Inaugural Pharmacogenomics Access and Reimbursement Symposium.

The Pharmacogenomics Access & Reimbursement Symposium, a landmark event presented by the Golden Helix Foundation and the Pharmacogenomics Access & Reimbursement Coalition, was a 1-day interactive meeting comprised of plenary keynotes from thought leaders across healthcare that focused on value-based strategies to improve patient access to personalized medicine. Stakeholders including patients, healthcare providers, industry, government agencies, payer organizations, health systems and health policy organizations convened to define opportunities to improve patient access to personalized medicine through best practices, successful reimbursement models, high quality economic evaluations and strategic alignment. Session topics included health technology assessment, health economics, health policy and value-based payment models and innovation.

Evaluation of new medicines in Spain and comparison with other European countries / Evaluación de nuevos medicamentos en España y comparación con otros países europeos

OBJECTIVE: To compare the use of health technology assessment (HTA) as a tool to support pricing and reimbursement (P&R) of new medicines in Spain with England, Sweden, France and Germany. METHOD: For each country, the literature is used to identify the purpose and timing of the P&R decision, the HTA and decision-making procedures used to generate evidence, and the criteria used to make decisions. RESULTS: Results are presented as a summary of the HTA landscape for P&R of new medicines in each country.comparisons are made between Spain and other countries regarding the procedure and implementation of HTA. CONCLUSIONS: Based on these assessments, we made recommendations for how HTA might develop in Spain with the aim of improving governance and efficiency. Spain has made considerable progress in recent years, but still falls short of international standards in terms of independence of the HTA agencies and decision-making committees from political influence and industrial policy, the setting of prices of medicines in relation to health gain, improve the transparency of the process and results of the evaluation, and promote the participation of stakeholders. In common with other countries, Spain needs to clarify the role of cost-effectiveness criteria. Further progress needs to be made to coordinate effort across the various agencies, strengthen technical staff, and ensure equitable access to medicines between regions

OBJETIVO: Comparar el uso de la evaluación de tecnologías sanitarias (ETS) como instrumento para apoyar la fijación de precios y el reembolso de nuevos medicamentos en España con otros países europeos como Inglaterra, Suecia, Francia y Alemania. MÉTODO: Se realiza una revisión de la literatura para identificar, en cada país, el objetivo y la cronología de la decisión, los procedimientos para realizar la ETS y los criterios para tomar decisiones. RESULTADOS: Se presenta una descripción narrativa de la situación en cada país y una comparación entre España y otros países sobre los procedimientos y la implementación de ETS. CONCLUSIONES: Basándose en estas evaluaciones, se propone una serie de recomendaciones para mejorar el proceso. España ha avanzado significativamente en ETS en los últimos años, pero aún falta garantizar la independencia de las agencias de ETS, eliminar la influencia de la política económica e industrial de los comités de decisiones sanitarias, fijar precios basados en el valor terapéutico, mejorar la transparencia del proceso y de los resultados de las evaluaciones, y por último, aumentar la participación de los grupos de interés. Al igual que en otros países de su entorno, España tiene que clarificar el papel de la evaluación económica como criterio de decisión. Hace falta una mejor coordinación entre las diversas agencias que participan en ETS en España, fomentar el personal técnico y monitorizar la equidad de acceso a nuevos medicamentos entre las comunidades autónomas

Implementing Health Technology Assessments in Latin America: Looking at the Past, Mirroring the Future. A Perspective from the ISPOR Health Technology Assessment Roundtable in Latin America.

OBJECTIVES: In the last two decades, several countries in Latin America (LA) have shown an interest in developing health technology assessments (HTAs), but the process has not been uniform and has often been challenged by the health systems characteristics and the political or economic idiosyncrasies of these countries. METHODS: This article summarizes the discussions held by the participants at the 40th ISPOR HTA Council Roundtable for LA. An additional literature review was carried out to support some of the concepts included. RESULTS: This article includes a brief description of the implementation of HTA over the last 30 years and then a conceptual analysis using examples of the broader use of HTA to support procurement decisions and risk-sharing agreements, which might play a future role in healthcare priority-setting in LA. CONCLUSIONS: Formerly, HTA processes and methods played important although mostly isolated roles (with drug licensing or reimbursement being examples of this). Nowadays, with more and more innovative technologies and the establishment of value frameworks to support the priority setting in healthcare, HTA features a promising panorama for the health systems sustainability.

