Implementation Of Health Technology Assessment Research Articles

The development of a roadmap for Health Technology Assessment implementation in Moldova

Abstract* Background Moldova strives for universal health coverage (UHC) and considers health technology assessment (HTA) an important policy instrument to inform the choice of services that should be covered to progressively realize UHC. It plays a key role in determining which technologies are coved, considering various dimensions often including cost-effectiveness, budget impact, and feasibility. This paper reports on work undertaken to develop a roadmap for HTA implementation, using evidence-informed deliberative processes (EDPs) as the guiding framework. Methods Between 2020 and 2022, we undertook several activities that informed the roadmap. We conducted a needs assessment and an assessment of European HTA best practices using a combination of desk research, interviews and surveys. We then conducted a document review of six selected HTA systems, complimented by expert interviews from three neighbouring countries. Results The roadmap provided a suggested HTA process, which included instructions on how to execute the different steps of the EDP framework to enhance the legitimacy of HTA-informed decision-making. The roadmap encompasses several aspects such as how to organize stakeholder involvement, how to identify and operationalize decision criteria, and how to make the decision process transparent. Guidance was given to the country on establishing a legal framework for HTA; a communication strategy; strengthening capacity and leveraging HTA expertise. The country was also given tailored advice on the positioning of the HTA-agency, first as an entity within the Ministry of Health or the National Agency of Public Health but with the long-term vision for it to be independent of any state institution. Conclusions Despite several challenges, including a partial disruption because of the Covid-19 pandemic, the development of the roadmap for HTA implementation was completed and agreed upon by the Ministry of Health in Moldova. This work has helped motivate and support the country in HTA institutionalization.

Institutionalizing Health Technology Assessment in Ghana: Enablers, Constraints, and Lessons

ABSTRACT Health Technology Assessment (HTA) has been institutionalized in Ghana with structures, processes, and methods. This paper identifies and analyzes the policy players involved; the way in which issues were framed; and the manner in which administrative structures were used to set the agenda for, adopt, and implement HTA. It shows that the Ministry of Health, supported by other players, led HTA agenda-setting through training activities and discussions on evidence of selection pharmaceuticals, medical devices, and other health-related technologies. HTA was then captured in a health sector aide memoire that summarized the decisions made at a national health summit. In implementing the HTA policy, technical working groups and a steering committee were constituted to provide recommendations to the minister of health on high-level decisions. The ability of agenda influencers to maneuver existing administrative and bureaucratic structures, align them with national strategic goals, and sustain HTA implementation enabled Ghana to institutionalize HTA. Limited financial support and a dearth of in-country expertise are being addressed through capacity building and funding. To ensure early national buy-in and uptake, policy makers and agenda influencers need to understand each country’s health system and align HTA with national policy decision-making processes.

PP138 Awareness Of Health Technology Assessment And Its Predictors Among Medical Students In Public Universities In Klang Valley, Malaysia

IntroductionLack of awareness has been recognized as one of the most important barriers in the implementation of health technology assessment (HTA) across numerous countries. Medical students have been identified as a vital target group to instill an awareness, basic knowledge, and positive attitude towards HTA from the beginning of their medical career. Presently, there was no study found conducted on HTA awareness in medical students in Malaysia. This study aims to determine the level of awareness of HTA, and its predictors among clinical year medical students in public universities in Klang Valley, Malaysia.MethodsA cross-sectional study using the stratified random sampling method was conducted among clinical year medical students in four public universities in Klang Valley, Malaysia. The data on level of awareness of HTA and its associated factors were collected using a self-administered online questionnaire. Data were analyzed using IBM SPSS version 27 to determine the level of awareness of HTA, its associated factors and predictors.ResultsThe total number of study participants was 323 and the response rate was 90 percent. The analysis showed that 69 percent of respondents had low level of awareness of HTA while 31 percent had high level of awareness of HTA. Factors associated with the level of awareness of HTA was attitude towards HTA (p < 0.001). The predictors of level of awareness of HTA were attitude towards HTA (Adjusted Odds Ratio (AOR) = 7.417, 95% confidence interval [CI]: 3.491, 15.758), peer interaction on HTA (AOR = 0.320, 95% CI: 0.115, 0.888), and previous training on HTA (AOR = 4.849, 95% CI: 1.096, 21.444).ConclusionsThe majority of clinical year medical students in public university have low awareness of HTA which can be predicted by the level of attitude, peer interaction and training of HTA. Therefore, it is important to increase awareness among these future medical practitioners to encourage evidence-based decision-making. Early exposure and introduction of HTA in the current university curriculum in collaboration with a local HTA agency can be recommended to increase awareness as well as to improve students’ attitude towards HTA.

