Savings from reducing low-value general surgical interventions.

BACKGROUND: Finding opportunities for improving efficiency is important, given the pressure on national health budgets. Identifying and reducing low-value interventions that deliver little benefit is key. A systematic literature evaluation was done to identify low-value interventions in general surgery, with further assessment of their cost. METHODS: A multiplatform method of identifying low value interventions was undertaken, including a broad literature search, a targeted database search, and opportunistic sampling. The results were then stratified by impact, assessing both frequency and cost. RESULTS: Seventy-one low-value general surgical procedures were identified, of which five were of high frequency and high cost (highest impact), 22 were of high cost and low frequency, 23 were of low cost and high frequency, and 21 were of low cost and low frequency (lowest impact). Highest impact interventions included inguinal hernia repair in minimally symptomatic patients, inappropriate gastroscopy, interval cholecystectomy, CT to diagnose appendicitis and routine endoscopy in those who had CT-confirmed diverticulitis. Their estimated cost was €153 383 953. CONCLUSION: Low-value services place a burden on health budgets. Stopping only five high-volume, high-cost general surgical procedures could save the National Health Service €153 million per annum.

An evaluation of the quality of evidence available to inform current bone conducting hearing device national policy.

OBJECTIVES: In 2016, NHS England published the commissioning policy on Bone Conducting Hearing Devices (BCHDs). This policy was informed by updated evidence on the clinical and cost-effectiveness of BCHDs as well as by the 2013 Bone Anchored Hearing Aid (BAHA) policy. Commissioning policies set the criteria for service delivery and therefore have a major impact on the care received by patients. It is important that stakeholders have a good appreciation of the available evidence informing policy, as this will promote engagement both with the policy and with future research leading on from the policy. In this article, we provide stakeholders with a transparent and pragmatic assessment of the quality of the body of evidence available to inform current BCHD national policy. METHOD: (i) A systematic review of the literature on BCHDs published since the development of the 2013 policy was performed in September 2016, adhering to PRISMA recommendations. The search terms used were as follows bone conduction; bone conducting; bone anchor; BAHA; Bone Anchored Hearing Aid; Bone Conducting Hearing Device; BCHD; Bone Conducting Hearing Implant; BCHI; Sophono; Bonebridge; Soundbite; Ponto; Hearing aid; implant; device; hearing device. Publications that could inform current BCHD policy were included. The quality of included articles was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. (ii) The quality of evidence referenced by the 2013 BAHA policy was assessed using the GRADE system. RESULTS: (i) Of the 2576 publications on BCHDs identified by the systematic search, 39 met the inclusion criteria for further analysis. Using the GRADE criteria, the quality of evidence was classified as of 'very low quality'. (ii) The 2013 BAHA policy was informed by 14 references. The GRADE system classifies the quality of evidence that informed the policy as of 'very low quality'. CONCLUSIONS: The GRADE system defines the body of evidence available to inform current national BCHD policy as of 'very low quality'. There is an urgent need for high-quality research to help make informed policy decisions about the care of patients with hearing loss. An (inter)national registry of BCHDs could address this need.

Genetic testing and insurance: opportunities and challenges for society.

The increased availability of genetic tests poses new challenges to society. Here, we address the wider implications of genetic testing, with an emphasis on the markets for insurance. It also considers issues such as confidentiality, patient autonomy and fear of discrimination and the doctor-patient relationship.

Outstanding regulatory aspects in the European pharmaceutical market.

This paper identifies and analyses a number of outstanding regulatory aspects in the completion of the European pharmaceutical single market. It discusses pricing and competition in pharmaceuticals in the aftermath of the 3 Frankfurt Roundtables and their results. It analyses the environment for generic competition in the European Union (EU) and the extent to which this environment needs to be amended in order for such competition to be promoted. It links the issues of parallel trade, standardisation, single trademark, the European databank and the definition of innovation with the current situation in the functioning of the single market, particularly the sovereignty of the member states in determining pricing and reimbursement levels. It argues that the above problems need to be tackled in conjunction with pricing and reimbursement. The paper further points at new developments, in particular biotechnology patenting and orphan drug regulation, where the EU has introduced or is about to introduce new legislation that has been needed for a long time and examines how this legislation can be beneficial. Finally, the paper analyses the implications for healthcare provision in the member states of 2 legal cases heard before the European Court of Justice in relation to the free movement of goods and healthcare provided across borders. The paper concludes that there is still a long list of regulatory aspects that remain unresolved despite the fact that significant progress has been made to date, and observes that economic analysis in pharmaceutical regulation is very much intertwined with political expediency. In addition, the definition of political expediency varies as one considers developments at the EU or national level, since it does not necessarily follow that individual actors coincide in opinion.

