Role Of Health Technology Assessment Research Articles

Health technology assessment and healthcare environmental sustainability: Prioritizing effort and maximizing impact.

The growing global focus on and sense of urgency toward improving healthcare environmental sustainability and moving to low-carbon and resilient healthcare systems is increasingly mirrored in discussions of the role of health technology assessment (HTA). This Perspective considers how HTA can most effectively contribute to these goals and where other policy tools may be more effective in driving sustainability, especially given the highly limited pool of resources available to conduct environmental assessments within HTA. It suggests that HTA might most productively focus on assessing those technologies that have intrinsic characteristics which may cause specific environmental harms or vulnerabilities, while the generic environmental impacts of most other products may be better addressed through other policy and regulatory mechanisms.

OP141 Expert Knowledge Elicitation in Health Technology Assessment: Our Experience Using the Sheffield Elicitation Framework

IntroductionExpert judgement has an important role in health technology assessment (HTA), including as a source of evidence to inform economic modeling when published data are lacking. Quantitative information may be elicited from experts to inform model inputs and associated uncertainty using one of many expert elicitation methodologies. Here, the feasibility and potential benefits of one expert elicitation method, the Sheffield Elicitation Framework (SHELF), to the HTA process is examined.MethodsThe SHELF method seeks to express the knowledge of multiple experts in the form of a subjective probability distribution. Eliciting a subjective probability distribution allows the uncertainty of experts to be included in probabilistic sensitivity analysis, which is becoming an increasingly prominent feature of HTAs. The individual knowledge of participating experts is combined through behavioral aggregation, where experts participate in a discussion before being asked to provide judgments from the perspective of a rational impartial observer. The whole process is led by a facilitator who ensures all participants contribute and confirm that the final distribution is a product of consensus, not compromise.ResultsWe recently conducted two SHELF elicitations as part of an ongoing project aiming to streamline the assessment of positron emission tomography (PET) in Australia. These elicitations provided insight into the usefulness of SHELF within the HTA setting. Given the constraints imposed by the COVID-19 pandemic, the elicitation sessions were conducted online rather than in the ideal face-to-face manner. In collaboration with one of the developers, we successfully adapted the method by making use of video conferencing technology to provide an online environment that mimicked the face-to-face setup as much as possible.ConclusionsSHELF provides a rigorous and scientific method by which to elicit the knowledge of multiple experts in the form of a probability distribution. However, the method is resource intensive and may be best reserved for when data on key drivers are lacking.

PP14 The Role Of Health Technology Assessment In The Public Hospitals Of The National Health Service Of Catalonia

IntroductionHospitals play an essential role to facilitate the appropriate introduction of health technologies into the National Health System. We aimed to analyze if the decision-making at the hospital level is based on health technology assessment (HTA).MethodsWe developed a seventeen-question survey to assess the decision-making mechanisms for the introduction of health innovation into the public hospitals of the National Health Service (NHS) of Catalonia. All questions were related to the field of HTA and health innovation. We asked about the process of new health technology acquisition, the existence of HTA units, and the impact those units might have within the center. We invited the three main public healthcare providers (n= 68 centers). We performed a quantitative analysis grouping the results by type of healthcare provider.ResultsThirty-five different health providers (51.5%) remitted forty-two responses. We identified two differential mechanisms for the introduction of health innovation in those centers: 51.4 percent used a directive committee for decision-making, whereas 37.1 percent employed a technical commission. Some centers (8.6%) used both options. Both the directive committees and technical commissions predominantly considered the professional experience or scientific evidence provided by the healthcare professionals of the center (80%) or external HTA reports or clinical practice guidelines (65.7%) to guide their decision-making. Using HTA products developed within the center was less frequent (34.3%). Only 57.1 percent of the healthcare providers had an HTA unit, but 75 percent of them declared that HTA products had a direct and quantifiable impact on their decision-making regarding the introduction of innovation. Healthcare providers without HTA units manifested their willingness to adopt HTA practices into their decision-making processes.ConclusionsHTA at the hospital level is not a common practice when deciding to introduce innovative health technologies in the NHS of Catalonia. However, the main healthcare providers agreed that the introduction of HTA is necessary for improving their decision-making and that the HTA agency, Agency for Health Quality and Assessment of Catalonia (AQuAS) will play a key role (training, promoting, and assessing).