PP109 The Use Of Health Technology Assessment In Decision Making: Evidence From The Balkan Countries

IntroductionAccording to the most recent definition health technology assessment (HTA) “is a multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle. The purpose is to inform decision-making in order to promote an equitable, efficient, and high-quality health system”. This article aimed to evaluate implementation of HTA in decision making in the Balkan countries.MethodsA scoping review of the existing literature took place to locate relevant scientific articles, policy papers and documents released by the respective Ministries. We searched data for 6 Western Balkan countries (Albania, Bosnia and Herzegovina, Kosovo, Montenegro, North Macedonia and Serbia) and didn’t focus on those countries that are part of the European Union (EU). For the literature search key words were used, while documents only in English were included in the analyses. Additionally, the search was conducted for the period January 2010 until October 2022.ResultsThe Western Balkan countries are in process of integration to the EU and based on this they are trying to make improvement in different sectors including health services. However, the use of HTA in most of the studied countries is in its preliminary phase. Most of the countries have established HTA bodies or specific authorities but with limited resources (both human and financial). Additionally, their reports are non-binding for policy makers and healthcare decisions are taken based on experts’ opinions and not an extensive HTA analyses.ConclusionsDespite their efforts, the Western Balkan countries need to improve and considerably increase the use of HTA in decision-making. Its use can help in provision of better healthcare services as well as to decrease costs. Specific attention should be put on human and financial resources that are lacking in all settings.Western Balkan countries need to put much more efforts for harmonization of their legal framework with that of the EU countries.

Health technology assessment implementation in WHO South-East Asia Region: a realist review protocol

Background: A robust Health Technology Assessment (HTA) mechanism is crucial to address the rising burden of healthcare costs and expenditures of patients. This research aims to describe the HTA methods and mechanisms for successful implementation of HTA in the WHO South-East Asia region, and contextualize the synthesized evidence relevant to Indian settings. Methods: Realist review involves developing a program theory by conducting a systematic search strategy, screening, study selection, data extraction, and data synthesis. A systematic search for literature will be conducted on PubMed (NCBI), EMBASE (Elsevier), Scopus (Elsevier), Web of Science (Clarivate), and ProQuest Central for identifying the methods used for HTA of health technology interventions. Stakeholder consultations will be conducted to develop a program theory following the Context-Mechanism-Outcome configurations (CMOcs) framework. Searches for primary evidence will be conducted iteratively. Data will be extracted and tested against the programme theory. The proposed realist review will be reported as per the Realist and MEta-narrative Evidence Syntheses: Evolving Standards [RAMESES II] guidelines. Conclusions: To our knowledge, there has been no comprehensive review conducted to understand the mechanisms of HTA methods in the WHO South-East Asia region. The findings from the realist review will help us understand the mechanisms through which the HTA could work in WHO South-East Asian countries. We will then contextualize the findings obtained from evidence to Indian settings, based on program theory development through stakeholder consultation. A framework will be developed that can be used by policymakers/HTA experts in India for effective implementation of the same.

HTA47 Implementation of Health Technology Assessment in Algeria: Comparison between the Current and Preferred Status

The scarcity of resources poses restrictions on health policy decisions in middle income countries. Health technology assessment (HTA) balances restricted budgets with maximized population health. We aim to characterize the current status of HTA in Algeria and describe the future directions for HTA implementation according to the priorities set by local stakeholders.

Recommendations to overcome barriers to the use of artificial intelligence-driven evidence in health technology assessment.