The impact of managed care on clinical research.

Traditionally, US teaching hospitals have subsidised research by charging higher costs for treatment; however, this approach is being challenged. The growth of managed-care organisations, concerned about maximising profits, has led many to argue that clinical research will be damaged, whether by the loss of internal funds for research or by reductions in the numbers of patients available for studies. This review examines the evidence on which this argument is based. There is some evidence that managed-care organisations are refusing to cover patients who are involved in clinical trials, although, in general, they are receptive towards research providing that it is explicit and seen as relevant. The indirect effects of competition are, arguably, more important. Although many academic centres have established strategies to protect research funds, those working in the most competitive healthcare environments are obtaining fewer externally funded research grants. They are also publishing fewer papers and are working in climates that are seen as less supportive, with less ability to undertake research that is not externally funded. There is little evidence that managed care is reducing access to patients for clinical research. The growth of managed care is, together with certain other trends, also influencing the nature of clinical research. The overall consequences of these different factors are difficult to predict, although there are grounds for concern about recruitment and retention of junior researchers. The relationship between the various actors involved in healthcare and research is dynamic and, as pressure is excerpted in a particular direction, others adapt. It may be some time before the consequences of policies being enacted now are apparent.

Will managed care work in Europe?

This paper examines major trends in healthcare reforms in the European Union Member States during the last decade. It focuses on managed care developments and shows that, to a certain extent, managed care in Europe is moving towards a consensus. The paper analyses major trends observed across the European Union including the establishment of overall budgets for health services, separation of purchasers from providers, competition between providers, capitation payments for doctors, budget controls on pharmaceutical expenditure and priority-setting methodologies. It then discusses the potential introduction of new forms of managed care and the current weaknesses in information needs and systems. Finally, the policy-makers' dilemmas for resource allocation are examined and a frame-work for policy debate is suggested.

International comparisons of health care expenditures: what we know and what we do not know.

International comparisons of health care expenditures and their determinants have attracted considerable attention since the early 1960s and have since been used widely to compare countries. The impetus for this has been two-fold: firstly, to assess the macroeconomic efficiency of health systems by determining whether different methods of financing and delivering health care have contributed to the control of overall spending levels; and, secondly, to investigate the determinants of the level of health care expenditure. Empirical research has suggested that there is a causal and statistically significant relationship between growth in health spending and growth in gross domestic product (GDP), and that an increase in the latter brings about a proportionately larger increase in the former. This relationship holds even when other potential determinants, such as urbanisation and age structure of the population, are included in the analysis, leading to the conclusion that health care is a luxury good. This paper examines the extent to which this finding is valid from a methodological perspective and how far it assists policy analysis. We argue that there are significant problems in the measurement of health spending and GDP, discuss the methodological problems in the analysis and suggest that the observed relationship between GDP and health spending is unhelpful and almost certainly misleading for health policy development.

Citizens and rationing: analysis of a European survey.

While many studies have reviewed the issues involved in rationing and priority setting within health care services, few studies have comprehensively analysed the views and attitudes of a significant stakeholder in the debate - the public. The aims of this paper are to discuss the issues involved in involving the public in rationing and priority setting decision-making; and to analyse data pertaining to citizen's attitudes towards rationing and priority setting. The data analysed were taken from the 1998 Eurobarometer Survey, with specific questions pertaining to rationing and priority setting asked in six countries within the European Union: Germany; France; Italy; the Netherlands; Britain and Sweden. The review of previous studies and the analysis of the Eurobarometer data, focus on issues relating to funding for health care; the need to set limits in health coverage; the role of stakeholders in setting priorities; and the use of age, and other factors, as a criteria for setting priorities.

Cost containment and health care reform: a study of the European Union.

This article gives a short summary of the organisation and financing of health services of the 12 Member States of the European Union. It then describes the latest developments in cost containment in each of the countries. The third section describes the new initiatives for reform in Spain, Italy, the Netherlands, Portugal and the United Kingdom. Finally, it gives a summary of the cost containment measures in the 12 countries, listing them under a set of headings. They are classified as budget control, alternatives to hospital care, cost sharing, influencing authorizing behaviour and limits on supply. The article shows the considerable convergence of policies which is developing. Overall budget control in some form is to be found in 8 of the countries. Where providers are paid by a number of different insurers, budgets are nevertheless applied to hospitals in three countries and in another only to public hospitals. Both Germany and France have used budgets to control other items of expenditure. Profits or the prices of drug companies are controlled in 8 countries and in one indirectly. Three have adopted reference price systems for drugs and another has taken powers to do so. Two have adopted or are moving towards provider markets.