Future Role of Health Technology Assessment for Genomic Medicine in Oncology: A Canadian Laboratory Perspective.

Genome-based testing in oncology is a rapidly expanding area of health care that is the basis of the emerging area of precision medicine. The efficient and considered adoption of novel genomic medicine testing is hampered in Canada by the fragmented nature of health care oversight as well as by lack of clear and transparent processes to support rapid evaluation, assessment, and implementation of genomic tests. This article provides an overview of some key barriers and proposes approaches to addressing these challenges as a potential pathway to developing a national approach to genomic medicine in oncology.

HEALTH TECHNOLOGY ASSESSMENT AS A TOOL FOR HEALTHCARE POLICY MAKING

Background. The article briefly describes the genesis of the concept of health technology assessment, which emerged in the 60s of the XX century. This was due to the emergence of technologies that gave rise to social, ethical, legal and political problems.
 Aim:To highlight the role of health technology assessment (HTA) in providing evidence-based information for health policy making. 
 Materials and methods. The object of the study was the information obtained from the relevant regulations and foreign and domestic literature sources describing the HTA process in terms of its impact on policy making.
 The basics of the HTA process and its purpose, which is to help develop safe and effective health care policies that focus on the needs of the patient and seek to achieve the best value for money, are established.
 Results. The list of factors that contribute to the use of HTA in health policy development, as well as the variety of models of real-world policy processes, is briefly reviewed. 
 It is emphasized that the interaction between policy makers and researchers, as well as the role of each party in the HTA process, especially the application of the results, depends on the social model of society. The introduction of a scientific approach inevitably leads to increased openness and accountability of government decisions and actions. In such a society, social and economic reforms become more successful. 
 Conclusion. It has been determined that the introduction of the HTA institute in Ukraine provides healthcare policy makers with a reliable resource for implementing healthcare reform.

Ethics information retrieval in HTA: state of current practice.

Though there have been longstanding discussions on the value of ethics in health technology assessment (HTA), less awareness exists on ethics information retrieval methods. This study aimed to scope available evidence and determine current practices for ethics information retrieval in HTA. Literature searches were conducted in Ovid MEDLINE, LISTA, Scopus, and Google Scholar. Once a list of relevant articles was determined, citation tracking was conducted via Scopus. HTA agency websites were searched for published guidance on ethics searching, and for reports which included ethical analyses. Methods sections of each report were analyzed to determine the databases, subject headings, and keywords used in search strategies. The team also reached out to information specialists for insight into current search practices. Findings from this study indicate that there is still little published guidance from HTA agencies, few HTAs that contain substantial ethical analysis, and even less information on the methodology for ethics information retrieval. The researchers identified twenty-five relevant HTAs. Ten of these reports did not utilize subject-specific databases outside health sciences. Eight reports published ethics searches, with significant overlap in subject headings and text words. This scoping study of current practice in HTA ethics information retrieval highlights findings of previous studies-while ethics analysis plays a crucial role in HTA, methods for literature searching remain relatively unclear. These findings provide insight into the current state of ethics searching, and will inform continued work on filter development, database selection, and grey literature searching.

2.G. Workshop: The development of HTA collaboration in Europe: where we are and where we are going

