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The COVID-19 pandemic triggered abrupt challenges for health care providers, requiring them to simultaneously plan for and manage a rise of COVID-19 cases while maintaining essential health services. Since March 2020, the COVID-19 Health System Response Monitor, a joint initiative of the European Observatory on Health Systems and Policies, the WHO Regional Office for Europe, and the European Commission, has documented country responses to COVID-19 using a structured template which includes a section on provision of care. Using the information available on the platform, this paper analyzes how countries planned services for potential surge capacity, designed patient flows ensuring separation between COVID-19 and non-COVID-19 patients, and maintained routine services in both hospital and ambulatory settings. Despite very real differences in the organization of health and care services, there were many similarities in country responses. These include transitioning the management of COVID-19 mild cases from hospitals to outpatient settings, increasing the use of remote consultations, and cancelling or postponing non-urgent services during the height of the first wave. In the immediate future, countries will have to continue balancing care for COVID-19 and non-COVID-19 patients to minimize adverse health outcomes, ideally with supporting guidelines and COVID-19-specific care zones. Looking forward, policymakers will have to consider whether strategies adopted during the COVID-19 pandemic will become permanent features of care provision.

Background - The COVID-19 pandemic created substantial disruptions in the delivery of health services around the world. Reductions in hospital admissions have been reported for several conditions in the adult population; less evidence currently exists for children. To what extent such changes reflect a risk for patients due to unmet care needs, or a “correction” of previous overprovision of care has not been thoroughly examined yet. Methods - Based on complete national hospital discharge data available via the German National Institute for the Reimbursement of Hospitals (InEK) data browser, we compare the top 30 diagnoses for which children were hospitalised in 2019, 2020 and 2021. We analyse the development of monthly admissions between January 2019 and December 2021 for three tracers of variable urgency and severity: acute lymphoblastic leukaemia (ALL), appendicitis/appendectomy and tonsillectomy/adenoidectomy. Results - Total admissions were approximately 20% lower in 2020 and 2021 compared to 2019. The composition of the most frequent principal diagnoses did not change dramatically across years, although changes in rank were observed. Large decreases were observed in 2020 for respiratory and gastrointestinal infections, with cases picking up again for some in 2021. The number of ALL admissions showed a slight increasing trend and a periodicity prima vista unrelated to pandemic factors. Appendicitis admissions decreased by about 9% in 2020 and a further 8% in 2021, while tonsillectomies/adenoidectomies decreased by more than 40% in 2020 and a further 30% in 2021; for these tracers, monthly changes are in line with pandemic waves. Conclusions - Observed variations in child hospitalisations reflect the effects of pandemic mitigation measures and/or changes in demand. In Germany, inpatient care for critical conditions appears to have been largely upheld, potentially at the expense of elective treatments. Complementary data on ambulatory care and health outcomes would enable a better understanding of change in healthcare patterns and effects on children’s health.

Background The coronavirus disease 2019 (COVID-19) pandemic has developed into an unprecedented global challenge. Differences between countries in testing strategies, hospitalization protocols as well as ensuring and managing ICU capacities can illustrate initial responses to a major health system shock, and steer future preparedness activities. Methods Publicly available daily data for 18 European countries were retrieved manually from official sources and documented in an Excel table (March–July 2020). The ratio of tests to cases, the share of hospitalizations out of all cases and the share of ICU admissions out of all hospitalizations were computed using 7-day rolling averages per 100 000 population. Information on country policies was collected from the COVID-19 Health System Response Monitor of the European Observatory on Health Systems and Policies. Information on health care capacities, expenditure and utilization was extracted from the Eurostat health database. Results There was substantial variation across countries for all studied variables. In all countries, the ratio of tests to cases increased over time, albeit to varying degrees, while the shares of hospitalizations and ICU admissions stabilized, reflecting the evolution of testing strategies and the adaptation of COVID-19 health care delivery pathways, respectively. Health care patterns for COVID-19 at the outset of the pandemic did not necessarily follow the usual health service delivery pattern of each health system. Conclusions This study enables a general understanding of how the early evolution of the pandemic influenced and was influenced by country responses and clearly demonstrates the immense potential for cross-country learning.

Background Increased electronic cigarette (ECIG) use has motivated new regulations to address the changing landscape of tobacco use and promote public health. Method This policy scan compares ECIG prevalence and regulations in the European Union (EU), Canada, and the United States (US) at the federal- and local-level to foster a policy dialogue around modern tobacco prevention and control regulations. Results Among young adults, 40 % in the US, 29 % in Canada, and 28 % in the EU report ever using an ECIG. Results from the policy scan find significant variation in approach to regulating ECIGs. EU member states are subject to the most stringent requirements regarding nicotine concentration regulations, and several member states have also opted to ban flavors and/or require plain packaging or out of sight retail sales. Among EU and US states, taxation is a popular strategy, though taxing strategies vary widely. Regarding youth use, US states have led the way for increasing the legal age of sale to 21 at the federal level, and in Canada recent federal regulations are innovative in their approach to banning advertising that may appeal to youth. Conclusion Strategies to achieve public health goals related to ECIGs vary widely, with federalism playing an important role in policy innovation, offering opportunities to evaluate their effectiveness and inform future regulations.

