The United States has one of the world's largest criminal justice systems, with nearly 5.5 million people under correctional supervision and almost 2 million incarcerated. This scale of confinement, coupled with the rise of privatization across correctional and related services, reflects a broader neoliberal trend in public governance. This paper explores the consequences of privatization and marketization of the U.S. criminal justice system-particularly the proliferation of private prisons and immigrant detention centers-and draws parallels to the consequences of privatization of health and social care, especially long-term care (LTC). Both systems reveal shared logics of marketization that prioritize profit maximization, efficiency, and cost-cutting at the expense of care, justice, and equity. Relying on interdisciplinary perspectives from public health and criminology, this paper situates private corrections within the health policy framework of the Commercial Determinants of Health (CDoH), arguing that privatized carceral institutions not only harm incarcerated individuals but also endanger workers, families, and surrounding communities through systemic under-resourcing, precarious labor conditions, and structural violence. By comparing the private, for-profit prison industry with private for-profit LTC systems, we illustrate how these structures have commodified both care and correctional systems. These findings suggest that privatization within carceral and care sectors perpetuates health inequities and reinforces cycles of racial, gendered, and economic disadvantage. Accordingly, this paper calls for strengthening publicly held models and a reassertion of public accountability and interdisciplinary collaboration to restore social justice, health, and human dignity as central organizing principles of both systems for residents, workers, their families, and communities.
This paper summarizes an analysis of the Joint Clinical Assessment (JCA) subgroup’s recommendations for systematic literature reviews (SLRs). While the JCA offers clear guidance on study classification, exclusion criteria reporting, and PRISMA diagram use, several of its recommendations diverge from established best practices in evidence-based medicine (EBM). A comparison with recognized guidelines, such as those from Cochrane and EUnetHTA, reveals that the JCA guidance may lack reliability, comprehensiveness, and reproducibility. Aligning JCA recommendations with gold standards in SLR methodology—would address these shortcomings and enhance methodological rigor.
Introduction: This systematic literature review (SLR) provides an analytical framework for clinical trials evaluating clinical outcomes of artificial intelligence-based digital health interventions (AI-DHI). Methods: The SLR was conducted in accordance with the PRISMA guidelines. Search was conducted (September 2025) in PubMed and Embase. Population included patients using AI-DHI. Only clinical trials exploring clinical outcomes, written in English, were considered. NICE checklist was used to assess studies’ quality. Results were analyzed descriptively. Results: Final sample had 84 studies, with metabolic (28.6%), musculoskeletal (20.2%), and mental health disorders (19.0%) as the most common indications. Most studies (75.0%) were controlled, parallel-group trials with 2+ arms, mostly comparing AI-DHI with standard-of-care or waitlist. Although type of intervention often precludes blinding (64.3% were open-label), a double-blinding is strongly recommended (only 6.0%). Only 9.5% of studies were conducted at multiple sites across different countries. Dropout rates in the total sample and each study arm should be <20% at all endpoints (64.3%). Statistical tests were used based on the outcome measures. The small sample sizes and limited generalizability of findings were reported as the main limitations. Conclusions: This SLR emphasized current methodological gaps and an urgent need for unified global guidelines. Standard SLR limitations apply to this research.
Traumatic brain injury (TBI), mainly caused by road traffic accidents, is a serious global public health concern. Computed tomography (CT) is the best way to detect intracranial haemorrhage (ICH), but it is not always feasible because it is hard to access, exposes people to radiation, and is expensive, especially in low- and middle-income countries. Portable near-infrared spectroscopy (NIRS) devices offer a non-invasive, point-of-care option for early detection of ICH. The objectives of this study were to estimate the cost per case detected for patients with mild-to-moderate TBI, to estimate incremental cost and to perform a budget impact analysis to assess the financial feasibility of implementing this technology. This study employed a decision tree model from a health system perspective to calculate the cost per detected case and the incremental cost of NIRS across three tiers of care: ambulances, community health centres (CHCs), and tertiary hospitals. The cost per mild-to-moderate TBI case found was Rs. 2177.90 in ambulances, Rs. 748.09 in CHCs, and Rs. 628.14 in tertiary hospitals. The extra cost per patient was Rs. 984.15, Rs. 360.90, and Rs. 289.78, respectively. At the system level, NIRS raised the total costs for 264 ambulance patients from Rs. 37.71 lakh to Rs. 40.31 lakh and for 858 CHC patients from Rs. 115.64 lakh to Rs. 118.73 lakh. National extrapolation indicates a first-year budgetary impact of approximately Rs. 442 crores for ambulances and Rs. 187 crores for CHCs. These results support the strategic, phased implementation of NIRS to use resources better and improve early diagnosis of TBI.
