Re-thinking performance assessment for primary care : opinion of the Expert Panel on Effective Ways of Investing in Health

Background: In 2017, the European Commission (EC) identified as a policy priority the performance assessment of primary care systems, which relates to a country’s primary care structure, services delivery and outcomes. The EC requested its Expert Panel on Effective Ways of Investing in Health (Expert Panel) to provide an opinion on ways for improving performance assessment of primary care. Objectives: To provide an overview of domains and dimensions to be taken into consideration in assessing primary care and specific indicators to be collected and analysed to improve understanding of primary care performance. Methods: A sub-group of the Expert Panel performed a literature review. The opinion was drafted, improved and approved through working-group discussions, consultations with the EC, the Expert Group on Health Systems Performance Assessment, and a public hearing. Results: Drawing on the main characteristics of primary care, we propose essential elements of a primary care performance assessment system based on specific indicators. We identified ten domains with accompanying dimensions for which comparative key indicators and descriptive indicators are proposed: (1) universal and accessible care, (2) integrated, (3) person-centred, (4) comprehensive and community-oriented care, (5) provided by a team accountable for addressing a vast majority of personal health needs, (6) sustained partnership with patients and informal caregivers, (7) coordination, (8) continuity of care, (9) primary care organization, and (10) human resources. Conclusion: The identified characteristics and criteria for development of a primary care performance assessment system provides a starting point for strengthening the coherence of assessment frameworks across countries and exchanging best practices

Opinion on Options to Foster Health Promoting Systems: Expert Panel on Effective Ways of Investing in Health (EXPH)

The Expert Panel provides its analysis and recommendations on the following points: (a) What are the mechanisms for strengthening the implementation of health promotion within health systems, how can health systems incorporate, integrate and foster health promotion efforts and paradigms, and what policies need to be in place to make this happen from a health-in-all policies perspective? (b) As public health services and primary health care are operating in an increasingly integrated way, how can this joint approach contribute to action and implementation of health promotion and improved health literacy and how could this development be linked to social care? (c) What could be the success factors for further integration from a conceptual, organisational and financing point of view? And what are the main obstacles and challenges to address?Panel odborníků poskytuje svou analýzu a doporučení k následujícím bodům: a) Jaké jsou mechanismy pro posílení provádění podpory zdraví v rámci zdravotních systémů, jak je mohou zdravotní systémy začlenit, integrovat a podporovat úsilí a paradigmata podpory zdraví a jaké politiky je třeba zavést, aby se toto odvíjelo z perspektivy politiky "Health-in-all"? b) Jak veřejné zdravotnické služby a primární zdravotní péče fungují stále integrovanějším způsobem, jak může tento společný přístup přispět k akci a provádění podpory zdraví a zlepšení zdravotní gramotnosti a jak by mohl být tento vývoj spojen se sociální péčí? c) Jaké by mohly být faktory úspěchu pro další integraci z hlediska koncepčního, organizačního a finančního? A jaké hlavní překážky a výzvy je třeba řešit?The Expert Panel provides its analysis and recommendations on the following points: (a) What are the mechanisms for strengthening the implementation of health promotion within health systems, how can health systems incorporate, integrate and foster health promotion efforts and paradigms, and what policies need to be in place to make this happen from a health-in-all policies perspective? (b) As public health services and primary health care are operating in an increasingly integrated way, how can this joint approach contribute to action and implementation of health promotion and improved health literacy and how could this development be linked to social care? (c) What could be the success factors for further integration from a conceptual, organisational and financing point of view? And what are the main obstacles and challenges to address

EXPH (EXpert Panel on effective ways of investing in Health). Opinion on Benchmarking Access to Healthcare in the EU.