Clinical practice and the UK Human Rights Act 1998: protecting individual rights in the interest of the wider community.

Health professionals have expressed concern that the UK Human Rights Act 1988, which came into force in 2000, may threaten their autonomy in clinical practice/decision-making and resource allocation by health authorities. Although healthcare-related cases have so far been slow to emerge under the Act, it seems clear that in clinical practice the transition from duty to legal obligation will involve a degree of change for health professionals, in attitude if not in behaviour. With regard to resource allocation, it appears that the UK courts are likely to consider challenges to health authorities' decisions in a way that takes into account the need to set priorities, so long as these decisions do not discriminate unfairly and can be shown to have been made in the best interest of the wider community.

Pharmaceutical expenditure in Spain: cost and control.

In recent years, the Spanish government has been battling to keep pharmaceutical expenditures under control. Its measures include control of prices, introduction of a "negative list" of drugs no longer reimbursed, increased cost-sharing, and introduction of overall budgets for pharmaceutical expenditures. Although the average prices of old pharmaceutical products declined by 39 percent over the last 15 years and consumption in value increased by only 10 percent, real pharmaceutical expenditures in Spain increased by 264 percent over that period. The main reason for the continuing rise in these expenditures and the failure of cost-containment measures is the introduction of new, more expensive drugs, which often fail to offer any real therapeutic advantages over products already on the market. This situation is exacerbated by a lack of effective demand-side measures such as budgets for doctors and lack of a generics market.

Affordably priced new drugs for poor populations: Approaches for a global solution.

A very large proportion of the world's population, particularly the poor in developing countries, still have insufficient access or none at all to treatment with essential drugs. This situation can arise with any drug and for various reasons, but it exists in extreme form where the drug is irreplaceable yet entirely unaffordable. That is the case with new or relatively recent drugs which could save lives or eradicate endemic disease, but which (particularly during their period of patent protection) are usually sold at prices higher than patients or their community can afford to pay. The consequences of this situation in terms of persistent illness, suffering and large-scale mortality are felt most immediately in the developing world, but because today disease travels so rapidly it represents a threat to the world as a whole. As of late 2001, only a number of limited ad hoc solutions to these problems have emerged. They have provided relief in a number of specific situations but they offer no guarantee of permanence, are applied mainly at the discretion of multinational companies or aid agencies and leave the bulk of the global problem unchanged. The problem must be capable of a broad and lasting solution since the basic costs of manufacturing and distributing most of the drugs in question are not in themselves prohibitive. High prices are primarily a consequence of the need to provide an adequate return on investment, to finance research and development, and to pay the very high costs of promotion in intensively competitive markets. At present, however, these secondary costs are almost entirely covered by the sales income from industrialized countries, and that is unlikely to change. In the developing world, where the sales of such drugs has been negligible, it must be possible to supply them in more adequate quantities, at a fair and affordable prices which are very close to the basic manufacturing and distribution costs. This will require an innovative commercial approach but it may not demand a sacrifice; in many instances it will be the key to opening new emergent markets where low profit margins can be outweighed by high unit sales. The feasibility of sharply differential pricing for drugs has indeed been demonstrated already in various countries and regions where specific agreements for low-cost supply have operated successfully, for example, for vaccines and contraceptives but also for some therapeutic drugs still protected by patent. If this type of approach can be extended so that important new drugs are as a matter of routine made available to developing countries at highly preferential prices it would contribute greatly to the solution of major health problems. Naturally a number of safeguards are necessary. The most important of these is that drugs sold at "minimal" prices to a developing country must not leak across its borders to be re-sold at a profit elsewhere. Experience with vaccine and contraceptive agreements shows that this risk can be virtually eliminated, although the parallels with therapeutic drugs are not exact and the possibility of theft and "leakage" might be greater with such items, especially where they have a high potential market value. Nor must a drug, which enters a developing country at a preferential price then be burdened by taxes, customs duties or excessive wholesale or retail profit margins that might again put it out of reach of those who need it. Again, one would not wish to discourage the further evolution of good-quality drug manufacturing in developing countries, which is already making an important contribution to health and to the national economy. Safeguards on these and other matters could well be incorporated into a global working agreement between all parties, seeking to define and promote the use of minimum-level pricing for vital new drugs. That agreement would be implemented through specific arrangements and unilateral initiatives of an already familiar type; these would be centrally registered and monitored, as would situations of ongoing need. In this way, activities could be better attuned to need, progress assessed and the entire situation rendered transparent.