Abstract Health decision-making should be always well-informed. This draws the attention on the need to make the best use of available evidence in respect to different clinical and non-clinical issues to make a value-based allocation of resources. Health Technology Assessment (HTA) is a method for supporting evidence-informed health policymaking as it is defined as a multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle. The role of HTA is of utmost importance at European Union level considering that citizens have the right to access healthcare in any EU country with reimbursement by their home country. Therefore, Member States (MS) cooperation in the evaluation of health technologies is envisaged to ensure safe, high-quality, and efficient healthcare. Several efforts have been put in place at EU level to make this collaboration possible. The cross-border healthcare directive 2011/24/EU have led to the establishment of a voluntary network of MS to facilitate their cooperation and the exchange of scientific information. This network has been supported by another network, namely the European Health Technology Assessment Network (EUnetHTA) that was launched in 2006 with the aim to increase the contribution of HTA to decision-making in EU MS, strengthen the link between HTA and health policymaking, and reduce the overlap and duplication of HTA efforts by promoting a more effective use of resources. EUnetHTA has created a long-lasting Joint Action that has developed principles, methodological guidelines, as well as functional online tools for the sharing production of HTA. In the meantime, starting from 2018, a proposal for an EU regulation on HTA has been discussed within the European Commission first and the European Council and Parliament later. The discussion led to the approval of the Regulation (EU) 2021/2282 on health technology assessment (HTAR) that entered into force on 11 January 2022 and will apply from 12 January 2025 onwards. The HTAR calls for mandatory participation in and use of joint clinical assessments at MS level opening a new era for HTA at EU level. In order to make public health professionals ready for the challenge, this skill-building seminar will provide the audience with basic knowledge in respect to the objective, the application, the methods, and the history of HTA at European level. After two formal presentations on these issues, a case study will lead the following interactive discussion with the audience. Key messages • Health decisions should be informed by the determination of the value of health technologies through shared methods, such as Health Technology Assessment. • Collaboration on Health Technology Assessment at European level has had a long-lasting story and is now looking out into a new challenging era that will be the EU regulation being implemented.

Health Technology Assessment in Tanzania: Capacity and experience of HTA committee members

Background Tanzania established a Health Technology Assessment Committee in recognition of the increasing role of Health Technology Assessment (HTA) to achieve universal health coverage. The committee has the mandate to develop recommendations on the reimbursement of technologies for decision-makers. It is widely recognized that there are challenges to the technical capacity and human resource availability of HTA, including that of decision-making committees. Committee members need to combine scientific and social judgments vis-a-vis the technology under evaluation. This paper reports on a self-administered survey among committee members to assess their capacity for the tasks at hand. Methods A survey was developed and sent to all members of the HTA committee in Tanzania. Responses were analyzed, and key themes explored. Results Out of 20 committee members, 15 members completed the survey (response rate 75%). Committee members were primarily government employees who were qualified and well-experienced in clinical medicine. However, they were less qualified and experienced in HTA and expressed low confidence in this subject matter. Conclusions The results indicate the type of evidence an advisory committee can reasonably be expected to understand and handle. It can also guide future capacity-strengthening activities and programmes, and serve as a baseline for measuring the impact of these programmes.

Key Considerations in the Health Technology Assessment of Advanced Therapy Medicinal Products in Scotland, The Netherlands, and England

ObjectivesAdvanced therapy medicinal products (ATMPs) are highly innovative therapies. Their costs and uncertain value claims have raised concerns among health technology assessment (HTA) bodies and payers. Little is known about how underlying considerations in HTA of ATMPs shape assessment and reimbursement recommendations. We aim to identify and assess key considerations that played a role in HTA of ATMPs underlying reimbursement recommendations. MethodsA review of HTA reports was conducted of all authorized ATMPs in Scotland, The Netherlands, and England. Considerations were extracted and categorized into EUnetHTA Core Model domains. Per jurisdiction, considerations were aggregated and key considerations identified (defined as occurring in >1/assessment per jurisdiction). A narrative analysis was conducted comparing key considerations between jurisdictions and different reimbursement recommendations. ResultsWe identified 15 ATMPs and 18 HTA reports. In The Netherlands and England most key considerations were identified in clinical effectiveness (EFF) and cost- and economic effectiveness (ECO) domains. In Scotland, the social aspects domain yielded most key considerations, followed by ECO and EFF. More uncertainty in evidence and assessment outcomes was accepted when orphan or end-of-life criteria were applied. A higher percentage of considerations supporting recommendations were identified for products with positive recommendations compared with restricted and negative recommendations. ConclusionsThis is the first empirical review of HTA’s using the EUnetHTA Core Model to identify and structure key considerations retrospectively. It provides insights in supporting and opposing considerations for reimbursement of individual products and differences between jurisdictions. Besides the EFF and ECO domain, the social, ethical, and legal domains seem to bear considerable weight in assessment of ATMPs.

