Health Technology Assessment Methods Research Articles

Pharmaceutical innovativeness index: methodological approach for assessing the value of medicines – a case study of oncology drugs

ABSTRACT Background We propose a framework to assess the value of pharmaceutical innovations, with explicit clinical and methodological parameters, based on the therapeutic value and health needs. Research design and methods The study was based on the adaptation of health technology assessment methods documented in the literature, which was applied to a sample of oncological drugs. Difficulties and issues during the application of those tools were identified and addressed to develop a new framework with new and revised domains and clear classification criterion for each domain. Scores were assigned to each level and domain according to their relevance to generate the final score of innovativeness. Results The Pharmaceutical Innovation Index (PII) includes four domains, two related to clinical and social dimensions – Therapeutic Need and Added Therapeutic Value – and other two about methodological features – Study Design and Quality (risk of bias). The scores combined after assigned to each domain results Index of the Innovativeness of the medicines represents the degree of pharmaceutical innovation. Conclusion This work proposes a transparent methodology with well-defined criteria and script; the algorithm developed with authors’ weightings and criteria may be switched to best adjust to other applications, perspective or clinical indications, while keeping the transparency and objectiveness.

Non-empirical methods for ethics research on digital technologies in medicine, health care and public health: a systematic journal review.

Bioethics has developed approaches to address ethical issues in health care, similar to how technology ethics provides guidelines for ethical research on artificial intelligence, big data, and robotic applications. As these digital technologies are increasingly used in medicine, health care and public health, thus, it is plausible that the approaches of technology ethics have influenced bioethical research. Similar to the "empirical turn" in bioethics, which led to intense debates about appropriate moral theories, ethical frameworks and meta-ethics due to the increased use of empirical methodologies from social sciences, the proliferation of health-related subtypes of technology ethics might have a comparable impact on current bioethical research. This systematic journal review analyses the reporting of ethical frameworks and non-empirical methods in argument-based research articles on digital technologies in medicine, health care and public health that have been published in high-impact bioethics journals. We focus on articles reporting non-empirical research in original contributions. Our aim is to describe currently used methods for the ethical analysis of ethical issues regarding the application of digital technologies in medicine, health care and public health. We confine our analysis to non-empirical methods because empirical methods have been well-researched elsewhere. Finally, we discuss our findings against the background of established methods for health technology assessment, the lack of a typology for non-empirical methods as well as conceptual and methodical change in bioethics. Our descriptive results may serve as a starting point for reflecting on whether current ethical frameworks and non-empirical methods are appropriate to research ethical issues deriving from the application of digital technologies in medicine, health care and public health.

Economic Viability of Cutting-Edge Genetic Treatments: Balancing Innovation and Fiscal Sustainability in India's Healthcare Sector

Recent breakthroughs in genetic treatments offer unprecedented opportunities for addressing previously incurable conditions, but their astronomical costs present significant challenges to healthcare systems globally, particularly in developing economies like India. This comprehensive study conducts an in-depth economic analysis of three recently approved genetic treatments, meticulously comparing their long-term financial impacts with traditional care methods in the Indian healthcare context. Utilizing advanced economic modeling techniques and drawing from a diverse array of data sources including clinical studies, real-world evidence, and Indian health databases, we evaluate the treatments' cost-effectiveness, budget impact, and potential for long-term savings over an extended 30-year period. Our findings reveal a complex economic landscape: while these cutting-edge treatments require substantial initial investments, ranging from Rs. 10 crore to Rs. 18 crore per patient, they may offer significant long-term economic benefits in specific scenarios. The study goes beyond mere cost analysis, exploring the broader economic implications of these treatments, including their potential impact on workforce productivity, caregiver burden, and the development of India's biotechnology sector. We propose a comprehensive framework for assessing the economic sustainability of such high-cost treatments, taking into account both immediate budgetary constraints and potential long-term societal benefits. Furthermore, we discuss detailed policy implications for the integration of these treatments into India's healthcare system, emphasizing the need for innovative financing mechanisms, value-based pricing models, and adaptive health technology assessment methods. This research aims to provide policymakers, healthcare providers, and industry stakeholders with crucial insights to navigate the complex intersection of medical innovation and economic sustainability in the rapidly evolving landscape of genetic treatments.

