug Administration, the Deputy Minister of Treatment, the General Directorate of Medical Equipment, the Deputy Minister of Health, and the Deputy Minister of Research, must participate in the creation of the upstream institution and try to establish and maintain the necessary communications, coordination, and interactions with each other and even other stakeholders. This institution should also specify that the decision-making, monitoring, and evaluation processes should be designed with greater care and sophistication so that, in addition to transparency and prevention of potential conflicts of interest, it can provide appropriate accountability to stakeholders and society.\u003c/p\u003e\u003cp\u003eIn direct governance under the supervision of the Minister of Health, it means that the Minister directly supervises and also finances it more appropriately. Also, specialized committees should be formed, such as what we see in NICE or CADTH. In this option, it is suggested that the existing offices be specialized under the titles of the Office of Drug Technology Assessment, the Office of Non-Drug Treatment Methods and Interventions Assessment, the Office of Medical Equipment and Devices Assessment, and the Office of Public Health Interventions Assessment in the Food and Drug Administration, the Treatment, the General Administration of Medical Equipment, and the Health Administration, respectively.\u003c/p\u003e\u003cp\u003ePrioritizing and selecting HTA topics should be sent to the main institution after the requests of each of the departments, then the plans should be carried out scientifically and in defined processes by a knowledge intermediary institution such as the National Institute for Health Research, and then the main institution should judge in its own evaluation phase and send its recommendations and advice to the decision-making institution after the judgment, and the results should be published in the database for the use of other stakeholders. Creating a specialized health technology foresight unit can activate the proactive approach of this system and pursue more sensitive prioritization and selection of HTA topics to prevent waste of resources.\u003c/p\u003e\u003cp\u003e\u003cb\u003eOption 3: Creating an independent structure from the Ministry of Health and within the country\u0026rsquo;s technology system\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThis option suggests that an independent structure of the country\u0026rsquo;s technology system be formed and a HTA system be established under this structure. It seems that an independent complex outside the ministries, such as under the Islamic Consultative Assembly or the presidential institution, can partially solve the challenges of technology assessment, especially in the health sector. Under the establishment of such an institution, the HTA Agency can be placed, and under it, specialized committees that can be formed temporarily and conduct relevant and specific assessments. Shaping the process and creating influence, as well as legislation at this level of decision-making, can give more legitimacy to the HTA Agency in terms of law and regulation.\u003c/p\u003e\u003cp\u003eTo create an independent structure from the Ministry of Health, cross-sectoral interactions and cooperation are needed between the complexes managed by the Ministry of Health, the Ministry of Science, Research and Technology, and the entire government. In this structure, the technological perspective should not be limited to technologies in a specific field, and under this set of HTA systems, health and environmental attachments of other technologies should also be seen. The most important requirement of this policy is to pay attention to inter-sectoral cooperation and the obligation of the Ministry of Health and the managed entities to cooperate and respond to this institution and vice versa. Also, in this structure, evidence-based decision-making processes should be drawn and formulated in order to prevent person-centered and silo-based decision-making.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003ePolicy options, considerations, advantages and disadvantages\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"4\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePolicy option\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eOption 1: Maintaining the status quo by implementing a comprehensive strategy\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eOption 2: Establishing a higher body under the direct authority of the Minister with specialized committees in the deputy ministries of the Ministry of Health\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eOption 3: Creating an independent structure from the Ministry of Health and within the country\u0026rsquo;s technology system\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eConsideration\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e- Defining and redefining legal roles for HTA in the health system\u003c/p\u003e\u003cp\u003e- Defining and redefining the role of existing offices in HTA\u003c/p\u003e\u003cp\u003e- Designing a mechanism for HTA to respond to needs\u003c/p\u003e\u003cp\u003e- Creating transparency by designing and redesigning processes and mechanisms for conducting HTA\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e- Creation