The role of HTA in COVID-19 vaccination campaign: the Italian experience

Issue/problemItaly was one of the four European countries that started to join forces to accelerate access and distribution of a much-needed vaccine against COVID-19. When the first vaccine was approved, a National Strategic Plan for COVID-19 vaccination, examining the most relevant domains for Health Technology Assessment (HTA), has just been issued in Italy.Description of the problemConsidering the possible provision of COVID-19 vaccines in the short time, in Autumn 2020 the necessity for a comprehensive assessment came up. In Italy HTA has been identified as the method for assessing the broad value of existing and new vaccines by the last two National Immunization Plans. However, the pandemic highlighted the need for a quick introduction and distribution of COVID-19 vaccines. A multidisciplinary Steering Group was therefore appointed by the Ministry of Health, in order to define vaccination strategies, organizational models, economic aspects, communication and social issues.ResultsTaking into account plans already released by other countries, a National Strategic Plan for COVID-19 vaccination was issued in December 2020. Main topics covered were: epidemiology and priority groups to be immunized, logistic and organization, efficacy and safety monitoring, economic and burden of disease assessments, communication. The application of these recommendations has finally proven to be difficult, because of vaccines procurement delays, suspected adverse events, inequalities in the different Regional settings.LessonsGiven the concerns and difficulties faced by Italy and other European countries in the appraisal and management of COVID-19 vaccines, a HTA adapted framework could be an option for guiding the definition of National Strategic Plans. This could offer a common structured approach, make decision-making process more transparent, and be significant for a timely, convenient, and affordable access to new vaccines against SARS-CoV-2.

3.H. Workshop: The role of HTA for COVID-19 vaccines: present and future perspectives

It is well known how vaccines typically require many years of research and testing before being on the market, but in 2020 the COVID-19 pandemic pushed scientists to embark on a race to produce safe and effective SARS-CoV-2 vaccines in record time. In such an emergency situation, striking the right balance between urgency and acceptable safety and efficacy evidence is challenging. Furthermore, other relevant issues need to be more comprehensively addressed, including cost-effectiveness of vaccination campaigns and real-world data on effectiveness and safety. Currently the European Medicines Agency (EMA) has approved for use four vaccines against COVID-19. Data on their efficacy and safety will continue to be collected beyond licensure and submitted to EMA, but the need for a more complete assessment, which includes contextual and societal considerations (e.g. impact on population health, population's demand, attitudes and behaviours, ethical considerations) and economic analysis, is unquestionable to support national decision-maker processes. In this kind of “holistic” approach, the Health Technology Assessment (HTA) could be the answer in order to support the allocation of resources into different COVID-19 vaccines and to make it possible a timely and equitable access to vaccination. As also stated in the HTAi Position Paper on “HTA's Critical Role in the (Early) Assessment of (potential) Vaccines to prevent the spread of COVID-19 globally”, the following issues should be carefully tackled: 1) affordability, sustainability and distributional effects; 2) cost-effectiveness considerations; 3) fostering HTA collaborations; 4) need for early, adaptive and living HTA. Accounting for such issues is essential to ensure that HTA is successfully implemented in the field of COVID-19 vaccines, at the present time and in its future developments on a national and international scale. This workshop will discuss how HTA could help the EU-wide and national decision-making process about COVID-19 vaccines.Key messages An adapted and living HTA framework considering the unique characteristics of COVID-19 vaccines could be an answer to current and future challenges in vaccination campaigns.There are several challenges in current and future HTA of COVID-19 vaccines, namely the evaluation of their broad economic impacts, their effectiveness and safety and organization issues.

