The risk of revision is higher following shoulder hemiarthroplasty compared with total shoulder arthroplasty for osteoarthritis: a matched cohort study of 11,556 patients from the National Joint Registry, UK.

BACKGROUND AND PURPOSE: Total shoulder arthroplasty (TSA) and hemiarthroplasty (HA) are used in the management of osteoarthritis of the glenohumeral joint. We aimed to determine whether TSA or HA resulted in a lower risk of adverse outcomes in patients of all ages with osteoarthritis and an intact rotator cuff and in a subgroup of patients aged 60 years or younger. PATIENTS AND METHODS: Shoulder arthroplasties recorded in the National Joint Registry, UK, between April 1, 2012 and June 30, 2021, were linked to Hospital Episode Statistics in England. Elective TSAs and HAs were matched on propensity scores based on 11 variables. The primary outcome was all-cause revision. Secondary outcomes were combined revision/non-revision reoperations, 30-day inpatient complications, 1-year mortality, and length of stay. 95% confidence intervals (CI) were reported. RESULTS: 11,556 shoulder arthroplasties were included: 7,641 TSAs, 3,915 HAs. At 8 years 95% (CI 94-96) of TSAs and 91% (CI 90-92) of HAs remained unrevised. The hazard ratio (HR) varied across follow-up: 4-year HR 2.7 (CI 1.9-3.5), 8-year HR 2.0 (CI 0.5-3.5). Rotator cuff insufficiency was the most common revision indication. In patients aged 60 years or younger prosthesis survival at 8 years was 92% (CI 89-94) following TSA and 84% (CI 80-87) following HA. CONCLUSION: The risk of revision was higher following HA in patients with osteoarthritis and an intact rotator cuff. Patients aged 60 years and younger had a higher risk of revision following HA.

Resource allocation in public sector programmes: does the value of a life differ between governmental departments?

BACKGROUND: The value of a life is regularly monetised by government departments for informing resource allocation. Guidance documents indicate how economic evaluation should be conducted, often specifying precise values for different impacts. However, we find different values of life and health are used in analyses by departments within the same government despite commonality in desired outcomes. This creates potential inconsistencies in considering trade-offs within a broader public sector spending budget. We provide evidence to better inform the political process and to raise important issues in assessing the value of public expenditure across different sectors. METHODS: Our document analysis identifies thresholds, explicitly or implicitly, as observed in government-related publications in the following public sectors: health, social care, transport, and environment. We include both demand-side and supply-side thresholds, understood as societies' and governments' willingness to pay for health gains. We look at key countries that introduced formal economic evaluation processes early on and have impacted other countries' policy development: Australia, Canada, Japan, New Zealand, the Netherlands, and the United Kingdom. We also present a framework to consider how governments allocate resources across different public services. RESULTS: Our analysis supports that identifying and describing the Value of a Life from disparate public sector activities in a manner that facilitates comparison is theoretically meaningful. The optimal allocation of resources across sectors depends on the relative position of benefits across different attributes, weighted by the social value that society puts on them. The value of a Quality-Adjusted Life Year is generally used as a demand-side threshold by Departments of transport and environment. It exceeds those used in health, often by a large enough proportion to be a multiple thereof. Decisions made across departments are generally based on an unspecified rationing rule. CONCLUSIONS: Comparing government expenditure across different public sector departments, in terms of the value of each department outcome, is not only possible but also desirable. It is essential for an optimal resource allocation to identify the relevant social attributes and to quantify the value of these attributes for each department.

The Allocation of the Economic Value of Second-Generation Antipsychotics Over the Product Life Cycle: The Case of Risperidone in Sweden and the United Kingdom.