Are Medical Device Characteristics Included in HTA Methods Guidelines and Reports? A Brief Review.

It is well accepted that medical devices (MDs) and procedures have several unique characteristics compared with pharmaceuticals, such as learning curve (LC), incremental innovation (II), dynamic pricing (DP), and organizational impact (OI). The objective of this study was to determine the extent to which these MD characteristics are routinely assessed by health technology assessment (HTA) agencies and incorporated in their guidelines and reports. Three approaches were taken. First, a review of the most recent HTA methods guidelines from 14 selected HTA agencies and 5 HTA networks was undertaken. Next, HTA reports from these agencies were reviewed for inclusion of MD-specific characteristics for 16 selected MDs. Finally, a narrative literature review on this topic was conducted. A total of 13 of the included HTA organizations, and some HTA networks (2/5), have published either general or MD-specific method guidelines, whilst several addressed MD-specific characteristics. NICE included all four MD characteristics in their guidelines, but this did not equate to their inclusion in published HTA evaluations. European Network HTA (EUnetHTA) described the inclusion of LC (within patient safety) and OI within their guidance. The results highlight a lack of consistency. For the narrative review, 10/149 articles identified were reviewed. Most provided recommendations on challenges faced by HTAs, proposed steps to address uncertainties around MD characteristics and reported a lack of methodological guidance for evaluating MDs. A lack of inclusion of MD characteristics in HTA is a complex interplay of several important factors. For these characteristics to become a formal part of HTA of MDs in the future, clear guidance and frameworks are required to enable manufacturers to develop appropriate evidence, and HTA practitioners to assess their impact more broadly.

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

A robust Health Technology Assessment (HTA) framework is crucial to address the rising burden of healthcare costs and to inform decision-making to promote high-quality health systems. This research aims to describe the HTA methods and mechanisms for the successful implementation of HTA in the WHO South-East Asia region, and contextualize the synthesized evidence relevant to Indian settings. 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. 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.

Informing the United States Medicare Drug Price Negotiation for Apixaban and Rivaroxaban: Methodological Considerations for Value Assessments Many Years After Launch

ObjectivesTo demonstrate how health technology assessment methods can be used to support Medicare’s price negotiations for apixaban and rivaroxaban. MethodsFollowing the statutory outline of evidence that will be considered by Medicare, we conducted a systematic literature review, network meta-analyses, and decision analyses to evaluate the health outcomes and costs associated with apixaban and rivaroxaban compared with warfarin and dabigatran for patients with nonvalvular atrial fibrillation. Our methods inform discussions about the therapeutic impact of apixaban and rivaroxaban and suggest price premiums above their therapeutic alternatives over a range of cost-effectiveness thresholds. ResultsNetwork meta-analyses found apixaban resulted in a lower risk of major bleeding compared with warfarin and dabigatran and a lower risk of stroke/systemic embolism compared with warfarin but not compared with dabigatran. Rivaroxaban resulted in a lower risk of stroke/systemic embolism versus warfarin but not dabigatran, and there was no difference in major bleeding. Decision-analytic modeling of apixaban suggested annual price premiums up to $4350 above the price of warfarin and up to $530 above the price for dabigatran at cost-effectiveness thresholds up to $200 000 per equal value of life-years gained. Analyses of rivaroxaban showed an annual price premium of up to $3920 above warfarin and no premium above that paid for dabigatran. ConclusionsAlthough health technology assessment is typically performed near the time of regulatory approval, with modifications, we produced comparative clinical and relative cost-effectiveness findings to help guide negotiations on a “fair” price for drugs on the market for over a decade.