Giving patients a voice in Health Technology Assessment decision-making in Greece: a patient advocacy group consensus analysis

Abstract Objective This analysis aimed to assess patient advocacy groups’ (PAGs) perspectives on patients’ and PAGs’ potential role in Health Technology Assessment (HTA) decision-making in Greece. Methods In total, 22 representatives of PAGs participated in a consensus panel meeting. Participants’ views were elicited via a consensus panel meeting, through a televoting procedure, based on a structured questionnaire with close-ended questions. Voting was anonymous, to avoid the influence of the dominant personality. After voting, the results were presented to the participants and televoting was repeated to achieve consensus. Key findings The majority of participants (94.8%) believe that valid information on the developments regarding HTA in Greece is not conveyed to them by the official national regulatory sources. Key sources of valid information on developments regarding HTA were: conferences (95.2%), international PAGs (85.7%) and HTA experts/scientists (76.2%). About 76.2% of participants evaluated PAGs’ competence to participate in policy-making concerning HTA scheme formation as moderate or higher. Regarding patients’ effective participation in HTA decision-making, greater importance (points 4 and 5 on a 5-point scale) was given to their education on treatment effects in terms of quality of life (100.0%), basic principles of health economics and pharmaceutical policy (95.5%) and ethical aspects of HTA (95.0%). About 55.0% strongly agree that patients should formally express their opinion on HTA issues, while 72.7% believe that patients’ opinions on HTA issues should be expressed through participation in the process and right to vote. Conclusions The participation of patients in HTA decision-making is an issue not only of justice but also of essence. For a productive participation, PAGs training is essential.

Beyond the relationship between the healthcare provider and the patient with an emerging next generation of electronic health records

IntroductionAn emerging next generation of electronic health records (EHRs) is expected to see greater realisation of benefits through empowering healthcare stakeholders including patients, providers, and researchers to do things differently. EHR technology is evolving because of the widespread availability of key enabling technologies, such as the Internet of Things (IoT), artificial intelligence (AI), genomic sequencing, and cloud storage. With the increasing adoption of EHRs and their ever-evolving functionality and utility, comes a wide spectrum of associated ethical and social concerns. Emerging technology, such as ePortals, AI decision support systems, voice recognition software and wearable devices, are expected to increase the prominence of EHR technology within the health domain.Policy context and objectiveThis research is timely because EHR technology is still at an early stage of adoption in many countries. For example, large improvements are projected in the next 10 years in the Irish health IT infrastructure. Several Irish government policies aim to transform healthcare through eHealth, e.g. Sláintecare eHealth pillar extends to 2030, the National Development Plan 2018 – 2027, the Department of Health Statement of Strategy 2016 – 2019, and Project Ireland 2040.We have conducted a scoping literature review, to explore which EHR related ethical concerns were being debated in the literature and why these ethical concerns were debated. This review will be useful to a range of stakeholders involved in a safe, legal and ethical development, implementation and use of EHRs including healthcare providers, policymakers, and IT developHighlights The literature identified a large range of ethical values associated with EHR technology. There was a strong consensus in the academic literature on the ethical values associated with EHR technology. Privacy has been identified as the most frequently mentioned value in the academic literature. The literature on the ethical and social effects of EHRs focuses predominantly on the relation between the healthcare professional and the patient.Comments on transferabilityThis abstract describes the academic discussion on the ethics of EHRs in the English language. The findings are therefore not limited to one jurisdiction.ConclusionsBecause of the growing prominence of EHR technology, the focus on the relationship between care provider and patient needs to be expanded. More emphasis is needed on relationships between the technology and healthcare stakeholders including patients, providers, and technologists.The growing awareness of the value of personal data is being experienced across all sectors incorporating digital technology. Recent scandals around technology in other sectors, for example around disinformation and news on social networks, can inform ethical inquiries into EHR technology. These inquiries should elucidate issues around the importance of relationships between stakeholders, transparency and accountability or lack thereof. The role of health technology assessment (HTA) to inform stakeholders about the social aspects, and ethical and legal issues is becoming more urgent. "

Vaccine market access pathways in the EU27 and the United Kingdom − analysis and recommendations for improvements