Artificial intelligence (AI) has attracted much attention because of its enormous potential in healthcare, but uptake has been slow. There are substantial barriers that challenge health technology assessment (HTA) professionals to use AI-generated evidence for decision-making from large real-world databases (e.g., based on claims data). As part of the European Commission-funded HTx H2020 (Next Generation Health Technology Assessment) project, we aimed to put forward recommendations to support healthcare decision-makers in integrating AI into the HTA processes. The barriers, addressed by the paper, are particularly focusing on Central and Eastern European (CEE) countries, where the implementation of HTA and access to health databases lag behind Western European countries. We constructed a survey to rank the barriers to using AI for HTA purposes, completed by respondents from CEE jurisdictions with expertise in HTA. Using the results, two members of the HTx consortium from CEE developed recommendations on the most critical barriers. Then these recommendations were discussed in a workshop by a wider group of experts, including HTA and reimbursement decision-makers from both CEE countries and Western European countries, and summarized in a consensus report. Recommendations have been developed to address the top 15 barriers in areas of (1) human factor-related barriers, focusing on educating HTA doers and users, establishing collaborations and best practice sharing; (2) regulatory and policy-related barriers, proposing increasing awareness and political commitment and improving the management of sensitive information for AI use; (3) data-related barriers, suggesting enhancing standardization and collaboration with data networks, managing missing and unstructured data, using analytical and statistical approaches to address bias, using quality assessment tools and quality standards, improving reporting, and developing better conditions for the use of data; and (4) technological barriers, suggesting sustainable development of AI infrastructure. In the field of HTA, the great potential of AI to support evidence generation and evaluation has not yet been sufficiently explored and realized. Raising awareness of the intended and unintended consequences of AI-based methods and encouraging political commitment from policymakers is necessary to upgrade the regulatory and infrastructural environment and knowledge base required to integrate AI into HTA-based decision-making processes better.

Understanding of the Readiness for HTA Implementation in Jordan as a Step Towards Universal Health Coverage

As Jordan strives to achieve universal health coverage, the mechanism for determining which health technologies to include in the basket of reimbursed services has become increasingly important. This study sought to understand stakeholder perspectives in the Jordanian health system regarding the readiness and need to implement health technology assessment (HTA) to support decision-making quality and transparency, ensure value for money on health system spending, and support the achievement of universal health coverage. This study used a cross-sectional survey methodology, and a quantitative analysis was conducted. A questionnaire based on the HTA implementation scorecard was administered in-person to capture responses regarding fourteen dimensions. Thirty-one responses from representatives across the Ministry of Health, regulatory authority, and other stakeholders in the national health system were collected. Most respondents were familiar with HTA and there was nearly unanimous agreement on the need for HTA implementation in Jordan. While the perspectives on how the implementation would occur were varied, careful consideration may be warranted in the areas of the legal framework for HTA, the quality of available data, financial constraints, and limited human resource capacity, as Jordan progresses towards implementing HTA on the road to universal healthcare.

Institutionalizing health technology assessment in Ethiopia: seizing the window of opportunity.

Ethiopia's commitment to achieving universal health coverage (UHC) requires an efficient and equitable health priority-setting practice. The Ministry of Health aims to institutionalize health technology assessment (HTA) to support evidence-based decision making. This commentary highlights key considerations for successful formulation, adoption, and implementation of HTA policies and practices in Ethiopia, based on a review of international evidence and published normative principles and guidelines. Stakeholder engagement, transparent policymaking, sustainable financing, workforce education, and political economy analysis and power dynamics are critical factors that need to be considered when developing a national HTA roadmap and implementation strategy. To ensure ownership and sustainability of HTA, effective stakeholder engagement and transparency are crucial. Regulatory embedding and sustainable financing ensure legitimacy and continuity of HTA production, and workforce education and training are essential for conducting and interpreting HTA. Political economy analysis helps identify opportunities and constraints for effective HTA implementation. By addressing these considerations, Ethiopia can establish a well-designed HTA system to inform evidence-based and equitable resource allocation toward achieving UHC and improving health outcomes.

A roadmap toward implementing health technology assessment in Egypt.

