The Spanish network of health technology assessment (HTA) agencies (REDETS) is a collaboration of eight agencies, units and services, commissioned by the national and regional governments. The network coordinates work within a common methodological and work framework, guided by the principles of mutual recognition and cooperation. In 2016, a common self-assessment quality tool was developed for the implementation of an overall Quality Management System. Currently we are working on the second step that deals with actions about management, joint activities as a network, and organizational aspects of the network.

A structured search strategy in the main electronic databases and a manual search in websites of networks national and international agencies were carried out in June 2017, in order to gather previous knowledge and developed standards. Through the information included in this review, and with the collaboration of all members, a group of standards for REDETS was developed. Finally, standards proposed were discussed in a face-to face meeting until an agreement was reached.

A proposal of 31 standards was put forward taking all the collected information. The aim of each standard was defined, and its level of compliance was specified. Those standards were grouped under nine quality criteria structured in four dimensions: (i) Responsibility and Resources, (ii) Performance and Membership, (iii) Procedures, and (iv) Relations.

Based on the gathered information and the agreement of the all members, we developed a toolkit embracing a group of standards for the joint activities within the Spanish Network, network administration and management. It is a complementary instrument of the previous self-evaluating tool, following the establishment of an overall quality management system and under the philosophy of continuous improvement processes.

Providing high-quality and affordable care is a big challenge facing policy makers, especially in low and middle income countries (LMIC). The purpose of this presentation is to illustrate how health technology assessment (HTA) benefits the improvement of the healthcare quality, and to highlight the fact that HTA domains match to the dimensions of health quality: safety, effectiveness, efficiency and patient-centeredness.

This presentation will be based on explaining the ability of HTA to improve the quality of healthcare. Some countries, mainly LMIC where resources are limited, do not have formal HTA whose goal is to inform the development of safe, effective and patient centered health policies. The theoretical concepts of HTA demonstrate a strong connection between HTA and healthcare quality improvement. By way of illustration an example of successful experiences will be given.

The presentation items are: - The definition of health technology - Introduction to health technology assessment as a multidisciplinary process that summarizes information about the medical, social, economic and ethical issues related to the use of a health technology. - Why is health technology assessment used, the identification of the HTA report domains including Safety, Clinical Effectiveness, Ethical analysis, Social aspects, Legal aspects and the importance of patient experience in HTA. - The identification of the six dimensions of healthcare quality and the determination of the connection between HTA and healthcare quality improvement. - A presentation of the international Decision Support Initiative (iDSI) experience in some LMIC.

HTA has many meeting points with healthcare quality dimensions. HTA is likely to become an increasingly important influence in health decisions.

King's Technology Evaluation Centre (KiTEC), a United Kingdom- based health technology assessment consultancy, was tasked with identifying a specific group of heart failure patients who had repeat readmissions in order to accurately identify the potential market for an innovative device designed to diagnose heart failure as a way to avoid costly and avoidable hospital readmissions. The device enables clinicians to remotely diagnose heart failure and appropriate medication can be administered instead of a hospital visit. Our methodology describes an accurate way to quantify the at risk population without the need for a costly trial.

Using big data from national registries – the heart failure specific National Institute for Cardiovascular Outcomes Research (NICOR) database and the national Hospital Episodes Statistics for the National Health Service (HES) – KiTEC has devised a methodology of linking the two datasets in order to (i) accurately identify patients with repeat readmissions over a 5-year period and (ii) calculate the risk factors for readmissions. Data is linked using a common field, meaning information from both databases can be analyzed at patient level (it is pseudo-anonymized before KiTEC receives it). This allows for unprecedented granularity, as we are able to exploit the heart failure specific detail of NICOR alongside the wealth of admissions data available in HES.

There are significant challenges surrounding the use of registry data, especially in the enormous size of the datasets and in privacy legislation aimed at protecting personally identifying data. The usual regulatory approvals for health research are also more complex when linked datasets are proposed. These are important considerations, especially when linking two complementary databases.