Transferability of new methods for health technology assessment in the field of diabetes between early and late adopters’ countries

This study aimed to investigate the transferability of novel artificial intelligence (AI) methods for prediction modelling of diabetes based on real-world data (RWD) between early and late adopters of emerging health technologies from the perspective of developers and health technology assessment (HTA) experts. A two-step approach was used. Developers of the new AI methods within HTx consortium completed a survey about the benefits, usability, barriers associated with implementing the new prediction models in routine HTA practices. Then, HTA experts from Central and Eastern European (CEE) countries participated in a focus group discussion. Developers generally expressed optimism regarding the transferability of the methods, while acknowledging potential disparities across CEE countries. Key benefits that were identified included enhanced understanding of diabetes, improved cost-effectiveness modelling, and refined patient stratification, all of which could contribute to clinical and reimbursement decisions across various jurisdictions. The focus group underscored the value of real-world data for diabetes prediction modelling, serving as a beneficial resource for both clinicians and HTA agencies. However, there was a recognized need to clarify the processes of integrating randomized clinical trial data with real-world data. For the other stakeholders, the advancement of the methodology will improve the diagnosis and therapy during the process of decision making. Experts from CEE countries recognized the potential of artificial intelligence-based methods employing real-world data for diabetes modelling. These methods are seen as instrumental in elucidating the heterogeneous nature of the disease, supporting clinician decision-making and holding promises for HTA purposes.

Contextual factors influencing the equitable implementation of precision medicine in routine cancer care in Belgium.

Precision medicine represents a paradigm shift in health systems, moving from a one-size-fits-all approach to a more individualized form of care, spanning multiple scientific disciplines including drug discovery, genomics, and health communication. This study aims to explore the contextual factors influencing the equitable implementation of precision medicine in Belgium for incorporating precision medicine into routine cancer care within the Belgian health system. As part of a foresight study, our approach evaluates critical factors affecting the implementation of precision oncology. The study scrutinizes contextual, i.e. demographic, economic, societal, technological, environmental, and political/policy-related (DESTEP) factors, identified through a comprehensive literature review and validated by a multidisciplinary group at the Belgian Cancer Center, Sciensano. An expert survey further assesses the importance and likelihood of these factors, illuminating potential barriers and facilitators to implementation. Based on the expert survey, five key elements (rising cancer rates, dedicated healthcare reimbursement budgets, increasing healthcare expenditures, advanced information technology solutions for data transfer, and demand for high-quality data) are expected to influence the equitable implementation of precision medicine in routine cancer care in Belgium in the future. This work contributes to the knowledge base on precision medicine in Belgium and public health foresight, exploring the implementation challenges and suggesting solutions with an emphasis on the importance of comparative analyses of health systems, evaluation of health technology assessment methods, and the exploration of ethical issues in data privacy and equity.

Assessment of Information Technology in Electronic Medical Records Using the Concept Health Technology Assessment at X Jepara Hospital

<div><table cellspacing="0" cellpadding="0" align="left"><tbody><tr><td align="left" valign="top"><p><em>Hospitals as health service providers need to study the equipment used in health services, which is called a Health Technology Assessment. This research aims to determine the assessment of electronic medical record information technology using the Health Technology Assessment concept at regional General Hospital X Jepara. This research uses a qualitative method with a descriptive design. The research was conducted at the regional general hospital X Jepara which was carried out from March to June 2023. There were 13 informants in this research with 9 main informants and 3 triangulation informants. Data collection techniques use in-depth interviews, observation, and document study. Data analysis for this research is data reduction, data presentation, and conclusion. The results of this research on the concept of effectiveness can increase productivity, be more efficient, make it very easy to publish patient medical records in summary and detail, and doctors and nurses can easily access patient data by logging in using their password. Patient privacy is also maintained with limited access to open it. Service is fast and can increase satisfaction and improve hospital services from an economic perspective using health technology assessment methods. The characteristic aspect of using electronic medical records is that it makes hospital services easier. The security aspect of patient data is guaranteed because system access can only be accessed by users with an account, and the rights of each user are guaranteed. The management of the regional general hospital will easily use electronic medical records and improve the service and quality of Regional General Hospital X Jepara.</em></p></td></tr></tbody></table></div> <strong><em>Keywords: Electronic medical record, Effectiveness, Economic, Technical characteristic, Security</em></strong>