Four years after the European Regulation on Health Technology Assessment (EU HTAR) came into force and a little over a year after the implementation phase of the Regulation started, with the publication of the first Joint Clinical Assessment (JCA) report imminent, it is good timing to take a step back and revisit what has been achieved and look at what the main challenges on the way forward are [...]
The Joint Clinical Assessment (JCA) evaluates the relative effectiveness (RE) of interventions over comparators. While randomised control trials (RCTs) are considered the gold standard, single-arm trials (SATs) require an external control for accurate RE estimation. This study reviewed Health Technology Assessment (HTA) outcomes for medicinal products supported by SATs in France, Germany, Poland, and Spain, and simulated the JCA for these products based on evidence submitted in France. Among HTA evaluations published in France in 2019–2024, 16% were SAT-driven, and 5.6% of them included external controls. SAT-supported drugs had a high reimbursement approval rate (74%) and showed better HTA outcomes when controls were used. In Germany, 64% of SAT-based HTA outcomes indicated no added benefit and 30% a non-quantifiable benefit. In Poland and Spain, 63% and 72% HTA evaluations recommend reimbursement, respectively. Despite wide acceptance by Member States, experts determined that 94% of SAT-supported products would not qualify for JCA review due to insufficient evidence. Only 6% would qualify for JCA for a likely limited number of PICOs (Population–Intervention–Comparator–Outcome), but the certainty rating would be low. These findings suggest that SATs, as primary evidence, may not be suitable for JCA, potentially undermining HTA in EU Member States.
Background: Pediatric glaucomas are sight-threatening conditions that frequently require surgical intervention and may expose vulnerable young patients to repeated episodes of general anesthesia. While the clinical efficacy of pediatric glaucoma surgeries has been described, comparative data on operative cost and anesthesia exposure time are scarce, limiting evidence-based decision-making for surgeons, caregivers, and health systems. Objective: To quantify and compare the operative costs and total operating room (OR) time of common pediatric glaucoma surgeries, with particular attention to unilateral angle surgery versus immediately sequential bilateral angle surgery (ISBAS), and to single-incision ab interno trabeculotomy (SIT) versus other angle techniques. Methods: A retrospective review of patients who received glaucoma surgery by one of three experienced glaucoma surgeons between January 2012 and August 2019 at the University of Minnesota Medical Center. Each surgery was classified by type, cost, and operative time. Results: A total of 160 surgical encounters were analyzed. Average total cost was $6564 for all unilateral procedures, $6782 (±1952.03) for unilateral angle surgeries, and $11,391 (±2396) for ISBAS. Mean OR time was 121 min for all unilateral procedures, 120 min (±46.3) for unilateral angle surgeries, and 208 min (±53.8) for ISBAS—approximately the cost and time of two unilateral angle surgeries combined into a single anesthetic encounter. Compared to separate encounters for bilateral angle surgeries, ISBAS saved $2174 (p = 0.008) and trended toward saving 33 min of OR time (p = 0.068). Single-incision ab interno trabeculotomy (SIT) was $1647 more expensive than conventional incisional goniotomy or trabeculotome trabeculotomy (p < 0.0001) and reduced OR time by 23.5 min (p = 0.011). SIT was as expensive as 360-degree trabeculotomy ab externo with the iScienceTM catheter (p = 0.098) and reduced OR time by 74.4 min (p = 0.0004). There was no difference in complications between unilateral surgery and ISBAS. Conclusions: Reduced cost and a trend toward reduced anesthesia time support the use of ISBAS. SIT substantially reduced general anesthesia exposure for a neutral or slightly increased cost.
