OBJECTIVES:The increasing relevance of horizon scanning (HS), early awareness (EA), and disinvestment (DIS) highlights the need for a structured approach to capacity building. Although these fields are essential for evidence-based policy decisions, a harmonized education and training framework to develop necessary competencies is lacking. This article presents the development of a curriculum designed to address this gap in training. METHODS:A transdisciplinary working group was established, drawing on international stakeholders from academia, the public sector, and industry. Using an iterative consensus-driven approach, the group developed a modular curriculum. The curriculum design incorporated best practices from existing education programs in related fields and emphasized case-based learning strategies to ensure contextual adaptability. RESULTS:The resulting curriculum covers theoretical foundations, practical applications, and decision-making processes related to HS, EA, and DIS in eight modules. It supports diverse learner needs, including trainees, training institutions, and public and private organizations, and is designed to be flexible, scalable, and applicable across different regional and organizational contexts. CONCLUSIONS:This curriculum initiative represents a major step toward harmonizing capacity building in HS, EA, and DIS. It fosters sustainability, enhances global health system preparedness, and provides a structured educational platform to support the effective integration of emerging health technologies and evidence-based disinvestment strategies.

IntroductionBiosimilar medicines play a critical role in enhancing global health outcomes by improving access to effective biologic treatments. However, their acceptance and implementation, particularly in emerging markets, depend not only on clinical evidence but also on the integration of societal, individual, and cultural values. This paper explores how value-based decision-making can support the adoption of biosimilars across diverse contexts.MethodsA multi-stakeholder workshop was conducted with participants from various countries, focusing on decision-making processes for biosimilars in emerging health systems. Discussions addressed stakeholder roles, contextual influences, and the alignment of evidence with values. A Multi-Criteria Decision Analysis (MCDA) framework was proposed as a tool to systematically integrate measurable outcomes and intangible factors such as trust, perceived quality, and cultural acceptance.ResultsKey barriers identified included regulatory uncertainties, limited local evidence, regional data protection constraints, and patient preferences for originator biologics. Participants emphasized the importance of adaptable frameworks that reflect local cultural, economic, and systemic conditions. The proposed MCDA approach was viewed as a promising method for capturing complex value dimensions and facilitating transparent, inclusive decision-making. Broader societal benefits of biosimilars, such as economic development through local production, were also highlighted.DiscussionThe workshop underscored the need for value-sensitive implementation strategies that go beyond clinical effectiveness. Integrating context-specific values into evidence-based decision-making can foster trust and support the sustainable adoption of biosimilars. The MCDA framework offers a structured approach to operationalize these principles. Future research should test and refine this model in varied health system settings to support its practical application by policymakers, healthcare providers, and industry stakeholders.

Although platform trials have many benefits, the complexity of these designs may result not only in increased methodological but also regulatory and ethical challenges. These aspects were addressed as part of the IMI project EU Patient-Centric Clinical Trial Platforms (EU-PEARL). We reviewed the available guidelines on platform trials in the European Union and the United States. This is supported and complemented by feedback received from regulatory interactions with the European Medicines Agency and the US Food and Drug Administration. Throughout the project we collected the needs of all relevant stakeholders including ethics committees, regulators, and health technology assessment bodies through active dialog and dedicated stakeholder workshops. Furthermore, we focused on methodological aspects and where applicable identified the corresponding guidance. Learnings from the guideline review, regulatory interactions, and workshops are provided. Based on these, a master protocol template was developed. Issues that still need harmonization or clarification in guidelines or where further methodological research is needed are also presented. These include questions around clinical trial submissions in Europe, the need for multiplicity control across the whole master protocol, the use of non-concurrent controls, and the impact of different randomization schemes. Master protocols are an efficient and patient-centered clinical trial design that can expedite drug development. However, they can also introduce additional operational and regulatory complexities. It is important to understand the different requirements of stakeholders upfront and address them in the trial. While relevant guidance is increasing, early dialog with relevant stakeholders can help to further support such designs.