The use of real world data has the potential to paint a true and accurate picture of a patient population, while avoiding many of the biases inherent in typically research studies. However, there are other important challenges to overcome, namely difficulties analyzing huge datasets and navigating complex legislation to access patient data.

Health technologies are fundamental in an operational health system. Medical devices, in particular, are crucial for disease prevention, diagnosis, treatment and rehabilitation. Recognizing this important role of health technologies, the World Health Assembly adopted, in May 2007, resolution WHA60.29, which addresses issues arising from inadequate installation and use of health technologies, as well as the need to formulate national strategies for the implementation of evaluation, planning, procurement and management systems for health technologies, in collaboration with personnel dedicated to the evaluation of health technologies and biomedical engineering. Maintenance management computer systems and software have evolved to help maintain medical equipment and control associated costs. A Computerized Maintenance Management System contains a database about an organization's maintenance operations.

The pilot study of observational and descriptive design will include all the medical/laboratory equipment that the Research Institute of Health Sciences (IICS) has that meets the inclusion criteria. The work will be carried out at the IICS, which aims to develop a computerized system for the maintenance of equipment that allows the linking of Quick Response (QR) codes to an application (WebApp) by means of cameras in smartphones, able to relate each QR code (attached to a medical/laboratory equipment) to its corresponding URL, and thus able to access all the technical information of each IICS team and therefore monitor their maintenance (preventive, corrective, predictive), history, spare parts, budgets, and technical specifications.

We have a database of all medical devices installed in the research center; we look forward to developing the program to include the data. The project focuses on the effective tool for decision making regarding the evaluation of the installed sanitary technology and those that will be installed.

The study proposes an effective solution for maintenance management, using data that supports administrative decisions regarding the acquisition of equipment in the future; that is, the system can contribute when it comes to evaluating installed and acquired sanitary technology.

The utilization of medical resources in China is unbalanced and insufficient. In order to find a way to maximize their utilization to face challenges in the upcoming decade, this study aims to investigate the elderly's first choice of health institutions when they were ill in the Zhejiang and Qinghai provinces, and to explore the potential pathways related to their choices, respectively.

The data used in this study was from cross-sectional surveys in Zhejiang and Qinghai. According to the Anderson Health Service Utilization Model, we applied structural equation modeling to explore the complex pathways from socioeconomic status (SES), accessibility, and health status to the elderly's first choice of health institutions.

The proportion of the elderly who selected community health institutions (CHI) as their first choice of medical institutions in Qinghai was higher than in Zhejiang. The Zhejiang model revealed a significantly negative direct effect of SES and significantly positive direct effects of accessibility to CHI and health status on the choice of institutions, and a significantly positive indirect effect of SES on choice of institutions, through the mediating factor of health status. SES played an important role in the Zhejiang model in direct and indirect ways. In the Qinghai model, only SES and accessibility to CHI had significantly direct effects on the choice of institutions, with accessibility to CHI having the biggest effects. SES had a significant and positive indirect impact on choice of institutions, through the factor of accessibility to CHI.

A better understanding of the complex pathways from factors to elderly's choices of health institutions was essential, which may inform priorities for maximizing the utilization of CHI further and prepare to face challenges in the new decade. Through this research method, policymakers could explore the specific pathways based on their own economic and societal status.

The Brazilian Network for Health Technology Assessment (REBRATS) is a network of collaborating centers and teaching and research institutions, focused on the generation and synthesis of scientific evidence in the field of health technology assessment. Currently, the network is composed of 119 member institutions and mobilizes approximately 1,094 researchers and 4,998 relations. The objective of this study was to evaluate the member institutions of REBRATS.

The evaluation process was developed in seven stages, including the identification of the objectives of the Network; identification of evaluation criteria; selection of performance indicators for each criterion; identification of the measures appropriate to each indicator; data collection and analysis; classification of the institutions and production of the final report.