OP116 Building Alignment Between Industry, Academia, And Patients On Health Technology Assessment Methods

IntroductionWith the announcement of the health technology assessment (HTA) review in Australia, a HTA Summit was organized by ISPOR Australia in November 2022. The aim of the Summit was to provide a forum for industry, academia, and patients to share ideas and find common ground with respect to HTA policy, processes, and methods. Topics were determined by a Steering Committee and included: managing uncertainty; patient engagement; second order effects; genetics, genomics and precision medicines; conditional listing; and real-world evidence. Presentations on each topic were conducted by industry and non-industry experts. Breakout sessions led by facilitators were also held for each topic with members of the audience.MethodsDiscussions were recorded during the event and a thematic analysis was performed.ResultsThe following themes were identified from the event.•There was a strong sentiment that participants enjoyed the opportunity to discuss ideas and work toward solutions.•There was a consistent theme that many of the issues arising in HTA were due to a lack of communication between sponsors, evaluators, patients, and decision makers.•It was noted that HTA encompasses several technical terms that have different meanings among various stakeholders.•There was a clear consensus that patients should be involved in HTA earlier and throughout the process.•HTA reform can help drive better access to real-world evidence.•To improve the efficiency of the process, uncertainty could be reframed as risk management, which incorporates the effect of uncertainty in the funding decision.•HTA includes policies, processes, and methods and is used as a tool by decision makers to make informed funding decisions. It was noted on several occasions during the Summit that funding decisions have a political element that should be separated from the HTA process.ConclusionsIt is possible to achieve better collaboration between industry, academic, and patient groups with respect to HTA reform. To promote more collaborative work a consistent conflict of interest definition would be helpful.

PP53 Increasing Emergence Of Novel Digital Health Technologies Identified Through Horizon Scanning

IntroductionRecently, there have been calls for the development of new health technology assessment (HTA) methodologies to address the growing emergence of novel digital health technologies (DHTs). In particular, the lack of robust evidence base and technology-specific considerations of DHTs, such as software updates, present challenges for evaluation with conventional HTA methods. In Singapore, the Agency for Care Effectiveness (ACE) has established a horizon scanning (HS) system to provide the healthcare system with advance notice on emerging medical technologies (MedTechs) that may enter the Singapore market. This study aims to investigate the anticipated emergence of DHTs identified by ACE’s HS system and the potential implications on subsequent HTA methodology.MethodsBased on ACE’s HS methodology, which is in line with international best practices, new and emerging MedTechs that address the top five local disease burden (i.e., cardiovascular, cancer, mental, neurological and musculoskeletal disorders) were identified from various sources and monitored for its development. These MedTechs were further filtered to shortlist potential technologies for HS assessment based on its innovative nature and appropriate time horizon to local regulatory approval. For this exercise, the filtered MedTechs were classified into categories such as DHTs, comprising technologies involving software or artificial intelligence (AI), and non-DHTs.ResultsBetween 2021 and 2022, ACE has completed two topic filtration exercises. Based on 807 and 1,231 monitored MedTechs, 35 and 42 technologies remained after filtration, respectively. Among them, six out of 35 (17%) and 15 out of 42 (36%) filtered MedTechs were classified as DHTs, accounting for approximately two-fold increase in the number of DHTs shortlisted year-on-year. These DHTs include standalone AI software, software in a medical device, and digital therapeutics.ConclusionsThere is a substantial increase in DHTs identified that are anticipated to enter the local healthcare system. Given their unique characteristics, this may call for the modification of current HTA method to enable meaningful evaluation of DHTs.