and establishment of an institution/agency under the direct supervision of the Minister of Health\u003c/p\u003e\u003cp\u003e- Establishment of specialized committees in the deputy ministries of the Ministry of Health\u003c/p\u003e\u003cp\u003e- Establishment of a specialized monitoring and evaluation committee\u003c/p\u003e\u003cp\u003e- Establishment of temporary advisory committees\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e- Designing processes for cross-sectoral collaboration\u003c/p\u003e\u003cp\u003eGiven that in this option, the HTA area will be separated from the Ministry of Health, specific processes should be designed for cross-sectoral collaboration between organizations involved outside the Ministry of Health and the Ministry of Health so that the Ministry, as the end user of HTA, does not experience new challenges.\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAdvantages\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e- Involving the two main areas of treatment and food and medicine in HTA\u003c/p\u003e\u003cp\u003e- Conducting drug HTA in a specialized manner at the Food and Drug Administration\u003c/p\u003e\u003cp\u003e- Compliance with these processes by many stakeholders\u003c/p\u003e\u003cp\u003e- Acceptability for the Food and Drug Administration and also the Deputy Minister of Treatment\u003c/p\u003e\u003cp\u003e- The presence of people with experience in this process in the current situation\u003c/p\u003e\u003cp\u003e- Good and appropriate communication with the National Institute of Health Research as a knowledge intermediary institution\u003c/p\u003e\u003cp\u003e- The HTA system will operate more coherently.\u003c/p\u003e\u003cp\u003e- Needs will be better met.\u003c/p\u003e\u003cp\u003e- Roles are clearly defined.\u003c/p\u003e\u003cp\u003e- Transparency in processes will be easily accessible to stakeholders.\u003c/p\u003e\u003cp\u003e- Mechanisms for preventing conflicts of interest will be deepened.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e- The existence of an independent body with a clearly defined context and structure\u003c/p\u003e\u003cp\u003e- Resolving many conflicts of interest\u003c/p\u003e\u003cp\u003e- Creating transparency in HTA processes\u003c/p\u003e\u003cp\u003e- The existence of specialized committees in the structure of the independent body\u003c/p\u003e\u003cp\u003e- Only one decision-making body is accountable to higher levels\u003c/p\u003e\u003cp\u003e- Avoiding duplication of work\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e- Accepting the independence of the HTA Agency from the Ministry of Health and Medical Education\u003c/p\u003e\u003cp\u003e- Transparency of processes, of course, by designing assessment mechanisms and processes\u003c/p\u003e\u003cp\u003e- Creating an environmental and health continuum for all technologies\u003c/p\u003e\u003cp\u003e- Creating an independent institution with government governance and a stable budget\u003c/p\u003e\u003cp\u003e- Accountability of an institution/agency for decisions made\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003edisadvantages\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e- Broken structure of the HTA system\u003c/p\u003e\u003cp\u003e- Lack of proper communication and coordination between existing structures\u003c/p\u003e\u003cp\u003e- Lack of transparency in existing processes\u003c/p\u003e\u003cp\u003e- Conflict of interest in HTA\u003c/p\u003e\u003cp\u003e- Lack of definition of communication system between existing structures\u003c/p\u003e\u003cp\u003e- Lack of participation of the Health Deputy in HTA processes\u003c/p\u003e\u003cp\u003e- Lack of transparency regarding results and recommendations and whether it is mandatory to consider them\u003c/p\u003e\u003cp\u003e- Lack of sustainable financing\u003c/p\u003e\u003cp\u003e- Lack of independence of both offices\u003c/p\u003e\u003cp\u003e- Lack of coordination of processes and possibility of conducting two similar projects in two offices\u003c/p\u003e\u003cp\u003e- Lack of proactive approach to technologies\u003c/p\u003e\u003cp\u003e- Coordination between departments will continue to be difficult.\u003c/p\u003e\u003cp\u003e- Individuals will be indifferent to and resistant to changes.\u003c/p\u003e\u003cp\u003e- Processes will continue to be incompletely implemented due to the lack of an upper organizational unit to create uniformity between the processes of the departments.\u003c/p\u003e\u003cp\u003e- Communication between the units involved will remain incomplete due to the lack of commitment.\u003c/p\u003e\u003cp\u003e- Lack of independence and lack of sustainable financing will continue to be major challenges.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e- Silo-based decision-making not resolved\u003c/p\u003e\u003cp\u003e- Conflicts of interest and lack of transparency still remain to some extent.