OBJECTIVE: This article estimates the life-cycle value of risperidone as representative of second-generation antipsychotics (SGA) relative to haloperidol (first-generation antipsychotics). METHODS: We estimated the number of patients treated with risperidone in Sweden and the United Kingdom, from 1994 to 2017, using data of usage and volume sales. We collected data from the literature on the effectiveness (quality-adjusted life-years per patient per year), direct costs (health services), and indirect costs (productivity) of risperidone and haloperidol. We proxied the incremental value added by the new class (SGA) using a comparator from the inferior class. Next, we modeled the life-cycle uptake of risperidone to estimate the life-cycle incremental cost (ie, direct, indirect, and medicine costs), incremental quality-adjusted life-years, and net monetary benefit of risperidone. We also assessed the life-cycle distribution of the social surplus between the payer (consumer surplus) and the innovator (producer surplus). RESULTS: For the United Kingdom, consumer surplus represents around 72% of the total surplus before patent expiration and around 95% after patent expiration. For Sweden, the consumer surplus represents around 94% of the total surplus before patent expiration and around 99% after generic competition. CONCLUSION: These results suggest that the value added by SGAs to the system is higher than the expected value estimated using cost-effectiveness analysis at launch. Pricing and reimbursement decisions could recognize the full life cycle of value of innovative medicines. This not only presents a challenge of estimation but also of assessing the appropriate division of shares of social value.

Estimating health system opportunity costs: the role of non-linearities and inefficiency.

BACKGROUND: Empirical estimates of health system opportunity costs have been suggested as a basis for the cost-effectiveness threshold to use in Health Technology Assessment. Econometric methods have been used to estimate these in several countries based on data on spending and mortality. This study examines empirical evidence on four issues: non-linearity of the relationship between spending and mortality; the inclusion of outcomes other than mortality; variation in the efficiency with which expenditures generate health outcomes; and the relationship among efficiency, mortality rates and outcome elasticities. METHODS: Quantile Regression is used to examine non-linearities in the relationship between mortality and health expenditures along the mortality distribution. Data Envelopment Analysis extends the approach, using multiple measures of health outcomes to measure efficiency. These are applied to health expenditure data from 151 geographical units (Primary Care Trusts) of the National Health Service in England, across eight different clinical areas (Programme Budget Categories), for 3 fiscal years from 2010/11 to 2012/13. RESULTS: The results suggest differences in efficiency levels across geographical units and clinical areas as to how health resources generate outcomes, which indicates the capacity to adjust to a decrease in health expenditure without affecting health outcomes. Moreover, efficient units have lower absolute levels of mortality elasticity to health expenditure than inefficient ones. CONCLUSIONS: The policy of adopting thresholds based on estimates of a single system-wide cost-effectiveness threshold assumes a relationship between expenditure and health outcomes that generates an opportunity cost estimate which applies to the whole system. Our evidence of variations in that relationship and therefore in opportunity costs suggests that adopting a single threshold may exacerbate the efficiency and equity concerns that such thresholds are designed to counter. In most health care systems, many decisions about provision are not made centrally. Our analytical approach to understanding variability in opportunity cost can help policy makers target efficiency improvements and set realistic targets for local and clinical area health improvements from increased expenditure.

Supply-Side Cost-Effectiveness Thresholds: Questions for Evidence-Based Policy.

There is growing interest in cost-effectiveness thresholds as a tool to inform resource allocation decisions in health care. Studies from several countries have sought to estimate health system opportunity costs, which supply-side cost-effectiveness thresholds are intended to represent. In this paper, we consider the role of empirical estimates of supply-side thresholds in policy-making. Recent studies estimate the cost per unit of health based on average displacement or outcome elasticity. We distinguish the types of point estimates reported in empirical work, including marginal productivity, average displacement, and outcome elasticity. Using this classification, we summarise the limitations of current approaches to threshold estimation in terms of theory, methods, and data. We highlight the questions that arise from alternative interpretations of thresholds and provide recommendations to policymakers seeking to use a supply-side threshold where the evidence base is emerging or incomplete. We recommend that: (1) policymakers must clearly define the scope of the application of a threshold, and the theoretical basis for empirical estimates should be consistent with that scope; (2) a process for the assessment of new evidence and for determining changes in the threshold to be applied in policy-making should be created; (3) decision-making processes should retain flexibility in the application of a threshold; and (4) policymakers should provide support for decision-makers relating to the use of thresholds and the implementation of decisions stemming from their application.

The cost-per-QALY threshold in England: Identifying structural uncertainty in the estimates.

