The role of quantitative bias analysis for nonrandomized comparisons in health technology assessment: recommendations from an expert workshop.

The use of treatment effects derived from nonrandomized studies (NRS) in health technology assessment (HTA) is growing. NRS carry an inherently greater risk of bias than randomized controlled trials (RCTs). Although bias can be mitigated to some extent through appropriate approaches to study design and analysis, concerns around data availability and quality and the absence of randomization mean residual biases typically render the interpretation of NRS challenging. Quantitative bias analysis (QBA) methods are a range of methods that use additional, typically external, data to understand the potential impact that unmeasured confounding and other biases including selection bias and time biases can have on the results (i.e., treatment effects) from an NRS. QBA has the potential to support HTA bodies in using NRS to support decision-making by quantifying the magnitude, direction, and uncertainty of biases. However, there are a number of key aspects of the use of QBA in HTA which have received limited discussion. This paper presents recommendations for the use of QBA in HTA developed using a multi-stakeholder workshop of experts in HTA with a focus on QBA for unmeasured confounding.

Learning and practicing more value-reflective, problem-setting health technology assessment: experiences and lessons from the VALIDATE project.

OBJECTIVES: To conduct a formative evaluation of applying the VALIDATE approach in practice by (i) assessing how students appreciated the e-learning course, (ii) exploring how, for what purposes and with what outcomes the acquired VALIDATE competences subsequently were used in internships in different institutional contexts, and how this was shaped by these contexts, and (iii) what this shows on real-world use of VALIDATE. METHODS: Comparative discussion of experiences of applying the VALIDATE approach via a semistructured survey and oral feedback from e-course students; final reports on internships in health technology assessment (HTA) practice, followed by semistructured interviews with interns and supervisors to complement and interpret results. RESULTS: All students considered the VALIDATE approach an enlightening and important addition to current HTA knowledge, especially regarding understanding the relation between empirical analysis and normative inquiry, identifying policy relevant questions and using the method of reconstructing interpretive frames for scoping. The latter appeared intellectually challenging and requiring some prior HTA knowledge. The use the VALIDATE approach in practice shows that interns productively redefined the HTA problem, based on appreciation of different stakeholders' definition of the issue; they experienced constraints from retrieving all relevant perspectives from existing literature as well as from institutional rules and routines. CONCLUSIONS: Some challenges in applying the VALIDATE approach deserve attention for its future use: currently used research approaches often assume a problem as "given"; and the data needed on different perspectives is often not reported in scientific literature. Finally, data gathering on and evaluation of value dimensions was experienced as challenging.

Integrating Empirical Analysis and Normative Inquiry in Health Technology Assessment: The Values in Doing Assessments of Health Technologies Approach.

Health technology assessment (HTA) aims, through empirical analysis, to shed light on the value of health technologies (O'Rourke et al. [2020, International Journal of Technology Assessment in Health Care 36, 187-90]). HTA is, then, where facts and values meet. But how, where, and when do facts and values meet in HTA? Currently, HTA is usually portrayed as a sequential process, starting with empirical analysis (assessment), followed by a deliberation on the implications of the findings for a judgment of a health technology's value (appraisal). In this paper, we will argue that in HTA, empirical analysis and normative inquiry are much more closely entwined. In fact, as we hope to show, normative commitments act as an indispensable guide for the collection and interpretation of empirical evidence. Drawing on policy sciences, we will suggest a concrete methodology that can help HTA practitioners to integrate empirical analysis and normative inquiry in a transparent way. The proposed methodology can be conceived as a concrete means for conducting a scoping exercise in HTA. Moreover, it offers a distinct way of giving stakeholders a structural and constructive role in HTA. This paper outlines the approach developed by the values in doing assessments of health technologies project, a project funded by the Erasmus+ program (contract number 2018-1-NL01-KA203-038960), which is the European Union's program to support education, training, youth, and sport in Europe. The project has resulted in an E-learning course, an accompanying handbook, and a consensus statement, all freely available from the project's website www.validatehta.eu.