\u003c/p\u003e\u003cp\u003e- Resistance of the Health and Food and Drug Administrations to be accountable to an independent scientific body\u003c/p\u003e\u003cp\u003e- Difficulty in coordinating between the agencies\u003c/p\u003e\u003cp\u003e- Difficulty in finding scientific and HTA-aware individuals to sit on expert committees\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e- Resistance in downstream institutions to implement laws\u003c/p\u003e\u003cp\u003e- Uncertainty about the responsiveness of such a structure to the country's health sector\u003c/p\u003e\u003cp\u003e- Creation of a centralized structure and a vertical structure in the decision-making area\u003c/p\u003e\u003cp\u003e- Uncertainty and trust in the processes created in the created structure\u003c/p\u003e\u003cp\u003e- Difficulty in networking and interactions\u003c/p\u003e\u003cp\u003e- Difficulty and challenges related to data flow\u003c/p\u003e\u003cp\u003e- Employing and hiring skilled individuals and increasing the volume of government human resources\u003c/p\u003e\u003cp\u003e- Lack of trained and skilled individuals in the field of health technology decision-making\u003c/p\u003e\u003cp\u003e- Lack of responsiveness of downstream areas to higher areas\u003c/p\u003e\u003cp\u003e- Difficulty in coordination between departments (other departments with the Ministry of Health)\u003c/p\u003e\u003cp\u003e- Creating more opportunities for silo-based decision-making\u003c/p\u003e\u003cp\u003e- Cultural problems, fear of being separated from the Ministry of Health and the problems arising from it\u003c/p\u003e\u003cp\u003e- Unresolved conflicts of interest problems in the HTA system and the likelihood of more conflicts\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThree policy options, each with their requirements, advantages, and disadvantages, were introduced to strengthen Iran\u0026rsquo;s HTA system. Since most of the challenges related to Iran\u0026rsquo;s HTA are related to the governance and structure of this institution, the proposed policy options target the structure and governance, and the options proposed to improve the status of the HTA system emphasize first reviewing the structure and laws, and then HTA processes and communications.\u003c/p\u003e\u003cp\u003eThe shift from traditional decision-making to a decision-making process that follows modern principles of evidence-based medicine, cost-effectiveness and patient-centred services is a major challenge for health systems with multiple stakeholders (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e, \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e), so moving towards a formal and systematic HTA programme requires a high and strong commitment from government officials and a dedicated and motivated team of experts responsible for the HTA development plan. Accordingly, when aiming to establish or enhance national HTA capacity, the establishment of a formal HTA agency should not necessarily be the sole focus of decision-makers. According to Lehoux, the establishment of a structured HTA network that integrates existing national institutions and is guided by an HTA coordinating body or board is a more appropriate solution (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e), and it is therefore more logical to target policy options to the HTA body/agency. Building HTA capacity requires advocacy and discussion among relevant stakeholders, and the objectives, potential benefits and needs should be clearly stated in the documents, as this will help lobby for public political support and obtain funding. Targeted advocacy and consensus building should be undertaken among identified stakeholders, potential funding bodies, potential users of policy advice and research institutions interested in HTA-related positions.\u003c/p\u003e\u003cp\u003eIn the first option, it is proposed that the existing structures remain subject to the definition and redefinition of their roles and responsibilities in a way that forms a proper relationship between the existing units. The second option refers to the establishment and establishment of an institution or body above the deputy levels, in which the agency will be independent from the deputy areas and will have greater power to establish communications and interactions among the interested and involved areas at lower levels. In this agency, specialized committees will be formed at the deputy levels and activities will move towards specialization, and the monitoring and evaluation areas will become independent of each other. This agency will also have funding from the Ministry of Health in planning. To establish such an institution, organizational stakeholders, including the Food and Drug Administration, the Deputy for Treatment, the General Directorate of Medical Equipment, the Deputy for Health, and the Deputy for Research, should participate in the establishment of the upstream institution and try to establish and maintain the necessary communications, coordination, and interactions with each other and even other stakeholders. This body should also specify that decision-making, monitoring, and evaluation processes should be designed with greater care and sophistication to ensure transparency and prevent potential conflicts of interest, and to provide appropriate accountability to stakeholders and society.\u003c/p\u003e\u003cp\u003eThe third option suggests that an independent structure for the country\u0026rsquo;s technology system be established under the Islamic Consultative Assembly or the presidential institution, and within this structure, a HTA system be formed that assesses all health technologies and adapts them to the country\u0026rsquo;s context. Shaping the process and creating impact, as well as legislation, at this level of decision-making could give greater legal and regulatory legitimacy to the HTA agency. What is more important are the implementation considerations that are necessary for each of these options.