The 4th PPRI Conference, held in Vienna in October 2019, addressed issues related to equitable and affordable access to medicines. A multi-stakeholder audience from around the globe discussed solutions and best practice models for current challenges such as high-priced medicines, limitations of current pricing and reimbursement policies and tight budgets for health technologies. A multi-faceted approach (so-called balance, evidence, collaboration and transparency/BECT strategy) was also discussed. This includes an improved balance of different interests and policy areas, generation of relevant evidence, collaboration between countries and stakeholders, and transparency, and was considered as the most promising pathway for the future.

Mapping algorithms are developed using data sets containing patient responses to a preference-based questionnaire and another health-related quality-of-life questionnaire. When data sets include repeated measurements from the same individuals over time, the assumption of observations' independence, required by standard models, is violated, and standard errors are underestimated. This review aimed to identify how studies deal with methodological challenges of repeated measurements, provide an overview of practice to date, and potential implications for future work.We conducted a systematic literature search of MEDLINE, Cumulative Index to Nursing and Allied Health Literature, specialized databases, and previous systematic reviews. A data template was used to extract, among others, start and target instruments if the data set(s) used for estimation and validation had repeated measurements per patient, used regression techniques, and which (if any) adjustments were made for repeated measurements.We identified 278 publications developing at least 1 mapping algorithm. Of the 278 publications, 121 used a data set with repeated measurements, among which 92 used multiple time points for estimation, and 39 selected specific time points to have 1 observation per participant. A total of 36 studies did not account for repeated measurements. An adjustment was conducted using cluster-robust standard errors (21), random-effects models (30), generalized estimating equations (7), and other methods (7).The inconsistent use of methods to account for interdependent observations in the literature indicates that mapping guidelines should include recommendations on how to deal with repeated measurements, and journals should update their guidelines accordingly.

Background: Oral health has received increased attention over the past few years coupled with rising awareness on the impact of limited dental care coverage for oral health and general health and well-being. The purpose of the study was to compare the statutory coverage and access to dental care for adult services in 11 European countries using a vignette approach.Methods: We used three patient vignettes to highlight the differences of the dimensions of coverage and access to dental care (coverage, cost-sharing and accessibility). The three vignettes describe typical care pathways for patients with the most common oral health conditions (caries, periodontal disease, edentulism). The vignettes were completed by health services researchers knowledgeable on dental care, dentists, or teams consisting of a health systems expert working together with dental specialists.Results: Completed vignettes were received from 11 countries, including Bulgaria, Estonia, France, Germany, Republic of Ireland (Ireland), Lithuania, the Netherlands, Poland, Portugal, Slovakia and Sweden. While emergency dental care, tooth extraction and restorative care for acute pain due to carious lesions are covered in most responding countries, root canal treatment, periodontal care and prosthetic restoration often require cost-sharing or are entirely excluded from the benefit basket. Regular dental visits are also limited to one visit per year in many countries. Beyond financial barriers due to out-of-pocket payments, patients may experience very different kinds of physical barriers to access dental care. Major access barriers to public dental care represent the limited availability of contracted dentists especially in rural areas and the unequal distribution and lack of specialised dentists.Conclusions: According to the results, statutory coverage of dental care varies across European countries while access barriers are largely similar. Many dental services require substantial cost-sharing in most countries which in turn leads to high out-of-pocket spending. The individual socioeconomic status is thus a main determinant for access to dental care, but also other factors such as geography, age and comorbidities can inhibit access and affect outcomes. Moreover, coverage in most oral health systems is targeted at treatment and less at preventative oral health care.

Background and purpose: Complex surgery and radiotherapy are the central pillars of loco-regional oncology treatment. This paper describes the reimbursement schemes used in radiation and complex surgical oncology, reports on literature and policy reviews. Material and methods: A systematic review of the literature of the reimbursement models has been carried out separately for radiotherapy and complex cancer surgery based on PRISMA guidelines. Using searches of PubMed and grey literature, we identified articles from scientific journals and reports published since 2000 on provider payment or reimbursement systems currently used in radiation oncology and complex cancer surgery, also including policy models. Results: Most European health systems reimburse radiotherapy using a budget-based, fee-for-service or fraction-based system; while few reimburse services according to an episode-based model. Also, the reimbursement models for cancer surgery are mostly restricted to differences embedded in the DRG system and adjustments applied to the fees, based on the complexity of each surgical procedure. There is an enormous variability in reimbursement across countries, resulting in different incentives and different amounts paid for the same therapeutic strategy. Conclusion: A reimbursement policy, based on the episode of care as the basic payment unit, is advocated for. Innovation should be tackled in a two-tier approach: one defining the common criteria for reimbursement of proven evidence-based interventions; another for financing emerging innovation with uncertain definitive value. Relevant clinical and economic data, also collected real-life, should support reimbursement systems that mirror the actual cost of evidence-based practice. (C) 2021 The Author(s). Published by Elsevier Ltd. on behalf of British Association of Surgical Oncology and European Society of Surgical Oncology, and Elsevier B.V.