Identification and selection of health technologies for assessment by agencies in support of reimbursement decisions in Latin America.

OBJECTIVE: There is no health system that has the resources to evaluate all technologies. The presence of a clear process to prioritize health technologies for assessment by health technology assessment (HTA) agencies is a good practice principle recognized at the international level. The objective of Health Technology Assessment International's 2020 Latin American Policy Forum (LatamPF) was to explore how to improve the way HTA agencies in Latin America identify and prioritize technologies for assessment. METHODS: This paper is based on a background document, a survey, and the deliberations of the members of the LatamPF (forty-six participants from eleven countries) using a design thinking methodology. RESULTS: Participants agreed that a lack of clear prioritization mechanisms results in HTA processes and decisions that are perceived to be of low transparency and overly exposed to political or interest group pressures. The LatamPF identified barriers and recommended actions to improve HTA prioritization mechanisms in Latin America. The criteria identified as the most important to be taken into consideration by HTA agencies in the region when prioritizing a technology for assessment were: the burden of illness, the potential clinical benefit, the alignment with national health priorities, the potential impact on equity, a lack of treatment alternatives for patients, and the potential economic impact. CONCLUSIONS: Forum participants agreed that the establishment of transparent prioritization processes is a key element for all health systems. Improvements in these processes will strengthen HTA and provide greater legitimacy to decision making.

[Mecanismos de identificación y priorización de las tecnologías sanitarias a ser evaluadas por las Agencias de ETESA para decisiones de cobertura en Latino America].

OBJETIVO: Ningún sistema de salud cuenta con los recursos necesarios para evaluar todas las tecnologías. Contar con un proceso claro para priorizar qué tecnologías serán evaluadas por las agencias de evaluación de tecnologías sanitarias (ETESA) constituye un principio de buena práctica reconocido a nivel internacional. El objetivo del Foro de Políticas en Latino América (LatamPF) 2020 de Health Technology Assessment International fue explorar cómo puede mejorarse la forma en que las agencias de ETESA de Latino América identifican y priorizan las tecnologías a ser evaluadas. MÉTODOS: Este manuscrito está basado en un documento base, una encuesta, y en el trabajo deliberativo realizado por los miembros (cuarenta y seis participantes, once países) que participaron del LatamPF, a través de la metodología design-thinking. RESULTADOS: Los participantes coincidieron en que la falta de mecanismos claros de priorización trae como consecuencia una falta de legitimidad de las decisiones y procesos de ETESA, que son percibidos como poco transparentes y demasiado expuestos a presiones políticas o de grupos de interés. También se identificaron barreras y acciones para mejorar los mecanismos de priorización de ETESA en América Latina. Los criterios identificados como más importantes para ser tenidos en cuenta por las agencias de ETESA de la región al momento de priorizar una tecnología para ser evaluada fueron la carga de enfermedad, el potencial beneficio clínico, la alineación con prioridades de salud nacionales, el potencial impacto en la equidad, ausencia de otras alternativas para los pacientes, y el potencial impacto económico. CONCLUSIONES: Los participantes del Foro coincidieron en que el establecimiento de procesos transparentes de priorización es un elemento clave para todos los sistemas de salud. Las mejoras en este proceso fortalecerán la ETESA en Latino América y darán mayor legitimidad a sus decisiones.

Burning Issues in Health Technology Assessment and Policy Making: What's Keeping Senior Health Technology Assessment Users and Producers up at Night?