The evaluation of the member institutions of REBRATS mapped the capacity of these institutions to produce health technology assessment activities. The evaluation also provided information on the advances and challenges of health technology assessment in the country. In the long term, the initiative will contribute to the strengthening of the evaluation of health technology in Brazil, since the weaknesses of these institutions in the development of activities were mapped.

The production of this study will contribute to the dissemination of the evaluation methodology at the national and international level. This study is one of the few initiatives that exist in the world on the evaluation of networks and will contribute to the strengthening of the evaluation of health technology in Brazil.

To inform the development of a national clinical guideline for Chronic Obstructive Pulmonary Disease (COPD), prioritized by the National Clinical Effectiveness Committee in Ireland, a systematic review was conducted to examine the cost-effectiveness of pulmonary rehabilitation programs (PRPs), outreach programs (OPs), and long-term oxygen therapy (LTOT), compared with usual care.

Medline, Embase, the Cochrane Library and grey literature sources were searched up to 19 June 2018. Studies evaluating cost-effectiveness published post-2008 in English were included. Screening, data extraction, and quality assessment using the Consensus Health Economic Criteria and International Society for Pharmacoeconomics questionnaires were conducted independently by two reviewers. Costs were converted to 2017 Irish Euro using consumer price indices for health and purchasing power parity.

From 8,661 articles identified, seven studies (one comparing both PRPs and LTOT) were included (PRPs: five; OPs: one; LTOT: two). PRP cost-utility analyses (n = 4) reported conflicting results due to considerable heterogeneity in program and study design, with incremental cost-effectiveness ratios (ICERs) ranging between EUR 12,391 and EUR 509,122 per quality adjusted life-year (QALY) gained. The remaining study investigated hospitalizations avoided and found outpatient and community-based PRPs to be dominant, while home-based PRP produced an ICER of EUR 1,913. OPs were found to be less costly, but also less effective. However, the results of the underpinning trial were neither statistically nor clinically significant. LTOT was found to be cost-effective, with ICERs of EUR 17,603 and EUR 26,936 per QALY gained.

Applying a willingness-to-pay threshold of EUR 45,000 per QALY gained, this systematic review found that, compared with usual care, there is inconsistent but generally favorable evidence for PRPs, no clear evidence for the cost-effectiveness of OPs, and that LTOT is likely to be cost-effective. However, there was a lack of methodologically robust studies included in the review and most were not directly transferable to the Irish context.

Economic evaluations are a growing field of interest in the rehabilitation area. Research has questioned the quality of reporting of health economic evaluations. Poor reporting hinders the ability to provide accurate information for health care decision making. Therefore, the objectives of this study are to document on overall reporting quality of the published literature for rehabilitation economic evaluations; to identify if reporting quality has improved in health economic evaluations within the field of rehabilitation therapy since the publication of the Consolidated Health Economic Evaluation Reporting Standards (CHEERS); and to identify factors that could influence the reporting trends.

We searched databases for economical evaluations performed in the rehabilitation area published between 2013 and 2018. Study selection was performed by two independent reviewers using Covidence software. Data extraction was conducted by one reviewer using Microsoft Excel and independently verified by another reviewer. The quality of reporting was evaluated independently by two reviewers using the CHEERS checklist.

The search of the literature resulted in a total of 2195 published articles. Of these, 117 were considered to be potentially relevant. Independent review of these 117 articles led to the inclusion of 88 articles. This study is ongoing and complete results will be presented at the conference. Fifty papers have been analyzed in full. In general, the quality of reporting of the economical evaluations in the rehabilitation field was poor. The total mean and median for the CHEERS checklist was 17 points (out of 25) (range 8-24). Most of the analyzed studies did not report important methodological features of the economical evaluation as evaluated by the CHEERS checklist.

