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Center for Health System Sustainability

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New England Journal of Medicine

The Rise of Drug Innovation in China — Implications for Patient Access in the United States and Globally

September 4, 2025
Trade-related tensions between the United States and China have escalated dramatically in recent months. Despite a tentative agreement in May 2025 (extended in August 2025) to reduce the size of newly imposed tariffs on both sides, geopolitical frictions remain. Among other implications, these tensions threaten the cross-border trade of medicines. China has long been a major global supplier of generic drugs and active pharmaceutical ingredients. In recent years, it has also emerged as an important player in new drug development — a field traditionally dominated by the United States and European countries. This shift has implications for global access to promising new medicines and presents challenges for U.S. regulators and policymakers.

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Health Policy

Measuring health system resilience: Understanding the relationship between excess mortality and health system performance

September 4, 2025
The COVID-19 pandemic has underscored the importance of resilient health systems that can manage and adapt to large-scale health crises. However, the relationship between resilience and health system performance remains unclear. While some view performance as a feature of resilience, others conflate the two. Excess mortality—defined as the difference between observed and expected deaths during a given period—is often used to assess resilience, but may introduce bias. In particular, countries with stronger pre-pandemic performance and lower baseline mortality may appear to have worse resilience simply because they had less “room” for mortality to rise under normal conditions.

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JAMA

Reporting of Clinical Trial Uncertainties With New Cancer Drugs in Journal Publications and Clinical Guidelines

September 3, 2025
More than 75% of cancer drugs are approved by the US Food and Drug Administration (FDA) through expedited regulatory programs,(1) the use of which often leaves clinical uncertainties that may arise from issues related to trial design, conduct, analysis, or reporting—such as unvalidated end points, limited long-term data, or approval based on a single trial—about drug efficacy and safety.(2) Communicating these uncertainties is important, as clinicians may otherwise be unaware and overestimate a drug’s benefits and underestimate its risks.(3)

Although the FDA describes these uncertainties in detail in its benefit-risk assessments,(2) these documents are not widely read by clinicians. Instead, clinicians often rely on journal publications and guidelines. It is unclear whether clinical trial uncertainties about newly approved cancer drugs are reported in these sources.

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The Lancet Public Health

Addressing public health and health system challenges in Greece: reform priorities in a changing landscape

September 1, 2025
Health systems globally face growing challenges, including ageing populations, increasing prevalence of chronic diseases, and limited resources to fund advances in health care. Emerging issues, such as climate change, infectious disease outbreaks, large-scale migration, and geopolitical instability, are placing additional strain on already burdened health systems. In Greece, many of these stressors have converged in the past 15 years, exposing structural vulnerabilities and testing health system resilience.(1–3)

Against this backdrop, Greece has implemented a series of reforms to improve service delivery and address public health challenges, but their long-term sustainability remains uncertain. The COVID-19 pandemic offered an illustrative example; the initial response was effective and driven by the prompt adoption of public health measures and interministerial coordination. However, as the pandemic progressed, persistent weaknesses and underdeveloped public health infrastructure exposed crucial vulnerabilities, ultimately undermining the health system's capacity to sustain an effective response.(4) Examining the Greek health system's adaptive capacity more broadly offers important insights for policy makers, in Greece and in other contexts facing comparable structural and fiscal constraints.

This Health Policy paper explores the key and emerging public health and health system challenges in Greece. The paper also provides an overview of recent reform efforts, identifying crucial gaps and opportunities for strengthening the health system to ensure its long-term sustainability.

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Schizophrenia Bulletin

Weight Loss in Veterans with Schizophrenia and Multimorbidity Prescribed Semaglutide: Results From a National Retrospective Cohort Study

August 17, 2025
People with schizophrenia are at heightened risk for physical multimorbidity and premature death. Semaglutide improves cardiometabolic outcomes, yet research is limited among individuals with schizophrenia. This study explored weight loss in Veterans with schizophrenia and physical multimorbidity (ie, heart failure and diabetes) prescribed semaglutide and compared weight changes to those in Veterans without schizophrenia. We hypothesized that those with schizophrenia would experience less weight loss compared to those without schizophrenia.