The Development of Health Technology Assessment in Asia: Current Status and Future Trends.

Health technology assessment (HTA) has long been employed by many countries around the world, but its adoption in Asia has been slower. Only recently have a growing number of Asian countries started to implement HTA for pricing and reimbursement decisions. The objective of this article is to provide an overview of how HTA has been or is being implemented in Asia within the context of a country's existing-and often complex-coverage, reimbursement, and pricing schemes. Three countries at different stages of HTA implementation were selected as case studies: South Korea, where there is a young yet established HTA program; Japan, where a 3-year HTA pilot program has just concluded; and China, where HTA efforts are underway but have not been formally implemented. Not only do the experiences of these 3 countries well exemplify how the organization and scope of HTA can be customized to meet a country's unique healthcare needs, but they also provide the opportunity to outline some common key challenges that must be overcome to implement and develop HTA competencies and capabilities.

Tackling the 3 Big Challenges Confronting Health Technology Assessment Development in Asia: A Commentary.

There has been continuous development in the field of health technology assessment (HTA) owing to the added value of HTA in supporting healthcare reimbursement decisions. Collaboration and engagement among countries in Asia has been carried out to share experiences and learning on the barriers and factors facilitating the implementation and use of HTA in policy making. A symposium on the topic of Health Technology Assessment (HTA): Selecting the Highest Value Care was held on January 10, 2019 at the National University of Singapore, during which 3 major challenges confronting HTA development in Asia were identified. The symposium also offered possible ways to overcome the challenges.

Horizon scanning in Brazil: outputs and repercussions.

OBJECTIVE: To describe the four types of horizon scanning (HS) outputs developed by the National Committee for Health Technology Incorporation (CONITEC) and show their main repercussions on the decision-making processes of the Brazilian Ministry of Health (MH). METHODS: Descriptive study based on participant observation and document analysis of HS outputs (internal reports, alert reports, briefs and sections for CONITEC recommendation reports) developed between January 2014 and July 2018. RESULTS: Fifteen internal reports, six alert reports, two briefs and 57 HS sections were produced. Each output has a specific structure according to its purpose. The methodological approach adopted for developing HS outputs in Brazil is described by EuroScan International Network. The outputs had institutional and international repercussions. The activities resulted in the inclusion of HS as a tool for reducing health lawsuits in the legal framework of the MH. One of the internal reports on a high-cost drug not approved in Brazil for a rare disease was requested by the Health Technology Assessments Network for the Americas (RedETSA), showing the international relevance of the outputs. The HS sections in recommendation reports influenced discussions about incorporating technologies into the Unified Health System. CONCLUSIONS: The developed outputs have purposes ranging from helping build arguments for defense of the MH in cases of health judicialization to inform decision-making processes. In addition, HS sections in recommendation reports have grown in importance recently. CONITEC's HS system has been structured, and its role as a tool to inform health managers has shown to be been relevant.

Mapping the rise of digital mental health technologies: Emerging issues for law and society.

The use of digital technologies in mental health initiatives is expanding, leading to calls for clearer legal and regulatory frameworks. However, gaps in knowledge about the scale and nature of change impede efforts to develop responsible public governance in the early stages of what may be the mass uptake of 'digital mental health technologies'. This article maps established and emerging technologies in the mental health context with an eye to locating major socio-legal issues. The paper discusses various types of technology, including those designed for information sharing, communication, clinical decision support, 'digital therapies', patient and/or population monitoring and control, bio-informatics and personalised medicine, and service user health informatics. The discussion is organised around domains of use based on the actors who use the technologies, and those on whom they are used. These actors go beyond mental health service users and practitioners/service providers, and include health and social system or resource managers, data management services, private companies that collect personal data (such as major technology corporations and data brokers), and multiple government agencies and private sector actors across diverse fields of criminal justice, education, and so on. The mapping exercise offers a starting point to better identify cross-cutting legal, ethical and social issues at the convergence of digital technology and contemporary mental health practice.