INTRODUCTION:This paper summarizes the results from a forum of healthcare experts, academia representatives, and public agency officials from emerging and established market countries on Value-Based Healthcare (VBHC) and Health Technology Assessment (HTA). Presentations from experts provided insights into current developments and challenges, followed by interactive roundtable discussions. Emerging markets have unique healthcare systems, patient populations, resource constraints and needs. AREAS COVERED:Each roundtable explored specific topics including the role of HTA and Real-world evidence (RWE) in healthcare decision-making, challenges in biosimilar value assessment and incorporating non-price criteria reflecting context-related specifications of emerging markets such as the multifaceted nature of value in healthcare decision-making, emphasizing stakeholder perspectives and system complexities. EXPERT OPINION:RWE emerged as important in understanding biosimilar value recognition and decision-making processes, with insights into its applications and challenges. Recommendations were provided for utilizing Multi-Criteria Decision Analysis (MCDA) in pharmaceutical procurement, particularly for off-patent medicines, underscoring the importance of comprehensive evaluation frameworks and adherence to value-based principles. Overall findings suggest avenues for collaboration between industry, academia, and public agencies to address implementation barriers and promote equitable, efficient, and high-quality healthcare systems in emerging markets through public-private partnerships, joint capacity building and training initiatives, and knowledge transfers.

Managed entry agreements (MEA) represent one of the main topics of discussion between the European National Payers Authorities. Several initiatives on the subject have been organized over the past few years and the scientific literature is full of publications on the subject. There is currently little international sharing of information between payers, mainly as a result of the confidentiality issues. There are potential benefits from the mutual sharing of information, both about the existence of MEAs and on the outcomes and results. The importance of involving all the players in the decision-making process on market access for a medicinal product (MP) is that it may help to make new therapies available to patients in a shorter time. The aim of this project is to propose a new pathway of value-based MEA (VBMEA), based on the analysis of the current Italian pricing and reimbursement framework. This requires elaboration of a transparent appraisal and MEA details with at least a 24-month contract. The price of the MP is therefore valued based on the analysis of the VBMEA registries of the Italian Medicines Agency. Although the proposal focuses on the Italian context, a similar approach could also be adapted in other nations, considering the particularities of the single health technology assessment (HTA)/payer system.

Introduction Early advice in the process of developing health technologies allows manufacturers to plan their production and transfer to health care systems more accurately. This review aims to describe frameworks used within HTA and their current use by HTA Agencies. Material and methods We carried out a systematic literature review in Pubmed, Embase, Scopus, and WoS, including all references published in Spanish and English. This was last updated in March 2022. We extracted all available information regarding the organizations involved, services offered, types of technology, collaborators involved, fees, output and impact. Websites of several HTA organizations and Google were also searched in order to update and complete the information obtained from this generic search. Results Five-hundred and forty one articles were identified and screened, of which 26 met the eligibility criteria and were selected. Seven of them were non-systematic reviews that described two or more HTA organizations. Ten studies were focused on the advice offered by individual organizations, and eight described the EMA and EUnetHTA parallel or joint advice. We found variations in the technology assessed, services offered, stage of development and costs for advisory services. Conclusions Early and scientific advice would help manufacturers focus their product development on what is needed for the management of specific diseases. Most of the examples or services found refer to drugs as well as to some medical devices and diagnostics. A common definition of the type of advice that could be offered for different health technologies by HTA bodies to ascertain health care systems and manufacturers' needs, in addition to the timeline in which that advice needs to be given, would help HTA bodies provide the right support at the right time. Systematic review registration https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020219401 , PROSPERO CRD42020219401.

