There is an increasing interest in divesting activities, giving rise to several initiatives both academic and governmental to identify and address one of the problems of health systems. In 2013 the Spanish Atlas of Variability in Clinical Practice (VPM) in collaboration with the Spanish Network of Health Technology Assessment (HTA) Agencies started a project with the purpose of providing elements to support a national strategy aimed at minimizing the use of doubtful procedures in the Spanish National Health System (1).

The identification, selection and definition of low added value procedures and the determination of the most cost-effective alternatives were carried out jointly between the AtlasVPM group and the HTA agencies of Andalusia (AETSA), Catalonia (AQUAS), Galicia (Avalia-t), Basque Country (Osteba), Madrid (UETS) and Aragon (IACS). The process consisted of the following phases: (i) Literature review; (ii) Preliminary list of procedures of dubious value; (iii) Analysis of feasibility and construction of the indicators (variability); and (iv) Empirical validation of the defined indicators. Different lists and sources of evidence were used to identify the procedures and evidence that support their low-value.

The synthesis of the evidence gave rise to an initial list of fifty-nine procedures of doubtful value that could be classified as: obsolete or outdated procedures in comparison to more effective / cost-effective alternatives (n = 31), procedures of doubtful value when used outside their main indication (n = 17) and procedures for which the evidence around effectiveness was still insufficient (n = 11). With the advice of clinical experts and coders, the original list was reduced to seventeen procedures and after some adjustments to thirteen.

Identifying procedures of low-added value is a complex task and is context dependent. Literature could be useful to identify a preliminary list but the analysis of the clinical practice, its variability and reasons that justify it are required to determine which procedures are good candidates for disinvestment.

Medical devices (MDs) differ regarding their risk class (I to III), operational area (in-, outpatient), intended use (diagnostic, monitoring, intervention), and with regard to available clinical evidence. Therefore, the market access processes as well as the approach of gaining reimbursement differ significantly. From a variety of potential approaches the underlying analysis illustrates five MD-specific processes.

Based on a systematic search of publicly available regulations the main pathways of potential reimbursement for MDs were evaluated.

MDs to be used in the in-patient setting can be divided into three categories: an innovative MD (a) is exceeding a current reimbursement framework (German Operations and Procedures Key (OPS) / diagnosis related groups (DRG)), (b) falls within an existing reimbursement rate, or (c) the MD is based on a known mode of action (MoA) for which already adequate reimbursement exists. Due to less empirical data from MDs for a) and b), a health technology assessment (HTA) is required before inclusion in a DRG, whereas a MD with known concept (c) will be grouped into existing price structures. Initiators of these processes are hospitals through a so-called NUB application. MDs entering the outpatient sector are covered by another reimbursement catalogue (EBM/GOÄ) and have to pass an assessment by the G-BA (rapid HTA) if based on new MoA (d). Such an assessment can only be initiated by respective umbrella organizations of service providers (e.g. KBV (National Association of Statutory Health Insurance Physicians)). MDs not being positively recommended by the G-BA are not reimbursable. For MDs (e) with known MoA no HTA is required.

For a successful market launch including sufficient reimbursement not only the market potential, but also the specific regulatory pathways have to be considered carefully. New and innovative MDs in the outpatient sector may have a longer application process to gain a positive reimbursement decision than MDs used in inpatient setting.

Real world evidence (RWE) is changing the overall data landscape and it has potential to advance the evaluation of real world performance (comparative effectiveness) of healthcare technologies by providing a greater quantity and quality of evidence. However, many are concerned that non-randomized RWE may be substituted for RCT data and thus increase uncertainty about effectiveness. This presentation sets out the opportunities and challenges for use of RWE by payers and HTA bodies to evaluate health care technologies.

Current uses, opportunities and challenges were identified via a literature review and interviews with nine experts. Interim results were discussed at the 2017 ICER Policy Summit, which brought together leaders from payer and life sciences organizations, to develop specific and actionable recommendations for the use of RWE in drug coverage and policy decision-making.