Faced with growing evidence that some groups within European Union Member States have been unable to achieve access to necessary healthcare, the European Union has committed to action to reduce levels of unmet need, most recently as an element of the European Pillar of Social Rights. In response, the Expert Panel on Effective Ways of Investing in Health has been requested to propose a series of quantitative and qualitative benchmarks for assessing progress in reducing unmet need for healthcare and to discuss means by which EU funds or other mechanisms might be used to improve access to healthcare. A first step is to define need for healthcare. This is the ability to benefit from it, meaning that the individual in question has a condition that causes him or her to be in less than good health but also that there is a treatment available that can improve their health, whether curative, life-sustaining or enhancing, or merely palliative. While recognising that there may be clinical reasons, such as low levels of cost effectiveness, for denying treatment in the face of limited resources, treatment should never be withheld on moral grounds. In practice, however, there are many challenges involved in measuring unmet need for particular interventions, precluding its routine use. Consequently, a pragmatic solution involves the use of survey data in which individuals are asked whether they have experienced a need for healthcare but were unable to obtain that care. These data are collected throughout the European Union annually in the Survey of Income and Living Conditions (EU-SILC), with subsidiary questions that ask about the reasons for unmet need. The report of the Panel recognises that this approach has a number of limitations, and also that there are other sources of data that provide insights into the extent to which you need for healthcare is being met, including comparative data on outcomes related to healthcare, but for the present, the EU-SILC data are the only timely and comparable source of information available across all Member States. Using this measure, the Panel draws attention to persisting evidence of relatively high rates of unmet need in some Member States, and some groups within them. The Panel notes that, consistent with the political objective of achieving convergence within the European Union, there is a strong argument for setting a target for unmet need that is close to that already achieved by the most privileged group within the best performing Member State. However, given the very differing starting positions, the Panel considers that this is, for the present time, unrealistic. It is beyond the scope of the Panel to propose a precise target for reduction in unmet need, given that this will require the commitment of financial and other resources. Instead, the Panel has proposed a mechanism for setting such a target. This involves setting a benchmark of the median value achieved by the best performing Member States, with the expectation that those Member States not yet achieving it should narrow the gap by a given percentage, which might be around 50%, over a defined period of time, which might be three years. Such a target would be ambitious, requiring a significantly faster rate of reduction and has been achieved in recent years in many Member States but, in our view, would be achievable. The Panel was also asked to identify second level indicators. Taking a pragmatic approach, based on the availability of data, it proposes that this should follow the questions that are included in the EU-SILC data. These provide information on affordability, availability, and acceptability of health services. The Panel did, however, note the importance of developing additional sources of data that can be collected regularly to provide more detailed insights into the levels, patterns, and determinants of unmet need for healthcare across the European Union. The Panel was requested to identify qualitative measures of unmet need. This is particularly challenging, given the many and diverse reasons for unmet need for healthcare, both among and within Member States. The Panel was not convinced that a standard reporting system was appropriate. Rather, it was recommended that each Member State identify those groups that are most likely to be disadvantaged, according to factors such as age, gender, education, ethnicity, or employment status, analyse the appropriate data, and prepare a report on the level and pattern of unmet need among disadvantaged groups, accompanied by recommendations for action. The Panel also note the value of shadow reports produced by civil society organisations in other areas and encourages the production of such reports. Finally, the Panel reviews the scope for using European Union funds to improve access to healthcare. It notes that, as the problems facing each Member State differ, as well as the extent to which each of them is eligible for different forms of support. However, it notes that there are many opportunities for using vehicles such as Structural Funds, research funds, and European Reference Networks

EXPH (EXpert Panel on effective ways of investing in Health). Opinion on Vaccination Programmes and Health Systems in the European Union.