The quality of reporting of economic evaluations in the rehabilitation field is poor and inconsistent. Commonly the methods of the analyzed studies are under reported, thereby creating challenges in determining whether the information presented is sound.

HIV drug resistance (HIVDR) has significantly increased in Thailand. However, a new generation integrase inhibitor, dolutegravir, has not yet been included in the country's National List of Essential Medicines (NLEM). Since these drugs are high in costs, an economic evaluation is needed to support the decision. This study aims to assess the cost-utility analysis of dolutegravir for HIV-1 infection in Thailand.

A Markov model was developed to evaluate the cost-utility as follows: (i) the current practice of darunavir/ritonavir (DRV/r) + tenofovir (TDF) + lamivudine (3TC); (ii) DRV/r + etravirine (ETR) + TDF + 3TC; (iii) DRV/r + raltegravir (RAL) + TDF + 3TC; (iv) DRV/r + RAL + ETR; and (v) DRV/r + RAL + maraviroc (MVC); (vi) DRV/r + dolutegravir (DTG) + MVC; (vii) DRV/r + DTG + ETR; (viii) DRV/r + DTG + TDF + 3TC. The model incorporated cost data adjusted for 2017 using the consumer price index, and effectiveness data from a review of published studies. Outcomes were measured in life years, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs), and future costs and outcomes were discounted at 3 percent per annum. Finally, a probabilistic sensitivity analysis was conducted to deal with uncertainties around the parameters.

All alternative treatment regimens for HIV patients resistant to first- and second-line antiretroviral therapies (ARTs) in Thailand were found to be not cost-effective at the willingness-to-pay (WTP) of THB 160,000/QALY (USD 5,197/QALY). However, the eighth regimen of DRV/r + DTG + TDF + 3TC had the lowest lifetime cost at THB 5.3 million (USD 172,145) while increasing QALY by approximately 14 QALYs.

At a societal WTP of THB 160,000 per QALY gained (USD 5,197 per QALY gained), dolutegravir for HIV patients resistant to first- and second-line ARTs in Thailand was found to be not cost-effective.

The National Committee for Health Technology Incorporation (CONITEC) evaluates health technologies to recommend their inclusion or exclusion within the Brazilian Public Health System (SUS), and uses the budget impact assessment to estimate costs to the system. The Ministry of Health (MS) guideline recommends treatment of phenylketonuria (PKU) with restricted phenylalanine diet and phenylalanine-free amino acid formula (PFAAf) supplementation. CONITEC evaluated the inclusion of sapropterin dihydrochloride for PKU in the SUS.

The population eligible for treatment was evaluated by the number of patients receiving PFAAf between 2014 and 2017 registered in the SUS. Patients were stratified by age/weight and a simple linear regression was performed to estimate the future population. The costs of treatment and testing the responsiveness of sapropterin dihydrochloride were estimated according to the recommended dosage guideline of the MS, leaflet and public purchasing prices. A univariate deterministic sensitivity analysis was performed to evaluate different prices, responsiveness test methods and variations in the reduction of formula use.

The incorporation of sapropterin dihydrochloride would generate an incremental budget impact in the SUS of around BRL 79 million (USD 21.7 million) in 2019 and BRL 300 million (USD 82.1 million) in five years (2019-2023). The univariate sensitivity analysis estimated that the incremental budget impact could be between BRL 66 and BRL 103 million (USD 18 and USD 28 million) in the first year and between BRL 251 and BRL 388 million (USD 69 and USD 106 million) in five years. Sensitivity analysis showed that the price of sapropterin dihydrochloride was the most sensitive variable in the model.

The incorporation of sapropterin dihydrochloride in the SUS represents a significant budgetary impact and covers a small number of patients. Sapropterin dihydrochloride was recommended by CONITEC for the treatment of women with PKU, with a positive drug responsiveness test, and who are in the preconception period or in the gestational period.