OP10 Standardized Multilingual Reporting Of Health Technology Assessment And Stakeholder Involvement

IntroductionThere is currently no standardized way to share information about health technology assessment (HTA). Standardised Data on Initiatives (STARDIT) addresses current limitations and inconsistencies in sharing data about HTA processes by providing a way to report these data, including which stakeholders have been involved, their tasks, what methods and data sources were used, and any impacts or outcomes observed.MethodsSTARDIT development began in 2019 and was guided by participatory action research paradigms. A multidisciplinary international team of over 100 citizens, experts, and data users was involved in co-creating STARDIT. These co-creators include cancer patients, people affected by rare diseases, Indigenous peoples from multiple countries, representatives involved in HTA processes, health researchers, environmental researchers, economists, librarians, and academic publishers. Methods of involving people included public events, online discussions, and a public consultation process. STARDIT is free to use, and data can be submitted by anyone. Report authors can be verified to improve trust and transparency, and data can be checked for quality.ResultsSTARDIT can help create high-quality standardized information about HTA processes that can be accessed and edited by anyone. STARDIT enables data reporting at all stages of the HTA process and works in multiple languages. This allows stakeholders involved in or affected by HTA processes (including patients, the public, Indigenous peoples, and people from industry) to appraise and edit information and to self-identify the labels and terminology used to describe them. Organizations such as the Cochrane Collaboration, Australian Genomics, and multiple universities have created STARDIT reports. A link to the working beta version can be found at scienceforall.world/STARDIT.ConclusionsSTARDIT offers those conducting HTA access to standardized information that enables well-founded comparisons of the effectiveness of different HTA methods, including the most effective methods of involving stakeholders. STARDIT allows anyone to access data about HTA processes, which can support participatory ways of working and help improve the equity and quality of HTA processes worldwide.

Clinical comprehensive evaluation of Jinsang Sanjie Pills/Capsules in treatment of vocal nodule/polyp of vocal cord

This study used health technology assessment methods and multi-criteria decision analysis(MCDA) model, according to the guideline for clinical comprehensive evaluation of Chinese patent medicine, we developed this assessment tool. The comprehensive evaluation score of Jinsang Sanjie Pills/Capsules is calculated based on the additive model. This score is calculated by "quantitative evaluation software v1.0 for clinical comprehensive evaluation of Chinese patent medicines" which developed by the project team. The evaluation yielded the following results.(1)Effectiveness: compared with the control group, Jinsang Sanjie Pills/Capsules can improve the total effectiveness rate of vocal nodule/polyp of vocal cord, and improve the symptoms and signs.(2)Safety: Jinsang Sanjie Pills/Capsules did not show acute toxicity and long-term toxicity. The most common adverse reaction was gastrointestinal system damage, all of the adverse reactions were either improved or cured.(3)Economy: from the perspective of the health system, evaluating the single use or combination of Jinsang Sanjie Pills/Capsules with conventional medication in the treatment of vocal nodule/polyp of vocal cord is relatively effective and cost-effective compared to conventional medication, with a stable cost-effectiveness advantage.(4) Innovation: Jinsang Sanjie Pills/Capsules are used for the treatment of slow throat paralysis(vocal nodules, polyp of vocal cord, thickening of vocal mucosa) caused by heat toxin accumulation, Qi stagnation and blood stasis, and the resulting hoarseness. Jinsang Sanjie Pills/Capsules have good innovation and targeted indications.(5) Suitability: the investigated doctors, pharmacists and patients all believed that Jinsang Sanjie Pills/Capsules have good suitability.(6)Accessibility: Jinsang Sanjie Pills/Capsules are included in the category B of the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalogue(2021 edition), which have good cost-effectiveness and affordability for medical insurance and self-paid patients. Jinsang Sanjie Pills/Capsules do not contain endangered animals and plants. The supply of raw materials can meet the demand of production at present. The comprehensive evaluation score is 76.06 points. Based on all dimensions of evidence, 71.4% experts consensus on Jinsang Sanjie Pills/Capsules is class A, which can be directly converted into decision making. This study comprehensively evaluated the clinical application value of Jinsang Sanjie Pills/Capsules in the treatment of vocal nodule/polyp of vocal cord, so as to provide evidence for their rational clinical use and regulatory decision-making.