IntroductionHorizon Scanning (HS) has been part of the health technology assessment (HTA) world since the end of 20th century. In accordance with the life cycle concept of heath technologies, there have been different organizations that have devoted part of their portfolio to HS’s so called Early Awareness and Alert Systems. In 2017, a legal entity international Health Tech Scan (iHTS) was created on the basis of the previous existing network EuroScan. Our aim is to describe the current achievements of the network, the methods used by its members, and their achievements.MethodsIn 2010, EuroScan decided to analyze its members’ methods and processes to perform HS. We used a previously defined questionnaire to revisit the analysis of methods, processes, and impact of the founded legal entity i-HTS. We analyzed the clients, stakeholders involved, impact on health systems and alliances, as well as the current achievements as a group.Resultsi-HTS is currently rooted mainly in Europe and Asia-Pacific with members in the Americas and with ambassador programmes in Africa. The individual members have continued their achievements with special focus on three main aspects: proactive approach to innovators, stakeholder involvement, and client orientation. In most cases, the members of i-HTS produce information that is used for decision-making purposes, some of which influences the national or regional benefit package. Methods did not differ but the level of involvement of stakeholders in the different phases of the process. Some members also include in their portfolio early advice to innovators.ConclusionsEarly Awareness and Alert Systems are key to inform health care systems around technologies that could impact the management of patients in different contexts. There is a need to better understand the needs of the clients and the importance of HS in order to improve their efficiency. iHTS is in the process of redesigning its methods toolkit with the participation of all its members.

Introduction There is a range of activities that health technology assessment (HTA) doers have started to improve the process of generation of required evidence for new technologies, and the alignment of regulatory and reimbursement processes that retard the access to patients to them. Different organizations call those processes early advice, early dialogue, or scientific advice to those activities. Methods We performed a systematic review of the activities named scientific advice (SA), early advice (EA) and early dialogue (ED). Major databases and HTA organizations were explored. The protocol and search strategy were published in PROSPERO. The selection of final articles and documents was done in pairs, and when discrepancies were found a third person resolved with the consensus of the others. A matrix was used to define the commonalities and differences of the described processes. Results We initially retrieved 949 documents, after the analysis of duplications and the full text reading of the selected ones, we finally selected 39 documents and described: the type of technologies, the process, the stakeholders, the duration, the costs, and the impact. Big HTA agencies such as the Canadian Agency for Drugs and Technologies in Health (CADTH) or the National Institute for Health and Care Excellence (NICE) included EA or SA among their portfolio of activities as well as networks (European Network for HTA (EUnetHTA) or smaller agencies such as HTA Wales or Basque Office for HTA (Osteba) among others. The type of activity, the process, duration, purpose and costs differ among HTA doers. Conclusions There is a need to define what we meant when we are talking about SA, ED, and EA. In fact, regulators used the same processes with different purposes. Our systematic review and the lessons learnt from the European-funded SAFENMEDTECH project will propose a detailed framework that can be useful to better understanding the needs of each of the involved parties and how to make the processes involved more efficient.

Significant progress has been achieved in human health in the European Union in recent years. New medicines, vaccines, and treatments have been developed to tackle some of the leading causes of disease and life-threatening illnesses. It is clear that investment in research and development (R&D) for innovative medicines and treatments is essential for making progress in preventing and treating diseases. Ahead of the legislative process, which should begin by the end of 2022, discussions focus on how Europe can best promote the huge potential benefits of new science and technology within the regulatory framework. The challenges in European healthcare were spelled out by the panellists at the roundtable organised by European Alliance for Personalised Medicine (EAPM). Outcomes from panellists' discussions have been summarized and re-arranged in this paper under five headings: innovation, unmet medical need, access, security of supply, adapting to progress, and efficiency. Some of the conclusions that emerged from the panel are a call for a better overall holistic vision of the future of pharmaceuticals and health in Europe and a collaborative effort among all stakeholders, seeing the delivery of medicines as part of a broader picture of healthcare.