Introduction: There are increasing numbers of estimates of opportunity cost to inform the setting of thresholds as ceiling cost-per-quality-adjusted life year (QALY) ratios. To understand their ability to inform policy making, we need to understand the degree of uncertainty surrounding these estimates. In particular, do estimates provide sufficient certainty that the current policy "rules" or "benchmarks" need revision? Does the degree of uncertainty around those estimates mean that further evidence generation is required? Methods: We analyse uncertainty and methods from three papers that focus on the use of data from the NHS in England to estimate opportunity cost. All estimate the impact of expenditure on mortality in cross-sectional regression analyses and then translate the mortality elasticities into cost-per-QALY thresholds using the same assumptions. All three discuss structural uncertainty around the regression analysis, and report parameter uncertainty derived from their estimated standard errors. However, only the initial, seminal, paper explores the structural uncertainty involved in moving from the regression analysis to a threshold. We discuss the elements of structural uncertainty arising from the assumptions that underpin the translation of elasticities to thresholds and seek to quantify the importance of some of the effects. Results: We find several sets of plausible structural assumptions that would place the threshold estimates from these studies within the current National Institute for Health and Care Excellence (NICE) range of £20,000 to £30,000 per QALY. Heterogeneity, an additional source of uncertainty from variability, is also discussed and reported. Discussion: Lastly, we discuss how decision uncertainty around the threshold could be reduced, setting out what sort of additional research is required, notably in improving estimates of disease burden and of the impact of health expenditure on quality of life. Given the likely value to policy makers of this research it should be a priority for health system research funding.

EQ-5D-5L Health-State Values for the Mexican Population.

OBJECTIVE: To generate a value set for the Mexican adult general population to support and facilitate the inclusion of quality-adjusted life years (QALYs) into the health technology assessment process of the Mexican healthcare authorities. METHODS: A representative sample of the Mexican adult population stratified by age, sex and socio-economic status was used. Following version 2.0 of the EuroQol EQ-5D-5L valuation protocol, trained interviewers guided participants in completing composite time trade-off (cTTO) and discrete-choice experiment (DCE) tasks included in the EQ-VT software. Generalized least squares, Tobit and Bayesian models were used for cTTO data. The choice of value set model was based on criteria that included: theoretical considerations, parsimony, logical ordering of coefficients, and statistical significance. RESULTS: Based on quality control criteria and interviewer judgment, 1000 out of 1032 participants provided useable responses. Participants' demographic characteristics were similar to the 2010 Mexican Population Census and followed the socioeconomic structure defined by the Mexican Association of Marketing Research and Public Opinion Agencies (AMAI). The predicted index values in the final cTTO model (a heteroscedastic censored model with Bayesian estimation) ranged from - 0.5960 to 1, with 19.7% of all predicted health state scores less than 0 (i.e., worse than dead). CONCLUSION: This study has generated the first value set representing the stated preferences of the Mexican adult population for use in estimating QALYs. The resulting EQ-5D-5L value set is technically robust and will facilitate health economic analyses as well as quality-of-life studies.

Reconciling ACEA and MCDA: is there a way forward for measuring cost-effectiveness in the U.S. healthcare setting?

BACKGROUND: The ISPOR Special Task Force (STF) on US Value Assessment Frameworks was agnostic about exactly how to implement the quality-adjusted life year (QALY) as a key element in an overall cost-effectiveness evaluation. But the STF recommended using the cost-per-QALY gained as a starting point in deliberations about including a new technology in a health plan benefit. The STF offered two major alternative approaches-augmented cost-effectiveness analysis (ACEA) and multi-criteria decision analysis (MCDA)-while emphasizing the need to apply either a willingness-to-pay (WTP) or opportunity cost threshold rule to operationalize the inclusion decision. METHODS: The MCDA model uses the multi-attribute utility function. The ACEA model is based on the expected utility theory. In both ACEA and MCDA models, value trade-offs are derived in a hierarchical model with two high-level objectives which measure overall health gain separately from financial attributes affecting consumption. RESULTS: Even though value trade-offs can be elicited or revealed without considering budget constraints, we demonstrate that they can be used similarly to WTP-based cost-effectiveness thresholds for resource allocation decisions. The consideration of how costs of medical technology, income, and severity of disease affect value trade-offs demonstrates, however, that reconciling decisions in ACEA and MCDA requires that health and consumption are either complements or independent attributes. CONCLUSIONS: We conclude that value trade-offs derived either from ACEA or MCDA move similarly with changes in main factors considered by enrollees and decision makers-costs of the medical technology, income, and severity of disease. Consequently, this complementarity between health and consumption is a necessary condition for reconciling ACEA and MCDA. Moreover, their similarity would be further enhanced if the QALY is used as the key attribute or anchor in the MCDA value function: the choice between the two is a pragmatic question that is still open.