ZusammenfassungDie Covid-19-Pandemie stellt seit Anfang 2020 insbesondere die Gesundheitssysteme weltweit vor ungeahnte Herausforderungen und führte u. a. dazu, dass ursprüngliche Intensivkapazitäten in einigen Ländern nicht zur Behandlung aller Patienten ausreichten. In diesem Beitrag werden die Entwicklungen der Covid-19-Hospitalisierungen und der Ausbau der Intensivkapazitäten in Europa im Verlauf der ersten Pandemiewelle vor dem Hintergrund der jeweiligen Ausgangsbedingungen veranschaulicht und darüber hinaus Unterschiede in der Patientensteuerung aufgezeigt. Dazu wurde auf zwei Datenbanken zurückgegriffen, die mit dem Ausbruch der Covid-19-Pandemie vom Fachgebiet Management im Gesundheitswesen der Technischen Universität Berlin und dem European Observatory on Health Systems and Policies im März 2020 ins Leben gerufen wurden. Der Beitrag zeigt auf, dass viele europäische Länder auf das Verschieben planbarer Eingriffe und die Aufstockung von Intensivbetten gesetzt haben, um dem rasanten Anstieg an Covid-19-Patienten zu begegnen. Weiterhin wird gezeigt, dass dies in den meisten Ländern ausreichend war und initiale Kapazitätsgrenzen in der Akutversorgung nicht überschritten wurden. In einigen stärker betroffenen Ländern wie Schweden und den Niederlanden hätten jedoch die verfügbaren Intensivbetten ohne Aufstockung nicht ausgereicht.

In Germany, some digital health applications (DiHA) became reimbursable through the statutory health insurance system with the adoption of the Digital Healthcare Act in 2019. Approaches and concepts for the German care context were developed in an iterative process, based on existing concepts from international experience. A DiHA categorization was developed that could be used as a basis to enable the creation of a reimbursed DiHA repository, and to derive evidence requirements for coverage and reimbursement for each DiHA. The results provide an overview of a possible classification of DiHA as well as approaches to assessment and evaluation. The structure of remuneration and pricing in connection with the formation of groups is demonstrated.

Background: The reimbursement of new technologies in inpatient care is not always linked to a requirement for evidence-based evaluation of patient benefit. In Germany, every new technology approved for market was until recently reimbursable unless explicitly excluded. It was therefore unclear whether the implementation of innovative technologies is guided by scientific evidence. This work aimed to explore the relationship between clinical evidence and utilization for 25 selected technologies in German inpatient care.Methods: Different methods were applied. A systematic search for evidence published between 2003 and 2017 was conducted in four bibliographic databases; clinical trial registries; resources for clinical guidelines; and health technology assessment - databases. Information was also collected on funding mechanisms and safety notices. Utilization was measured by hospital cases captured in claims data. The body of evidence, funding and safety notices per technology were analysed descriptively. The relationship between utilization and evidence was explored empirically using a multilevel regression analysis.Results: The number of included publications per technology ranges from two to 498. For all technologies, non-comparative studies form the bulk of the evidence. The number of randomised controlled clinical trials per technology ranges from zero to 19. Some technologies were utilized for several years without an adequate evidence base. A relationship between evidence and utilization could be shown for several but not all technologies.Conclusions: This study reveals a mixed picture regarding the evidence available for new technologies, and the relationship between the development of evidence and the use of technologies over time. Although the influence of funding and safety notices requires further investigation, these results re-emphasize the need for strengthening market approval standards and HTA pathways as well as approaches such as “coverage with evidence development”.