OP114 Health Technology Assessment Of Digital Technologies: Results From Two Past Examples And Thoughts For The Future

IntroductionDigital health care is a rapidly growing and increasingly diverse area of medicine and social care. Health technology assessment (HTA) agencies around the world are engaging with digital health technologies and developing methods for appropriately assessing their value. Given our experience in HTA for pharmaceuticals and how methodologies must differ when assessing medical devices and diagnostics, we must be proactive in rapidly developing useful methods for assessing a variety of digital health technologies.MethodsWe will first present the results of two completed HTAs from the UK and contrast their methods and results, while looking at the UK approach to assessing digital health care in general. Next, we will present preliminary results from an ongoing consensus conference study of HTA’s for integrated digital technologies. This study will use a modified Delphi methodology to develop statements for discussion at a consensus conference. The primary research question is “how digital technologies can help build resilient healthcare systems and how HTAs can assess their value”.ResultsAn HTA conducted in the UK of an artificial intelligence-enabled ambulatory electrocardiogram device resulted in a recommendation for further real-world evidence generation. Another HTA of a digital therapeutic app for insomnia, which was also conducted in the UK, resulted in a positive recommendation but the process was lengthy and needed to be flexible. The preliminary results of an upcoming consensus conference study will also be presented. The consensus panel will consist of a range of stakeholders from digital experts, HTA practitioners, clinicians, health economists, industry representatives, and policy makers.ConclusionsDigital technology is now a broad field with a wide range of very different technologies included in its definition. Questions remain as to whether digital technologies should be assessed using a traditional pharma-based framework for HTA, a MedTech model, or something else entirely. Given our past experience of developing flexible methods for HTA, we have an opportunity to develop useful recommendations and best practices from the ground up.

OP133 COVIDIAGNOSTIX: Health Technology Assessment For COVID-19 Serological Tests As Companion Diagnostics To Vaccination

IntroductionIn scenarios of vaccine scarcity or the context of organizational complexity, it is necessary to define prioritization strategies for allocating vaccine in compliance with the criteria of equity and efficiency of health resources. The COVIDIAGNOSTIX project, based on health technology assessment (HTA), assessed the role of SARS-CoV-2 serological tests as a companion diagnostic in the definition of strategies for vaccine administration. To guarantee evidence support for health policy choices, two different strategies were analyzed: one based on administering the vaccine booster dose to the entire population (VACCINE strategy) and the other based on allocation criteria (TEST&VACCINE strategy).MethodsAn Italian multidisciplinary team conducted a decision-oriented HTA using a combination of the EUnetHTA Core Model and the multicriteria decision analysis model based on the Analytic Hierarchy Process.Moreover, the Department of HTA method was integrated with the Susceptible-Exposed-Infectious-Recovered model, appropriate modelling techniques, simulation, and quantification of uncertainty that considered the ability to reduce deaths and to contain the pandemic. After identifying the evaluation elements and the decision-making structure, the weights of the evaluation areas and key performance indicators were calculated. This is a constituent part of the mathematical model of data processing, as the Analytic Hierarchy Process was based on a structured questionnaire that compared the relative importance of the two elements on a qualitative scale (1=equal importance; 9=more important).ResultsThe processing of the scores attributed to the key performance indicators concerning all the evaluation domains resulted in a performance of 94 percent for the TEST&VACCINE strategy and 84 percent for the VACCINE strategy. The TEST&VACCINE strategy was the most advantageous in various scenarios due to the greater speed of response from an operational and economic point of view.ConclusionsThe assessment schemes defined by COVIDIAGNOSTIX (i.e., technologies, intended use, and settings), which highlight the characteristics that differentiate the tests from each other and guarantee a timely and appropriate evaluation, can be adapted to respond to similar health policy management situations.

