Health Technology Assessment Approach Research Articles

What are the challenges in the Health Technology Assessment of genetic and genomic applications?

Abstract Introduction Evaluating genetic/genomic applications (GGAs) is crucial for their implementation in clinical practice but hindered by several issues, such as rapid development processes and unclear benefits. Since these challenges lack comprehensive discussion, this study aims to identify and analyze all barriers emerged in the Health Technology Assessment (HTA) of genetic/genomic tests, filling a gap in the current literature. Methods PubMed, Scopus and Web of Science were searched to identify studies that specifically discussed any challenge or barrier in the HTA evaluation of GGAs. No restriction was applied on evaluation aspect or study type. Challenges/barriers were then grouped into the domains outlined in the EUnetHTA Core Model. A narrative synthesis of the main findings was performed. This study was supported by the EC and MUR- PNRR-M4C2-I1.3 Project PE_00000019 ‘HEAL ITALIA’. Results 19 articles were included: one third involved experts from different countries, and about 50% were author perspectives. Articles either focused on one aspect only (37%) or were more general (47%). The most challenging domain was economic aspects (69%), followed by clinical effectiveness (47%) and social impact (42%), but issues were found in all domains. The lack of a standardized HTA approach, the paucity of evidence on clinical outcomes, the challenges in capturing all health benefits, and the difficulties in identifying the healthcare pathways triggered by the test were consistently mentioned across the HTA domains. Conclusions Our study systematically summarized challenges in the HTA evaluation of GGAS, providing a thorough analysis and categorization of these issues. Various challenges surfaced, notably related to the identification of costs, as well as clinical and non-clinical benefits. There is a need for exhaustive discussion on potential solutions to facilitate the assessment process of these technologies to ultimately foster their implementation in clinical practice. Key messages • There are multiple challenges in the HTA evaluation of genetic and genomic tests in clinical practice that impact every HTA domain. • There is a need for concrete efforts in generating further evidence in relation to the definition of costs and benefits of the healthcare pathways triggered by genetic/genomic applications.

A Health Technology Assessment Perspective on Communicating Local Knowledge of Hippolite O. Amadi et al.'s Neonatal Interventions in Global Health Research

Background: This study employed a health technology assessment approach to explore the impact of Hippolite O. Amadiet al.’s neonatal care interventions. Methods: The research design was a qualitative desk research method. The purposive sampling procedure was adopted focusing on a subset of 10 out of a population of 45 journal articles authored by Amadi and others. Textual analysis was the method of data collection and interpretation analysis was used to analyze the data. Results: Locally tailored interventions such as the ‘handy approach’ temperature control, Neonatal Rescue Scheme, PoliteO2blend®, community-integrated neonatal care, Initial-Setpoint-Algorithm, weatherproof nursery designs, and the recycled incubator technique. These health technology interventions, designed to address challenges in low- and middle-income countries like Nigeria, underscored the significance of locally derived solutions in improving neonatal health outcomes. Conclusion: The study advocated for leveraging scientific journals as a pivotal medium for health technology assessment and science communication, facilitating the seamless exchange of local knowledge and innovations in neonatal care. By highlighting Hippolite Amadi’s research publications, the research emphasized the transformative role of journals in disseminating local innovations globally, promoting collaboration, and knowledge exchange beyond geographical boundaries. Recommendation: This study underscored the importance of active stakeholder involvement in optimizing neonatal outcomes through effective science communication, with a focus on prioritizing journals to facilitate the dissemination of local innovations on a global scale and foster collaboration among healthcare professionals, researchers, and local communities to address unique challenges faced by low- and middle-income countries in neonatal care practices.

A health technology assessment of COVID-19 vaccination for Nigerian decision-makers: Identifying stakeholders and pathways to support evidence uptake

BackgroundNigeria commenced rollout of vaccination for coronavirus disease 2019 (COVID-19) in March 2021 as part of the national public health response to the pandemic. Findings from appropriately contextualized cost–effectiveness analyses (CEA) as part of a wider process involving health technology assessment (HTA) approaches have been important in informing decision-making in this area. In this paper we outline the processes that were followed to identify COVID-19 vaccine stakeholders involved in the selection, approval, funding, procurement and rollout of vaccines in Nigeria, and describe the process routes we identified to support uptake of HTA-related information for evidence-informed policy in Nigeria.MethodsOur approach to engaging with policy-makers and other stakeholders as part of an HTA of COVID vaccination in Nigeria consisted of three steps, namely: (i) informal discussions with key stakeholders; (ii) stakeholder mapping, analysis and engagement; and (iii) communication and dissemination strategies for the HTA-relevant evidence produced. The analysis of the stakeholder mapping uses the power/interest grid framework.ResultsThe informal discussion with key stakeholders generated six initial policy questions. Further discussions with policy-makers yielded three suitable policy questions for analysis: which COVID-19 vaccines should be bought; what is the optimal mode of delivery of these vaccines; and what are the cost and cost–effectiveness of vaccinating people highlighted in Nigeria’s phase 2 vaccine rollout prioritized by the government, especially the inclusion of those aged between 18 and 49 years. The stakeholder mapping exercise highlighted the range of organizations and groups within Nigeria that could use the information from this HTA to guide decision-making. These stakeholders included both public/government, private and international organizations The dissemination plan developed included disseminating the full HTA results to key stakeholders; production of policy briefs; and presentation at different national and international conferences and peer-reviewed publications.ConclusionsHTA processes that involve stakeholder engagement will help ensure important policy questions are taken into account when designing any HTA including any underpinning evidence generation. Further guidance about stakeholder engagement throughout HTA is required, especially for those with low interest in vaccine procurement and use.

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).