The Egyptian healthcare system is currently in the early phase of health technology assessment (HTA) implementation. The aim of this study is to propose an implementation roadmap based on the national healthcare system status. A survey was conducted among Egyptian healthcare sector decision-makers to assess the current and future (preferred) HTA implementation status in Egypt based on a widely used international scorecard methodology. Subsequently, interviews were conducted with experts representing middle- and top-tier management in the Egyptian healthcare system to interpret the survey results and recommend specific actions. Experts recommended more capacity-building programs for HTA and health economics. Additionally, they proposed establishing HTA units in separate healthcare authorities and merging them into a single central HTA unit in the long term. Regarding the scope of implementation, experts recommended commencing with the assessment of innovative pharmaceuticals, and thereafter, expanding the scope to cover all health technologies in the long term. Additionally, they recommended using innovative tools such as "multi-criteria decision analysis (MCDA)" for tendering, and "managed entry agreements" for reimbursement decisions. Local burden of diseases and costing studies were also recommended to facilitate the implementation of HTA. Experts agreed that several actions are required for successful HTA implementation in Egypt, including coordination between HTA bodies, application of an explicit MCDA framework, and strengthening of local evidence generation. To implement these actions, investment in technical capacity-building is indispensable. Most experts favored using multiple and soft cost-effectiveness thresholds. Efforts should be made to publish HTA submission guidelines and timelines of the processes.

Impact of health technology assessment implementation with a special focus on middle-income countries

ObjectivesBuilding an efficient health technology assessment (HTA) system requires significant effort and political commitment, in addition to human and financial resources. Expectations of what HTA can offer to middle-income countries (MICs) are continuously rising, which drives health policymakers to raise the question of whether HTA could help secure the financial sustainability needed to implement universal health coverage. In this study, we explored the impact HTA adoption may have on the countries and its impact on health system objectives, as well as transferability of benefits and drawbacks observed in higher-income to middle-income countries. MethodsWe utilized secondary data from a systematic literature review and primary data by disseminating a survey among local stakeholders in three MICs across three continents to capture their perspective on the impact of HTA implementation from a local context. ResultsIt was evident from the results of both the literature review and survey that the positive impacts of HTA implementation outweigh the negative impacts. Most of the reviewed literature discussed the impact of HTA on the intermediate objectives of the health finance policy in relation to the broad health system goals. According to the survey respondents, the most evident benefit of HTA implementation is improving the transparency and accountability of healthcare decisions. ConclusionsOverall, HTA implementation can introduce a myriad of benefits to healthcare systems in MICs as well. Our findings show that while HTA implementation may have the potential to generate cost savings in specific areas, there is no guarantee that HTA can generate savings at the macro level. Public Interest SummaryHealth technologies (medicines, devices, and interventions) are rapidly increasing in complexity and cost. Health Technology Assessment (HTA) guides healthcare decision-makers in choosing the most suitable, effective, affordable, and acceptable health technology to invest limited healthcare resources. However, healthcare decision-makers in middle-income countries (MICS) are still uncertain about whether adopting HTA would help them achieve the financial sustainability needed to achieve universal health coverage. Thereforewe sought to gather evidence on how HTA has affected the health systems of countries that have already adopted it by reviewing published research reports. In addition, healthcare decision-makers from three MICs were questioned about their perception of how HTA implementation will affect their country's health system. Wefound that the positive effects of HTA implementation outweigh the negative ones; specifically, the transparency and accountability of decisions are improved. However, although HTA implementation may generate cost savings in specific areas, it may not significantly contribute to overall financial sustainability.

Capacity Building for Health Technology Assessment in Jordan: Institutionalization and Its Use in Pricing and Reimbursement Decisions

ObjectivesThis study aimed to describe the process of the institutionalization of health technology assessment (HTA) in Jordan. In particular, this study presents local policy perspectives on capacity building for HTA and the progress made toward its use in pricing and reimbursement decisions. HTA capacity buildingUniversity-based education and professional development training in pharmacoeconomics and pharmaceutical policy have been the starting points to create a receptive environment, necessary expertise, and local tools across many settings in Jordan. International collaboration with HTA supporting bodies helped to build connections and informed policy development on local levels through projects, meetings, and discussions. HTA institutionalization and its use in pricing and reimbursement decisionsInstitutionalizing HTA in the King Hussein Cancer Center and the Royal Medical Services was the driving factor for HTA implementation and practice advancement; nevertheless, process transparency and experience sharing through reports and publications are still limited. The Jordan Food and Drug Administration’s pricing and formulary decisions require pharmacoeconomic consultation in selected cases according to the Jordanian Drug Law. Nevertheless, there is a lack of local methodological guidelines for conducting HTA. In addition, HTA practitioners and the regulatory scope of future HTA activities in Jordan cannot be determined yet. Recommendations and future directionsOver the past 2 decades, Jordan has crossed a number of milestones and advanced further to implement HTA as a tool for evaluating health interventions. As a next step, legislation is needed to mandate the use of HTA and to enhance transparency in decision-making processes.