Health Technology Assessment and Biomedical Engineering: Global trends, gaps and opportunities.

The diffusion of medical devices is expanding at an astonishing rate. The increasing number of novel patents per year suggests this growth will continue. In contrast to drugs, medical devices are intrinsically dependent on the environment in which they are used and how they are maintained. This created an unprecedented global need for well-trained biomedical engineers who can help healthcare systems to assess them. The International Federation for Medical and Biological Engineering (IFMBE) is the global scientific society of biomedical engineers in official relations with the United Nations World Health Organisation (WHO) and has been very active in promoting the role of the biomedical engineer in Health Technology Assessment (HTA). The IFMBE Health Technology Assessment Division (HTAD) is the IFMBE operative branch in this field, promoting studies, projects and activities to foster the growth of this specific and very important science sector, including summer schools, training material, an HTA eLearning platform, HTA guidelines, awards and more. This article describes the vision, the mission and the strategy of the HTAD, with a focus on the results achieved and the impact this is having on global policymaking.

Desimplementación de actividades clínicas de bajo valor. De la evidencia, pasando por el consenso, hasta el cambio de prácticas / Disimplementation of low-value clinical activities. From the evidence, through consensus, to a change in practices

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Scientific Development of HTA-A Proposal by the Health Technology Assessment International Scientific Development and Capacity Building Committee.

OBJECTIVES: To report from the Scientific Development and Capacity Building Committee of Health Technology Assessment International (HTAi) on activities that are being undertaken within HTAi regarding the promotion of scientific rigor in the field of health technology assessment (HTA). METHODS: Retrieval of definitions of HTA that the SDCB committee considered reflective of the current practice of HTA, followed by a narrative synthesis of the core components of HTA. RESULTS: Several definitions of HTA have been provided, all sharing the notion that HTA is the formal, systematic, and transparent inquiry into the meaning and value, broadly defined, of health technologies, when used in specific patient populations.Many frameworks and tools have been developed for assessing the quality of specific tasks that may be conducted in the context of HTA. Collating such frameworks and tools is likely to be helpful in developing standards and in providing guidance as to how the scientific quality of HTA may be secured. Two current trends in HTA were noted: a stronger health systems focus, and the need to involve stakeholders throughout the HTA process. A wider systems' perspective requires that plausible alternative scenarios are being developed, and wide consultation of various stakeholders is a prerequisite to the development of such scenarios with data from various sources. CONCLUSIONS: Current trends in HTA will lead to different demands on the HTA expert. The task of this emerging policy professional would be not just to provide technical information for problem-solving, but also to combine it with a new function of facilitating public deliberation and learning.

Scanning the horizon: a systematic literature review of methodologies.

OBJECTIVES: Society is confronted with the rapid emergence of innovation in science and technology. To manage this, horizon scanning is being adopted globally to identify, assess and prioritise innovations and trends at an early stage of their development. This enables decision-makers to be better informed and to prepare for change. The aim of this paper is to systematically identify and evaluate horizon scanning methodologies employed in the healthcare and biomedical fields. METHODS: A systematic literature review was performed using PubMed and Embase and was supplemented with grey literature searches (2008-2018). The principal methodologies used in horizon scanning were extracted. RESULTS: Approximately 100 articles were summarised in a literature map. The search revealed many examples of horizon scanning across disciplines. Challenges, such as the need to refine prioritisation criteria, manage uncertainty inherent in the findings and improve the dissemination of identified issues, have been highlighted. CONCLUSION: Horizon scanning, when performed appropriately, is a flexible and potentially reliable tool, with a wide variety of methods. Horizon scanning can inform and influence decision-making, through identifying opportunities and challenges, from an organisational to an international level. Further research to identify the most effective methodologies available would add depth to this landscape and enable the evolution of best practice to most efficiently anticipate novel developments and innovations.

Augmented Reality in Medicine: Systematic and Bibliographic Review.

