Health Technology Assessment Approach Research Articles

Health Technology Assessment and vaccine: new needs and opportunities?

Health Technology Assessment (HTA) can represent an innovative and effective approach to supply decisionmakers with a valid instrument to improve the allocation of resources in the field of vaccines. We proposed a HTA approach for considering the introduction of a new vaccine that could potentially have a great impact on the population’s health, using as an example the vaccine against Human Papilloma Virus (HPV). This approach could be of great interest when the decision making process involves choices regarding new vaccines. We developed a HTA approach for assessing all of the aspects involved in the introduction of vaccines against HPV in Italy, considering the following issues: - epidemiological evaluation of HPV infection and related pathologies through the consultation of data banks and the scientific literature; - evaluation of health care resources utilisation by people suffering from the infection/ related diseases, through the consultation of hospital archives; - systematic review and meta-analysis of randomised clinical trials on HPV vaccination effectiveness and safety; - mathematical modelling and economic evaluation of the vaccination using a cost-effectiveness analysis; - evaluation of the impact of vaccination on the Health System [organisational aspects, vaccine surveillance, relationship between different decisional levels (national, regional)]; - analysis of the ethical, social (acceptability, availability, accessibility, information) and legislative aspects of vaccination. A HTA report on the new vaccine could represent an new important tool to support the choice of decision makers in order to better inform the allocation of economic resources and maximize healthcare services, since it takes into account not only the burden and the epidemiology of the disease, and the economic evaluation of different scenarios, but also the social, legal and bioethical aspects. For HTA to support the introduction of new technologies, and new vaccines can be considered in this sense, there to utilise a process that is well defined, transparent and widely used.

Rapid cost-effectiveness analysis: hemodialysis versus peritoneal dialysis for patients with acute kidney injury in Rwanda

BackgroundTo ensure the long-term sustainability of its Community-Based Health Insurance scheme, the Government of Rwanda is working on using Health Technology Assessment (HTA) to prioritize its resources for health. The objectives of the study were to rapidly assess (1) the cost-effectiveness and (2) the budget impact of providing PD versus HD for patients with acute kidney injury (AKI) in the tertiary care setting in Rwanda.MethodsA rapid cost-effectiveness analysis for patients with AKI was conducted to support prioritization. An ‘adaptive’ HTA approach was undertaken by adjusting the international Decision Support Initiative reference case for time and data constraints. Available local and international data were used to analyze the cost-effectiveness and budget impact of peritoneal dialysis (PD) compared with hemodialysis (HD) in the tertiary hospital setting.ResultsThe analysis found that HD was slightly more effective and slightly more expensive in the payer perspective for most patients with AKI (aged 15–49). HD appeared to be cost-effective when only comparing these two dialysis strategies with an incremental cost-effectiveness ratio of 378,174 Rwandan francs (RWF) or 367 United States dollars (US$), at a threshold of 0.5 × gross domestic product per capita (RWF 444,074 or US$431). Sensitivity analysis found that reducing the cost of HD kits would make HD even more cost-effective. Uncertainty regarding PD costs remains.Budget impact analysis demonstrated that reducing the cost of the biggest cost driver, HD kits, could produce significantly more savings in five years than switching to PD. Thus, price negotiations could significantly improve the efficiency of HD provision.ConclusionDialysis is costly and covered by insurance in many countries for the financial protection of patients. This analysis enabled policymakers to make evidence-based decisions to improve the efficiency of dialysis provision.

Evaluating clinical decision support software (CDSS): challenges for robust evidence generation.