3rd Annual International Pharmacoeconomic Forum Highlights.

3rd Annual International Pharmacoeconomic Forum Highlights.

Implementation of Health Technology Assessment and Management Course in Undergraduate Program in Biomedical Engineering ITB.

The Undergraduate Program in Biomedical Engineering ITB, Indonesia, introduce the Health Technology Assessment and Management as an elective course in 2021. This course is implemented to support the World Health Assembly that urges the member states to establish national strategies in health technology assessment and management, particularly medical devices. Furthermore, it is designed to give biomedical engineering students a broader insight into their career opportunities. Therefore, this course is delivered by the practitioner and guided by the main lecturer. The course syllabus is developed from the WHO Medical Devices Technical Series and European Network for Health Technology Assessment. It tries to implement HTA Core Model for Rapid Relative Effectiveness Assessments. A questionnaire is used to measure the students' perception of the course implementation. Moreover, it is used to obtain the students' comments and feedback. The course that is delivered by the practitioner not only gives the course content but also the context. After attending the course, students have a broader insight into the career opportunities as biomedical engineers in Indonesia.

POSA260 Common Drivers in Countries That Are Developing HTA Systems Had Led to Shared Challenges for Innovative Therapies

To understand the drivers and challenges facing countries transitioning towards full implementation of Health Technology Assessment (HTA) in the Asia Pacific, Latin America and Europe. We conducted a literature review focusing on HTA systems of 11 selected countries (Argentina, Columbia, Mexico, South Korea, Singapore, Philippines, Malaysia, Vietnam, Austria, Slovakia, and Greece). The literature review was followed by interviews with reimbursement decision-makers to supplement the findings. One of the most important common drivers that have been associated with the initiation of HTA systems was government initiatives to provide universal healthcare. This driver was common across countries despite different healthcare system structures. In the newly initiated HTA systems that we investigated, some of the HTA frameworks used for assessment have led to problems with access to innovative treatments. For example, conservative and strict application of the World Health Organisation's Incremental Cost-Effectiveness (ICER) threshold based on country GDPs can hinder patients’ access to innovative and irreplaceable treatments, although this practice might help establish fiscal discipline to enable the provision of universal healthcare. We also found that HTA has been used to inform efficient healthcare resourcing, such as value-based contracting, and to identify inexpensive but equally effective alternatives (for example, generics and biosimilars). Using HTA assessments in this way, HTA can open opportunities to create budgetary headroom for innovative medicines. Our analysis of 11 countries that are transitioning towards full implementation of HTA systems indicate that they are also facing budgetary constraints in providing better healthcare to broader populations. Some HTA approaches that these countries use focus narrowly on easing the budgetary burden of drugs. This practice hinders patients’ access to innovative and irreplaceable treatments. Instead, HTA can be used to find creative solutions to create budgetary headroom for all necessary medications. This approach will require collaboration across stakeholders, including governments and manufacturers.

POSC269 Health Technology Assessment Implementation for Development of Basic Benefit Package in 2021 in Ukraine

The aim of the study is to determine the impact of health technology assessment (HTA) implementation for the basic benefit package to justify the medicines inclusion on the National list of essential medicines in Ukraine according to new legislation.

Assessing progression of health technology assessment implementation in Asia: a balanced scorecard for cross comparison of selected countries in Asia.