BACKGROUND: Augmented reality (AR) is a technology that integrates digital information into the user's real-world environment. It offers a new approach for treatments and education in medicine. AR aids in surgery planning and patient treatment and helps explain complex medical situations to patients and their relatives. OBJECTIVE: This systematic and bibliographic review offers an overview of the development of apps in AR with a medical use case from March 2012 to June 2017. This work can aid as a guide to the literature and categorizes the publications in the field of AR research. METHODS: From March 2012 to June 2017, a total of 1309 publications from PubMed and Scopus databases were manually analyzed and categorized based on a predefined taxonomy. Of the total, 340 duplicates were removed and 631 publications were excluded due to incorrect classification or unavailable technical data. The remaining 338 publications were original research studies on AR. An assessment of the maturity of the projects was conducted on these publications by using the technology readiness level. To provide a comprehensive process of inclusion and exclusion, the authors adopted the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. RESULTS: The results showed an increasing trend in the number of publications on AR in medicine. There were no relevant clinical trials on the effect of AR in medicine. Domains that used display technologies seemed to be researched more than other medical fields. The technology readiness level showed that AR technology is following a rough bell curve from levels 4 to 7. Current AR technology is more often applied to treatment scenarios than training scenarios. CONCLUSIONS: This work discusses the applicability and future development of augmented- and mixed-reality technologies such as wearable computers and AR devices. It offers an overview of current technology and a base for researchers interested in developing AR apps in medicine. The field of AR is well researched, and there is a positive trend in its application, but its use is still in the early stages in the field of medicine and it is not widely adopted in clinical practice. Clinical studies proving the effectiveness of applied AR technologies are still lacking.

The Iterative Convergent Design for Mobile Health Usability Testing: Mixed Methods Approach.

Although patients express an interest in using mobile health (mHealth) interventions to manage their health and chronic conditions, many current mHealth interventions are difficult to use. Usability testing is critical for the success of novel mHealth interventions. Researchers recognize the utility of using qualitative and quantitative approaches for usability testing, but many mHealth researchers lack the awareness of integration approaches from advances in mixed methods research that can add value to mHealth technology. As efficient usability testing proceeds iteratively, we introduce a novel mixed methods design developed specifically for mHealth researchers. The iterative convergent mixed methods design involves simultaneous qualitative and quantitative data collection and analysis that continues cyclically through multiple rounds of mixed methods data collection and analysis until the mHealth technology under evaluation is found to work to the satisfaction of the researcher. In cyclical iterations, early development is more qualitatively driven but progressively becomes more quantitatively driven. Using this design, mHealth researchers can leverage mixed methods integration procedures in the research question, data collection, data analysis, interpretation, and dissemination dimensions. This study demonstrates how the iterative convergent mixed methods design provides a novel framework for generating unique insights into multifaceted phenomena impacting mHealth usability. Understanding these practices can help developers and researchers leverage the strengths of an integrated mixed methods design.

Identification, Review, and Use of Health State Utilities in Cost-Effectiveness Models: An ISPOR Good Practices for Outcomes Research Task Force Report.

Cost-effectiveness models that present results in terms of cost per quality-adjusted life-year for health technologies are used to inform policy decisions in many parts of the world. Health state utilities (HSUs) are required to calculate the quality-adjusted life-years. Even when clinical studies assessing the effectiveness of health technologies collect data on HSUs to populate a cost-effectiveness model, which rarely happens, analysts typically need to identify at least some additional HSUs from alternative sources. When possible, HSUs are identified by a systematic review of the literature, but, again, this rarely happens. In 2014, ISPOR established a Good Practices for Outcome Research Task Force to address the use of HSUs in cost-effectiveness models. This task force report provides recommendations for researchers who identify, review, and synthesize HSUs for use in cost-effectiveness models; analysts who use the results in models; and reviewers who critically appraise the suitability and validity of the HSUs selected for use in models. The associated Minimum Reporting Standards of Systematic Review of Utilities for Cost-Effectiveness checklist created by the task force provides criteria to judge the appropriateness of the HSUs selected for use in cost-effectiveness models and is suitable for use in different international settings.