A key working session, held as part of the Health Technology Assessment international (HTAi) Global Policy Forum meeting asks members to share "What's Keeping Me Up At Night." Members-senior thought leaders from health technology assessment (HTA) agencies, payer organizations, industry, and the HTAi Board-share without fear or favor the thorny issues related to HTA that are challenging them now or likely to do so in the near future. This article contains a reflection on the discussions at this session over the last 2 years and focuses on the recurrent and repeated themes: internal and external stakeholder involvement in HTA processes; globalization of HTA and the future of HTA (namely innovative technologies, tide of data and the "war for talent"). While the aim of these informal sessions is not to produce solutions, it reinforces the importance of developing a truly multi-stakeholder HTA community with working relationships built on mutual trust and long-standing engagement.

The link between health technology assessment and decision making for the allocation of health resources in Latin America.

OBJECTIVE: One of the good practice principles for health technology assessment (HTA) is having a clear link between the assessment and decision making. The objective of the 2019 Latin American Policy Forum (LatamPF) of Health Technology Assessment International was to explore different models of connection between HTA and decision making and to discuss the potential applicability of such models in Latin America. METHODS: This paper is based on a background document and the deliberations of the members of the LatamPF (fifty-four participants from twelve countries) where a design-thinking methodology was used. RESULTS: The participants agreed that insufficient links between HTA and decision making undermine the legitimacy of decisions, expose the HTA process to excessive political and judicial influence, and promote the exclusion of some stakeholders from participating in the assessment process and decision making. High priority aspects of the HTA process that could feasibly be improved and which hold the greatest potential to generate positive changes in the health systems in the region were identified. The majority of these aspects were associated with the appropriate institutionalization of HTA, a greater degree of participation by different stakeholders, and improved transparency in the HTA process. CONCLUSIONS: The LatamPF identified barriers and recommended actions to strengthen the link between HTA and decision making. Participants emphasized that there is now a window of opportunity in the region as many societal actors see this as a priority. For this reason, health system stakeholders must take this opportunity to increase efforts toward strengthening the link between HTA and decision making.

[Vínculo Entre La Evaluación De Tecnologías Sanitarias y La Toma De Decisión Para La Asignación De Recursos Sanitarios en Latino-América].

OBJETIVOS: Un vínculo claro entre la evaluación y la toma de decisión constituye un principio de buena práctica en evaluación de tecnologías sanitarias (ETESA) reconocido a nivel internacional. El objetivo del Foro de Políticas en Latino-América (LatamPF) 2019 de Health Technology Assessment International fue explorar los diferentes modelos que vinculan la ETESA y la toma de decisión y discutir su potencial aplicabilidad en Latino-América. MÉTODOS: Este manuscrito está basado en un documento base y en el trabajo deliberativo realizado por los miembros (54 participantes, 12 países) que asistieron al LatamPF, a través de la metodología design thinking. RESULTADOS: Los participantes coincidieron en que la relación inapropiada entre la ETESA y la toma de decisión atenta hoy contra la legitimidad de las decisiones, expone al proceso de ETESA a una excesiva influencia política y judicial, y condiciona que algunos actores se sientan relegados del proceso de evaluación y toma de decisión. Se identificaron los atributos del proceso de ETESA más prioritarios y factibles de ser mejorados en la región, y con el mayor potencial para generar un cambio positivo en los sistemas de salud. La mayor parte de estos están vinculados con la apropiada institucionalización de la ETESA, ampliar la participación de los diferentes actores y mejorar la transparencia de los procesos de ETESA. CONCLUSIONES: El LatamPF ha identificado barreras y recomendado acciones para reforzar el vínculo entre ETESA y la decisión. A su vez, existe en estos momentos una ventana de oportunidad en la región, ya que el tema es visualizado como una prioridad por gran parte de los actores de la sociedad. Por ello, los diferentes actores de los sistemas sanitarios deberían ahora tomar esta oportunidad para avanzar en el fortalecimiento del vínculo entre ETESA y toma de decisión.

On the integration of early health technology assessment in the innovation process: reflections from five stakeholders.