The methodological guides for the assessment of new/emerging non-pharmacological technologies differ from the traditional health technology assessment (HTA) guidelines developed by the Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS). The aim of this study is to identify the special features and challenges of carrying out HTA on new/emergent non-pharmacological technologies.

The application of traditional and new/emergent HTA guidelines is compared along the consecutive evaluation phases in four practical cases carried out at the Agency for Health Quality and Assessment of Catalonia (AQuAS) in 2017-2018.

Main learning and outstanding challenges: (i) Instead of following a defined protocol, the evaluations are carried out from a preliminary short report which generates a lack of justification and delimitation of its scope. (ii) References’ identification and data extraction are often limited due to lack of studies, and sometimes require the use of grey literature or other sources less informative, for example, trial registries. It can be challenging to exclude references related to other indications. (iii) The assessment of resource use and costs of running the technology is complicated due to the lack of public prices information and specific impacts of use. (iv) The evidence considered during the assessment usually does not meet high quality requirements (risk of bias) because of indirect evidence, lack of comparator or no having clearly defined outcomes, among others. (v) It's difficult to draw conclusions and, consequently, recommendations due to abovementioned aspects and especially for the usual evidence gap that faces this type of technology in early stages of diffusion and/or in a competition situation of manufacturer companies.

The most recent innovation in non-pharmacological technologies merits a differentiated assessment approach. However, there is need to reconsider the methodology applied in order to overcome the challenges and limitations identified.

In 2011 the Arzneimittelmarkt-Neuordnungsgesetz (AMNOG) evaluation process for new drugs was implemented in Germany. Since then, the evidence requirements follow high standards and results impact reimbursement price negotiations. More recently, in 2016, a legal norm (§137h SGBV) to evaluate new treatment and diagnostic methods (MDs) of high risk classes by the Federal Joint Committee (G-BA) was introduced. The requirements, involved stakeholders, timing and results for both processes are outlined and compared.

Methodological guidelines from G-BA and Institute for Quality and Efficiency in Health Care (IQWiG), consultations and evaluations for MDs according to §137h and for drugs according to AMNOG were reviewed and compared. Published assessment results were analyzed according the decision criteria and impact on price negotiations with Statutory Health Insurance.

Hospitals need to submit jointly with the manufacturer comparative evidence on clinical efficacy, safety and cost when applying for additional compensation (Neue Untersuchungs- und Behandlungsmethoden [NUB] application) for new high risk class MDs being subject to §137h. A fast track assessment by IQWiG/G-BA follows within four months resulting in benefit proven, potential benefit or no benefit compared to alternatives. The latter can lead to exclusion from reimbursement. Until now one MD was granted a benefit, two treatments were assigned a potential benefit and six MDs no benefit, while 55 percent of drugs evaluated under AMNOG were granted an additional benefit. Compared to drugs, the required evidence for MDs is similar. Whereas assessment time is shorter, manufacturers can seek advice from G-BA upfront for free and need to collaborate closely with hospitals.

Half of MDs examined did not qualify for an assessment under §137h. Unlike for drugs evaluated under AMNOG, the majority of new MDs failed to be granted potential benefit as a treatment alternative and might be excluded from reimbursement. Manufacturers are challenged to generate high quality, comparative evidence within their studies.

Australia has a two-tier public funding system, and many genetic tests are funded by different states and territories prior to being considered for public funding by the Federal government. In this context, health technology assessments (HTAs) of genetic tests for heritable conditions are problematic. We aimed to discuss the possible impacts on HTA methodology of a shift from regional to federal funding for genetic testing for heritable conditions.

Several HTA reports and economic models on genetic tests considered by the Medical Services Advisory Committee (MSAC) were reviewed and compared to ‘real world’ clinical practice.