Adaptive Evolution in Rapid Assessments: A 25-Year Perspective.

OBJECTIVES: This article retrospectively examines the evolution of rapid assessments (RAs) produced by the Health Technology Assessment (HTA) Program at the Institute of Health Economics over its 25-year relationship with a single requester, the Alberta Health Ministry (AHM). METHODS: The number, types, and methodological attributes of RAs produced over the past 25 years were reviewed. The reasons for developmental changes in RA processes and products over time were charted to document the push-pull tension between AHM needs and the HTA Program's drive to meet those needs while responding to changing methodological benchmarks. RESULTS: The review demonstrated the dynamic relationship required for HTA researchers to meet requester needs while adhering to good HTA practice. The longstanding symbiotic relationship between the HTA Program and the AHM initially led to increased diversity in RA types, followed by controlled extinction of the less fit (useful) "transition species." Adaptations in RA methodology were mainly driven by changes in best practice standards, requester needs, the healthcare environment, and staff expertise and technology. CONCLUSIONS: RAs are a useful component of HTA programs. To remain relevant and useful, RAs need to evolve according to need within the constraints of HTA best practice.

Health Technology Assessments in Radiology in Germany: Lack of Demand, Lack of Supply. / Health-Technology-Assessments in der Radiologie in Deutschland: Fehlende Nachfrage, fehlendes Angebot.

BACKGROUND: Health technology assessments (HTAs) are an interdisciplinary method to support sustainable, evidence-based healthcare decisions. They systematically assess medical products, procedures, and technologies with respect to medical, economic, legal, social, and ethical aspects. METHOD: This review analyzes the current use of HTAs in radiology in Germany and discusses challenges associated with HTAs. In particular, incentive structures of various players in the healthcare field involved in HTA implementation are considered for both the inpatient and outpatient sectors. Taking into account that the Joint Federal Committee (G-BA) has different authority between sectors ("ban reservation" for inpatients and "authorization right" for outpatients), we focus on the repercussions on reimbursement for new diagnosis or treatment methods by statutory health insurance companies. RESULTS: The G-BA's authority implicitly creates a paradox in terms of incentives to implement and finance HTAs: in the outpatient sector HTAs are considered necessary to evaluate new medical services while players may not have sufficient incentive to implement and finance HTAs in the inpatient sector. CONCLUSION: Characteristics of HTAs differ widely with respect to the items to be assessed. Therefore, an HTA for drug effectiveness is not easily transferable to radiological procedures. Within radiology, each method must be assessed individually (e. g. according to tumor stage). Despite these challenges, systematic compilation and critical assessment (regarding both cost and medical effectiveness) of available evidence should be a basic component of evidence-based radiology. As companies in healthcare fail to invest in studies that advance evidence-based radiology and considering the lack of incentive for such investments, public funding institutions need to accept the challenge to support studies that assess the benefit of radiological procedures. KEY POINTS: · HTAs should be a basic component of evidence-based radiology.. · G-BA's authority implicitly creates a paradox in terms of inventives to implement and finance HTAs.. · University hospitals and public funding institutions need to support studies that assess the benefit of radiological procedures.. CITATION FORMAT: · Winkelmann C, Neumann T, Zeidler J et al. Health Technology Assessments in Radiology in Germany: Lack of Demand, Lack of Supply. Fortschr Röntgenstr 2019; 191: 635 - 642.

An Ecological Approach to Smart Homes for Health Care Services: Conceptual Framework of a Smart Servicescape Wheel.