To provide an update on the use of health technology assessment (HTA) in Asia and lessons for countries seeking to advance HTA. Build upon the research by Chootipongchaivat and the World Health Organization identifying eighteen "factors conducive to the development of HTA in Asia." These factors were used to create a balanced scorecard to assess the progress of HTA, measuring progress against each factor in China, India, Indonesia, Malaysia, Philippines, South Korea, Taiwan, Thailand, and Vietnam. A scoring system was used wherein: 1, No progress; 2, milestone at early stages, ad hoc HTA use; 3, progress on milestone but limited impact; 4, significant progress but limited remit; and 5, significant progress on milestone, routine HTA informs decisions. Total scores indicated progress of HTA while milestone scores provided contextual insights within countries. Literature reviews and expert interviews were used to complete scorecards. South Korea and Thailand scored highest with seventy-three and seventy-one points, respectively, while Vietnam scored lowest at 28.5. Advanced HTA programs have independent HTA agencies with a broad remit, explicit process and methods, network of researchers, and routine use of HTA. Taiwan and Malaysia fall in a middle tier, with established HTA programs with limited remit. The final tier with China, India, Indonesia, Philippines, and Vietnam, emerging HTA processes. Universal Health Coverage goals have catalyzed expansion of HTA. Political will, technical expertise, and sustained financing remain challenges for sustainable HTA programs. Legislation supporting HTA is helpful but political will is key. Recommendations for regional collaboration are provided.

Expectations for the Development of Health Technology Assessment in Brazil.

The implementation of health technology assessment (HTA) in emerging countries depends on the characteristics of the health care system and the needs of public health care. The objective of this survey was to investigate experts’ expectations for the development of HTA in Brazil and to derive measures to strengthen the impact of HTA in Brazil on health care decisions. Based on a scoping literature review, a questionnaire was developed proposing eight theses for seven domains of HTA: (i) capacity building, (ii) public involvement, (iii) role of cost-effectiveness analysis (CEA), (iv) institutional framework, (v) scope of HTA studies, (vi) methodology of HTA, and (vii) HTA as the basis for jurisdiction. Thirty experts responded in full to the survey and agreed to five of the eight theses proposed. Experts suggested several measures to promote HTA within the scope of each domain, thus addressing capacity building related to HTA, availability, and reliability of population data, and legal endowment of the HTA system. Finally, HTA processes in Brazil should also address public health issues (e.g., appraisal of interventions directed at chronic diseases).

Controversy Over Using Quality-Adjusted Life-Years In Cost-Effectiveness Analyses: A Systematic Literature Review.

Researchers and policy makers in the US are exploring the implementation of health technology assessment and value-based pricing to negotiate drug prices and limit spending. Objections made to the quality-adjusted life-year (QALY), the most frequently used health economic outcome for such assessments, are a barrier to the adoption of these tools. This literature review identifies and addresses the range of criticisms made against QALYs. Methods-based criticisms require attention from stakeholders to address well-known shortcomings of the QALY and ensure consistency. Ethical criticisms, however, do not apply only to the QALY and require political decisions about societal values. Understanding and overcoming criticisms of the QALY to enable its use as part of health technology assessment and value-based pricing will be crucial as US policy makers seek to address high drug costs and health care spending.

Value drivers for pharmaceutical products in health technology assessment (HTA) in Saudi Arabia: Results from a capacity Building, Multi-Stakeholder workshop

ObjectivesCapacity building exercises are important to increase understanding of healthcare processes by key stakeholders, and to facilitate open discussions to build consensus. This study explored the views of a multi-stakeholder group of local Saudi experts on possible value elements that could be important for health technology assessment (HTA) processes and methods regarding pharmaceutical products in Saudi Arabia (‘value drivers’). MethodsA diversified group of local experts were invited to a two-day capacity building workshop from 18 to 19 December 2019 in Riyadh, Saudi Arabia. Information regarding the participants’ demographic and educational/professional background, along with their self-assessed knowledge and experience of HTAs and the concept of value in the pharmaceutical market was collected. For each of 22 value drivers identified during a targeted literature search, participants were asked either to ‘opt out’ of its consideration for future HTA assessments, or rate it from 1 to 10 (low–high) on feasibility and acceptability. ResultsEfficacy and safety were the highest rated value drivers for acceptability and feasibility. Explicit cost-effectiveness thresholds had the lowest ratings for acceptability and feasibility. Participants highlighted data availability and accuracy as a potential challenge to HTA implementation in Saudi Arabia. ConclusionsParticipants valued a pharmaceutical product’s efficacy and safety alongside the consideration of disease characteristics for HTA processes. Participants also valued a binding HTA recommendation and the use of local real-world evidence, where available, to support HTA submissions.