Every HTA of germline testing performed for the MSAC have so far compared genetic testing versus no genetic testing. However, testing for BRCA1/2 for patients with breast cancer currently occurs in Familial Cancer Centres, and testing for germline mutations for familial hypercholesterolaemia currently occurs through specialist lipid clinics. In both settings, the index patient and family members are given multidisciplinary support, including genetic counselling. The HTA comparison therefore did not reflect what the true clinical and cost-effectiveness impact of federal funding would be. Federal funding means that tests may be ordered by a broader range of specialists or general practitioners. The evidence identified was predominantly sourced from specialised centres, where knowledge regarding how to interpret the tests is high. The clinical utility of these tests largely depended on how clinicians understood and conveyed the results.

The benefit of testing may have been overestimated due to the comparator and setting used (i.e. specialised and centralized care, associated with high clinical utility). Any HTA of genetic testing for heritable conditions, which could result in a shift in the delivery of testing or care for the patient, should consider the applicability of the evidence identified. Further, it should assess the subsequent impact this may have on the effectiveness and cost-effectiveness of the test and the quality of care provided for patients and their family.

Decision-making regarding an open or a closed fluid waste management system (FWMS) in the planning of thirty operating rooms (ORs) of a new hospital at the CHU de Québec-Université-Laval was an opportunity to explore additional capabilities in health technology assessment (HTA) to support evidence-based planning.

Issues related to FWMSs in ORs were assessed from multiple data sources including: (i) systematic review in indexed databased and grey literature, (ii) waste management laws and regulations, (iii) local registry of reported incidents/accidents, (iv) occupational health and safety database, (v) electronic patient records (EPRs), (vi) field evaluation of two closed FWMSs, (vii) costs, and (viii) survey on FWMSs in ORs of other Quebec hospitals.

Closed FWMSs in ORs could reduce health care professional exposure to blood and body fluids (BBF) according to two low-quality studies. Cases of occupational and patient exposure to BBF with closed FWMSs, some of which had severe issues, were reported to the U.S. Food and Drug Administration. Depending on the volume, discharge of BBF to the sanitary sewer may be authorized upon the approval of the competent municipal authorities. Compared to an open system, a closed FWMS has the potential to reduce manipulation of canisters during the cases because of large canister capacity (24 L). However, local data showed that BBF and irrigation fluid amounts in ORs are <2 L in 84 percent of cases and >2 L in a minority of surgeries, whereas a closed FWMS is associated with higher costs for BBF volumes <12 L. Other issues were observed during field evaluation (e.g., occupational noise). Closed FWMS implementation in other hospitals was very limited in the survey.

Available evidence does not support the widespread use of a closed FWMS. Use of mixed-methods in this particular HTA allowed to assist decision makers on the choice of an FWMS in the OR planning.

The specificities of non-pharmaceuticals can require adapting classical health technology assessment (HTA) methodologies and developing additional regional approaches to support decision-making processes. However, little information exists regarding the explicit approaches used in different countries. The aim of this work is to provide an overview of the role and activities of the Galician HTA agency (avalia-t, Spain) regarding assessment, appraisal and continued evaluation across the whole life cycle of non-pharmaceutical technologies.

In depth review and analysis of the activities undertaken by avalia-t during the past five years to support the introduction and appropriate use of non-pharmaceutical health care technologies at the regional level.

A multidisciplinary Commission judges the added value of new non-pharmaceuticals and establishes the indications and conditions for use. HTAs, which are mandatory for all relevant technologies, rely on the best available evidence on safety and effectiveness but also provide fit for purpose contextualized information based on organizational data and administrative registers. Interaction with multidisciplinary stakeholders is commonly needed to complement the evidence base (ad hoc working groups, face to face discussions), and post-launch studies can be implemented to analyze the utilization and results in real world practice. Performance indicators and other HTA based products can also be required to ensure the quality of health care (e.g., appropriate use indications, quality indicators, evidence based patient information). In addition, technical and scientific advice/support can be provided at different decision levels of the health organization to promote the quality of care and appropriate use of technologies (e.g., regional mental health program, suicide management strategy, bariatric surgery surveillance registry).