BACKGROUND: Smart homes are considered effective solutions for home health care for the elderly, as smart home technologies can reduce care costs and improve elderly residents' independence. To develop a greater understanding of smart homes for health care services (SHHSs), this study accentuated the necessity of ecological approaches with an emphasis on environmental constraints. This study was based on 2 rationales: (1) users are inclined to perceive the service quality and service experience from environments (ie, servicescape) owing to the intangibility of health care and the pervasiveness of smart home technologies, and (2) both service domains are complex adaptive systems in which diversified and undefined service experiences-not only a few intended service flows-can be generated by complex combinations of servicescape elements. OBJECTIVE: This study proposed the conceptual framework of a Smart Servicescape Wheel (SSW) as an ecological approach delineating the extensive spectrum of environmental constraints in SHHSs. METHODS: The SSW framework was established based on a literature review. RESULTS: Generally divided by perceptible and imperceptible servicescapes, the SSW consists of the perceptible Physical scape (ie, hardware components, environmental cues, and human states) and Social scape (ie, service relationships and social relationships) as well as the imperceptible Datascape (ie, computing intelligence, databases, and communication networks). Following the ecological approach, each category of the SSW is subdivided and defined at the level of components or functions. CONCLUSIONS: The SSW's strengths lie in the various application opportunities for SHHSs. In terms of service planning and development, the SSW can be utilized to (1) establish the requirements for SHHS development, (2) associate with work domain analysis by defining component layers, and (3) understand the real contexts of SHHSs for the enhanced prediction of diverse service experiences. Regarding service management, it can be applied to develop measurement items for the operation and evaluation of SHHSs.

Revisiting Roles of Health Technology Assessment on Drug Policy in Universal Health Coverage in Thailand: Where Are We? And What Is Next?

OBJECTIVES: To describe the process, challenges, and future direction of health technology assessment (HTA), focusing on the drug selection of the National List of Essential Medicines (NLEM) in Thailand. METHODS: Literature and government documents were reviewed and analyzed by authors with experiences in HTA and drug policy in the country. RESULTS: The structure of HTA and its process in the drug selection of the NLEM were described, followed by the outcomes of the use of HTA. Examples of lowering drug prices, as a result of price negotiation using HTA, were presented. A few examples were also provided to demonstrate how decisions were made from considering factors beyond cost-effectiveness findings. Finally, challenges on various issues including improvement of HTA structure and process were discussed for the future direction of HTA in Thailand. CONCLUSIONS: HTA has been adopted as a tool for the drug selection of the NLEM to help Thailand achieve universal health coverage. Nevertheless, various challenges exist and need to be addressed.

Role of Health Technology Assessment in Drug Policies: Korea.

South Korea is the first Asian country to mandate the submission of pharmacoeconomic data for reimbursement decision making. For a new drug to be listed, it must demonstrate its value in terms of comparative effectiveness and cost effectiveness. The Health Insurance Review and Assessment Service (HIRA) judges the submitted drug's value and decides whether its coverage is appropriate on the basis of the recommendation of the Pharmaceutical Benefit Coverage Assessment Committee. Once the drug has been accepted by HIRA, the National Health Insurance Service and the sponsoring company negotiate the price and expected sales volume. Even if HIRA acknowledges the value of the drug, it cannot be listed if the negotiation fails. In the off-patent market, generic and original branded drugs are treated equally in terms of pricing. Once generics enter the market, both drug prices should be lowered to 53.55% or less of the on-patent price. Since the current system was implemented, concerns have been raised about a decline in the accessibility of new drugs, especially for high-priced drugs used to treat serious diseases. In 2013, several measures had been introduced aimed at improving the accessibility of these drugs. A risk-sharing scheme and an increase in the maximum acceptable cost-effectiveness ratio were subsequently initiated. Although these schemes have been successful in improving access to high-priced drugs, they are often criticized for reducing transparency in pricing. Finding a balance between accessibility and efficiency is still a challenge in Korea.

Technology-Enabled Assessment of Functional Health.

The maturation of pervasive computing technologies has dramatically altered the face of healthcare. With the introduction of mobile devices, body area networks, and embedded computing systems, care providers can use continuous, ecologically valid information to overcome geographic and temporal barriers and thus provide more effective and timely health assessments. In this paper, we review recent technological developments that can be harnessed to replicate, enhance, or create methods for assessment of functional performance. Enabling technologies in wearable sensors, ambient sensors, mobile technologies, and virtual reality make it possible to quantify real-time functional performance and changes in cognitive health. These technologies, their uses for functional health assessment, and their challenges for adoption are presented in this paper.