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Health Economics

The Impact of Multimarket Competition on Generic Drugs' Regulated Prices

August 16, 2025
Competition between firms selling similar drugs is often fostered by policymakers as a means to curb pharmaceutical spending. While firms may compete within these specific drug markets, they also repeatedly encounter rival firms in different markets. This may shape competitive dynamics within and between markets. Yet, multimarket contacts, particularly relevant for multiproduct firms such as pharmaceutical companies, are often overlooked by pricing regulations. This paper investigates how multimarket contacts influence competition between pharmaceutical firms in off-patent markets. Using detailed product-level information on all retail pharmacy sales of generic statin drugs, we quantify the universe of multimarket contacts between firms in these off-patent markets, in Portugal, between 2015 and 2017. We then assess how multimarket contacts affect price competition. To do so, we explore the strict price regulation in Portuguese generic drug markets. Specifically, the Portuguese Internal Reference Pricing System (RPS) defines a price cap for each generic drug. Rather than examining absolute drug prices, we quantify the degree of price competition as the ratio between a firm's drug price and its regulatory price cap (price-to-cap ratio). We find that firms with more multimarket interactions set prices closer to price caps, consistent with the mutual forbearance hypothesis. This effect persists after controlling for brand status, lagged market share, and is not explained by common ownership. Our main results are consistent across alternative model specifications. However, due to limited within-firm variation over time, the effect is not significant in system generalized method of moment instrumental variable estimates. These results suggest that price caps may act as coordination anchors, thus lowering price competition between firms. Policymakers should consider targeted price cap adjustments as safeguards to preserve competition in off-patent drug markets.

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JAMA Health Forum

Prices and Affordability of Essential Medicines in 72 Low-, Middle-, and High-Income Markets

August 15, 2025
Equitable access to essential medicines, which the World Health Organization (WHO) defines as those that meet the priority needs of the population,1 is key to achieving universal health care coverage.(2) However, it is estimated that essential medicines are unaffordable or unavailable to 1 in 4 people worldwide.(3) As governments strive to achieve universal access to essential medicines, it is important to understand how the prices and affordability of these medicines vary between countries. High drug prices strain both personal and government budgets, especially in low- and middle-income countries, where patients often face high out-of-pocket costs.

Although many national surveys of medicine prices and affordability have been conducted, fewer analyses have compared these variables internationally, with most research dating back to 2011 or earlier.(4-20) Many of these studies have focused on high-income countries. Of the studies that also included low- and middle-income nations, most compared the prices of 15 or fewer medicines or included a small number of countries, limiting the generalizability of those findings. Therefore, little is known about the relationship between national income and drug prices. The question remains whether some poor countries routinely pay more than rich countries for the same prescription drugs, possibly owing to weaker pharmaceutical pricing policies.

This cross-sectional study used global data on pharmaceutical sales to compare the list prices of 549 essential medicines in 72 high-, middle-, and low-income markets (covering 87 countries) in 2022, both in nominal and purchasing power–adjusted terms. We also evaluated the affordability of 8 essential medicines used to treat major causes of death and disability globally.