Early health technology assessment (HTA), which includes all methods used to inform industry and other stakeholders about the potential value of new medical products in development, including methods to quantify and manage uncertainty, has seen many applications in recent years. However, it is still unclear how such early value assessments can be integrated into the technology innovation process. This commentary contributes to the discussion on the purposes early HTA can serve. Similarities and differences in the perspectives of five stakeholders (i.e., the hospital, the patient, the assessor, the medical device industry, and the policy maker) on the purpose, value, and potential challenges of early HTA are described. All five stakeholders agreed that integrating early HTA in the innovation process has the possibility to shape and refine an innovation, and inform research and development decisions. The early assessment, using a variety of methodologies, can provide insights that are relevant for all stakeholders but several challenges, for example, feasibility and responsibility, need to be addressed before early HTA can become standard practice. For early evaluations to be successful, all relevant stakeholders including patients need to be involved. Also, nimble, flexible assessment methods are needed that fit the dynamics of medical technology. Best practices should be shared to optimize both the innovation process and the methods to perform an early value assessment.

How to Deal with the Inevitable: Generating Real-World Data and Using Real-World Evidence for HTA Purposes - From Theory to Action.

OBJECTIVES: Real-world evidence (RWE), derived from real-world data (RWD), is already used, to some extent, for health technology assessment (HTA) purposes. With the increased availability of RWD, there is potential for more widespread use but also challenges ensuring reliable RWE for HTA. Opportunities to overcome key challenges, identified at a scoping meeting, were discussed during the 2019 HTA international (HTAi) Global Policy Forum (GPF). METHODS: Reflection of discussions using Design Thinking (an interactive process aimed to solve complex problems) between seventy-three representatives from not-for-profit, for-profit organizations, and HTAi leadership. The discussions were informed by a background paper, and presentations from three invited keynote speakers and eleven GPF members. RESULTS: Several options were listed for addressing the identified key challenges: quality and acceptability, governance and accountability, transferability, and informing decision making. The GPF emphasized that the HTA community should first understand what questions could be answered with RWE. Additionally, more clarity on methods, standards, streamlining RWD collection, data sharing across jurisdictions, replication of RWD, and expert analysis were mentioned as important priorities. CONCLUSIONS: The HTA community is currently standing at a cross-road as it is not yet fully equipped to address these key challenges. It is, therefore, time for action. The community should start aligning on what is the best source of evidence according to purpose and how the data should be collected to create reliable evidence. It should also initiate the development of actions and guidance to properly develop and manage RWD/RWE to inform decision making across the technology lifecycle.

Definiendo el valor de las tecnologías sanitarias en Latino-América: desarrollo de marcos de valor para informar la priorización de recursos sanitarios.

ResumenObjetivosEl reciente desarrollo de marcos de valor responde a una demanda por hacer más explícito e inclusivo el proceso de toma de decisiones sobre asignación de recursos sanitarios. El objetivo del Foro de Políticas en Latino América 2018 de Health Technology Assessment International fue explorar las experiencias internacionales y discutir la potencial aplicación de marcos de valor en la región.MétodosEste manuscrito está basado en un documento base y en las presentaciones y discusiones mantenidas por los miembros del Foro (43 participantes, 12 países) durante el Foro del 2018.ResultadosLos participantes coincidieron en que un proceso de evaluación y toma de decisión basado en marcos de valor más inclusivos y abarcativos podría mejorar la efectividad, eficiencia, sustentabilidad y equidad; promover la transparencia y una evaluación más completa de las tecnologías, mejorar la rendición de cuentas de las decisiones y la participación de actores. Se identificaron como criterios esenciales para ser incluidos en marcos de valor en la región a la carga de enfermedad y severidad de la condición, la efectividad y seguridad de la tecnología, la calidad de la evidencia, la costo-efectividad e impacto presupuestario. Los potenciales desafíos para su implementación identificados incluyeron la escasez de recursos humanos y las demoras en el proceso de evaluación que se podrían producir.ConclusionesLos participantes remarcaron que los próximos pasos deberían ser identificar procesos y metodologías apropiadas, adaptadas al contexto de cada país, para facilitar la aplicación de marcos de valor y mejorar el vínculo entre la evaluación y la toma de decisiones.