Computerized clinical decision support software (CDSS) are digital health technologies that have been traditionally categorized as medical devices. However, the evaluation frameworks for traditional medical devices are not well adapted to assess the value and safety of CDSS. In this study, we identified a range of challenges associated with CDSS evaluation as a medical device and investigated whether and how CDSS are evaluated in Australia. Using a qualitative approach, we interviewed 11 professionals involved in the implementation and evaluation of digital health technologies at national and regional levels. Data were thematically analyzed using both data-driven (inductive) and theory-based (deductive) approaches. Our results suggest that current CDSS evaluations have an overly narrow perspective on the risks and benefits of CDSS due to an inability to capture the impact of the technology on the sociotechnical environment. By adopting a static view of the CDSS, these evaluation frameworks are unable to discern how rapidly evolving technologies and a dynamic clinical environment can impact CDSS performance. After software upgrades, CDSS can transition from providing information to specifying diagnoses and treatments. Therefore, it is not clear how CDSS can be monitored continuously when changes in the software can directly affect patient safety. Our findings emphasize the importance of taking a living health technology assessment approach to the evaluation of digital health technologies that evolve rapidly. There is a role for observational (real-world) evidence to understand the impact of changes to the technology and the sociotechnical environment on CDSS performance.

Conducting a health technology assessment in the West Bank, occupied Palestinian territory: lessons from a feasibility project.

To achieve universal health coverage (UHC), countries must make difficult choices to optimize the use of scarce resources. There is a growing interest in using evidence-based priority setting processes, such as Health Technology Assessment (HTA), to inform these decisions. In 2020, the Palestinian Institute of Public Health (PNIPH) and the Norwegian Institute of Public Health (NIPH) initiated a pilot to test the feasibility of coproducing an HTA on breast cancer screening in the West Bank, occupied Palestinian Territory. Additionally, a secondary aim was to test whether using an adaptive HTA (aHTA) approach that searched and transferred published evidence syntheses could increase the speed of HTA production. The applied stepwise approach to the HTA is described in detail and can be summarized as defining a core team, topic selection, and prioritization; undertaking the HTA including adaptation using tools from the European Network for HTA (EUnetHTA) and stakeholder engagement; and concluding with dissemination. The aHTA approach was faster but not as quick as anticipated, which is attributed to (i) the lack of availability of local evidence for contextualizing findings and (ii) the necessity to build trust between the team and stakeholders. Some delays followed from the COVID-19 pandemic, which showed the importance of good risk anticipation and mitigation. Lastly, other important lessons included the ability of virtual collaborations, the value of capacity strengthening initiatives within low- and middle-income countries (LMICs), and the need for early stakeholder engagement. Overall, the pilot was successfully completed. This was the first HTA of its kind produced in Palestine, and despite the challenges, it shows that HTA analysis is feasible in this setting.

The Health Technology Assessment Approach of The Economic Value of Diagnostic Test: A Literature Review

The Health Technology Assessment Approach of The Economic Value of Diagnostic Test: A Literature Review

PP01 Health Technology Assessment Of Cervical Artificial Disc Replacement: Highlighting The Need For A Consistent International Approach

IntroductionCervical artificial disc replacement (C-ADR) is not a new technology but one that has seen many technological advances in the past 10 years. Indeed, a recent review described total disc arthroplasty as the most innovative development in the history of spinal surgery. The primary goals of C-ADR are to reduce or eliminate pain, and restore normal segmental motion. The aim of this analysis was to identify, extract and examine key health outcomes and economic data from published health technology assessment (HTA) reports on C-ADR, with the aim of understanding how the evolution of this technology has influenced assessments internationally.MethodsA comprehensive search of over 90 HTA organization websites and the INAHTA HTA database using key terms for C-ADR surgical procedures was coupled with a literature search of recent systematic reviews. No language restrictions were applied.ResultsTwenty HTA reports of C-ADR surgery published from 2005 to 2022 were included for review. Several HTAs (4/20) were updates or reassessments by the same agency and one was an update across agencies (Italy update of Belgian HTA). While many of the HTAs concluded C-ADR is as effective as standard care and superior in certain outcomes, there was no pattern or consistency in the conclusions or recommendations from these assessments, even as the evidence base expanded over time. Our analysis found this was largely due to variations in HTA approaches among agencies including: differences in research questions asked, PICO (Population, Intervention, Comparator, Outcomes) criteria and methods performed, such as: rapid versus full systematic reviews; inclusion of economic evaluations and/or budget impact analyses.Indeed, one of the only predictive factors for a positive HTA was a favorable cost-effectiveness analysis.ConclusionsC-ADR is an established technology with extensive HTA investigation internationally. The lack of a consistent approach taken by HTA bodies made prediction of successful HTA outcomes difficult. Future alignment of key evaluation processes and methods may help address current international variations and support consistent decision making on patient access.