Rigorous, comprehensive and systematic processes for supporting non-pharmaceutical technology adoption and implementation are required. Although it is acknowledged that core information does not differ substantially within countries, contextualized information is recognized as essential for establishing the conditions for use at the regional level.

In an effort to expedite the approval of drugs treating serious illnesses or addressing unmet medical need, conditional approvals have been used by the European Medicines Agency. In this study, the effects of conditional approvals were investigated in terms of health technology assessment (HTA) recommendations and timing in Europe.

First HTA recommendations of new active substances (NASs) issued between 2015 and 2017 were collected from the National Institute for Health and Care Excellence (England), Haute Autorité de Santé (France), Institute for Quality and Efficiency in Health Care (Germany), Scottish Medicine Consortium (Scotland) and Tandvårds-Läkemedelförmånsverket (Sweden). The HTA recommendations were then classified into the following categories: positive, positive with restrictions, negative and multiple and if the regulatory approval pathway had been standard or conditional.

Of this cohort of NASs that received an HTA recommendation, eight of 56 in England, 12 of 83 in France, 11 of 77 in Germany, nine of 58 in Scotland and four of 49 in Sweden were approved via a conditional review. Generally, except in England, there were a higher proportion of positive first recommendations for conditional approvals when compared to standard approvals, with Germany showing the largest proportional difference (43 percent) between the two pathways and also a faster time to recommendation. This may relate to the proportion of conditional assessments that were orphan medicines. With the exception of Germany, the time taken from regulatory approval to first HTA recommendation for products with conditional approvals is higher than those for standard approvals, with the largest difference seen in Sweden (241 days longer).

Conditionally approved NASs showed a variable HTA outcome; although there was generally a higher proportion of positive recommendations thus enabling more likely access in conditional approvals, the timing from regulatory approval to HTA recommendation was longer compared with standard approvals. This warrants a better understanding of the factors and uncertainties underlying these recommendations, supporting timely access of NASs with conditional approval.

In 2017, the European Union (EU) commission released the final versions of the Medical Device Regulation (MDR) and In-vitro Diagnostic Device Regulation. These regulations will replace the EU directives (Medical Device Directive [MDD], In-vitro Diagnostic Device [IVDD], and Active Implantable Medical Device [AIMD]). EU regulations are effective in all EU countries at date of publication. In contrast, the EU directives must be implemented in national law first.

Guidelines and respective legislation, consultation results and methods/medical device (MD) evaluations were reviewed and analyzed. Decision criteria and reasoning, assessment outcomes and potential impact on price negotiations were the main aspects for comparison.

Manufacturers have to be aware of the importance of clinical data for demonstrating the compliance of their products. This applies both to the approval of the products and the “post-market activities” and particularly to the “post-market clinical follow-up” for which requirements for Class I and II products need to be further developed. The MDR requires manufacturers to collect clinical data before and after approval, which could lead to excessive documentation requirements. The term “sufficient clinical data” from the MDR is unclear. A functional Eudamed specification is necessary, which enables an automated processing of relevant data. A stronger involvement in the evaluation process is needed as well as more transparency in the Joint Federal Committee (G-BA) and faster evaluation processes.

The MDR increases the burden especially for small businesses, and it is doubtable that the ultimate goal – improving patient safety – will be achieved. The increased demands and rising costs of the new EU MDR and bottlenecks at Notified Bodies can be a risk for the MD industry. Due to the general reduction in the remuneration for services with a high proportion of technical services, it is feared that products will be withdrawn from the market for economic reasons or that they will not be marketed.