\u003c/p\u003e\u003cp\u003eDefining and redefining the legal roles for HTA is a key priority in the health system, given its unclear legal and regulatory status. Health systems and HTA do not operate in a legal vacuum and the law surrounds them. Therefore, the relevant mandatory or optional laws should be placed within the scope of the organization and regulation of health as a public service, which is public law. Since HTA eliminates the need for government authorities to set criteria and analyses for making decisions on the reimbursement of technologies, HTA should essentially be in the nature of public law and subject to mandatory government laws (\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eTherefore, it is necessary to establish HTA in the legal system of the country in order to move forward in the legal and regulatory system of the country. For this reason, policymakers should seek to identify or enact laws within the framework of which HTA and the HTA system will have legal support and facilitate further moves towards the establishment, institutionalization, and full implementation of HTA with the support of such laws. Also, in defining and redefining the role of existing offices in HTA in Iran, the roles, relationships, and how to carry out the processes of each of the existing offices and structures should be clearly defined. In the case of agencies with multiple sub-companies, the Australian HTA (\u003cspan additionalcitationids=\"CR29\" citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e) can be considered as a successful model.\u003c/p\u003e\u003cp\u003eIn this regard, it is necessary for all offices to work in line with each other and with completely transparent and specific processes for carrying out the assigned activities. In such a way that the processes related to the evaluation of drugs in the Food and Drug Administration, the evaluation of procedures and treatment methods, and diagnostic tests are carried out in the Health Administration. Of course, how they are implemented and carried out, as well as how they interact with the stakeholders of such technologies, should be clearly defined. Also, how the health ministries and the General Directorate of Medical Equipment interact and their position in the process with the treatment ministry should be explained. Therefore, based on studies on obtaining legal support, a specific policy or legal statement to establish a new institution or grant HTA tasks to an existing organization is an important step in formalizing HTA activities (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eDesigning a mechanism to respond to needs is one of the necessities of HTA in Iran, and this requires the ability to anticipate issues, contextualize information, and ensure communication. The predictive capacity of HTA organizations is assessed through activities such as early warning and foresight. Also, responding to needs requires background knowledge, factors of change, barriers to using HTA, and the availability of resources to use outputs and implement changes. Therefore, it is necessary to establish a committee for foresight and early warning in health technologies in order to take proactive measures. Also, since Iran's HTA lacks appropriate transparency processes in all stages of HTA, it is necessary to create a more suitable situation for its transparency by designing and redesigning the processes and mechanisms for conducting HTA.\u003c/p\u003e\u003cp\u003eSince transparency is a key element of fair and reliable processes, the link between HTA findings and decision-making processes should be made clear and explicit. Therefore, those involved in the assessment and critical evaluation process should be aware of the issues under consideration and the content of the deliberations, and the processes, deliberations, decisions, and reasoning of the decision-making body should be made available to stakeholders (\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e). In practice, transparency is believed to improve the usefulness, consistency, and generalizability of HTA reports. Furthermore, participatory transparency demonstrates the democratic capacity to participate in the evaluation (\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e). Brown argues that the demonstration of transparency by an HTA body will always depend on the contexts in which it is initiated and practiced. It will vary according to the form of disclosure sought, the means by which disclosure is made, and any number of other limiting circumstances. Acknowledging this fact protects against the \u0026ldquo;na\u0026iuml;ve\u0026rdquo; assumption that a state of absolute transparency is achievable (\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eRedesigning the development of the human resources required for HTA systems is a policy that should be given special attention at the academic and national levels, given that international organizations have identified the lack of skilled human resources as the most important obstacle to the establishment of HTA capacities (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e). The literature emphasizes