OP102 Towards Universal Health Coverage: Health Technology Assessment Roadmap Development In The Emirate Of Abu Dhabi Involving The Whole Ecosystem

IntroductionThe mission of the Department of Health (DoH) of Abu Dhabi in the United Arab Emirates is to provide its population with a healthy life and world leading preventive and curative services. While the DoH has regulations in place to grant market approval to new health technologies, there is a need to develop a clear overall framework for reimbursement and disinvestment decisions. Establishing a structured health technology assessment (HTA) framework is critical for informing decisions on health technologies that offer value for money, with the aim of improving equitable access to health care, financial risk protection, and, ultimately, better health outcomes.MethodsDuring 2022, the DoH collaborated with the Radboud University Medical Center to explore the feasibility of applying an evidence-informed deliberative process (EDP) HTA approach through workshops and interviews involving all stakeholders in the ecosystem, such as policy makers, principal investigators, providers, patients and public groups, product manufacturers, payers, and purchasers. A situational analysis was conducted to collect stakeholders’ views and build EDPs. Based on this analysis, a structured roadmap was developed.ResultsThe comprehensive five-year roadmap to implement a holistic HTA framework in Abu Dhabi consisted of five major elements, starting with the establishment of an appropriate HTA policy framework as a foundation. Abu Dhabi should firmly establish its HTA structure and program (in one to two years), and at the same time invest in developing and retaining HTA training capacity so that over time (within three to five years) the country can build up its own expertise to sustain the program. This needs to be accompanied by continuous awareness raising among all relevant stakeholders.ConclusionsThis roadmap is the first and most important step toward implementing a holistic HTA framework in Abu Dhabi. Technical work needs to be complemented by continuously raising awareness and involving all relevant stakeholders. Looking at the initial results and international benchmarks, HTA will significantly contribute to achieving a sustainable, high quality healthcare system.

Health technology assessment of genetic and genomic applications: is it possible to standardize?

Abstract Background The assessment of genetic and genomic applications (GGA) has long been used ad hoc frameworks, often based on the ACCE model, while less used are more traditional health technology assessment (HTA) approaches. While ACCE frameworks are mainly focused on technical aspects, HTA ones often include economic and organizational aspects in their assessment. The aim of this study was to develop a framework able to address a comprehensive assessment of GGAs. Methods We analysed the most important HTA model currently used in EU, the EUnetHTA HTA Core Model, to identify any possible shortcomings in the evaluation of GGAs. The Sapienza framework, based on a previous systematic review of GGAs assessment frameworks, was used as a reference. The HTA Core Model applications were than used as a basis for an assessment framework for GGAs, classified according to ‘GGA function/Use setting’ pairs. Results The Sapienza framework found full correspondence in the HTA Core Model. The “Screening Technology” application was suitable for diagnostic, pre-symptomatic, predictive and carrier GGAs when used in screening settings. The “Diagnostic Technologies” application was appropriate for the pairs ‘Diagnostic/Diagnosis', ‘Pre-symptomatic/Diagnosis', ‘Prognostic/Staging’ and ‘Pharmacogenetic/Staging', although it may require additional considerations, such as the need of screening in case of germline mutations, the use of appropriate accuracy measures for prognostic GGAs, or the evaluation of the clinical utility of pharmacogenetic/prognostic GGAs. Conclusions The proposed methodology aims to be a flexible tool that allows the GGA assessment according to a shared and validated methodology already in use for the HTA of medical devices, considering for their technical aspect, the clinical utility, the economic value, and the delivery models. Indeed, the HTA Core Model seems to fit the needs of GGAs assessment. However, some peculiarity of GGAs should be carefully considered during the HTA. Key messages • The EUnetHTA Core Model can provide a comprehensive framework for the evaluation of genetic and genomic applications, allowing a standardization with the procedures usually used for medical devices. • Some peculiar characteristics of genetic and genomic applications must be taken into consideration during their evaluation.