IntroductionThis study aims to (i) describe the (evidence-based) reimbursement process of hospital individual services, (ii) evaluate the accordance between evidence-based recommendations and reimbursement decision of individual services and (iii) elaborate potential aspects that play a role in the decision-making process in Austria.MethodsThe reimbursement process is described based on selected relevant sources such as official documents. Evidence-based recommendations and subsequent reimbursement decisions for the annual maintenance of the hospital individual service catalogue in Austria between 2008 and 2020 were analyzed using a mixed methods approach, encompassing descriptive statistics and a focus group with Austrian decisionmakers.ResultsOne hundred and eighteen evidence-based recommendations were analyzed. There were 93 (78.8%) negative and 25 (21.2%) positive evidence-based recommendations. In total, 107 out of 118 evidence-based recommendations (90.1%) did not lead to a deviating reimbursement decision. We identified six aspects that may have played a role in the decision-making process for the annual maintenance of the hospital individual service catalogue, with clinical evidence being the most notable. Further aspects included quality assurance/organizational aspects (i.e., structural quality assurance), costs (if comparable to already existing medical services, not: cost-effectiveness), procedural aspects (e.g., if certain criteria for adoption have not been met formally through the proposals), “other countries” (i.e., taking into account how other countries decided) and situational aspects (such as the COVID-19 pandemic).ConclusionsThere is good accordance between evidence-based recommendations and reimbursement decisions regarding hospital individual services in Austria. Beyond clinical evidence, organizational aspects seem to be considered often with regard to quality assurance but costs do not appear to play a major role. The Austrian system has mechanisms in place that can restrict widespread adoption of novel hospital individual services with uncertain clinical benefits. Future studies could investigate how well these mechanisms work and how they compare to other health systems in Europe.

A Correction to this article was published on 24 January 2022 https://doi.org/10.1186/s13012-022-01187-7, Background: Innovative medical technologies are commonly associated with positive expectations. At the time of their introduction into care, there is often little evidence available regarding their benefits and harms. Accordingly, some innovative medical technologies with a lack of evidence are used widely until or even though findings of adverse events emerge, while others with study results supporting their safety and effectiveness remain underused. This study aims at examining the diffusion patterns of innovative medical technologies in German inpatient care between 2005 and 2017 while simultaneously considering evidence development. Methods: Based on a qualitatively derived typology and a quantitative clustering of the adoption curves, a representative sample of 21 technologies was selected for further evaluation. Published scientific evidence on efficacy/effectiveness and safety of the technologies was identified and extracted in a systematic approach. Derived from a two-dimensional classification according to the degree of utilization and availability of supportive evidence, the diffusion patterns were then assigned to the categories ���Success��� (widespread/positive), ���Hazard��� (widespread/negative), ���Overadoption��� (widespread/limited or none), ���Underadoption��� (cautious/positive), ���Vigilance��� (cautious/negative), and ���Prudence��� (cautious/limited or none). Results: Overall, we found limited evidence on the examined technologies regarding both the quantity and quality of published randomized controlled trials. Thus, the categories ���Prudence��� and ���Overadoption��� together account for nearly three-quarters of the years evaluated, followed by ���Success��� with 17%. Even when evidence is available, the transfer of knowledge into practice appears to be inhibited. Conclusions: The successful implementation of safe and effective innovative medical technologies into practice requires substantial further efforts by policymakers to strengthen systematic knowledge generation and translation. Creating an environment that encourages the conduct of rigorous studies, promotes knowledge translation, and rewards innovative medical technologies according to their added value is a prerequisite for the diffusion of valuable health care.

At the onset of the COVID-19 pandemic, health care providers had to abruptly change their way of providing care in order to simultaneously plan for and manage a rise of COVID-19 cases while maintaining essential health services. Even the most well-resourced health systems faced pressures from new challenges brought on by COVID-19, and every country had to make difficult choices about how to maintain access to essential care while treating a novel communicable disease. Using the information available on the HSRM platform from the early phases of the pandemic, we analyze how countries planned services for potential surge capacity, designed patient flows ensuring separation between COVID-19 and non-COVID-19 patients, and maintained routine services in both hospital and outpatient settings. Many country responses displayed striking similarities despite very real differences in the organization of health and care services. These include transitioning the management of COVID-19 mild cases from hospitals to outpatient settings, increasing the use of remote consultations, and cancelling or postponing non-urgent services during the height of the first wave. In the immediate future, countries will have to continue balancing care for COVID-19 and non-COVID-19 patients to minimize adverse health outcomes, ideally with supporting guidelines and COVID-19-specific care zones. Many countries expect to operate at lower capacity for routinely provided care, which will impact patient access and waiting times. Looking forward, policymakers will have to consider whether strategies adopted during the COVID-19 pandemic will become permanent features of care provision.

Objective The aims of this study were to assess whether there is a conceptual overlap between the questionnaires HIT-6 and EQ-5D and to develop a mapping algorithm allowing the conversion of HIT-6 to EQ-5D utility scores for Germany. Methods This study used data from an ongoing randomised controlled trial for patients suffering from migraine. We assessed the conceptual overlap between the two instruments with correlation matrices and exploratory factor analysis. Linear regression, tobit, mixture, and two-part models were used for mapping, accounting for repeated measurements, tenfold cross-validation was conducted to validate the models. Results We included 1010 observations from 410 patients. The EQ-5D showed a substantial ceiling effect (47.3% had the highest score) but no floor effect, while the HIT-6 showed a very small ceiling effect (0.5%). The correlation between the instruments’ total scores was moderate (− 0.30), and low to moderate among each domain (0.021–0.227). The exploratory factor analysis showed insufficient conceptual overlap between the instruments, as they load on different factors. Thus, there is reason to believe that the instruments’ domains do not capture the same latent constructs. To facilitate future mapping, we provide coefficients and a variance–covariance matrix for the preferred model, a two-part model with the total HIT-6 score as the explanatory variable. Conclusion This study showed that the German EQ-5D and the HIT-6 lack the conceptual overlap needed for appropriate mapping. Thus, the estimated mapping algorithms should only be used as a last resort for estimating utilities to be employed in economic evaluations.