Defining the Value of Health Technologies in Latin America: Developments in Value Frameworks to Inform the Allocation of Healthcare Resources.

OBJECTIVES: The recent development of value frameworks to inform healthcare resource allocation responds to a demand to make the decision-making process more inclusive and explicit. The objectives of the 2018 Latin American (LAtam) Health Technology Assessment International (HTAi) Policy Forum were to explore the current international experiences and to discuss the potential application of value frameworks in Latin America. METHODS: A background paper, presentations, and group discussions of Policy Forum members (43 participants, 12 LAtam countries represented) at the 2018 HTAi Policy Forum meeting informed this paper. RESULTS: Participants agreed that HTA and decision making based on more comprehensive and inclusive value frameworks could improve health system effectiveness, efficiency, sustainability, and equity; promote transparency in the decision process; sustain a more comprehensive assessment of technologies; and facilitate stakeholder participation as well as accountability of decisions. Criteria that were identified as essential to be included in a value framework for LAtam were burden of illness and severity of the disease, effectiveness and safety of the technology, quality of the evidence, cost-effectiveness, and budget impact. Potential challenges identified for the application of value frameworks in LAtam, included scarcity of human resources and delays in the assessment process. CONCLUSIONS: Forum participants agreed that the next steps should be to identify appropriate processes and methodologies, adapted to the context of each country, regarding the application of value frameworks to improve the link between HTA and decision making.

HOW CAN HEALTH SYSTEMS PREPARE FOR NEW AND EMERGING HEALTH TECHNOLOGIES? THE ROLE OF HORIZON SCANNING REVISITED.

OBJECTIVES: For many years, several health technology assessment (HTA) agencies scanned the horizon to identify health technologies that were safe, effective and offer value for money. However, there is limited evidence regarding its impact. The role of horizon scanning in preparing health systems for the uptake of new and emerging health technologies was discussed during the 2018 HTA International (HTAi) Global Policy Forum Meeting. METHODS: Reflection of the discussion between seventy-two senior representatives from for-profit, not-for-profit organizations, and HTAi leadership. It was informed by a background paper, and presentations from four invited experts and seventeen Policy Forum members. RESULTS: Current horizon scanning systems (HSS) mainly identify health technologies in the late stage of development, aiming to inform topic selection for HTA. Areas for improvement included the need for a clearer definition of the end user(s), purpose, scope, and focus of HSS, the long-term full health system effects, including all relevant stakeholders as early as possible, and considering smart data systems and international collaboration to improve HSS's efficiency. The way in which HSS could be further optimized and better shaped to prepare health systems was also discussed and good practice examples were presented. CONCLUSIONS: HSS have not yet reached their full potential in preparing health systems. To improve the current situation, the HTA community could act as convenors, bringing together all relevant stakeholders and providing the information that decision makers need. This would require a new, more integrative approach to define and use HSS and HTA, and requires new skills.

STAKEHOLDER INVOLVEMENT IN THE HEALTH TECHNOLOGY ASSESSMENT PROCESS IN LATIN AMERICA.

OBJECTIVES: Latin American countries are taking important steps to expand and strengthen universal health coverage, and health technology assessment (HTA) has an increasingly prominent role in this process. Participation of all relevant stakeholders has become a priority in this effort. Key issues in this area were discussed during the 2017 Latin American Health Technology Assessment International (HTAi) Policy Forum. METHODS: The Forum included forty-one participants from Latin American HTA agencies; public, social security, and private insurance sectors; and the pharmaceutical and medical device industry. A background paper and presentations by invited experts and Forum members supported discussions. This study presents a summary of these discussions. RESULTS: Stakeholder involvement in HTA remains inconsistently implemented in the region and few countries have established formal processes. Participants agreed that stakeholder involvement is key to improve the HTA process, but the form and timing of such improvements must be adapted to local contexts. The legitimization of both HTA and decision-making processes was identified as one of the main reasons to promote stakeholder involvement; but to be successful, the entire system of assessment and decision making must be properly staffed and organized, and certain basic conditions must be met, including transparency in the HTA process and a clear link between HTA and decision making. CONCLUSIONS: Participants suggested a need for establishing clear rules of participation in HTA that would protect HTA producers and decision makers from potentially distorting external influences. Such rules and mechanisms could help foster trust and credibility among stakeholders, supporting actual involvement in HTA processes.