Universal health coverage in India and health technology assessment: current status and the way forward.

In India, there is a renewed emphasis on Universal Health Coverage (UHC). Alongside this, Health Technology Assessment (HTA) is an important tool for advancing UHC. The development and application of HTA in India, including capacity building and establishing institutional mechanisms. We emphasized using the HTA approach within two components of the Ayushman Bharat programme, and the section concludes with lessons learned and the next steps. The UHC has increased the importance of selecting and implementing effective technologies and interventions within national health systems, particularly in the context of limited resources. To maximize the use of limited resources and produce reliable scientific assessments, developing and enhancing national capacity must be based on established best practices, information exchange between different sectors, and collaborative approaches. A more potent mechanism and capacity for HTA in India would accelerate the country's progress toward UHC.

Telemedicine Has a Social Impact: An Italian National Study for the Evaluation of the Cost-Opportunity for Patients and Caregivers and the Measurement of Carbon Emission Savings.

Background: Owing to COVID-19, all stakeholders have recognized the advantages of telehealth and they were available for its permanent implementation, both from the normative and economic point of view. It is, therefore, necessary to understand what were the real benefits created in society through telehealth. Objective: Develop a method to identify a social impact of telemedicine in Italy, considering the reduction on the patient moves with a consequent travel cost, time (opportunity costs), and carbon emission savings. Methods: Since March 2020, we have conducted a quality improvement study in 17 centers, collecting sociodemographic variables. To assess the social impact, we transform the data into outcome measures. The protocol used "Telemedicina Subito" allows the rapid implementation of telemedicine, using operating manual, structured according Health Technology Assessment approach. Results: We collected data related to 2,091 televisits, analyzing three different perspectives. First, one patient with a televisit had a saving equal to the median of EUR 97.16 (interquartile range [IQR]: 64.29-159.69), USD 113.88; considering that the median cost for the visit in presence was EUR 105.91 (p-value <0.05) and after the use of telehealth had a median of EUR 0 (mean: EUR 14.70; p-value <0.05). Second, informal caregivers have a median savings of EUR 65.06 (IQR: 55.52-89.21), USD 76.26. Finally, for one single telemedicine visits we can contribute with a median carbon emission savings of ∼13 kg (IQR: 6-24). Conclusions: The evaluation of the social impact on telemedicine facilitated the creation of an important framework for decision-makers.

Beyond clinical and cost-effectiveness: The contribution of qualitative research to health technology assessment.

Recent developments in health technology assessment (HTA), including the promotion of a new and internationally accepted definition of HTA, have highlighted the need to go beyond clinical and cost-effectiveness to fully understand the potential value of health technologies. Multidisciplinary efforts to generate patient-focused evidence relevant to HTA, using both quantitative and qualitative approaches, are needed. Although it has been more than 20years since opportunities for qualitative methods to inform HTA were first discussed, their use remains infrequent. The goal of this article is to resurrect the debate about the value of qualitative research in HTA. Drawing on examples from published literature, we propose five key areas where qualitative methods can contribute to HTA, complementary to studies of clinical and cost-effectiveness: (i) assessing acceptability and subjective value; (ii) understanding perspectives and providing context; (iii) reaching the groups other methods cannot reach; (iv) laying the groundwork for subsequent quantitative exercises; and (v) contributing to economic model development.

Are Health Technology Assessments Keeping Pace with Health Equity Priorities: A Review of Existing Approaches and Discussion of Emerging Practices