RWE is utilized for multiple purposes in the US and globally, including: aiding design of drug development pathways; supporting regulatory approval decisions; monitoring safety; and informing HTA assessments and payer coverage decisions. Some stakeholders see great value in RWE and want to make greater use of these data sources, including for: drug effectiveness evaluations (including supplementing network meta-analyses); innovative study designs (including pragmatic trials); real time patient monitoring; and adaptive pathways or coverage with evidence development. However, others see numerous challenges, many of which are related to the quality and reliability of RWE sources. Acceptance of an expanded future role for RWE is not universal, and payers and developers must work together to find mutually beneficial strategies for progressing the development and use of RWE.

Specific and actionable recommendations will be presented which highlight the role that each stakeholder group can play in overcoming the challenges and realizing the potential for RWE.

The Health Technology Assessment (HTA) of mobile health applications involves significant challenges including rapid product development cycles, sparse evidence and uncertainty over the economic impact. However apps also provide unique opportunities, such as their potential reach and use of real-world data, which will facilitate their contribution to healthcare delivery. The National Institute for Health and Care Excellence (NICE), alongside other agencies, has been piloting the development of a health app assessment programme. This presentation reports the results of a study about the development of the Health App Briefing (HAB) which is designed as the output from a rapid assessment of the effectiveness and cost-saving potential of apps to inform decision makers in the United Kingdom National Health Service.

The HAB is built on the success of the NICE Medtech Innovation Briefings programme because many of the HTA challenges are similar to those found with medical devices. HAB development is grounded in four principles: rapid assessment; transparent process; independence from industry or the health service and input from commentators. The content includes an evidence summary for effectiveness including comments from specialist experts and users; a summary of information relating to the cost saving potential and a summary of other user benefits (including issues of access and usability). Novel features are the presentation of a rating of the potential value of the app to the health system and working with commissioners of the app to obtain real-world information for a case study about the economic impact.

The development of four HABs along with a review of the learning from the piloting process will be presented. The review will include stakeholder feedback from a workshop.

We believe the evaluation of this work presented here will be of interest to other HTA agencies around the world that are deciding how to approach the issues surrounding the assessment of health apps.

In hospitals with standardized processes of health technology assessment (HTA), clinical studies are usually required to support incorporation requests. Factors such as conflicts of interest and confirmation bias affect the quality of the evidence. The objective of this study was to assess the quality of studies submitted to the university hospital to support the incorporation of non-drugs technologies.

All submissions received from 2017 to 2019 were reviewed. Data about methodological quality of studies sent by requesters and their utilization of final recommendation were collected, as well as about studies retrieved during additional search performed by HTA. The Jadad and Assessing the Methodological Quality of Systematic Reviews (AMSTAR) scales were used for assessing the quality of randomized clinical trials (RCTs) and systematic reviews (SRs), respectively.

Twenty-one requests for incorporation of equipment were analyzed. The average number of studies attached was 4.5. In eight requests (53.3%), both SRs and RCTs were attached. In seven (46.7%) only low quality studies were included were included; additional search identified RCTs and SRs in four of these cases. According to the Jadad and AMSTAR scales, 60 percent of the submitted RCTs showed a high risk of bias, while 57 percent of the SRs showed moderate quality, respectively.

The best evidence is not always submitted during the incorporation request process. Requirements for studies of moderate-to-high quality to accept the incorporation demand could be helpful to avoid inefficiencies in hospital-based HTA.

The use of multi-criteria decision analysis (MCDA) in health technology assessment (HTA) studies has become more common due to the fact that MCDA offers a comprehensive technique for decisions that involve multiple criteria and stakeholders. How MCDA contributes to the HTA decision making process is an issue to be investigated. A systematic review was carried out in order to provide an overview of the benefits identified in MCDA applications for the strategic HTA decision making process.

