The framework presented in the World Bank report Open and Inclusive: Fair processes for Financing Universal Health Coverage effectively connects proposed decision-making principles with practical examples that country governments can use to pursue greater fairness. In this commentary, we consider the suggestion that international development partners might use the report's criteria to examine their own processes. We consider what the report's primary Fair Process principles – equality, impartiality and consistency – imply for development partners. Specifically, we address two questions in turn: (i) how relevant the Fair Processes report is to development assistance for health; (ii) if it is deemed relevant, what practical implications does the report have for how aid works? We address the second question by briefly applying the framework to a particular global health initiative, namely the United States President's Emergency Plan for AIDS Relief (PEPFAR). Our analysis suggests that development partners' additional sets of accountabilities, particularly linked to funding sources, may pose more fundamental challenges to impartiality than to equality and consistency in decision-making processes. A question inviting further examination, then, is how development partners can redesign their processes to optimise impartiality given institutional constraints that bind them independently of the populations they purport to serve.

In response to our critics, we clarify and defend key ideas in the report Open and Inclusive: Fair Processes for Financing Universal Health Coverage. First, we argue that procedural fairness has greater value than Dan Hausman allows. Second, we argue that the Report aligns with John Kinuthia's view that a knowledgeable public and a capable civil society, alongside good facilitation, are important for effective public deliberation. Moreover, we agree with Kinuthia that the Report's framework for procedural fairness applies not merely within the health sector, but also to the wider budget process. Third, we argue that while Dheepa Rajan and Benjamin Rouffy-Ly are right that robust processes for equal participation are often central to a fair process, sometimes improvements in other aspects of procedural fairness, such as transparency, can take priority over strengthening participation. Fourth, while we welcome Sara Bennett and Maria Merritt's fascinating use of the Report's principles of procedural fairness to assess the US President's Emergency Plan for AIDS Relief, we argue that their application of the Report's principle of equality to development partners' decision-making requires further justification.

The increasing use of real-world evidence (RWE) and real-world data (RWD) to assess post-market medical devices (MDs) might satisfy the urgent need for data sharing and traceability. This study sought to (i) get an overview of current practice in post-market assessments of MDs reporting on RWE/RWD; (ii) draw policy recommendations for governments and health organisations and identify a research agenda for scholars.

A systematic review was undertaken until February 2024 following the PRISMA guidelines. Original peer-reviewed articles in English and incorporating RWE/RWD into any sort of post-market assessment strategy for an MD were included and their reference lists manually checked. A narrative synthesis was employed to describe evidence retrieved.

Totally, 145 research articles were identified. Administrative databases were mostly utilised; clinical and/or economic evidence gathered in a short/medium time horizon the most frequently reported; other evidence types (e.g., organisational) underreported; patient perspectives rarely incorporated; the innovation complexity of MDs relatively low.

To our knowledge, this study is the first in its kind to provide a comprehensive picture of how non-randomised evidence has been used when assessing MDs working in real-life conditions. The implications of this review might help health policy scholars in addressing the avenues for research in RWE for MDs and policy-makers to better understand the risks and benefits of medium and long-term use of MDs alongside clinical practice and make more informed decisions about adoption and use.

In Ukraine, patients and their family members face numerous barriers to health care services. In response, they use coping strategies, that are manifold and complex activities aimed at overcoming these barriers, the financial burden of the treatment, and the poor quality of health care services. These activities include formal and informal practices. Based on representative survey data from 2015 (N = 2,022), we identify patterns in the use of coping strategies, specific coping strategies used to secure good quality consultation and treatment, and analyse opinions and actions towards coping practices. We further analyse the factors associated with the last experience of coping and look at patterns of connection building. We find that the chances of using both money and connection as a coping strategy are higher for people with incomplete higher and highest levels of education. The size of this effect increases with the level of education. Older people, people with better health, and people with a higher opinion of the state use informal practices less, while women are more active in developing connections. The closer the relationship is with a medical doctor, the higher is the chance that such connection will be used in case of health service consumption.

We summarise key messages from the World Bank Report Open and Inclusive: Fair Processes for Financing Universal Health Coverage. A central lesson of the Report is that in decision-making on the path to Universal Health Coverage (UHC), procedural fairness matters alongside substantive fairness. Decision systems should be assessed using a complete conception of procedural fairness that embodies core commitments to impartial and equal consideration of interests and perspectives. These commitments demand that comprehensive information is gathered and disclosed and that justifications for policies are publicly debated; that participation in decision-making is enabled; and that these characteristics of the decision system are institutionalised rather than up to the good will of decision-makers. Procedural fairness can improve equity in outcomes, raise legitimacy and trust, and can help make reforms last. While improving procedural fairness can be costly and there are barriers to achieving it, the range of instruments that countries at varying levels of income and institutional capacity have used with some success shows that, in many contexts, advances in procedural fairness in health financing are possible and worthwhile.