Examining the variation across acute trusts in patient delayed discharge.

Delayed transfers of care, or delayed discharges, adversely affect patient care and increase costs to England's National Health Service. The main objective of this paper is to explain variation in the probability of delayed discharge from an acute trust and patient perspective. A novel approach is employed in using the Adult Inpatient Survey over the period 2007-2014. We use a two stage regression model to assess the impact of various patient, acute hospital trust, and regional characteristics on the probability of delayed discharge. In the first stage we model the patient-level probability of delayed discharge and estimate hospital trust-specific fixed-effects. Stage two includes multiple linear regressions to explain acute trust fixed effects from stage one by using acute trust characteristics and regional observable characteristics as explanatory variables. Results indicate the probability of delayed discharge varies among acute trusts and patients. Patient-mix complexity, staff skill-mix, size and scope of acute trust are among those factors affecting the trust-specific discharge efficiency.

Augmenting Cost-Effectiveness Analysis for Uncertainty: The Implications for Value Assessment-Rationale and Empirical Support.

DISCLOSURES: This study received unrestricted funding from the Pharmaceutical Research Manufacturers of America. The authors also do consulting, personally or through their employment, with numerous pharmaceutical manufacturers, payers, and other stakeholders with a general interest in this subject matter.

The Value of Diagnostic Information in Personalised Healthcare: A Comprehensive Concept to Facilitate Bringing This Technology into Healthcare Systems.

Health systems around the world seek to address patients' unmet health needs for a range of acute and chronic diseases. Simultaneously, governments strive to keep healthcare spending sustainable, while providing equal access to high-quality care. This has fuelled debate around what constitutes a valuable healthcare intervention in a health system and the corollary consideration of what governments are willing to pay for a certain health intervention. Until recently, the value of information in general, and the value of diagnostic information (VODI) specifically, was not part of the discussion.However, investment in diagnostic information can be a key development as information may guide more effective and efficient healthcare and help maintain an affordable health system. This paper therefore explores ways to best define, evaluate, and reward the value created from diagnostics in healthcare and how to include these value considerations in decision-making processes for diagnostics. The authors ultimately call for a holistic VODI framework that accounts for the full range of potential benefits of diagnostic testing, beyond the traditional clinical and health economic domains, and that is essential to recognise, measure, and fully leverage the benefits of diagnostics for patients, health systems, and society.

Comparing access to orphan medicinal products in Europe.

OBJECTIVES: The primary objective of this study was to compare the availability and access of orphan medicinal products (OMPs) in the devolved nations in the United Kingdom (UK), France, Germany, Italy and Spain. Availability is defined as the possibility to prescribe OMPs. Access refers to their full or partial reimbursement by the public health service. METHODS: Data were collated on: marketing authorisations, Health Technology Assessment (HTA) decisions, commissioning, and reimbursement decisions, and respective dates of these events for all the OMPs centrally authorised. Indicators of availability of and access to OMPs were calculated in each country and compared. RESULTS: We found that since the implementation of the OMPs Regulation in 2000 to end of May 2016, 143 OMPs obtained a marketing authorisation in the European Union. These OMPs are most widely accessible in Germany and France. In the other countries between 30 and 60% of OMPs are reimbursed. In particular in England, less than 50% of centrally authorised OMPs are routinely funded by the NHS, with one-third of these recommended by NICE. In Germany reimbursement is automatically granted to all medicines which receive a marketing authorisation, immediately after authorisation - but since 2011, there is an evaluation and potentially a pricing negotiation between companies and sickness funds (third party payers). In the other countries, the shortest time from authorisation to a reimbursement decision is observed in Italy and France where it takes 18.6 and 19.5 months respectively on average. CONCLUSIONS: Marketing authorisation granted to OMPs is only the first step, as medicines reach patients when reimbursement decisions are implemented by national health systems (this applies to non-OMPs too). We found that more than a half of centrally authorised OMPs were available in the five selected countries, but that access to patients was further restricted by different national reimbursement policies, especially in the UK, Italy and Spain.