that human resources for health are arguably the most important part of health systems (\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e). HRH brings together all the other elements of health systems. They link health technologies, infrastructure, knowledge, and financing (\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eTherefore, when HRH is low, inefficient, or ineffective, the entire health system is weakened. Vujicic has identified inadequate HRH capacity as one of the most important constraints in health systems. He also states that many global health initiatives fail to achieve their goals due to the lack of sufficient health workers (\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e). Given that in our country, four medical universities are engaged in training HTA specialists, the interdisciplinary nature of HTA should be emphasized at the outset in the development of the agency\u0026rsquo;s mission statement or charter (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e, \u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e). Therefore, in designing and redesigning human resource development, it is important not only to consider training, but also to deploy trained individuals in positions where they can bring the greatest benefit to the HTA system. When countries begin to institutionalize HTA, they are constrained by limited resources, especially skilled professionals and budgets. While many competing health technologies await assessment for potential integration or reimbursement from public resources, it is not possible to assess all of them. In practice, HTA institutions (even in affluent settings) must prioritize internal capacity and resources to meet the growing demand for assessment. When considering the costs of producing HTA, newly established agencies should prioritize their internal resource allocation during the development phase, starting with a limited scope of activities and growing gradually.\u003c/p\u003e\u003cp\u003eThe production costs for HTA vary based on the type and complexity of the analysis and the internal labor costs to perform such an analysis. Complex and time-consuming analyses have a higher opportunity cost than rapid reviews, which countries should consider when budgeting for HTA activities (\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eIn Iran, one of the challenges of Iranian HTA is the lack of sustainable funding, as it is financially dependent on ministries. Therefore, such systems, which can have a significant impact on decision-making areas, should be designed and their processes clearly defined in order to prevent conflicts of interest and maintain financial independence. Conducting assessments in developed countries involves high costs (\u003cspan additionalcitationids=\"CR39\" citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e), and when building an HTA organization, no one size fits all given the potential financial resources. However, it is clear that funding is essential for the sustainability of these institutions. Globally, most government-led HTA agencies are funded from public sources (e.g., annual budgets, earmarked taxes, levies on insurers). In other cases, private funding (project-based or through cost-recovery payments) may supplement the main public budget. Most HTA units are affiliated with academic institutions on a project-based or grant basis, or are the result of targeted funding from central institutions that commission collaborating centers or networks to conduct HTA (\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eOne of the criteria for a HTA system is accessibility, as well as transparency in the processes by which the system is implemented. Therefore, designing and redesigning the HTA system database/bank to make the details of HTA and its processes accessible to the public, especially to stakeholders, is a requirement and one of the policies that should be considered in the redesign of the HTA system. If HTA organizations are to successfully achieve their goals, they must be aware that the knowledge produced must be public and visible, and disseminated using various strategies. Effective communication, together with appropriate dissemination of HTA products, are essential elements to increase the visibility of HTA organizations. There is no denying that a high level of visibility can be achieved when HTA results are useful and influence decision-making. HTA researchers have found that dissemination activities are a key process that needs to be intensified. Why and how specific approaches should be adopted is still under debate (\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e, \u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e).