HEALTH TECHNOLOGY ASSESSMENT FOR DECISION MAKING IN LATIN AMERICA: GOOD PRACTICE PRINCIPLES.

OBJECTIVES: The aim of this study was to identify good practice principles for health technology assessment (HTA) that are the most relevant and of highest priority for application in Latin America and to identify potential barriers to their implementation in the region. METHODS: HTA good practice principles proposed at the international level were identified and then explored during a deliberative process in a forum of assessors, funders, and product manufacturers. RESULTS: Forty-two representatives from ten Latin American countries participated. Good practice principles proposed at the international level were considered valid and potentially relevant to Latin America. Five principles were identified as priority and with the greatest potential to be strengthened at this time: transparency in the production of HTA, involvement of relevant stakeholders in the HTA process, mechanisms to appeal decisions, clear priority-setting processes in HTA, and a clear link between HTA and decision making. The main challenge identified was to find a balance between the application of these principles and the available resources in a way that would not detract from the production of reports and adaptation to the needs of decision makers. CONCLUSIONS: The main recommendation was to progress gradually in strengthening HTA and its link to decision making by developing appropriate processes for each country, without trying to impose, in the short-term, standards taken from examples at the international level without adequate adaptation of these to local contexts.

TOWARD A CONTINGENCY MODEL FOR HOSPITAL-BASED HEALTH TECHNOLOGY ASSESSMENT: EVIDENCE FROM ADHOPHTA PROJECT.

OBJECTIVES: Hospital-based health technology assessment (HB-HTA) is becoming increasingly relevant because of its role in managing the introduction and withdrawal of health technologies. The organizational arrangement in which HB-HTA activities are conducted depends on several contextual factors, although the dominant models have several similarities. The aims of this study were to explore, describe, interpret, and explain seven cases of the application of HB-HTA logic and to propose a classification for HB-HTA organizational models which may be beneficial for policy makers and HTA professionals. METHODS: The study was part of the AdHopHTA Project, granted under the European 7th Framework Research Programme. A case study methodology was applied to analyze seven HB-HTA initiatives in seven countries, with collection of qualitative and quantitative data. Cross-case analysis was performed within the framework of contingent organizational theory. RESULTS: Evidence showed that some organizational or "structural" variables, namely the level of procedure formalization/structuration and the level of integration with other HTA bodies at the national, regional, and provincial levels, predominantly shape the HB-HTA approach, determining a contingency model of HB-HTA. Crossing the two variables, four options have emerged: integrated specialized HTA unit, stand-alone HTA unit, integrated-essential HTA, independent group unit. CONCLUSIONS: No one-best-way approach can be used for HTA at the hospital level. Rather, the characteristics of HTA models depend on many contextual factors. Such conceptualization may aid the diffusion of HB-HTA to inform managerial decision making and clinical practice.

[Health technology assessment for decision-making in Latin America: good practice principles]. / Evaluación de tecnologías sanitarias para la toma de decisiones en Latinoamérica: principios de buenas prácticas.