Words matter because they have profound power to shape thoughts, emotions, actions, and social realities [...]
Background/Objectives: Leakage of stomal effluent adversely affects the quality of life for people living with a stoma and increases healthcare resource utilisation and costs. The Heylo™ digital leakage notification system (DLNS) detects early signs of leakage under the baseplate, enabling proactive stoma management. We evaluated the impact of the DLNS on stoma-related costs in a real-world UK setting. Methods: This costing analysis used data from the first 100 DLNS users with 6 months of follow-up in an ongoing longitudinal observational study (NCT06554015). Costs were calculated as 3-month totals before DLNS (baseline): Month 3, and Month 6 for stoma-related healthcare provider consultations, hospitalisations, and ostomy solution components (pouching systems, supporting products, and DLNS sensor layers). Least squares (LS) means were estimated using a mixed model. Results: Total LS mean costs for stoma-related consultations plus ostomy solution use decreased significantly from baseline by 21.9% at Month 3 (−£304 [95% CI: −£456, −£153]; p = 0.001) and 24.5% at Month 6 (−£340 [95% CI: −£504, −£175]; p < 0.001). Stoma-related consultation costs decreased by 50.7% at Month 3 (−£309 [95% CI: −£447, 171]; p < 0.001) and 57.9% at Month 6 (−£353 [95% CI: −£493, −£213]; p < 0.001), driven by fewer physician and stoma care nurse consultations. Mean ostomy solution costs remained similar from baseline (£784/person) to Month 6 (£782/person; p = 0.955) as DLNS sensor layer costs were offset by less use of other ostomy products. Conclusions: Initiation of the Heylo™ DLNS was associated with significant cost savings from reduced stoma-related consultations, pouching systems, and supporting product use.
Health Technology Assessment (HTA) frameworks increasingly recognize the broader value elements of vaccines; however, their adoption remains inconsistent across jurisdictions and often incomplete in practice. Many HTA processes continue to prioritize narrow clinical outcomes and direct costs, leading to the underrepresentation of the full preventive and long-term benefits of vaccination. Building on the ISPOR “Elements of Value” framework and recent evidence, this study adapts and expands existing models specifically for vaccines to enhance HTA applicability in both high-income and resource-limited settings. We introduce an updated vaccine value framework comprising 21 distinct value elements. Notably, the original model was expanded by introducing four entirely new value drivers: (1) real-world evidence; (2) control of antimicrobial resistance; (3) health system strengthening; and (4) environmental impact. Additionally, existing elements were refined, such as broadening “fear of contagion” to “peace of mind” and expanding “productivity” to capture education and leisure gains. We map these elements to potential data sources and methodological tools to facilitate their inclusion in HTA. This study offers an operational, holistic, and context-sensitive framework that reflects current advancements in assessment. By capturing the full spectrum of vaccine value, this framework aims to support more comprehensive, transparent, and equitable HTA decision-making for global immunization programs, while considering conceptual overlap between value elements to reduce the risk of double counting.
Background: The benefit of pharmaceutical innovation manifests when patients access treatment. Following regulatory approval in Europe and Canada, reimbursement decisions depend on health technology assessments (HTAs), which can be prolonged. To quantify the impact of delays on patients, we evaluated market access timelines for olaparib, osimertinib, durvalumab, acalabrutinib, and trastuzumab deruxtecan across six high-income countries with established HTA systems (Canada, England, France, Germany, Italy, Spain). Methods: Time to access was from regulatory approval to reimbursement. Survival benefit was median overall survival (OS) and progression-free survival (PFS) assessed versus the comparator at approval and the latest data cut-off. The number of eligible patients per year multiplied by the years to patient access and survival benefit reflects the lost survival benefit. Results: Efficacy benefits observed at approval continued to the latest data cut-offs. The mean time to patient access was 18 months. Although this varied by country and treatment, with England and Germany typically being the fastest and France and Spain the slowest, timelines often exceeded the 180-day EU target despite identical evidence used in HTA submissions. This resulted in an estimated mean of 2836 patients being unable to access treatment and 3391 OS-derived and 2739 PFS-derived life-years lost. Conclusions: Access processes must evolve to ensure the timely realization of new medicines’ benefits.