A systematic review developed by Philip Wahlster et al. (2014) was updated. The papers were analyzed in order to determine how MCDA is connected with traditional HTA, and to identify opportunities through the application of MCDA. In total 965 papers were found, and 43 articles were included in the review. The included articles detailed MCDA applications oriented to tactical and strategic decision making processes. The review was conducted by two researchers.

Of the available studies published on MCDA, 76 percent were published between 2014 and 2017, and 24 percent were published prior to 2014. Regarding the MCDA methodology defined in the included studies, 10 used the analytical hierarchy process, four used multi-attribute theory, and others refer the methodology only as “MCDA”. Seventeen studies also included health technology economic analysis, in special cost-effectiveness, safety and technological innovation. The studies suggest MCDA adds value since it allows different stakeholders to be engaged in the decision making process.

The increase in studies on MCDA and healthcare point to the possibility to add different criteria, engage people with different knowledge levels, and make the decision-making process more transparent. In comparison with other technical areas, the use of MCDA in healthcare is more focused on achieving the decision about adding the new technology, and to show how to engage stakeholders than to explain how to develop the algorithms and methodologies.

The aim of the study was to measure the economic impact of informal care (IC) on caregivers assisting myocardial infarction (MI) survivors in France. Health and social impacts were also described.

Data from the prospective 2008 Health and Disabilities Households Survey (Enquête Handicap-Santé), carried out among the French general population, were used to obtain information about patients with MI and their informal caregivers. To estimate the approximate monetary value of IC, three methods were used: the proxy good method, opportunity cost method (OCM), and contingent valuation method (CVM). A multivariate analysis was performed to determine the associations of the IC duration and the existence of professional care with the health indicators stated by caregivers.

The analysis included data from 147 caregivers. The mean value of IC ranged from €9,679 per year using the CVM to €11,288 per year using the OCM (p > .05). The mean willingness to pay for an additional hour of IC was €10.9 (SD = 8.3). A total of 46.2 percent of caregivers reported that IC negatively affected theirs physical condition, and 46.3 percent reported that it negatively affected their psychological health. In addition, 40.1 percent declared that caregiving activity made them anxious and 38.8 percent stated they felt alone. Associations were identified between the duration of IC and feeling the need to be replaced, feeling alone and making sacrifices (p < .05).

Informal caregiver burden may be recognized in health technology assessment in order not to underestimate the cost of strategies and to facilitate the comparability of cost-effectiveness outcomes between studies.

This study aimed to introduce a pilot program for hospital-based health technology assessment (HB-HTA) in China and present the participants’ experiences based on seven case studies from seven tertiary hospitals.

One-year pilot projects were initiated at the beginning of 2018. Seven pilot hospitals were closely followed from the beginning until the completion of their pilot HTA project. Regular interviews were conducted with the hospital managers leading the HB-HTA projects and key members of the special HTA teams. Observations were made based on field trips and written HTA reports.

Three pilot projects evaluated the use of medical consumables, three evaluated the use of surgical or medical interventions, and one evaluated an innovative management model for ventilators. Real-world data were collected from all the pilot projects to assist with the assessments. Most HB-HTA pilot projects achieved remarkable results such as improvements in economic efficiency; however, there were also obvious deficiencies such as the lack of a necessary cost-effectiveness analysis.

The results varied among the seven HB-HTA pilot projects. The HB-HTA pilot program was implemented to promote the use of HB-HTA in hospital decision making in China. At the same time, HB-HTA in China faces challenges. We have made some policy recommendations based on the findings of the pilot projects.

Consistently high-quality health care is expected throughout Europe while concurrently, financial resources of member states are decreasing. National Health Technology Assessment (HTA) institutes are informing evidence-based reimbursement decisions in the national context, leading to redundancies in HTA production and tying up limited resources. Since 2006, the European Union project, the European Network for HTA (EUnetHTA) is aiming at enhancing the efficient use of HTA resources and facilitating transnational collaboration. Our aim is to present previous experience in joint assessment of medical devices. Furthermore, possible benefits of European collaboration for stakeholders will be discussed.