PP21 Are We Ready For It? Developing Criteria To Include Artificial Intelligence Medical Devices (AI-MDs) For Health Technology Assessment

IntroductionThe increasing pace at which artificial intelligence medical devices (AI-MDs) or digital health technologies (DHTs) have been introduced and integrated in healthcare has not been matched with appropriate selection criteria for health technology assessment (HTA) to inform funding decision-making. To align with international best practice and local regulatory guidance, the Agency for Care Effectiveness (ACE) developed criteria to include AI-MDs as part of its 2022 topic prioritization process for medical technologies. This abstract describes ACE’s approach to develop the inclusion criteria.MethodsTo develop key principles for including AI-MDs in ACE’s topic prioritization process, relevant information from overseas HTA agencies, local regulatory guidelines, and ACE’s existing topic selection criteria were reviewed. A search of international HTA agency websites was conducted in September 2022 to identify relevant information on inclusion of AI-MDs in healthcare for reimbursement recommendations.Additionally, local regulatory guidelines for AI-MDs in healthcare were also identified. The inclusion criteria were then piloted with AI-MDs identified from ACE’s horizon scanning workstream to examine their feasibility for HTA topic selection.ResultsOne overseas framework on DHTs from the National Institute for Health and Care Excellence (NICE) and two local regulatory guidelines were identified. Based on the key finding that the purpose of AI-MD use in guiding clinical management and its associated risks were important considerations, the following criteria were developed: (i) full registration with the regulatory body;(ii) device characteristics should be interventional, have direct impact on patient safety, or support accurate diagnosis or treatment which is critical to avoid death and serious health deterioration; and (iii) the AI algorithm should be fixed as opposed to adaptable as per regulatory requirements. Using this inclusion criteria, eight AI-MDs surfaced from horizon scanning were screened with the above criteria and deemed suitable for HTA topic selection.ConclusionsAs AI technologies are increasingly used to replace or supplement current clinical practice, continuous adaptation of HTA method is needed to ensure appropriate topic selection.

PP52 Will Joint European Health Technology Assessment Provide Additional Benefits Over Individual Country-wise Assessments?

IntroductionIn December 2021 the European Union (EU) Health Technology Assessment (HTA) Regulation, a key pillar of the EU Pharmaceutical Strategy, was adopted by the Council and the European Parliament. The focus areas of Joint HTA Cooperation include Joint Clinical Assessments (JCA), Joint Scientific Consultations (JSC), and joint early-stage horizon scanning. The European HTA regulation will be adopted in a stepwise approach and from 2030 onwards, all products (drugs, high-risk medical devices, and in vitro diagnostics) approved in all indications will be subjected to JCA in EU.MethodsA targeted literature research was performed for policies and the European Network for HTA (EUnetHTA) methodological guidelines describing the HTA methods including scoping process, comparators, endpoints, the applicability of evidence, and validity of clinical studies. Additionally, the anticipated opportunities and challenges were also summarized with respect to these methods.ResultsEUnetHTA put forward a timeline for different activities over the next three years as part of the new EU HTA Regulation, including key deadlines for ongoing EUnetHTA consultations on the processes and methods. EUnetHTA will set up a new ecosystem across the EU as it aims to reduce duplication and time to access by supplementing multiple national clinical assessments with a joint central assessment. In any case, assessment of added value and pricing and reimbursement decisions will still occur at the national level.Additionally, EU HTA may promote harmonization of processes, standards, and evidence requirements, which will increase predictability and simplify evidence requirements. However, differences in clinical practice, standard of care, and national priorities may lead to assessments that are not generalizable to all Member States.ConclusionsThe joint EU HTA cooperation will benefit countries which have less developed or do not have established HTA expertise or infrastructure. However, the JCA process could result in increased requirements for clinical evidence generation as relative effectiveness and relevance of outcomes to patients gain further importance for products to successfully gain access across countries.

P46 Drivers of Health Technology Assessment Methods and Process Reforms: An International Comparison of Real World Evidence, Patient Involvement and Discounting

P46 Drivers of Health Technology Assessment Methods and Process Reforms: An International Comparison of Real World Evidence, Patient Involvement and Discounting

Validating the rigour of adaptive methods of economic evaluation

BackgroundThere has been a lot of debate on how to ‘generalise’ or ‘translate’ findings of economic evaluation (EE) or health technology assessment (HTA) to other country contexts. Researchers have used...

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.