In Europe, the new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) that entered into force 2017 will have to be applied until 2020 and 2022, respectively. Under the old regulation, there was a large gap between evidence requirements for market approval and market access for high risk (class IIb and III) medical devices (MD). The MDR/IVDR will require appropriate clinical investigations for these MD classes. Despite the different purpose of market approval and surveillance and reimbursement decisions, there are possible synergies with regard to evidence generation, for example, design of pivotal trials and post-launch evidence generation with observational data. In the MDR, early scientific advice can be provided by expert panels of the European Commission if requested by MD developers. For medicinal products, the European network for Health Technology Assessment (EUnetHTA) has established joint early dialogs (JED) of HTA agencies with the European Medicines Agency and manufacturers. A similar approach might be possible with the Medical Device Coordination Group (MDCG). The objective was to explore possible synergies for JED with the MDCG and EUnetHTA.

In 2018, EUnetHTA established a task force for HTA and MDR/IVDR. A workshop, which will explore possible synergies and activities on JED as well as the viewpoints of stakeholders will be held in May 2019. Participants will be Directorate-Generals GROW (Internal Market, Industry, Entrepreneurship and SME) and SANTE (Health and Food Safety), EUnetHTA members assessing MD, representatives of national competent authorities, Team Notified Bodies, MedTech Europe, patient representatives and academia.

A report on the presentations, the results of the discussion, and next steps in a possible collaboration will be presented.

Joint early scientific advice to manufacturers on the European level for evidence generation by HTA agencies and the MDCG has the potential to streamline evidence generation in the life cycle of high risk MD.

Healthcare-associated infections (HAI) are among the most common preventable health adverse event, associated with significant burden globally. Limited data on HAI costs in lower and middle-income countries is available. The aim of this study is to assess the cost, additional length-of-stay (LOS) and extra-mortality of HAI in the Latin American and Caribbean (LAC) Region.

We searched Medline/PubMed, Embase, Web of Science, Lilacs, Cochrane, National Health Service Economic Evaluation Database, Centre for Reviews and Dissemination, EconLit, and gray literature published in any language without restriction of date till July 2017. We included observational studies addressing the outcomes of interest, in which hospitalized patients with HAI are compared to those without HAI. The following study designs were included: quasi-experimental, controlled before-after, prospective and retrospective comparative cohort, case-control, and cross-sectional studies. We considered the following HAI-sites: surgical site infections (SSI), catheter-associated urinary-tract infections (CA-UTI), ventilator-associated pneumonia (VAP), and central line-associated bloodstream infection (CLA-BSI), as well as cross-infection (CI). Screening of citations, data extraction, and risk of bias assessment were conducted in duplicate by independent reviewers, according to the study protocol registered on PROSPERO. Reported costs were converted to USD considering official exchange rates.

We identified 4,339 citations. After removing duplicates, a total of 3,029 citations were screened for eligibility. A total of 87 studies from 17 countries were included. The majority (27.4 percent) reported on VAP, followed by CLA-BSI (21.2 percent), SSI (16.4 percent), and CA-UTI (14.4 percent). Most studies (46.7 percent) reported on incremental LOS, with an average of 14.8 days (range 0.9-49 days). Costs were reported by 25 percent of studies, with average incremental costs of USD 3,460 (range 49-12,155). Average extra-mortality of 15.6 percent (range -2.8-45.2 percent) was reported by 12.6 percent of studies.

Available evidence from the LAC Region reports significant economic burden of HAI. This information will be useful for cost-effectiveness analysis of interventions aimed at reducing HAI economic and health burden.

There is a lack of knowledge about methods for valuing health intervention-related costs and monetary benefits in the education and criminal justice sectors, also known as ‘inter-sectoral costs and benefits’ (ICBs). The objective of this study was to develop methods for obtaining unit prices for the valuation of ICBs.

By conducting an exploratory literature study and expert interviews, several generic methods were developed. The methods' feasibility was assessed through application in the Netherlands. Results were validated in an expert meeting, which was attended by policy makers, public health experts, health economists and Health Technology Assessment (HTA) experts, and discussed at several international conferences and symposia.

The study resulted in four methods, including the opportunity cost method and valuation using available unit prices, self-constructed unit prices or hourly labor costs.

The methods developed can be used internationally and are valuable for the broad international field of HTA.