\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThe proposed policy options and recommendations target the structure more because most participants have pointed to reforming the structure and communications as well as infrastructure processes as the most important reform solutions. Of course, it should not be overlooked that the Iranian HTA has taken many steps and has traveled many paths. However, this does not mean that this institution has the right conditions. Given the results and findings of this study, researchers believe that very detailed structural and legal reforms should be applied to the HTA and its communications and processes in order to provide a way out of the challenges that have scarred this relatively new institution. However, it should be noted that creating change in organizations, especially in organizations that have been established and institutionalized for many years and are in a state of relative inactivity, will be very difficult. For this reason, changing the current structure requires the support of policymakers and major decision-makers in the country, and the need to change the current system involves involving all stakeholders in the field of health and health legislation in order to provide a legal environment and create intra- and inter-sectoral interactions and communications.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEthical approval was received by Kerman university of medical sciences ethics committee (approval number: IR.KMU.REC.1398.644.). this study was conducted in accordance with the Declaration of Helsinki, including the requirement of informed consent from participants (Informed consent was obtained from all individual participants included in the study).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors confirm that they have read the journal\u0026rsquo;s policies and that this manuscript is submitted in accordance with those policies.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare no competing interests, financial or non-financial.\u003c/p\u003e\n\u003ch2\u003eFunding:\u003c/h2\u003e\n\u003cp\u003eThis study is part of a Ph.D dissertation \u0026quot;The Analysis of Iran Health Technology Assessment System and the Presentation of Policy Options\u0026quot; supported financially by Kerman University of Medical Sciences. Grant number: [98000894].\u003c/p\u003e\n\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\n\u003cp\u003eS.B. and V.Y-F. and A.S. contributed to the study design, S.B. and A.S. contributed to data collection, S.B. and V.Y-F. and M.M. contributed to data analysis and all authors wrote the main manuscript text. Authors have read and approved the manuscript.\u003c/p\u003e\n\u003ch2\u003eAcknowledgement\u003c/h2\u003e\n\u003cp\u003eWe express our gratitude to all the experts and researchers who took part in this study.\u003c/p\u003e\n\u003ch2\u003eAvailability of data and materials:\u003c/h2\u003e\n\u003cp\u003eNo, I do not have any research data outside the submitted manuscript file.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eAngelis A, Kanavos P. Multiple Criteria Decision Analysis (MCDA) for evaluating new medicines in Health Technology Assessment and beyond: The Advance Value Framework. Social science \u0026amp; medicine (1982). 2017;188:137\u0026thinsp;\u0026ndash;\u0026thinsp;56.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eIseli C, Buchman CA. Management of Children with Severe, Severe-profound, and Profound Sensorineural Hearing Loss. Otolaryngologic clinics of North America. 2015;48(6):995\u0026ndash;1010.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eGarrido M V KFNCPBR. Health technology assessment and health policy-making in Europe: current status, challenges and potential2008.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eGoodman CSJTLGvUSA. Introduction to health technology assessment. 2004.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eWHO. Remdesivir and three other drugs for hospitalised patients with COVID-19: final results of the WHO Solidarity randomised trial and updated meta-analyses. The Lancet. 2022;399(10339):1941\u0026ndash;53.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSacchini D, Virdis A, Refolo P, Pennacchini M, de Paula IC. Health technology assessment (HTA): ethical aspects. Medicine, health care, and philosophy. 2009;12(4):453\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBertram M, Dhaene G, Tan-Torres Edejer T, Organization WH. Institutionalizing health technology assessment mechanisms: a how to guide. 2021.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBanta D, Jonsson E. History of HTA: introduction. International journal of technology assessment in health care. 2009;25(S1):1\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eCastro HE. Advancing HTA in Latin America: The Policy Process of Setting up an HTA Agency in Colombia. Global Policy. 2017;8:97\u0026ndash;102.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBulfone L, Younie S, Carter R. Health technology assessment: reflections from the Antipodes. Value in health. 2009;12:S28-S38.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eRajan A, Gutierrez-Ibarluzea I, Moharra M. Addressing issues in health technology assessment promotion: Motives, enablers, and barriers. International journal of technology assessment in health care. 2011;27(1):55\u0026ndash;63.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eJonsson E. History of health technology assessment in Sweden. International journal of technology assessment in health care. 2009;25(S1):42\u0026ndash;52.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSivalal S. History of health technology assessment: A commentary. International journal of technology assessment in health care. 2009;25(S1):285\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBanta D, Kristensen FB, Jonsson E. A history of health technology assessment at the European level. International journal of technology assessment in health care. 2009;25(S1):68\u0026ndash;73.