ObjectivesTo (1) describe the (evidence-based) reimbursement process of hospital individual services, (2) evaluate the accordance between evidence-based recommendations and reimbursement decision of individual services and (3) elaborate potential aspects that play a role in the decision-making process in Austria.Method:The reimbursement process is described based on selected relevant sources such as official documents. Evidence-based recommendations and subsequent reimbursement decisions for the annual maintenance of the hospital individual service catalogue in Austria between 2008 and 2020 were analysed using a mixed methods approach, encompassing descriptive statistics and a focus group with Austrian decision makers. Results:118 evidence-based recommendations were analysed. There were 93 (78.8%) negative and 25 (21.2%) positive evidence-based recommendations. In total, 107 out of 118 evidence-based recommendations (90.1%) did not lead to a deviating reimbursement decision. We identified six aspects that may have played a role in the decision-making process for the annual maintenance of the hospital individual service catalogue, with clinical evidence being the most notable. Further aspects included quality assurance/organisational aspects (i.e., structural quality assurance), costs (if comparable to already existing medical services, not: cost-effectiveness), procedural aspects (e.g., if certain criteria for adoption have not been met formally through the proposals), “other countries” (i.e., taking into account how other countries decided) and situational aspects (such as the COVID-19 pandemic).Conclusions:There is good accordance between evidence-based recommendations and reimbursement decisions regarding hospital individual services in Austria. Beyond clinical evidence, organizational aspects seem to be considered often with regard to quality assurance but costs do not appear to play a major role. The Austrian system has mechanisms in place that can restrict widespread adoption of novel hospital individual services with uncertain clinical benefits. Future studies could investigate how well these mechanisms work and how they compare to other health systems in Europe.

To (1) describe the (evidence-based) reimbursement process of hospital individual services, (2) evaluate the accordance between evidence-based recommendations and reimbursement decision of individual services and (3) elaborate potential aspects that play a role in the decision-making process in Austria.The reimbursement process is described based on selected relevant sources such as official documents. Evidence-based recommendations and subsequent reimbursement decisions for the annual maintenance of the hospital individual service catalogue in Austria between 2008 and 2020 were analysed using a mixed methods approach, encompassing descriptive statistics and a focus group with Austrian decision makers.118 evidence-based recommendations were analysed. There were 93 (78.8%) negative and 25 (21.2%) positive evidence-based recommendations. In total, 107 out of 118 evidence-based recommendations (90.1%) did not lead to a deviating reimbursement decision. We identified six aspects that may have played a role in the decision-making process for the annual maintenance of the hospital individual service catalogue, with clinical evidence being the most notable. Further aspects included quality assurance/organisational aspects (i.e., structural quality assurance), costs (if comparable to already existing medical services, not: cost-effectiveness), procedural aspects (e.g., if certain criteria for adoption have not been met formally through the proposals), "other countries" (i.e., taking into account how other countries decided) and situational aspects (such as the COVID-19 pandemic).There is good accordance between evidence-based recommendations and reimbursement decisions regarding hospital individual services in Austria. Beyond clinical evidence, organisational aspects seem to be considered often with regard to quality assurance but costs do not appear to play a major role. The Austrian system has mechanisms in place that can restrict widespread adoption of novel hospital individual services with uncertain clinical benefits. Future studies could investigate how well these mechanisms work and how they compare to other health systems in Europe.

Objective Medical devices (MDs) encompass a broad and heterogeneous range of technologies. While practices vary considerably across countries, MDs often find application in patient care with little or no evaluation of their effectiveness and safety following market approval. A recently proposed taxonomy of MDs considered devices from the viewpoint of Health Technology Assessment (HTA). The aim of the work presented here was to test its plausibility and applicability by considering real-world HTA practices. Methods HTA reports on MDs from European institutions were collected in a systematic manner and the evaluated devices and/or related procedures were matched to a position on the taxonomy. Following this, representatives from 16 European HTA institutions were asked about the usefulness of the taxonomy in semi-structured interviews. Results 1237 HTA reports (2004–2015) from 33 European institutions were included in the sample. The majority of reports was on technologies from the taxonomic positions initially estimated as having high relevance. Most of the experts interviewed stated that they found the taxonomy useful, particularly regarding its potential to aid in selecting technologies for assessment and to highlight potential methodological particularities per taxonomic position. Conclusions Overall, the distribution of identified reports on the matrix confirmed that the initial estimation of the relevance and necessity of HTA provided in the taxonomic model is plausible. In addition, interviews with representatives of European HTA institutions showed that the taxonomy could be useful.