Indirect treatment comparisons (ITCs) are essential in the context of joint clinical assessments (JCAs) under Regulation (European Union [EU]) 2021/2282, bridging evidence gaps where head-to-head data are lacking and enabling assessment across diverse national patient, intervention, comparator, and outcome (PICO) requirements. This paper critically reviews the EU Health Technology Assessment Coordination Group’s (HTACG) guidelines on direct and indirect comparisons, with particular focus on ITCs. While the guidelines promote transparency and rigorous evaluation of assumptions, they adopt a restrictive stance on assumption violations, the use of unanchored comparisons, and population-adjusted methods such as matching-adjusted indirect comparisons (MAIC) and simulated treatment comparisons (STC). The guidance shows limited support for Bayesian methods and undervalues meta-regression in favor of subgroup analyses. Operational implications for health technology developers (HTDs) are substantial, including new requirements for dual systematic reviews, multiple network structures, and shifted null hypothesis testing. Moreover, the guidelines effectively dissuade the use of non-randomized comparisons in rare or rapidly evolving indications and may inadvertently hinder access to effective treatments. Emerging practices such as external control arms (ECA) or target trial emulation are underdeveloped. Notably, there is no indication that the guidelines are grounded in systematic methodological validation studies. As JCAs evolve, greater methodological flexibility, empirical grounding, and clear operational guidance will be essential. Refining the guidelines along these principles would enhance their practical utility, mitigate intrinsic assessment variability, support consistent assessments across Member States (MS), and ultimately improve patient access to innovative therapies.
This study aims to update and integrate empirical evidence on the key drivers and consistency of the appraisals of drug innovativeness in Italy by the Italian Medicines Agency (AIFA), and discuss if this evidence is supportive of the reform and requirements implemented in 2025. Appraisals from July 2017 to December 2024 were retrieved from the AIFA website. The association between the innovativeness appraisal, the innovativeness domains (unmet need/added therapeutic value/quality of evidence) and disease/drug/evidence-specific variables was assessed using odds ratios (ORs) from binary/multinomial logistic regression models. Innovativeness status was strongly associated with added therapeutic value (OR > 70). Medicines for rare diseases were more likely to receive conditional innovativeness (OR = 2.95). Full innovativeness was more frequently recognized for indications including paediatric patients (OR = 3.60). References to severe diseases and patient-reported outcomes (PROs) had a higher, not statistically significant, likelihood of innovativeness, whereas reference to indirect treatment comparisons had a lower likelihood (OR = 0.18). The appraisal process showed high internal consistency, but its regulation needs more specific guidance. The innovativeness regulation was reformed in July 2025, including specific recommendations on the criteria to identify the alternative treatments; the role and robustness of indirect comparisons; and the role and requirements for PROs. Our evidence provides an empirical rationale for this reform.