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSivalal S. Health technology assessment in the Asia Pacific region. International Journal of Technology Assessment in Health Care. 2009;25(S1):196\u0026ndash;201.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eFacey K, Topfer L-A, Chan L. Health technology assessment (HTA) glossary. INAHTA\u0026ndash;International Network of Agencies for Health Technology Assessment. 2006.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMoharra M. EUnetHTA work package 8. EUnetHTA Handbook on health technology assessment capacity building. 2008.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eVondeling H. Handbook on Health Technology Assessment Capacity Building. Handbook on HTA Capacity Building: European Network for Health Technology Assessment Work Package 82008. p. 1\u0026ndash;90.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eDavari M, Walley T, Haycox A. Health Technology Assessment Programme for Iran; A Luxury or Real Need? Health Information Management. 2014;10(6):887\u0026ndash;900.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eDoaee S, Oliyaeemanesh A, Nejati M, Mobinizadeh M, Aboee P, Emami RSH. Establishment of health technology assessment in Iran. 2012.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eArab-Zozani M, Sokhanvar M, Kakemam E, Didehban T, Hassanipour S. History of Health Technology Assessment in Iran. International journal of technology assessment in health care. 2020;36(1):34\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSabermahani A, Yazdi-Feyzabadi V, Bashzar S. Evaluating the quality of health technology assessment reports in a developing country. Eastern Mediterranean health journal\u0026thinsp;=\u0026thinsp;La revue de sante de la Mediterranee orientale\u0026thinsp;=\u0026thinsp;al-Majallah al-sihhiyah li-sharq al-mutawassit. 2023;29(7):554\u0026ndash;61.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eWalt G. Health policy: an introduction to process and power. 1994.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBattista RN, Banta HD, Jonnson E, Hodge M, Gelband H. Lessons from the eight countries. Health Policy. 1994;30(1\u0026ndash;3):397\u0026ndash;421.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eCookson R, Maynard A. Health technology assessment in Europe - Improving clarity and performance. International Journal of Technology Assessment in Health Care. 2000;16(2):639\u0026ndash;50.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eLehoux P, Denis J-L, Tailliez S, Hivon M. Dissemination of health technology assessments: identifying the visions guiding an evolving policy innovation in Canada. Journal of Health Politics, Policy and Law. 2005;30(4):603\u0026ndash;42.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eOrganization WH. Institutionalizing health technology assessment mechanisms: A how to guide. WHO Licence: CC BY-NC-SA. 2021;3.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eAustralian Government, Department of Health,TGA and PBAC parallel process and requirements 2020 [Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttp://www.pbs.gov.au/info/publication/factsheets/shared/tga-pbac-parallel-process\u003c/span\u003e\u003cspan address=\"http://www.pbs.gov.au/info/publication/factsheets/shared/tga-pbac-parallel-process\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eAustralian Government, Department of Health,Procedure guidance for listing medicines on the Pharmaceutical Benefits Scheme 2020 [Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttp://www.pbs.gov.au/industry/listing/procedure-guidance/files/Procedure-Guidance-Listing-Medicines-on-the-PBS-v1-6.pdf\u003c/span\u003e\u003cspan address=\"http://www.pbs.gov.au/industry/listing/procedure-guidance/files/Procedure-Guidance-Listing-Medicines-on-the-PBS-v1-6.pdf\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eAustralian Government, Department of Health,Pharmaceutical Benefits Advisory Committee (PBAC) membership 2020 [Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttp://www.pbs.gov.au/info/industry/listing/participants/pbac\u003c/span\u003e\u003cspan address=\"http://www.pbs.gov.au/info/industry/listing/participants/pbac\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMartin DK, Giacomini M, Singer PA. Fairness, accountability for reasonableness, and the views of priority setting decision-makers. Health policy. 2002;61(3):279\u0026ndash;90.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBrown N, Michael M. From authority to authenticity: The performance of transparency in biotechnology. Health, Risk and Society. 2002;4(3):259\u0026ndash;73.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eHongoro C, McPake B. How to bridge the gap in human resources for health. The Lancet. 2004;364(9443):1451\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003ePhiri M. Investing in human resources for health to attain the health MDGs. African Health Monitor. 2007;7(1):15\u0026ndash;21.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eVujicic M. Macroeconomic and fiscal issues in scaling up human resources for health in low-income countries. Background paper prepared for the World Health Report 2006. 2005.