Ozempic and related semaglutide drugs represent a popular new strategy to address obesity in the United States, yet uptake of these medications has sparked opposition highlighting concerns about off-label drug use policies, drug safety, supply shortages and cost. Public attitudes towards off-label prescribing by physicians broadly, and towards Ozempic in particular, in light of this opposition are unclear. To better understand public sentiment on this topic, we analysed data from a representative survey of 3,420 US adults conducted from 13 to 22 June 2023. Public attitudes towards off-label prescribing were split, with 46.3 percent supporting physician discretion to prescribe off-label. Importantly though, 58 percent of respondents were at least somewhat concerned about Ozempic supply shortages caused by off-label use and 63 percent were concerned about Ozempic safety in the context of off-label use. Further analysis from an embedded survey experiment shows that rhetoric highlighting safety (but not supply) concerns surrounding off-label Ozempic prescribing is associated with a significant drop in support for off-label use. These results suggest that the introduction of obesity drugs like Ozempic present a pharmaceutical industry-led path for combatting obesity, but rhetoric opposing these drugs could blunt public support and uptake.

This study aimed to compare reimbursement prices for new, innovative non-orphan drugs in Germany based on price negotiation and cost-effectiveness analysis, using the efficiency frontier (EF) approach and cost-utility analysis (CUA). For the EF, the next effective intervention and no intervention were used as comparators. Three pairwise comparisons were conducted: negotiation vs EF, CUA vs EF and negotiation vs CUA. For the comparison between negotiation and EF, relative risk reductions for a given added health benefit were assigned, and resulting price premiums were determined using an empirical estimate from the literature and a conceptual model. The difference between CUA vs EF was determined based on an aggregation rule and thresholds for CUA based on the average and marginal cost-effectiveness of the health care system. The difference between negotiation and CUA was determined through an indirect comparison. Price premiums based on negotiation are approximately 10–40 per cent higher than those based on EF using no intervention as a comparator. Furthermore, price premiums based on CUA (threshold at system-average cost-effectiveness) are approximately 25–50 per cent higher than those based on EF using no intervention as a comparator. The indirect comparison predicts that price premiums based on CUA (threshold at system-average cost-effectiveness) are approximately 10–15 per cent higher than those based on negotiation. For a threshold set at system-marginal cost-effectiveness, price premiums based on CUA are more than threefold higher than those based on negotiation. In the German health care system, CUA with a threshold set at system-average or system-marginal cost-effectiveness is predicted to yield higher reimbursement prices than price negotiations or the EF approach based on no intervention as a comparator.

Therapeutic positioning reports (IPTs, Spanish acronym) are a crucial tool for informing funding and pricing decisions for drugs in the Spanish healthcare system. In 2020, for the first time the inclusion of economic evaluations (EEs) was explicitly set as a primary objective in a new Action Plan aimed at consolidating IPTs. This paper seeks to examine the uptake of EE into IPTs and to compare the methods and techniques employed in the EEs conducted during the two-year pilot phase following the reform, i.e., from June 2021 to July 2023. During this period, a total of 181 IPTs were published, with 19 (10.5%) incorporating an EE section. However, out of these 19 identified IPTs, six did not actually conduct a de novo EE, and four only performed a drug cost minimisation analysis. Six IPTs conducted EE analyses following international methodological standards. Based on this review, we observe that the percentage of IPTs incorporating EEs had remained low and exhibited significant heterogeneity. The experience of these two years must be translated into lessons that can serve to reinforce the evaluation of the efficiency of medicines in Spain in the coming years.

Legal status is an important social determinant of health. Immigration enforcement policies may be an important contributor to health disparities in the form of interior border checkpoints (IBCs). These checkpoints may prevent immigrants and their families from seeking needed medical care. Currently, we do not know how these barriers are perceived by the public. We administered a survey of 6,178 respondents from 13 November to 19 November of 2023 that contained a survey experiment to assess public attitudes on the issue. Respondents were generally not supportive of detaining individuals at IBCs or medical facilities for emergencies regardless of characteristics of the care-seeking individual. A majority was supportive of detention when medical treatment was complete. Respondents were generally more sympathetic towards children and pregnant women. Partisanship and sympathy expressed towards immigrants influenced attitudes towards detention. Findings based on race and ethnicity showed inconsistencies. A majority of Americans did not believe that IBCs should impede undocumented immigrants from accessing medical care, especially in emergency situations and for children and pregnant women. Our findings indicate that there is broad public support for expanding existing policies to allow for undocumented individuals to pass through IBCs to access medical care.