BackgroundVaccine market access (VMA) pathways across the European Union (EU) and the United Kingdom (UK) are complex, lengthy, and heterogeneous, particularly when compared with pharmaceuticals. The knowledge base to inform recommendations for optimization of VMA is lacking. We therefore conducted a comprehensive evaluation of EU VMA pathways. MethodsResearch in two phases included: (1) mapping VMA pathways in each EU member state (including the UK) based on a literature review, expert interviews, and mathematical archetyping; and (2) interviews with vaccine experts to identify barriers, drivers, and recommendations for regional VMA alignments. ResultsKey steps in VMA across the EU include horizon scanning, early advice, National Immunization Technical Advisory Group (NITAG) recommendation for inclusion in national immunization programs, health technology assessment (HTA), final decision and procurement. We found significant complexity and heterogeneity, particularly for early advice, and in the roles, decision-making criteria, and transparency of NITAGs and HTA bodies. The most important drivers for rapid VMA included demonstration of disease burden and vaccine benefit (e.g., efficacy, safety, economic). Key barriers were budget limitations and complexity/clarity of VMA processes (e.g., need for national-regional consensus, clarity on process initiation, and clarity on the role of HTA). Recommendations for alignment at EU and member-state levels include information sharing, joint clinical assessment, initiatives to address funding and political barriers, and improved transparency by decision-making bodies. Early engagement with vaccine stakeholders was a key recommendation for manufacturers. ConclusionsThere is significant potential for alignment, collaboration, and improvement of VMA across the EU. Roles, responsibilities, and transparency of key bodies can be clarified. The COVID-19 pandemic response should stimulate policies to improve access to all vaccines, including routine ones, and form the foundation upon which a consistent vaccine ecosystem can be created for the EU, one that is resilient, consistent between member states, and fit for purpose.

Improvement of Reimbursement Policies for Medical Products Through Health Technology Assessment

Reimbursement policies for medical devices in EU and health technology assessment (HTA) are at the heart of this article. Their development is the result of coordination of many institutions - the European Commission, the European Parliament, the government, agencies and their importance is key. The financial instruments in the reimbursement policies for medical devices in the EU are becoming more and more avant-garde, with the key importance of those from donations or crowdfunding, fundraising for patient organizations and others. The authors emphasize the role of public administration in the formation of effective reimbursement policies for medical devices in line with trends and good practices in the field of medical devices and active participation in the processes, together with European institutions and programs. The authors of the article discuss alternative and innovative approaches, budget impact assessment and reimbursement policies for medical devices in Europe and the EU based on HTA. The authors focus their research on the European experience, the synchronization with European regulations, the harmo-nization of management methods and the role of HTA in the field of management of public funds by institutions and public organizations in Bulgaria. The authors of the publication examine the experience of international institutes in the field of HTA-experience of Great Britain, Germany, France, given the benchmark they have and the need to educate health professionals, administrators, companies in Bulgaria.

PNS6 Saving Lives or the Environment - How about Both? the Role of Health Technology Assessment (HTA) Bodies in Creating Sustainable Healthcare Systems

The natural environment is widely accepted as a determinant of global health; clean air, safe water, and the distribution of vector-borne diseases are some examples. Yet, if healthcare were a country, it would rank fifth on greenhouse gas emissions, largely offsetting environmental-related health benefits. By focusing on immediate needs of individual populations, healthcare systems around the world may compromise their long-term mandate of meeting future generations’ health needs too.

Integrating technology, innovation and policy: COVID-19 and HTA

Scientific abstract: The ongoing pandemic of the corona virus disease 2019 (COVID-19) has adversely affected the health and wealth of nations worldwide. While this negative impact is very visible, it has also resulted in subtle positive growth of innovative health technologies. This article identifies the critical role of Health Technology Assessment (HTA) in analyzing innovations in health technology, using a case study from India. The first HTA on COVID-19 health technology from India, using the framework from the recent HTA definition, conducted on the innovative FNCAS9 Editor-Limited Uniform Detection Assay (FELUDA) diagnostic test shows the potential of HTA in health innovations in low and middle-income country (LMIC) settings. Hence, while COVID-19 has opened windows of opportunities for health innovation and entrepreneurship worldwide, HTA can play a critical role in ensuring the smooth confluence of technology, innovation and policy to ensure the positive impact of health innovation in addressing this pandemic and beyond. An integrated systems framework linking HTA with health innovation ecosystem is presented to conceptualize this link.Public interest abstract: The use of HTA for assessing impact of health innovations has been extremely low in India and other LMICs. The World Health Organization (WHO) in its definition of health innovations considers optimizing or improving performance of the health systems as the overarching goal of health innovation. The new definition of HTA also explicitly links the goals of HTA with that of the health systems objectives of efficiency, equity and quality. Technology embodies applicable knowledge that arises out of science, but not all technologies add value to health systems. In this case study, innovation was applied to create a novel technology (FELUDA) to address a void in testing capacity, while HTA was a tool used to assess the impact of this technology for health system and provide evidence for policy. This case study shows the potential for HTA to guide efficient, equitable and ethical policies for societal benefit. It is important that policy makers in LMICs recognize the role of HTA in assessing the value of health innovations and streamline policies based on evidence. A systems approach to HTA and health innovation is needed for optimizing the use of HTA in health innovations.