Vaccination is one of the most cost-effective public health interventions available and the main tool for primary prevention of communicable diseases. However, the EU is facing increasing outbreaks of vaccine preventable diseases, while some fatal cases of measles and diphtheria have been reported. This opinion identifies the main factors (enablers and obstacles) influencing vaccination uptake, and assesses measures that can be expected to improve vaccination coverage. After providing a systems approach to national vaccination programmes (including an appropriate legislative framework, governance arrangements, existence of a register of the target population, funding mechanisms and monitoring), a range of obstacles and enablers of high rates of vaccination coverage are identified. Obstacles to vaccination coverage include individuals’ and parents’ concerns or fears about vaccine safety and side effects, lack of trust, social norms, exposure to rumours and myths undermining confidence in vaccines, failure by some healthcare providers to counter these myths and provide evidence-informed advice, access barriers (e.g. poor availability, copayments), and failure to understand the underlying mechanisms that decrease vaccination confidence. Enablers include sources of reliable information about vaccination, exposure to positive media messages, building trust in institutions and providers, building confidence in vaccination, easy access and availability to healthcare services, ease of administration, active involvement and engagement by healthcare providers, and targeting of high-risk groups. There is a range of policy options that countries can implement to increase vaccination coverage. Communication strategies about the benefits of vaccination are important but need to be combined with opportunities for dialogue with vaccine hesitant groups and participatory approaches. These strategies need to be targeted not only at the uninformed (i.e. the lack of information) but also at the misinformed (when the information is incorrect) or disinformed (when information is spread with the intention to deceive). Vaccination is mandatory in some countries and recommended in others. When mandatory, it can be unpopular with some individuals or groups, which reinforces the case for good communication strategies to improve acceptability. One policy option is to allow individuals to opt out of vaccination subject to certain conditions to be determined depending on the institutional context (e.g. an exception process which includes a mandatory consultation and dialogue with a healthcare worker who can make individuals and parents aware of the risk of not being covered) but only if vaccination coverage levels are sufficiently high to ensure herd immunity. Family physicians are well positioned to improve child vaccination rates given frequent interactions with parents and children with other illnesses or attending check-ups. These interactions can be used as opportunities to raise awareness. Family physicians and nurses do not have to be the exclusive providers of vaccines. Better access could be achieved by improving availability of vaccines from other providers (e.g. pharmacists, providers of community services, subject to appropriate training) and ensuring equity- driven vaccination programmes. Healthcare and other workers engaging in communication and dialogue related to vaccination should be supported with specific training to address vaccine concerns from hesitant individuals, in particular in relation to safety and side effects.There is scope for strengthening the monitoring and the surveillance systems at international, national and sub-national level to ensure up-to-date data to guide policy and planning at a regional and country level that will optimise coverage and impact, and identifying areas where low coverage is concentrated. Finally, as a comprehensive programme considers populations and individuals, there is scope for close co-operation and better integration of public health and primary care services, strengthening accountability towards a population of primary care

EXPH (Expert Panel on effective ways of investing in Health). Opinion on Application of the ERN model in European cross-border healthcare cooperation outside the rare diseases area.

European Reference Networks (ERNs) were created by the Directive on the Application of Patients’ Rights in Cross-Border Healthcare. They offer a means by which patients with rare and complex diseases can gain access to highly specialised knowledge from across the European Union. The Expert Panel has been asked to advise on areas that can benefit most from the ERN model, options for the new networks in the longer term and the roles that they might assume, and how best national health systems could integrate networks into their national frameworks. ERNs are still a very new concept, having been launched in March 2017. So far, 24 have been established, bringing together over 300 hospitals from 26 Member States. Given the short time that they have been operating, the Expert Panel concluded that it was premature to draw any conclusions on their effectiveness. Instead, it sought to understand how other networks with similar goals have operated within member states and the lessons that have been learned, coupled with interviews with two of the coordinators of existing ERNs. The Expert Panel concluded that, while ERNs have considerable potential to improve the care of patients with rare diseases across the EU, both through advice on the management of individual patients, as well as through collaboration on research and development of guidelines, it is not yet possible to ascertain the extent to which these goals will be achieved. The Expert Panel also identified several issues which, even at this stage, appeared to need to be addressed, including long-term financial sustainability and the implementation of effective IT systems. Turning to the specific questions asked of the Expert Panel, we firstly concluded that the current criteria for establishing a ERN, as a means of improving the management of patients with rare and complex diseases, was appropriate. The ERN concept does not address other issues raised for our consideration, such as remote areas and border regions, or the development of new medicines or interventions, for which there are alternative and more appropriate mechanisms. We were also asked about the scope to extend the scope of ERNs to other areas such as the care of people who are homeless or emergency situations. In both cases, we believe that there are better alternative mechanisms to achieve the intended goals. Secondly, we examined the scope of the ERNs, and in particular their relationship with research and guideline development. Given the current state of implementation, it is not possible to come to a definitive conclusion, but we were persuaded by the arguments that there is considerable scope for incorporating these additional roles beyond the immediate objective of providing advice on individual patients. This will, however, require dedicated resources, some of which will have to come from other sources. Thirdly, while reinforcing the importance of ERN is to link with national health systems, the diversity of systems within Member States makes it impossible to provide detailed guidelines for how this can best be made to work. This is another area where it will be important to monitor the implementation of the existing ERNs and disseminate the lessons that arise from their experiences

EXPH (EXpert Panel on effective ways of investing in Health). Opinion on Tools and Methodologies for Assessing the Performance of Primary Care.