Distribution of the EQ-5D-5L Profiles and Values in Three Patient Groups.

BACKGROUND: The distribution of EQ-5D-3L values (health state profiles, weighted by value sets) often shows two distinct groups, arising from both the distribution of profiles and the characteristics of value sets. To date, there is little evidence about the distribution of EQ-5D-5L values. OBJECTIVES: To explore the distribution of EQ-5D-5L profiles; to compare the distributions of EQ-5D-5L values arising from the English value set (EVS) and a 'mapped' value set (MVS); and to develop further the methods used to investigate clustering within EQ-5D data. METHODS: We obtained data from Cambridgeshire Community Services NHS Trust containing EQ-5D-5L profiles before treatment for three patient groups: community rehabilitation (N=6919); musculoskeletal physiotherapy (N=19999); and specialist nursing services (N=3366). Values were calculated using the EVS and MVS. Clusters were examined using the k-means method and Calinski-Harabasz pseudo-F index stopping rule. RESULTS: We found no evidence for clustering of EQ-5D-5L values arising from the classification system and no strong or consistent evidence of clustering arising from the EVS. There was clearer evidence of clustering using the MVS, with two being the optimal number of clusters. The clusters that were found for the EVS were very different from the MVS clusters. CONCLUSIONS: Unlike the EQ-5D-3L, clustering of EQ-5D-5L values does not seem to be driven by clustering of its profile. This suggests the EQ-5D-5L is superior in that it is less likely to generate artefactual clusters - however, clusters may still result from using value sets such as MVS that have the tendency to generate them.

Does hospital ownership affect patient experience? An investigation into public-private sector differences in England.

Using patient experience survey data, the paper investigates whether hospital ownership affects the level of quality reported by patients whose care is funded by the National Health Service in areas other than clinical quality. We estimate a switching regression model that accounts for (i) some observable characteristics of the patient and the hospital episode; (ii) selection into private hospitals; and (iii) unmeasured hospital characteristics captured by hospital fixed effects. We find that the experience reported by patients in public and private hospitals is different, i.e. most dimensions of quality are delivered differently by the two types of hospitals, with each sector offering greater quality in certain specialties or to certain groups of patients. However, the sum of all ownership effects is not statistically different from zero at sample means. In other words, hospital ownership in and of itself does not affect the level of quality of the average patient's reported experience. Differences in mean reported quality levels between the private and public sectors are entirely attributable to patient characteristics, the selection of patients into public or private hospitals and unobserved characteristics specific to individual hospitals, rather than to hospital ownership.

Provider diversity in the English NHS: a study of recent developments in four local health economies.

OBJECTIVES: To assess the impact of provider diversity on quality and innovation in the English NHS by mapping the extent of diverse provider activity and identifying the differences in performance between Third Sector Organisations (TSOs), for-profit private enterprises, and incumbent organizations within the NHS, and the factors that affect the entry and growth of new providers. METHODS: Case studies of four local health economies. Data included: semi-structured interviews with 48 managerial and clinical staff from NHS organizations and providers from the private and third sector; some documentary evidence; a focus group with service users; and routine data from the Care Quality Commission and Companies House. Data collection was mainly between November 2008 and November 2009. RESULTS: Involvement of diverse providers in the NHS is limited. Commissioners' local strategies influence degrees of diversity. Barriers to entry for TSOs include lack of economies of scale in the bidding process. Private providers have greater concern to improve patient pathways and patient experience, whereas TSOs deliver quality improvements by using a more holistic approach and a greater degree of community involvement. Entry of new providers drives NHS trusts to respond by making improvements. Information sharing diminishes as competition intensifies. CONCLUSIONS: There is scope to increase the participation of diverse providers in the NHS but care must be taken not to damage public accountability, overall productivity, equity and NHS providers (especially acute hospitals, which are likely to remain in the NHS) in the process.