Prior to the No Surprises Act (NSA), numerous states passed laws protecting patients from surprise medical bills from out-of-network (OON) hospital-based physicians supporting elective treatment in in-network hospitals. Even in non-emergency situations, patients have little ability to choose physicians such as anaesthesiologists, pathologists or radiologists. Using a comprehensive, multi-payer claims database, we estimated the effect of these laws on hospital-based physician reimbursement, charges, network participation and potential surprise billing episodes. Overall, the state laws were associated with a reduction in anaesthesiology prices and charges, but an increase in pathology and radiology prices. The price effects for each state exhibit substantial heterogeneity. California and New Jersey experienced increases in network participation by anaesthesiologists and pathologists and reductions in potential surprise billing episodes, but, overall, we find little evidence of changes in network participation across all of the states implementing surprise billing laws. Our results suggest that the effects of the NSA may vary across states.

Although the fair financing report, ‘Open and Inclusive: Fair Processes for Financing Universal Health Coverage’, has many sage things to say about democratic deliberative processes, its title belies its content: the report does not offer any assessment of processes for financing universal health coverage. What it does instead is scrutinise processes for deciding how to finance universal health coverage without any linkage to substantive questions concerning financing, and, moreover, the discussion is not narrowly focused on fairness.

Private equity (PE) firms play an increasingly important role in healthcare. Yet, existing research remains uneven, mostly focused on the United States and on certain sectors such as nursing homes. Some geographical areas and health specialties remain under-explored. This brief paper outlines a research agenda focusing on three key issues: (1) PE's significance and (2) business strategies in healthcare, and (3) PE's impacts on health and healthcare. The paper uses primary care in Ireland as an example. The proposed research agenda should improve our understanding of the nature of PE in healthcare and serve as a basis for policy-makers to explore appropriate and effective regulation of PE to reduce its negative impacts if and when they exist.

The policy-making process for health financing in most places lacks equity, failing to adequately consider the voices of ordinary citizens, residents, and especially those facing significant disadvantage. Procedural fairness is about addressing this imbalance, which requires a recalibration of power dynamics, ensuring that decision-making incorporates a more diverse range of perspectives. In this comment, we highlight the important contributions made by the report ‘Open and inclusive: Fair processes for financing universal health coverage’ in furthering the understanding and importance of procedural fairness in health financing decision-making especially as it relates to the three sub-functions of financing – revenue raising, pooling, and purchasing. We also argue for the importance of conceptual clarity – especially as to the added value of procedural fairness vis-à-vis accountability – and critically review the proposed framework for procedural fairness, emphasising the role of voice as the linchpin to advancing equity in influence.

In many European countries, semi-autonomous agencies have been created in health policy to safeguard general public interests. In executing their tasks, these agencies need to deal with conflicting expectations. Particularly avoiding the risk of regulatory capture and aligning with parent ministries are frequently studied challenges, even more so when complex issues such as scarcity are at stake. In this paper, we use q-methodology to provide a thorough overview of the debate regarding the role of an important agency in the Dutch healthcare system; the National Health Care Institute (Zorginstituut Nederland). We conducted 41 q-interviews with agency employees, evaluators, regulatees, ministry employees, health policy experts, members of its advisory committees, and peer agencies. We identify three viewpoints on what the agency should focus on. These are on societally relevant issues, strict package management, and efficient organisation of care. In doing so, our study shows how agencies are pulled in different directions by conflicting expectations. We show that this can be problematic because it complicates a clear role of the agency that allows addressing such issues. We thereby contribute to theories on agencies' complex relations with their external environment such as regulatory capture, tripartism, reflexive regulation, legal boundaries, and stewardship theory.

The impact of health technologies may extend beyond the patient and affect the health of people in their network, like their informal carers. The National Institute for Health and Care Excellence (NICE) methods guide explicitly allows the inclusion of health-related quality of life (HRQoL) effects on carers in economic evaluations when these effects are substantial, but the proportion of NICE appraisals that includes carer HRQoL remains small. This paper discusses when inclusion of carer HRQoL is justified, how inclusion can be substantiated, and how carer HRQoL can be measured and included in health economic models. Inclusion of HRQoL in economic evaluations can best be substantiated by data collected in (carers for) patients eligible for receiving the intervention. To facilitate combining patient and carer utilities on the benefit side of economic evaluations, using EQ-5D to measure impacts on carers seems the most successful strategy in the UK context. Alternatives to primary data collection of EQ-5D include vignette studies, using existing values, and mapping algorithms. Carer HRQoL was most often incorporated in economic models in NICE appraisals by employing (dis)utilities as a function of the patient's health state or disease severity. For consistency and comparability, economic evaluations including carer HRQoL should present analyses with and without carer HRQoL.