Processes and challenges of the completed EUnetHTA Joint Action (JA) 2 are summarized and discussed. Benefits, aims and opportunities of the ongoing EUnetHTA JA 3 are described.

Six rapid assessments of medical devices, focusing on the assessment of effectiveness and safety, were published during EUnetHTA JA 2. Challenges in European medical device assessment encompass the choice of topics, the time point of assessments and the lack of European standards for systematic patient involvement. Characteristics of medical devices, like learning curves, call for monitoring them throughout their lifecycle.

The benefit of European collaboration for stakeholders is manifold: uncertainty with regard to actual added value of a technology is minimized through Early Dialogues; harmonized and transparent assessment processes increase the quality of reports; work division among HTA organizations allows a resource-efficient assessment of a bigger amount of technologies; patient involvement ensures consideration of patient relevant endpoints.

The importance of cross-border collaboration in HTA is shown in the continuation of the EUnetHTA project, which aims to sustainably strengthen international collaboration even after expiration of EU-funding.

European collaboration in medical device assessment can ensure cross-border health care and efficient cooperation of national health systems. The focus should be set on a wide implementation of jointly established methods and quality standards. The European collaboration can lead to a concrete benefit for various stakeholders.

The Brazilian health system has not been able to enforce the constitutional Right to Health for the entire population, leaving litigation as the last alternative for the fulfillment of the right. In order to harmonize and underpin the decision making of federal judges, an Academic Detailing (AD) program with concepts of evidence-based medicine and health policies for federal judges will be conducted nationwide in Brazil. AD is a strategy to provide information, combining an interactive outreach approach with the best evidence. This study reports the method used to define key messages to be used during visits.

Government, federal judges and academy representatives were invited to a workshop on health litigation in Brazil. They were divided into six groups to discuss five hypothetical scenarios. In each scenario, groups listed two possible key messages to disseminate during AD, addressing the legal, scientific, economic or ethical dimensions. After the definition, a vote was taken, according to the importance that each participant attributed to them (1 to 10), and then a score was generated.

Of the thirty-one participants, five were from the judiciary, three prosecutors, one health insurance representative, nine managers and thirteen from the academy. From the case study presented, fifty-five key messages were suggested. After removing duplicates, twenty-five were selected to assign importance values by each participant. The key messages were sorted from highest to lowest score, the most important being “Explain what evidence-based medicine means and what scientific evidence means”.

Knowledge of theoretical concepts of evidence-based medicine, health policies and the technology incorporation process seem to be of fundamental importance to federal judges. This information will serve as a basis for decision making regarding litigious proceedings involving the constitutional Right to Health in Brazil. From the selected key messages, bulletins to the academic detailing program to federal judges shall be produced.

The aim of this ethics analysis was to highlight the overt and covert value issues with regard to two health technologies (light therapy and vitamin D therapy), the health technology assessment (HTA) and the disease of seasonal affective disorder (SAD). The present ethics analysis served as a chapter of a full HTA report that aimed to assist decision makers concerning the two technologies.

First, we used the revised Socratic approach of Hofmann et al. to build overarching topics of ethical issues, and then, we conducted a hand search and a comprehensive systematic literature search on between 12 and 14 February 2019 in seven databases.

The concrete ethical issues found concerned vulnerability of the target population and the imperative to treat depressive symptoms for the sake of preventing future harm. Further disease-related ethical issues concerned the questionable nature of SAD as a disease, autonomy, authenticity, and capacity for decision making of SAD patients, and the potential stigma related to the underdiagnosis of SAD, which is contrasted with the concern over unnecessary medicalization. Regarding the interventions and comparators, the ethical issues found concerned their benefit-harm ratios and the question of social inequality. The ethical issues related to the assessment process relate to the choice of comparators and the input data for the selected health economic studies.

The concrete ethical issues related to the interventions, the disease, and the assessment process itself were made overt in this ethics analysis. The ethics analysis provided an (additional) value context for making future decisions regarding light and vitamin D therapies.