The COVID-19 pandemic has placed unprecedented pressure on health systems' capacities. These capacities include physical infrastructure, such as bed capacities and medical equipment, and healthcare professionals. Based on information extracted from the COVID-19 Health System Reform Monitor, this paper analyses the strategies that 45 countries in Europe have taken to secure sufficient health care infrastructure and workforce capacities to tackle the crisis, focusing on the hospital sector. While pre-crisis capacities differed across countries, some strategies to boost surge capacity were very similar. All countries designated COVID-19 units and expanded hospital and ICU capacities. Additional staff were mobilised and the existing health workforce was redeployed to respond to the surge in demand for care. While procurement of personal protective equipment at the international and national levels proved difficult at the beginning due to global shortages, countries found innovative solutions to increase internal production and enacted temporary measures to mitigate shortages. The pandemic has shown that coordination mechanisms informed by real-time monitoring of available health care resources are a prerequisite for adaptive surge capacity in public health crises, and that closer cooperation between countries is essential to build resilient responses to COVID-19.

Background Oral health is an important component of general health and healthy aging, yet financial protection for the costs of oral health care is often limited. Methods We systematically compare dental care coverage in Australia (New South Wales), Canada (Alberta), England, France, Germany, Italy, Sweden, and the United States. Drawing on the WHO Universal Coverage Cube, we compare breadth (who is covered), depth (share of total costs covered), and scope (services covered), with a focus on adults aged 65 and older. We populated data collection templates to provide detailed and comparable descriptions of dental care coverage in 8 jurisdictions. Results Overall there were four general types of coverage models: 1) deep public coverage for a small subset of the population based on strict eligibility criteria jurisdictions: Canada, Australia and Italy; 2) universal but shallow coverage of the population, combined with deeper coverage for a sub-set of the population meeting eligibility criteria: England, France, Sweden; 3) universal, and predominantly deep coverage for the whole population: Germany; and 4) shallow coverage available to some subgroups of the population in the United States. Conclusions While age, specifically turning 65, is an important consideration in the design of public coverage in Canada, Australia and the United States, many jurisdictions do not consider age as an eligibility criterion for public coverage. Yet all jurisdictions we include, except Sweden, provide differential coverage for those who meet a specific low-income threshold. Due to the limited availability of comparable data within and across jurisdictions, further research would benefit from standardized data collection initiatives for oral health measures. Key message Given the important role oral health plays in promoting healthy aging, the limited public coverage of oral health within statutory health systems warrants policy and research attention.

Background In Europe, countries have adopted very different approaches to providing publicly subsidized dental insurance coverage. However, little attention has been paid on these variations in the coverage, financing and provision of oral health care and its implications. This cross-country Health Systems in Transition (HiT) Review aims to fill this gap in the field of comparison of oral health systems. Methods The comparative HiT draws on multiple data sources. It builds on detailed country information from national HiTs and other international sources (MISSOC, OECD/OBS country profiles). International databases (Eurostat, OECD, EHIS, EU-SILC) are used as main sources to compare available oral health related indicators. National and international policy documents and information by country experts complement this information. The HiT covers all EU members states and countries belonging to the EU's single market (UK, Iceland, Norway, Switzerland). Results In almost all countries, dental care is funded to a greater extent by private patient payments than other health care sectors. Overall, contribution of voluntary health insurances (VHI) to dental spending is low, while out-of-pocket spending is substantial in many countries leading to high levels of unmet needs for dental care for financial reasons, mainly for poor households. Comparison of coverage reveals that most countries commit to a minimum scope of basic dental care (emergency care, children), but there is large variation in terms of restriction of service packages ranging from countries with very limited, partial to comprehensive coverage. Conclusions Dental care has become a priority for European policy makers as countries extend statutory dental care coverage recognising the importance of prevention of oral diseases. However, there remain wide variations in the level of coverage resulting in differences of likelihood of dental care use.