OBJECTIVE: Identify the most relevant, applicable, and priority good practice principles in health technology assessment (HTA) in Latin America, and potential barriers to implementing them in the region. METHODS: HTA good practice principles postulated worldwide were identified and then explored through a deliberative process in a forum of evaluators, funders, and technology producers. RESULTS: Forty-two representatives from ten Latin American countries participated in the forum. The good practice principles postulated at the international level were considered valid and potentially applicable in Latin America. Five principles were identified as priorities and as having greater potential to be expanded at this time: transparency in carrying out HTA; involvement of stakeholders in the HTA process; existence of mechanisms to appeal decisions; existence of clear mechanisms for HTA priority-setting; and existence of a clear link between assessment and decision-making. The main challenge identified was to find a balance between application of these principles and available resources, to prevent the planned improvements from jeopardizing report production times and failing to meet decision-makers' needs. CONCLUSIONS: The main recommendation was to gradually advance in improving HTA and its link to decision-making by developing appropriate processes for each country, without attempting to impose, in the short term, standards taken from examples at the international level without adequate adaptation to the local context.

DEVELOPMENTS IN VALUE FRAMEWORKS TO INFORM THE ALLOCATION OF HEALTHCARE RESOURCES.

BACKGROUND: In recent years, there has been a surge in the development of frameworks to assess the value of different types of health technologies to inform healthcare resource allocation. The reasons for, and the potential of, these value frameworks were discussed during the 2017 Health Technology Assessment International (HTAi) Policy Forum Meeting. METHODS: This study reflects the discussion, drawing on presentations from invited experts and Policy Forum members, as well as a background paper. RESULTS: The reasons given for a proliferation of value frameworks included: rising healthcare costs; more complex health technology; perceived disconnect between price and value in some cases; changes in societal values; the need for inclusion of additional considerations, such as ethical issues; and greater empowerment of clinicians and patients in defining and using value frameworks. Many Policy Forum participants recommended learning from existing frameworks. Furthermore, there was a desire to agree on the core components of value frameworks, defining the additional value elements as necessary and considering how they might be measured and used in practice. Furthermore, adherence to the principles of transparency, predictability, broad stakeholder involvement, and accountability were widely supported, along with being forward looking, explicit, and consistent across decisions. CONCLUSIONS: Value frameworks continue to evolve with significant implications for global incentives for innovation and access to health technologies. There is a role for the HTA community to address some of the key areas discussed during the meeting, such as defining the core components for assessing the value of a health technology.

Personalized respiratory medicine: exploring the horizon, addressing the issues. Summary of a BRN-AJRCCM workshop held in Barcelona on June 12, 2014.

This Pulmonary Perspective summarizes the content and main conclusions of an international workshop on personalized respiratory medicine coorganized by the Barcelona Respiratory Network ( www.brn.cat ) and the AJRCCM in June 2014. It discusses (1) its definition and historical, social, legal, and ethical aspects; (2) the view from different disciplines, including basic science, epidemiology, bioinformatics, and network/systems medicine; (3) the bottlenecks and opportunities identified by some currently ongoing projects; and (4) the implications for the individual, the healthcare system and the pharmaceutical industry. The authors hope that, although it is not a systematic review on the subject, this document can be a useful reference for researchers, clinicians, healthcare managers, policy-makers, and industry parties interested in personalized respiratory medicine.

RETHINKING STAKEHOLDER ENGAGEMENT AND TECHNOLOGY ACCESS IN HEALTH TECHNOLOGY ASSESSMENT: REACTIONS TO POLICY FORUM DISCUSSIONS.

The need to progress and innovate in health technology assessment (HTA) is a must in a continuously changing environment. The HTAi Policy Forum reflected on two specific areas for development where it was thought there was need for careful consideration and deliberation during the main annual meeting in February 2016. The study by Husereau et al. (1) in this journal presents the discussions resulting from this Forum. To further share the deliberations of the Forum and with a view to opening this debate to the wider HTA community, a panel session during the HTAi Annual Meeting in Tokyo was organized. Presentations at the panel included a summary of the HTAi Policy Forum discussions and perspectives from a patient, a representative of healthcare system provider, and a representative from an HTA organization and industry. This letter presents the issues raised in the panel session.