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JAMA Network

Lowering Drug Prices in the US—Look Within, Not Abroad

July 28, 2025
On May 12, 2025, the Trump administration issued an executive order to lower prescription drug costs by mandating that the US pay no more than prices in peer countries. The legality of implementing this so-called most favored nation (MFN) pricing through executive action is unclear. However, the idea of benchmarking US drug prices to prices in other countries is not new. The Trump administration unsuccessfully attempted a more limited MFN policy during its first term, and a 2019 bill passed by House Democrats used international prices as upper limits for Medicare price negotiations. Although lowering drug prices is a priority, achieving this by linking prices in the US to those in other countries is a misguided approach built on a misdiagnosis of the reason prices are higher in the US than in other countries.
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The New England Journal of Medicine

Response to the Editors - Wealth and Mortality in the United States and Europe

July 9, 2025
The responses to our study on wealth and mortality in the United States and Europe raise important questions about causal inference, potential confounding, and the interpretation of cross-national differences. As noted by the correspondents, our findings reflect associations, not causal relationships. Although the patterns we observed were consistent across settings, more work is needed to disentangle the complex relationship between wealth and health.
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Health Affairs

New Cancer Drug Approvals: Less Than Half Of Important Clinical Trial Uncertainties Reported By The FDA To Clinicians, 2019–22

July 7, 2025
Uncertainties about the benefits and harms of new drugs are common at the time of drugs’ approval. It is unclear to what extent the Food and Drug Administration (FDA) communicates these uncertainties in the FDA-approved prescribing information (the drug label), which is the primary channel of communication between the FDA and physicians. Although physicians might not regularly consult the drug label for prescribing decisions, other information sources used by physicians either index or incorporate information from the label. We searched FDA review documents for uncertainties identified by FDA reviewers with new cancer drugs. We considered the subset of uncertainties highlighted in the FDA’s Benefit-Risk Framework as important to the FDA’s approval decision. During the period 2019–22, the FDA approved fifty-two new cancer drugs. In review documents, FDA reviewers identified a total of 213 clinical trial uncertainties with new cancer drugs, 50 percent of which were considered to be important uncertainties to the FDA’s approval decision. Labels for physicians reported information on 26 percent of all uncertainties and 48 percent of uncertainties that were important to the FDA’s approval decision. Communicating uncertainties about the evidence of drugs in the label is essential for informing physicians about drugs’ safe and effective use.
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Health Affairs Scholar

Geographical variation in physician supply and its relationship to utilization of care across older adults in the United States

June 30, 2025
Scholars express concern that general practitioner shortages and specialist surpluses induce overspecialization, with overuse of costly specialist services and underuse of cost-effective primary care services. Yet few studies directly assess the relationship between physician supply and patient utilization. Given this gap, this paper examines the associations between physician supply, care utilization, and patient need and whether patients use more specialists in areas with lower primary care supply.
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The Lancet

Population health impact of NICE-recommended new drugs – Authors' reply

June 28, 2025
We appreciate the responses to our Article, which suggest that the health cost of paying for new pharmaceuticals in the National Health Service (NHS), estimated at £1·25 million quality-adjusted life-years (QALYs) lost between 2000 and 2020, might be justified by the benefits of incentivising future innovation, attracting industry funding, or prioritising certain populations—we disagree.
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European Journal of Public Health

Examining systemic differences in mortality after hip repair: a comparative analysis of 30- and 180-day adjusted mortality rates in five health systems

June 26, 2025

Outcomes after a hip repair in the older adult population are highly dependent on patients’ characteristics. However, contextual factors such as the hospital of treatment may have an impact not sufficiently studied. We aimed to elicit the effect of hospital providers on all-cause-adjusted mortality rates after hip fracture repair. Observational study on virtually all potentially eligible hip fracture patients treated in 2240 hospitals from Ontario (Canada), Aragon (Spain), Finland, Sweden, and the USA (40 states). The primary endpoint was the risk-adjusted all-cause mortality after hip repair measured 30 days and 180 days after surgery. Following a federated approach, GAMM-logit models were run for each region. Median odds ratio (MOR) were estimated to elicit the variation at hospital level. The study included 535 519 hip repairs. The overall predicted 30-day adjusted mortality rate was 40.5 per 1000 hip repair episodes; 136.3 per 1000 hip repair episodes in the 180-day adjusted mortality rate. 30- and 180-day adjusted mortality rates were larger within the regions than across regions. Variance in patients’ mortality at the hospital provider accounted for MOR: 1.43 in 30-day mortality and MOR: 1.35 in 180-day mortality. Beyond differences in the individual risk of death, our study found wide systemic variations in mortality rates in older adult patients exposed to hip fracture repair attributable to the hospital of treatment. Our results call for a reorientation of care pathways after hip repair in frail patients, both in the short- and the long-term.
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Journal of the Intensive Care Society