Background The hitherto largely unregulated market of mobile digital health applications is undergoing significant changes, particularly concerning the growing segment of apps that aim at integrating care processes or replacing traditional forms of diagnosis or therapy. The inclusion in the benefit basket of statutory health systems is of relevance when exploring viable business models for app developers. Description of the problem So far, countries largely limit coverage to apps developed by authorities within the statutory health system, or provide guidance for payers in the form of app lists or quality assessment criteria. However, there are new regulatory efforts aiming to promote innovation for mobile digital health applications by creating pathways to general reimbursement, as exemplified by the 2019 German Digital Healthcare Act. Results Our contribution illustrates how evidence-based reimbursement decisions can be configured for mobile digital health applications. We will compare frameworks from different contexts, including the new German regulation, the UK's NHS App Store and the Evidence Standards Framework for Digital Health by NICE as well as the work of the French National Health Authority (Haute Autorité de Santé). Building on case studies, we will provide a typology of practices, which covers elements spanning consumer guidance to assessment approaches to full reimbursement decision-making. Conclusions Based on the proposed typology, we will discuss challenges and opportunities of reimbursement systems for mobile health apps from a public health perspective and seek to refine the typology by incorporating input from session participants and profiting from the global nature of the conference.

Auf einen Blick In Biosimilars werden hohe Erwartungen hinsichtlich ihres Einsparpotenzials gesetzt. Um den Einsatz von Biosimilars zu fordern, wenden europaische Lander verschiedene Marktsteuerungsmasnahmen an. Ein Vergleich mit 15 europaischen Landern zeigt hierbei meist ahnliche Zugange bei den analysierten Landern und auch im Vergleich zu Deutschland. Zwei zentrale Ausnahmen sind: Deutschland zahlt gemeinsam mit Danemark, Grosbritannien, den Niederlanden und Schweden zu den Landern, die keine Preis-Link-Politik anwenden, bei welcher die Preise von Biosimilars (wie auch Generika) als Abschlag des Referenzarzneimittels-Preises festgelegt werden. Des Weiteren nimmt Deutschland mit der geplanten Einfuhrung der automatischen Substitution bei Biologika auf Apothekenebene eine Vorreiterposition in Europa ein. Durch konsequente Anwendung von Marktsteuerungsinterventionen, inklusive Einfuhrung von in anderen Landern angewandten Masnahmen, konnten in Deutschland die Einsparpotenziale besser ausgeschopft werden. Berechnungen fur verschiedene Szenarien (Varianten von Preis-Link-Politik, Festbetragsbildung, Ausweitung der Verordnungsmindestquoten, Biosimilarsubstitution) zeigten fur neun biologische Wirkstoffe (u. a. Adalimumab, Enoxaparin, Etanercept, Infliximab, Trastuzumab) Einsparpotenziale von 115,9 Mio. € (4,4 %) bis 306,4 Mio. € (11,7 %) fur den GKV-Markt 2019 auf.

Oral health is an important component of general health, yet there is limited financial protection for the costs of oral health care in many countries. This study compares public dental care coverage in a selection of jurisdictions: Australia (New South Wales), Canada (Alberta), England, France, Germany, Italy, Sweden, and the United States. Drawing on the WHO Universal Coverage Cube, we compare breadth (who is covered), depth (share of total costs covered), and scope (services covered), with a focus on adults aged 65 and older. We worked with local experts to populate templates to provide detailed and comparable descriptions of dental care coverage in their jurisdictions. Overall most jurisdictions offer public dental coverage for basic services (exams, x-rays, simple fillings) within four general types of coverage models: 1) deep public coverage for a subset of the older adult population based on strict eligibility criteria: Canada (Alberta), Australia (New South Wales) and Italy; 2) universal but shallow coverage of the older adult population: England, France, Sweden; 3) universal, and predominantly deep coverage for older adults: Germany; and 4) shallow coverage available only to some subgroups of older adults in the United States. Due to the limited availability of comparable data within and across jurisdictions, further research would benefit from standardized data collection initiatives for oral health measures.

Assessing and improving quality of care presupposes an understanding of what it does and does not entail. Different definitions often specify relatively long lists of various attributes that they recognize as part of quality. Effectiveness, patient safety, and responsiveness/patient-centeredness seem to have become universally accepted as core dimensions of quality of care. The inclusion of a list of additional elements is confusing and often blurs the line between quality of care and overall health system performance. This presentation provides an in-depth look at this interplay, recognizing that the definition of quality changes depending on the level at which it is assessed. At the level of health services, there seems to be an emerging consensus that quality of care is the degree to which health services for individuals and populations are effective, safe, and people-centered. On the other hand, a health care system as a whole is of high quality when it achieves the overall goals of improved health, responsiveness, financial protection, and efficiency; here, there seems to be an international trend towards using the term health system performance. The workshop looks at different strategies to assure or improve the quality of health care. To understand, analyze, compare and ultimately prioritize or align different quality strategies, this presentation will introduce a comprehensive framework, which includes the following lenses: i) the three core dimensions of quality: safety, effectiveness, and patient-centeredness; ii) the four functions of health care: primary prevention, acute care, chronic care, and palliative care; iii) the three main activities of quality strategies: setting standards, monitoring, and assuring improvements; iv) Donabedian’s triad: structures, processes, and outcomes; v) the five main targets of quality strategies: health professionals, technologies, provider organizations, patients, and payers.