Health technology assessments are evaluation tools used by decision makers and governing bodies to evaluate the relative effectiveness, safety, and cost of new health technologies. Despite the significant access and reimbursement implications of the decisions informed by health technology assessments, health equity is not consistently included in these assessments. This review explores current health technology assessment approaches using global examples, examines how health technology assessments include health equity considerations, reviews how health equity is not optimally included in health technology assessments using a case study example, and discusses emerging practices to include more health equity related metrics using examples from sponsors and health technology assessment agencies. Results show that health technology assessments do not have a consistent, clearly defined measures of health equity impact or methods to include health equity-oriented measures in assessments. Additionally, most do not provide differentiated value assessments for health equity-oriented data or impact. However, innovators and health technology assessment organizations are presenting new approaches to evaluation. Some outside groups are advocating for change and investing in developing health equity checklists and frameworks for incorporation in health technology assessments. Moving forward, more research is needed to understand how to best incorporate heath equity-oriented measures into health technology assessments and how innovators can get more involved to inform both product development and evaluation efforts. If done well, health technology assessments can be developed to reward technologies and research programs that have a significant and measurable impact on delivering more equitable health outcomes.

HTA102 Machine-Learning Technology Assisted Curated Reference Libraries as an Approach for Rapid Global Value Dossier Updates to Support Living Health Technology Assessment: A Case Study in Triple Refractory Multiple Myeloma (TRMM)

The rapid pace of evidence generation and clinical development along with the advent of machine-learning technologies (MLT) has led NICE and other reimbursement bodies toward a “living” approach to health technology assessment (HTA). Traditional development methods for global value dossiers (GVDs), which serve as the basis for HTA submissions, cannot support the Living HTA approach. We aimed to explore the utility of an MLT-assisted curated reference library to support Living GVD through a case study in TRMM.

Managing the introduction of genomic applications into the National Health Service: A special challenge for health technology assessment in Italy.

In recent years, the rapid proliferation of genomic tests for use in clinical practice has prompted healthcare systems to use a health technology assessment (HTA) approach to distinguish valuable from unwarranted applications. In this study, we narratively review the Italian HTA mechanisms for medical devices (MDs), both at the national and regional levels, and discuss the opportunity and benefits of extending them to genomic technologies, for which a dedicated assessment path was advocated by the National Plan for Public Health Genomics in 2017. We found that the National Health Technology Assessment Program for MDs, completed in 2019, had developed a structured pathway for the HTA of MDs; it established a hub-and-spoke structure, run by a governmental institution, and put in place transparent methodological procedures to cover all four HTA phases (i.e., proposal and prioritization, assessment, appraisal, and dissemination). However, several factors have hindered its adoption, and the regions are at different stages of its implementation. For these reasons, efforts should be made to ensure its effective deployment, both at national and regional levels. In addition, we argue that to harmonize the institutional roles and methodological procedures adopted, the time has come to concentrate resources on a single pathway for the assessment of all technologies that include both MDs and genomic applications.

Health Technology Assessment to assess value of biomarkers in the decision-making process.

Clinical practice guidelines (CPGs) on screening, surveillance, and treatment of several diseases recommend the selective use of biomarkers with central role in clinical decision-making and move towards including patients in this process. To this aim we will clarify the multidisciplinary interactions required to properly measure the cost-effectiveness of biomarkers with regard to the risk-benefit of the patients and how Health Technology Assessment (HTA) approach may assess value of biomarkers integrated within the decision-making process. HTA through the interaction of different skills provides high-quality research information on the effectiveness, costs, and impact of health technologies, including biomarkers. The biostatistical methodology is relevant to HTA but only meta-analysis is covered in depth, whereas proper approaches are needed to estimate the benefit-risk balance ratio. Several biomarkers underwent HTA evaluation and the final reports have pragmatically addressed: 1) a redesign of the screening based on biomarker; 2) a de-implementation/replacement of the test in clinical practice; 3) a selection of biomarkers with potential predictive ability and prognostic value; and 4) a stronger monitoring of the appropriateness of test request. The COVID-19 pandemic has disclosed the need to create a robust and sustainable system to urgently deal with global health concerns and the HTA methodology enables rapid cost-effective implementation of diagnostic tests allowing healthcare providers to make critical patient-management decisions.

Challenges of Conducting Value Assessment for Comprehensive Genomic Profiling.