Does NICE influence the adoption and uptake of generics in the UK?

The aim of this paper is to examine generic competition in the UK, with a special focus on the role of Health Technology Assessment (HTA) on generic market entry and diffusion. In the UK, where no direct price regulation on pharmaceuticals exists, HTA has a leading role for recommending the use of medicines providing a non-regulatory aspect that may influence the dynamics in the generic market. The paper focuses on the role of Technology Appraisals issued by the National Institute for Health and Care Excellence (NICE). We follow a two-step approach. First, we examine the probability of generic entry. Second, conditional on generic entry, we examine the determinants of generic market share. We use data from IQVIA British Pharmaceutical Index (BPI) for the primary care market for 60 products that lost patent between 2003 and 2012. Our results suggest that market size remains one of the main drivers of generic entry. After controlling for market size, intermolecular substitution and difficulty of manufacturing increase the likelihood of generic entry. After generic entry, our estimates suggest that generic market share is highly state dependent. Our findings also suggest that while NICE recommendations do influence generic uptake, there is only marginal evidence they affect generic entry.

PP385 Using Common Data Models And Data Networks For Evidence Generation In Health Technology Assessment

IntroductionDifferences between healthcare datasets in structure, content, and coding systems are widely recognized as significant barriers to generating robust evidence for regulatory and medical decision making. As a result, there is a growing interest in using common data models embedded within large data networks. By standardizing the structure, contents, and semantics of disparate healthcare databases, common data models like the Observational and Medical Outcomes Partnerships common data model (OMOP-CDM) enable multidatabase studies to be undertaken at speed and in a transparent way. To date, little attention has been given to their potential role in health technology assessment (HTA).MethodsWe identify the uses of observational data in generating evidence in HTA, some common analytical challenges faced in their estimation, and the infrastructural, technical, and data reusability constraints that limit its wider use. We discuss where and how the OMOP-CDM could overcome these barriers in relation to different types of evidence requirements.ResultsThe OMOP-CDM increases the interoperability of otherwise disparate datasets, allowing reliable evidence to be generated from multidatabase studies at speed and transparently. The current analytical tools are best suited for clinical characterization and population-level effect estimation. Further developments to these tools are required to support analyses common in HTA like parametric survival modeling. Differences in costing methods as well as the structure of healthcare delivery between countries may limit the feasibility and value of standardization.ConclusionsThe OMOP-CDM has the potential to support reliable and timely evidence generation in HTA. The analytical tools should be further developed to support common HTA use cases.

Landscape of vaccine access and health technology assessment role in decision-making process in ASEAN countries

ABSTRACT Over the past few years, many innovative vaccines became available that offer protection for diseases which have never been prevented before. While there are several factors that could have an impact on access, the use of health technology assessment (HTA) undoubtedly is also one of the contributing factors. Objectives: To explore the landscape of vaccine access and the role of HTA in new vaccine adoption in Association of Southeast Asian Nations (ASEAN) countries. Results: A great deal of progress has been made in terms of access to new and innovation vaccine in the region. Variation in access to these vaccines comparing between countries, however, is still observed. The use of HTA in supporting new vaccine adoption is still in an early stage especially in Gavi, the Vaccine Alliance-eligible countries. Conclusions: Improving the use of HTA evidences to support decision making could accelerate the efficient adoption of new vaccine in ASEAN region.