Geographical disparities in adult intensive care beds in the English National Health Service: A retrospective, observational panel data study

June 26, 2025
The English National Health Service (NHS) is a publicly funded system, however significant disparities in provision exist. Whereas the national picture of the distribution of Intensive Care Unit (ICU) beds has increased over time, less is understood about the regional variation in the rate of growth in ICU services and whether this is related to population growth. The aim of this study was to describe the national variation in the supply of ICU beds in England and evaluate whether there has been a narrowing of the regional disparities in providing ICU beds over time.
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Health Affairs Forefront

Making Health Spending Sustainable Means Targeting Increasingly Excessive Price Growth

June 25, 2025
In the most recent National Health Expenditure (NHE) Projections, for 2024-33, Sean Keehan and colleagues at the Centers for Medicare and Medicaid Services (CMS) predict strong growth in health care expenditures in 2024, and average annual growth over the entire projection period that exceeds growth in GDP. According to their projections, health care is set to comprise 20.3 percent of GDP by 2033. This increase in health spending is expected despite declines in coverage, prompted by the continued unwinding of Medicaid pandemic policies and lower enrollment in private insurance stemming from the expiration of the IRA’s temporarily enhanced premium tax subsidies for Marketplace plans.
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AcademyHealth

Publication-of-the-Year Award 2025

May 19, 2025
The Publication-of-the-Year Award recognizes the best and most relevant peer-reviewed, scientific work that the fields of health services research and health policy have produced and published in the prior calendar year.

Publication-of-the-Year Award
Differential Legal Protections for Biologics Vs Small-Molecule Drugs in the U.S.
Olivier J. Wouters, Ph.D.
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The Joint Commission Journal on Quality and Patient Safety

Patient Safety Metrics Monitoring Across Harvard-Affiliated Hospitals: A Mixed Methods Study

May 17, 2025
The past two decades have seen a surge in available patient safety metrics. However, the variability in how healthcare organizations choose and monitor these metrics remains unknown. We cataloged the metrics organizations chose and how actively they monitored them. We investigated factors influencing the monitoring of patient safety metrics using surveys and in-depth interviews with patient safety experts from 11 Harvard-affiliated organizations.
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Springer Nature Link

Contemporary human rights violations in female sterilization care: legal and ethical considerations when coerced patients do consent

May 13, 2025
In this piece we examine three forms of coercive or otherwise involuntary care that can occur with patient consent. To do so, we examine: (1) uninformed consent, (2) contingency-based consent and (3) constrained-market consent, amongst female sterilization patients. While there is broad recognition that “coercion” in sterilization care can manifest beyond instances of overt force and clarity on what constitutes coercion within clinical care, this has not translated to accountability. The current practice of identifying coercion through discrete civil cases may facilitate a narrow understanding of its contemporary prevalence; one that does not align with definitions of coercion supported by international human rights entities. We use three acute, and widely recognized, examples—hysterectomies in ICE detention facilities, India’s sterilization camp deaths and birth control quotas for Uyghur women—as an entry point to highlight less overt contemporary forms of coercive sterilization care, pairing each example with data that explores prevalence at a broader population level. These data suggest less visible forms of coercion may persist relatively unchallenged—raising the ethical case for a functional approach to the measurement of coercion. In turn, we argue the relevant question may not be “when is coercion ethically justified in public health,” but rather, why is coercion already the status quo?
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CHEST Critical Care