The report "Tools and methodologies for assessing the performance of primary care” starts with a definition of the role and goals of primary care, based on previous opinions by the EXPH. From the primary care definition formulated in 2014, 8 domains and dimensions of primary care can be defined. Additionally, the domains of primary care organisation and human resources are added, so that 10 dimensions are eventually identified. This opinion uses the adapted framework of structure, process and outcome as developed by Donabedian. Starting from the question "How is primary care structured?", a performance assessment system for primary care is defined, focusing on how access to primary care services occurs, how providers of primary care are organised, and how resources are managed in the system. With regards to the processes through which primary care is delivered, coordination of care and integration are described. When it comes to "outcomes" of primary care, the opinion examines relevance, equity, quality and financial sustainability. The need for using professional, contextual and policy evidence, when describing quality of care is emphasized. All these dimensions are translated into indicators: presenting on the one hand, a set of comparative key-indicators, and on the other hand, descriptive additional indicators. The EXPH proposes examples of comparative key-indicators related to the 10 domains of primary care that are identified. The procedural steps that are required for a performance assessment system are explored including: multi-dimensionality, shared design, evidence-based, benchmarking of results, timeliness and transparent disclosure. To ensure the selection of a set of indicators that are relevant to each health system, three criteria are proposed; alignment of indicators with objectives of the health system, ability to routinely collect the indicator, the validity and reliability of information. As a reality check, recent experiences from European countries, as documented by the EU Expert Group on Health Systems Performance Assessment, are considered. Actual problems and bottle necks in performance assessment in primary care are debated in the discussion, paying special attention to the importance of context when outcomes are reported. Finally, the report formulates recommendations for further development of the framework in the European Union

EXPH (EXpert Panel on effective ways of investing in Health). Opinion on Benchmarking Access to Healthcare in the EU.

Faced with growing evidence that some groups within European Union Member States have been unable to achieve access to necessary healthcare, the European Union has committed to action to reduce levels of unmet need, most recently as an element of the European Pillar of Social Rights. In response, the Expert Panel on Effective Ways of Investing in Health has been requested to propose a series of quantitative and qualitative benchmarks for assessing progress in reducing unmet need for healthcare and to discuss means by which EU funds or other mechanisms might be used to improve access to healthcare. A first step is to define need for healthcare. This is the ability to benefit from it, meaning that the individual in question has a condition that causes him or her to be in less than good health but also that there is a treatment available that can improve their health, whether curative, life-sustaining or enhancing, or merely palliative. While recognising that there may be clinical reasons, such as low levels of cost effectiveness, for denying treatment in the face of limited resources, treatment should never be withheld on moral grounds. In practice, however, there are many challenges involved in measuring unmet need for particular interventions, precluding its routine use. Consequently, a pragmatic solution involves the use of survey data in which individuals are asked whether they have experienced a need for healthcare but were unable to obtain that care. These data are collected throughout the European Union annually in the Survey of Income and Living Conditions (EU-SILC), with subsidiary questions that ask about the reasons for unmet need. The report of the Panel recognises that this approach has a number of limitations, and also that there are other sources of data that provide insights into the extent to which you need for healthcare is being met, including comparative data on outcomes related to healthcare, but for the present, the EU-SILC data are the only timely and comparable source of information available across all Member States. Using this measure, the Panel draws attention to persisting evidence of relatively high rates of unmet need in some Member States, and some groups within them. The Panel notes that, consistent with the political objective of achieving convergence within the European Union, there is a strong argument for setting a target for unmet need that is close to that already achieved by the most privileged group within the best performing Member State. However, given the very differing starting positions, the Panel considers that this is, for the present time, unrealistic. It is beyond the scope of the Panel to propose a precise target for reduction in unmet need, given that this will require the commitment of financial and other resources. Instead, the Panel has proposed a mechanism for setting such a target. This involves setting a benchmark of the median value achieved by the best performing Member States, with the expectation that those Member States not yet achieving it should narrow the gap by a given percentage, which might be around 50%, over a defined period of time, which might be three years. Such a target would be ambitious, requiring a significantly faster rate of reduction and has been achieved in recent years in many Member States but, in our view, would be achievable. The Panel was also asked to identify second level indicators. Taking a pragmatic approach, based on the availability of data, it proposes that this should follow the questions that are included in the EU-SILC data. These provide information on affordability, availability, and acceptability of health services. The Panel did, however, note the importance of developing additional sources of data that can be collected regularly to provide more detailed insights into the levels, patterns, and determinants of unmet need for healthcare across the European Union. The Panel was requested to identify qualitative measures of unmet need. This is particularly challenging, given the many and diverse reasons for unmet need for healthcare, both among and within Member States. The Panel was not convinced that a standard reporting system was appropriate. Rather, it was recommended that each Member State identify those groups that are most likely to be disadvantaged, according to factors such as age, gender, education, ethnicity, or employment status, analyse the appropriate data, and prepare a report on the level and pattern of unmet need among disadvantaged groups, accompanied by recommendations for action. The Panel also note the value of shadow reports produced by civil society organisations in other areas and encourages the production of such reports. Finally, the Panel reviews the scope for using European Union funds to improve access to healthcare. It notes that, as the problems facing each Member State differ, as well as the extent to which each of them is eligible for different forms of support. However, it notes that there are many opportunities for using vehicles such as Structural Funds, research funds, and European Reference Networks