Health Technology Assessment (HTA) is a systematic evaluation of a health technology, designed to appraise the direct or intended effects and indirect or unintended consequences of the technology with an overall goal of supporting informed decision making regarding the use of these health technologies in the healthcare system. In this paper, we present fundamental HTA concepts and provide a conceptual framework that embraces the processes and outcomes required for integrated healthcare decision-making. The "HTA Metro Map" was designed to guide the user through the different areas on: where to use, what and whom to involve within the decision process. The map reflects the complexity and inter-connectedness of the different kind of healthcare services that need to work together to be able to efficiently deliver coordinated decisions at local, regional, national, and international levels. This tool may also serve as base for facilitating developments and improvements of the HTA structure worldwide. The paper discusses the main features of the "HTA Metro Map" while reinforcing the key concepts underlying HTA's integrated approach. The first view of the map provides the several layers of complexity seen in HTA and the various lines within the map represent the main actors involved in the assessment processes. The map connections and crossings symbolize the interprofessional and interpersonal collaborations while the stations denote the knowledge, skills, experiences, and attitudes of each professionals as they interact within this framework. Every line represents a HTA stakeholder and the circular line in the centre represents the patient at the centre of the system. The zones, from social to community and hospital level, represent the need for integration from the perspective of health systems. The HTA Metro Map also has different dimensions depicted by the level of profoundness. Finally, the concepts of different healthcare stakeholder perspectives are introduced both in visual and temporal terms. The "HTA Metro Map" is designed as a flexible model for easy adaptability and in accurately capturing the complexity inherent in any healthcare system. It is hoped that the map will assist different stakeholders to build network capacity, pool existing resources, and develop a more holistic vision that will result in a sustainable, efficient and collaborative decision-making process.

Medizinische Klassifikationen systematisieren medizinische Begriffe (z. B. Diagnosen, Prozeduren). Sie sind unverzichtbare Instrumente für Statistiken und Finanzierungssysteme im Gesundheitswesen. Während Diagnosen weltweit einheitlich nach der Internationalen statistischen Klassifikation der Krankheiten und verwandter Gesundheitsprobleme (ICD) der Weltgesundheitsorganisation (WHO) klassifiziert werden, haben viele Länder eigene Prozedurenklassifikationen mit unterschiedlicher Struktur und unterschiedlichen Einsatzbereichen entwickelt.

OPINION article Front. Pharmacol., 24 January 2017Sec. Drugs Outcomes Research and Policies Volume 8 - 2017 | https://doi.org/10.3389/fphar.2017.00014

The first toolkit for the identification and assessment of new and emerging health technologies was developed by members of the EuroScan International Network and published in 2009. Five years later this revised toolkit continues to focus on methods that are integral to an early awareness and alert (EAA) system. It is once again a collaborative piece of work to which all members have contributed with new information based on their experiences being added. The main stages involved in EAA systems continue to be: identification of information on new and emerging technologies (horizon scanning); filtration and prioritisation of the identified information; and assessment of the technology or group of technologies. The toolkit provides guidance on these stages and highlights the various approaches that can be taken at each of these stages depending on the context of the EAA system and resources available.

We see a backlog in the effective and efficient integration of personalized medicine applications such as genome-based information and technologies into healthcare systems. This article aims to expand on the steps of a published innovative model, which addresses the bottleneck of real-time integration into healthcare. We present a deconstruction of the Learning-Adapting-Leveling model to simplify the steps. We found out that throughout the technology transfer pipeline, contacts, assessments and adaptations/feedback loops are made with health needs assessment, health technology assessment and health impact assessment professionals in the same order by the academic-industrial complex, resulting in early-on involvement of all stakeholders. We conclude that the model steps can be used to resolve the bottleneck of implementation of personalized medicine application into healthcare systems.