The Relationship Between Neighborhood Deprivation and Mortality in a Sepsis Cohort in England

May 2, 2025
Worse health outcomes have been described for patients with sepsis from more deprived neighborhoods, but it is unclear if this disparity gap has narrowed. Moreover, the mechanisms by which neighborhood disadvantage influences sepsis outcomes are not fully understood. This study aims to understand the trajectory of mortality among patients with sepsis in England across varying levels of neighborhood deprivation, and to what extent do patterns of ICU admission and treatment explain the observed differences.
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The Economist

How Britain decides which drugs to buy

April 16, 2025
Since 1999, the National Institute for Health and Care Excellence has weighed costs against benefits to help the NHS decide what it should buy. The institute’s boss, Sam Roberts, calls it a mindful “health-care innovation shopper”. Within a fixed budget, every new drug it buys risks squeezing essentials like GPs or ambulances among existing health-care services.
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Acta Anaesthesiologica Scandinavica

Fever management with or without a temperature control device after out-of-hospital cardiac arrest and resuscitation (TEMP-CARE): A study protocol for a randomized clinical trial

April 13, 2025
Fever is associated with brain injury after cardiac arrest. It is unknown whether fever management with a feedback-controlled device impacts patient-centered outcomes in cardiac arrest patients. This trial aims to investigate fever management with or without a temperature control device after out-of-hospital cardiac arrest. The TEMP-CARE trial will investigate if post-cardiac arrest management of fever with or without a temperature control device affects patient-important outcomes after cardiac arrest.
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The New England Journal of Medicine

Association between Wealth and Mortality in the United States and Europe

April 2, 2025
We performed a longitudinal, retrospective cohort study involving adults 50 to 85 years of age who were included in the Health and Retirement Study and the Survey of Health, Ageing, and Retirement in Europe between 2010 and 2022. Wealth quartiles were defined according to age group and country, with quartile 1 comprising the poorest participants and quartile 4 the wealthiest. Mortality and Kaplan–Meier curves were estimated for each wealth quartile across the United States and 16 countries in northern and western, southern, and eastern Europe. We used Cox proportional-hazards models that included adjustment for baseline covariates (age group, sex, marital status [ever or never married], educational level [any or no college education], residence [rural or nonrural], current smoking status [smoking or nonsmoking], and absence or presence of a previously diagnosed long-term condition) to quantify the association between wealth quartile and all-cause mortality from 2010 through 2022 (the primary outcome).
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STAT+

Recent pharma-telehealth partnerships feel ‘black boxy,’ and why that’s problematic

March 26, 2025
In recent months, a new kind of partnership between telehealth companies and pharmaceutical manufacturers has come under scrutiny over concerns that such arrangements could lead to inappropriate prescriptions and poor care. Eli Lilly and Pfizer, along with five telehealth companies accessible through the pharma companies’ websites, have recently received letters from four senators echoing those concerns, asking questions about care, prescription volume, and the flow of data and money between the firms. The lawmakers want to determine whether pharma-telehealth deals may be violating the federal anti-kickback statute. That question has also piqued the interest of three health policy researchers at Brown University.
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PLOS One

Does experience matter? Understanding the mechanism of the volume-outcome relationship: Learning-by-doing or economies of scale

March 26, 2025
The volume-outcome relationship has been a commonly invoked policy initiative aimed at improving the quality of healthcare. This inverse relationship between the caseload volume of patients treated and patient mortality has been described across many health settings and in many countries. Despite the large body of literature demonstrating this favourable relationship, most studies have focused on differentiating the effects of selective referral and the true effects of volume. In comparison, there are few studies evaluating the underlying mechanism of the volume-outcome relationship, namely dynamic learning-by-doing or the static effect of economics of scale. Resolving this tension between policies that allow providers to accrue experience over time and policies that promote centralisation of services would make a more compelling argument for policies such as minimum volume standards to be firmly established.
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