Clinical practice is shifting toward an era of precision medicine. The use of comprehensive genomic profiling (CGP) in oncology has broad potential as a universal companion diagnostic for targeted therapies which may significantly improve health outcomes while using healthcare resources more efficiently. Given the nature of this technology, assessing the value of CGP presents unique challenges. This paper draws on evidence from the academic and policy literature in oncology, as well as stakeholder interviews (health economists, payers, clinicians, and public policy officials) in countries using incremental cost-effectiveness ratios (ICER) as part of health technology assessment (HTA). The degree to which CGP is subject to a value assessment varies significantly across healthcare systems. Current HTA processes focus on evaluating diagnostic testing through co-dependent assessment of diagnostic testing and associated therapeutic interventions. Diagnostic tests with multiple associated therapeutic interventions are rapidly evolving and poorly unsuited to current HTA approaches. Moreover, HTA approaches are limited in their ability to consider broader systemic benefits of the expanded diagnostic capabilities and enhanced opportunities for clinical trial participation offered by CGP. The assessment of the overall value of CGP is limited by the current models of HTA. This paper suggests policy proposals for value assessment and funding reforms to help broaden patient access to CGP. These include investing in genomic testing infrastructure; decoupling the assessment of the value of CGP testing to identifying predetermined therapeutic interventions; tailoring evaluation methodology; and developing approaches to collecting evidence of clinical, healthcare system and societal benefit.

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.

POSC221 Payer and Industry Views on the Legislative Proposal for Joint Work on European Health Technology Assessment Approach

Based on an agreement in March 2021 the European commission entered into negotiations with the European Parliament which foresees the cooperation of member states at EU level on joint clinical assessments on health technologies. It is planned this will provide valuable scientific information to national health authorities when they take decisions about pricing and reimbursement of a health technology. This research explores the reactions to this from both representatives from industry and health authorities (payers).

Time to Align: A Call for Consensus on the Assessment of Genetic Testing.

In this paper, we updated our 2018 systematic review aimed to identify and compare ad hoc designed frameworks for genetic testing evaluation. Overall, we identified 30 frameworks (29 in the first systematic review and one in the update): they were mainly based on the ACCE model, whereas a minority were adjustments of the more traditional Health Technology Assessment (HTA) approach. After discussing the strengths and weaknesses of the retrieved frameworks, this perspective calls for consensus on the assessment of genetic testing. In line with the recent European recommendations that encouraged the generation of comparable evidence across Member States, we believe that the time has come to align all the ideas that have emerged over the last few decades and find a sustainable and sharable tool for the evaluation of genetic and genomic applications. Therefore, we suggest stopping the evaluation of such technologies using ad hoc strategies–affected by validation, implementation, and adoption issues–and we propose to use a general HTA approach, particularly the European reference tool for the assessment of health technologies, the EUnetHTA HTA core model, that is built on solid theoretical and methodological principles and provides a comprehensive assessment of the technologies value.

Health Technology Assessment (HTA) evidence, regulatory classification and reimbursement of medicine: the case of glucosamine

Abstract Objectives To examine the relationship among Health Technology Assessment (HTA) evidence, regulatory classification and reimbursement of health products using glucosamine as a case study. Data of HTA evidence, regulatory classification and reimbursement of glucosamine from 13 countries were extracted from official government websites and peer-reviewed journal articles. Role and responsibility of HTA in each country along as well as the regulatory approval process and reimbursement status of health products were reviewed. The case of glucosamine was then analysed to explore the regulatory classification, reimbursement and its HTA evidence from past to present. Key findings For regulatory classification, we found that glucosamine is classified as either medicine (9 from 13 countries) or a dietary supplement (4 from 13 countries) depends on where glucosamine is seeking its market approval. Reimbursement also differs among the countries. We summarized the key factors that could be the cause of these variations. First, the clinical evidence of glucosamine is still in question especially its efficacy and as a results its cost-effectiveness. This evidence is important for policy consideration. Secondly, different level of HTA approach in each healthcare system and country context effect on how HTA evidence is utilized and synthesized. Lastly, company’s strategic positioning is the first key stakeholder to decide whether their product would be registered as medicine or dietary supplement. Summary The variation of HTA evidence in a diverse healthcare system affects regulatory classifications and reimbursement. This can result in different levels of patient access to health products.