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eGiacomini MK. The which-hunt: Assembling health technologies for assessment and rationing. Journal of Health Politics, Policy and Law. 1999;24(4):715\u0026ndash;58.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eCastro H, Suharlim C. A roadmap for systematic priority setting and health technology. Assessment (HTA). Arlington, VA: USAID/MSH. 2020.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eten Have A, Oortwijn W, Broos P, Nelissen E. European cooperation on health technology assessment. Economic and governance analysis of the establishment of a permanent secretariat ECORYS. 2013.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMcIntosh B. Fee Schedule for CADTH Pharmaceutical Reviews-April 2022. 2022.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBarham L. Research gaps and Health Technology Assessment. Farmeconomia Health economics and therapeutic pathways. 2014;15(2):35\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eGranados A, Jonsson E, Banta HD, Bero L, Bonair A, Cochet MC, et al. EUR-ASSESS project subgroup report on dissemination and impact. International Journal of Technology Assessment in Health Care. 1997;13(2):220\u0026ndash;86.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMoharra M, Kubesch N, Estrada M, Parada A, Cort\u0026eacute;s M, Espallargues M. Survey report on HTA organisations. Barcelona: Catalan Agency for Health Technology Assessment and Research. 2008.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"health-research-policy-and-systems","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"hrps","sideBox":"Learn more about [Health Research Policy and Systems](http://health-policy-systems.biomedcentral.com/)","snPcode":"12961","submissionUrl":"https://submission.nature.com/new-submission/12961/3","title":"Health Research Policy and Systems","twitterHandle":"@HarpsJournal","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Health Policy, Policy Options, Health Technology Assessment","lastPublishedDoi":"10.21203/rs.3.rs-7359076/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7359076/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eSince health technology-related issues pose ongoing challenges for health systems, ensuring proper Health Technology Assessment (HTA) and its efficient and effective use for health care is essential. After more than a decade since the start of this system in the Iranian health structure, various and scattered HTA groups have been created, which are not under a single, unified policy, indicating a lack of coordination between the units defined in the structure of the HTA system and the decision-making units, and the specific performance of its components cannot be tracked transparently. We conducted a policy analysis study in 4 phases: comparative study, review study, policy analysis, HTA, relying on qualitative interviews with key informants and document analysis, and finally using a focus group discussion approach. As a result, we introduce policy options including maintaining the status quo by implementing a comprehensive strategy, establishing a higher institution under the direct authority of the Minister with specialized committees in the deputy ministries of the Ministry of Health, and establishing a structure independent of the Ministry of Health and within the country's technology system, with their advantages, disadvantages, and requirements, and finally, important recommendations for the formation of a coherent and responsive system.\u003c/p\u003e","manuscriptTitle":"Policy options for strengthening health technology assessment in Iran","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-10-25 21:58:18","doi":"10.21203/rs.3.rs-7359076/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-11-12T11:30:08+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-11-10T08:35:23+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"181882034627900641527817295905436897517","date":"2025-10-28T11:04:29+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-10-13T19:56:33+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"69925185350579197549124768540163705827","date":"2025-10-12T12:19:45+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-10-12T09:24:53+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-08-14T06:33:33+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-08-14T06:28:41+00:00","index":"","fulltext":""},{"type":"submitted","content":"Health Research Policy and Systems","date":"2025-08-12T20:47:13+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"health-research-policy-and-systems","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"hrps","sideBox":"Learn more about [Health Research Policy and Systems](http://health-policy-systems.biomedcentral.com/)","snPcode":"12961","submissionUrl":"https://submission.nature.com/new-submission/12961/3","title":"Health Research Policy and Systems","twitterHandle":"@HarpsJournal","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"af2771ac-cf6e-4db8-98cf-1393733d5081","owner":[],"postedDate":"October 25th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-05-19T21:38:15+00:00","versionOfRecord":[],"versionCreatedAt":"2025-10-25 21:58:18","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7359076","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7359076","identity":"rs-7359076","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}