OBJECTIVES:The aim of this study was to develop an health technology assessment (HTA) decision tool to support the decision-making process on health technologies for hospital decision makers in cross-border regions.METHODS:Several methods were used to collect information necessary to develop the cross-border mini-HTA decision tool. The literature was inventoried on HTA in border regions and local settings and the use of HTA by local decision makers. Semi-structured interviews with hospital decision makers in cross-border regions were also performed. Based on group discussion of the resulting information, it was decided to use the Danish mini-HTA guideline as a starting point for development of the decision tool. After finishing the first version of the decision tool it was tested in two pilot studies.RESULTS:Some questions in the Danish mini-HTA guideline were not relevant. Other questions needed rephrasing and questions about cross-border situations were added. The pilots showed several missing topics, including legal questions and reimbursement issues. The final decision tool consists of three sections: a general section, a section for hospitals not cooperating cross-border and a section for hospitals that are cooperating with hospitals across a national or regional border.CONCLUSIONS:Based on our literature search, this may be the first cross-border mini-HTA decision tool. The decision tool will be of help for healthcare professionals and decision makers in border settings who would like to use HTA evidence to support their decision-making process.

自20世纪90年代末以来,卫生技术评估(Health Technology Assessment,HTA)在德国引起了广泛讨论,这与循证医学的产生是密切相关的.在德国进行技术评估的论点首先由"国会技术评估办公室"提出.

Background Under the mandate of the European Association for Endoscopic Surgery (EAES) a guideline on methodology of innovation management in endoscopic surgery has been developed. The primary focus of this guideline is patient safety, efficacy, and effectiveness. Methods An international expert panel was invited to develop recommendations for the assessment and introduction of surgical innovations. A consensus development conference (CDC) took place in May 2009 using the method of a nominal group process (NGP). The recommendations were presented at the annual EAES congress in Prague, Czech Republic, on June 18th, 2009 for discussion and further input. After further Delphi processes between the experts, the final recommendations were agreed upon. Results The development and implementation of innovations in surgery are addressed in five sections: (1) definition of an innovation, (2) preclinical and (3) clinical scientific development, (4) scientific approval, and (5) implementation along with monitoring. Within the present guideline each of the sections and several steps are defined, and several recommendations based on available evidence have been agreed within each category. A comprehensive workflow of the different steps is given in an algorithm. In addition, issues of health technology assessment (HTA) serving to estimate efficiency followed by ethical directives are given. Conclusions Innovations into clinical practice should be introduced with the highest possible grade of safety for the patient (nil nocere: do no harm). The recommendations can contribute to the attainment of this objective without preventing future promising diagnostic and therapeutic innovations in the field of surgery and allied techniques.

Health technology assessment (HTA) has been discussed inGermany since the late 1990s, closely related to the advent ofevidence-based medicine. The idea of technology assessment wasinitially discussed in Germany by the “technology assessmentoffice of the parliament.” This was further supported by a scien-tific project to evaluate the use and benefit of HTA in the Germanhealth-care setting at the Hanover Medical School [1]. TheGerman Scientific Working Group Technology Assessment forHealth Care was then founded in 1997 with the objectives todevelop a database comprised of HTAs already available andimprove the methodology for HTA. The project group consistedof university-based scientists and representatives of the variousinstitutions within the statutory health insurance (SHI). Theproject was sponsored by the federal government and supervisedby the German Institute for Medical Documentation and Infor-mation (Deutsches Institut fur Medizinische Dokumentation undInformation [DIMDI]). The project was finished in 2001. HTAwas formally established with the German Health Care Reform2000. The reform included the assignment of the implementationof a database and a scientific working program on HTA withinthe remit of DIMDI. In the same year, the German Agency forHTA was established within DIMDI (Deutsche Agentur furHealth Technology Assessment [DAHTA@DIMDI]). Based onthe work done by the German Working Group TechnologyAssessment for Health Care, the principles and methods of HTAwere continuously adopted by various decision-making bodiesin Germany, such as the predecessors of the Federal Joint Com-mittee (Gemeinsamer Bundesausschuss, G-BA).In Sections I and II of this paper, German organizationsinvolved in HTA and their processes for conducting HTA aredescribed. In Sections III and IV, current issues for the assessmentand use of HTA are discussed. In Section V, HTA in Germany andlessons learned are presented.