Background The aim of this study was to examine the scientific evidence on clinical effectiveness and safety used in health technology assessments (HTAs) of high-risk medical devices (MDs) in Europe. Methods We applied a systematic approach to identify European institutions involved in HTA and to select reports assessing MDs considered high-risk according to the definition in the new German health care regulation §137h. Reports published between 2010 and 2015 were considered in our subsequent analysis. We used a structured tool based on widely accepted methodologic principles from Drummond's framework to extract key information on the clinical evidence considered in the reports. Results Out of 1376 identified reports, 93 were eligible for analysis. All reports based their assessment primarily on direct evidence, in most cases (68%) identified through an independent systematic literature search. In more than half the identified studies considered in the reports, clinical evidence for demonstration of effectiveness and safety was of moderate or low quality. Even when systematic reviews and randomized controlled trials were available for assessment, most studies showed an unclear or high risk of bias. Conclusions This study confirms that the quality of scientific evidence used in HTA of high-risk MDs is low and therefore the use of evidence needs improvement. The European Commission recently updated the regulation on MDs but mainly focused on the safety of materials and the CE (Conformite Europeene [European Conformity]) mark. Our results show that additional changes are necessary, specifically with regard to the marketing authorization process of MDs, with stricter quality requirements based on methodologically robust trials, possibly in combination with other evidence sources.

Objectives Health Technology Assessment (HTA) of Medical devices (MDs) and MD-based procedures can be challenging due to the unique features and particularities of this group of technologies, such as device-operator interaction. The aim of this study was to (1) clarify, and supplement earlier findings on European HTA institutions’ structural, procedural and methodological characteristics with regard to the assessment of MDs and to (2) capture the institutions’ perceptions regarding challenges and future trends. Methods Semi-structured telephone interviews with 16 representatives from leading European HTA institutions were performed between April and July 2015. Summative and directed content analysis was used for the analysis, which is reported according to the COREQ checklist. Results Findings from the analysis of the interviews were manifold and partially confirmed what has been noted in the literature (e.g. scarce evidence; identifying relevant studies challenging due to more incremental innovations). Additional themes emerged that can be important for future considerations by HTA institutions and policy-makers alike (e.g. areas for future research; need for specific tools). Conclusions The collective opinion of 16 European HTA institutions on MD evaluation could provide ideas to ameliorate the current regulatory situation beyond the modified EU regulation and start broader, more in-depth methodological discussions around the issue. Interviewed experts seem to agree that new approaches such as coverage with evidence development as some countries already introduced could help to overcome the problem with scarce evidence.

The German health care system resembles that of the United States in important ways — it is financed by multiple private payers and relies principally on negotiation rather than regulation to establish prices. New drugs that offer minimal benefits compared with existing alternatives within a therapeutic class are subject to reference pricing; those with incremental benefits are subject to price negotiations. Together, the reference and negotiated pricing systems have held German prices substantially below U.S. equivalents.To describe the German reference-pricing system and compare it to tiered formularies and consumer cost-sharing in the United States.Document review and interviews with leaders in payer, policy, and pharmaceutical industry organizations in Germany.The German pharmaceutical pricing system uses modest levels of consumer cost-sharing to influence consumers’ choices for drugs with therapeutically equivalent alternatives. Manufacturers are free to set the prices of their products, but insurers will not pay more for a new drug than for its comparators unless it offers an additional clinical benefit. For drugs covered by reference pricing, the insurers’ payment maximum is set at a level that ensures sufficient choices of low-priced options. These models offer an alternative to the U.S. system of tiered formularies.

Objectives A common characteristic of sending countries in cross-border dental care is that of high costs and/or high copayments for dental services. This study aims to provide an insight into the characteristics of German patients receiving planned and emergency (unplanned) dental care abroad and their satisfaction with received services. Methods The Europabefragung is a postal survey carried out by Techniker Krankenkasse for patients who are treated in EU/EEA countries. This study uses data from the Europabefragung 2012. The survey was sent to 45 189 individuals; descriptive statistics for the subset of respondents who received emergency (unplanned) or planned dental treatment are presented. Results There were 18 339 responses to the questionnaire, out of which 17 543 were deemed valid; 1416 respondents had received emergency (unplanned) (78%) or planned (22%) dental care and were included in the analysis. There were clear differences between unplanned and planned treatments regarding country and type of treatment as well as satisfaction with different aspects of treatment and the need for follow-up care. Overall, satisfaction with treatment was high for both groups; individuals who had received planned treatment were more satisfied on all aspects of care and reported a need for follow-up care less frequently. Conclusions While German patients who received both emergency (unplanned) and planned services abroad are mostly satisfied with their experience, some concerns arise with regard to continuity of care. Types of information provided to patients seeking care abroad and dissemination modalities should be carefully planned.