We use Benford's law to examine the non-random elements of health care costs. We find that as health care expenditures increase, the conformity to the expected distribution of naturally occurring numbers worsens, indicating a tendency towards inefficient treatment. Government insurers follow Benford's law better than private insurers indicating more efficient treatment. Surprisingly, self-insured patients suffer the most from non-clinical cost factors. We suggest that cost saving efforts to reduce non-clinical expenses should be focused on more severe, costly encounters. Doing so focuses cost reduction efforts on less than 10% of encounters that constitute over 70% of dollars spent on health care treatment.

Using data envelopment analysis, we examine the efficiency of Canada's universal health care system by considering a set of labour (physicians) and capital (beds) inputs, which produce a level of care (measured in terms of health quality and quantity) in a given region. Data from 2013–2015 were collected from the Canadian Institute for Health Information regarding inputs and from the Canadian Community Health Survey and Statistics Canada regarding our output variables, health utility (quality) and life expectancy (quantity). We posit that variation in efficiency scores across Canada is the result of regional heterogeneity regarding socioeconomic and demographic disparities. Regressing efficiency scores on such covariates suggests that regional unemployment and an older population are quite impactful and associated with less efficient health care production. Moreover, regional variation indicates the Atlantic provinces (Newfoundland, Prince Edward Island, Nova Scotia, New Brunswick) are quite inefficient, have poorer economic prospects, and tend to have an older population than the rest of Canada. Oaxaca-Blinder decompositions suggest that the latter two factors explain about one-third of this efficiency gap. Based on our two-stage semi-parametric analysis, we recommend Canada adjust their transfer payments to reflect these disparities, thereby potentially reducing inequality in regional efficiency.

As the world comes together through the WHO design and consultation process on a new medical counter-measures platform, we propose an enhanced APT-A (Access to Pandemic Tools Accelerator) that builds on the previous architecture but includes two new pillars – one for economic assistance and another to combat structural inequalities for future pandemic preparedness and response. As part of the APT-A, and in light of the Independent Panel on Pandemic Preparation & Response's call for an enhanced end-to-end platform for access to essential health technologies, we propose a new mechanism that we call the Pandemic Open Technology Access Accelerator (POTAX) that can be implemented through the medical countermeasures platform and the pandemic accord currently under negotiation through the World Health Assembly and supported by the High-Level Meeting review on Pandemic Prevention, Preparedness, and Response at the United Nations. This mechanism will provide (1) conditional financing for new vaccines and other essential health technologies requiring companies to vest licenses in POTAX and pool intellectual property and other data necessary to allow equitable access to the resulting technologies. It will also (2) support collective procurement as well as measures to ensure equitable distribution and uptake of these technologies.

This article identifies issues relating to the use of genetics and genomics in risk-rated insurance that may challenge existing regulatory models in the UK and elsewhere. We discuss three core issues: (1) As genomic testing advances, and results are increasingly relevant to guide healthcare across an individual's lifetime, the distinction between diagnostic and predictive testing that the current UK insurance code relies on becomes increasingly blurred. (2) The emerging category of pharmacogenetic tests that are predictive only in the context of a specific prescribing moment. (3) The increasing availability and affordability of polygenic scores that are neither clearly diagnostic nor highly predictive, but which nonetheless might have incremental value for risk-rated insurance underwriting beyond conventional factors. We suggest a deliberative approach is required to establish when and how genetic information can be used in risk-rated insurance.

Health systems’ insurance/funding can be organised in several ways. Some countries have adopted systems with a mixture of public–private involvement (e.g. Australia, Chile, Ireland, South Africa, New Zealand) which creates two-tier health systems, allowing consumers (groups) to have preferential access to the basic standard of care (e.g. skipping waiting times). The degree to which efficiency and equity are achieved in these types of systems is questioned. In this paper, we consider integration of the two tiers by means of a managed competition model, which underpins Social Health Insurance (SHI) systems. We elaborate a two-part conceptual framework, where, first, we review and update the existing pre-requisites for the model of managed competition to fit a broader definition of health systems, and second, we typologise possible roadmaps to achieve that model in terms of the insurance function, and focus on the consequences on providers and governance/stewardship.