EXPH (EXpert Panel on effective ways of investing in Health), Opinion on Innovative payment models for high-cost innovative medicines.

The growth of pharmaceutical expenditures due to new high-cost innovative medicines, under the current institutional framework, creates financial challenges to health systems. The recognition that the current path of growth cannot be continued indefinitely leads to the search of new ways to ensure that innovation “that matters” is produced, that patients have access to innovation and that health systems are financially sustainable. This context leads to the discussion of innovative payment models for new medicines that improves the way the three above-mentioned objectives are met. It is unlikely that a single payment model will be optimal for all situations. Some broad principles should be observed when defining specific payment models for innovative medicines and deciding on rewarding R&D in pharmaceutical products: • Greater price and cost transparency, including the acknowledgement that high prices (high costs to payers) may or may not have underlying high costs of R&D. • Revisit the promotion of innovation through patent law and market exclusivity, as other mechanisms to promote and reward high-value innovations can and should be devised. This is particularly true when clear areas of neglected attention can be identified in a consensual way. The patent system is the current best option for decentralized innovation efforts when consumers are price sensitive, but not necessarily otherwise. This opens space to explore new models of promoting innovation that will encompass novel payment models which may or may not be associated with different rules in R&D funding (say, making use of prize-awarding mechanisms). • Develop methodologies to measure the social value of pharmaceutical products and systematically use such methods, for instance in the context of Health Technology Assessment. • Have an assessment of exercise of market power in each price negotiation, as insurance protection set by health systems reduces the role of consumer’s price sensitivity in limiting price increases of new products under patent protection. • Set better rewards for higher therapeutic value added, so that innovation efforts are directed to the more relevant areas. • Payment systems should evolve in the direction of paying for acquisition of a service (treatment) and not of a product (pill). • Explore non-linear payment systems, including bundling, price-volume agreements, differentiation across geographies, and across indications, ensuring the conditions required for all parties to benefit. • Create dialogue platforms involving all relevant stakeholders

How to govern the digital transformation of health services

The impact of digitalization of health services has been profound and is expected to be even more profound in the future. It is important to evaluate whether digital health services contribute to health system goals in an optimal way. This should be done at the level of the service, not the 'digital transformation'. Decisions to adopt new digital health services, at different levels of the health care system, are ideally based on evidence regarding their performance in light of health system goals. In order to evaluate this, a broad perspective should be taken in evaluations of digital health services. Attainment of the broad health system goals, including quality, efficiency and equity, are objectives against which to judge new digital health services. These goals in a broad sense are unaltered by the process of digitalization. Governance should be designed and tailored in such a way to capture all relevant changes in an adequate way. When evaluating digital health services many specific aspects need to be considered. Like for other innovations and (new) technologies, such promises may or may not materialize and potential benefits may also be accompanied by unintended and/or negative (side) effects in the short or long term. Hence, the introduction, implementation, use and funding of digital health technologies should be carefully evaluated and monitored. Governments should play a more active role in the further optimization both of the process of decision making (both at the central and decentral level) and the related outcomes. They need to find a balance between centralized and decentralized activity. Moreover, the broader preparation of the health care system to be able to deal with digitalization, from education, through financial and regulatory preconditions, to implementation of monitoring systems to monitor its effects on health system performance remains important