In the United States, access to healthcare is shaped not only by patient need but also by payer policies that determine which providers are reimbursable, how care is sequenced, and what constitutes a legitimate entry point into the system. These gatekeeping functions, while valuable for supporting clinical prioritization, risk stratification, and continuity of care, can also unintentionally reinforce structural inequities and credential hierarchies that delay or limit timely and equitable care, particularly for historically marginalized populations. While reform efforts often focus on expanding benefits or provider networks, fewer address the underlying design of access itself or the rules that govern how patients enter care. It is argued in this paper that a more equitable and efficient healthcare system requires multi-entry care models, in which nurses, behavioral health clinicians, pharmacists, and community health workers may serve as condition-appropriate, reimbursable first points of contact within coordinated care teams. Drawing on evidence from Medicare, Medicaid, the Veterans Health Administration, and commercial payers, these models may support cost containment, improve care coordination, facilitate appropriate utilization, and promote earlier patient engagement. While findings from these models are not uniform across all settings, evidence suggests that outcomes are highly dependent on implementation context, system design, and supporting infrastructure. When implemented with appropriate safeguards (such as interoperable health records, team-based care requirements, and coordinated referral tracking), multi-entry systems can preserve continuity while expanding access. Payers are uniquely positioned to lead this transformation by aligning reimbursement policy with patient needs, supporting team-based care infrastructure, and embedding accountability into access pathways, thereby creating a system that can be more responsive, inclusive, and sustainable.
There is a well-documented gap between the prescription of adrenaline auto-injectors (AAIs) and their real-world use during anaphylaxis. Although several aspects of AAI underuse have been investigated, the potential role of shelf life in influencing patient adherence has not been quantified. This study assessed the real-world remaining shelf life of AAIs available at pharmacies in Denmark, Finland, Sweden, and Norway, using pharmacy-level stock data and pharmacy employee-reported perceptions. Across Denmark, Finland, and Sweden, the average remaining shelf life was 9.6 months, and in Norway it was 10.5 months at the point of dispensing. In Denmark, Finland and Sweden, 100%, 91%, and 94% of employees, respectively, considered shelf life an important or very important factor when dispensing AAIs to patients. Our findings suggest that patients and caregivers filling prescriptions for AAIs frequently receive devices with limited remaining shelf life, which may necessitate multiple renewals per year. This has potential implications in terms of adherence to clinical guidelines, dependence of expired devices during emergencies, patient cost, caregiver burden, and overall societal expenditure. These results highlight an unmet need for emergency treatment options with longer shelf life to better support continuous access to life-saving medicine during anaphylaxis.
Background: Real-world evidence (RWE) can complement clinical trials to inform health technology assessments (HTAs). This study examined the extent to which RWE is considered in HTAs of non-oncology orphan medicinal products across six agencies globally. Methods: Published European Medicines Agency decisions were reviewed to identify approved non-oncology orphan medicinal products (2018–2023) that included RWE within their submission package, which was anticipated to align with the inclusion of RWE in HTA submissions. Data were extracted from the corresponding HTA reports published by six national agencies (Australia, Canada, France, Germany, Sweden, and the UK). Results: RWE was included in 105 regulatory submissions and 52.6% of the corresponding HTA reports (range: 29.9% [Germany] to 78.8% [Canada]), nearly 90% of which received a positive decision (range: 44.4% [Australia] to 100.0% [Germany]). RWE was derived from a variety of study designs and commonly supported clinical efficacy across many therapeutic areas. Conclusions: RWE commonly supports HTAs of recently approved non-oncology orphan medicinal products, strengthening the evidence base and contributing to demonstration of product value.
Methodological guidelines for real-world evidence (RWE) in European Union (EU) joint clinical assessments (JCA) are lacking. This manuscript explores RWE potential in EU health technology assessment (HTA) and offers recommendations for generating high-quality RWE. An environmental scan of peer-reviewed and gray literature was conducted to review RWE frameworks and documents in EU regulatory and HTA decision-making. Extraction elements were standardized across key RWE themes: data quality, methodological rigor, stakeholder engagement, and applications. In JCA, RWE has multiple uses, including informing PICO simulation exercises, understanding disease landscape, identifying prognostic factors and effect modifiers, and directly or indirectly informing comparative clinical assessments. Methodological guidance from the HTA Coordination Group is limited to cases in which evidence from non-randomized studies is used as direct inputs in comparative assessments. Individual HTA bodies provide more detailed guidance, missing an opportunity to leverage RWE within JCAs that can offer insight for local Member State submissions. Generating high-quality RWE that is credible, actionable, and acceptable for JCA submissions and local HTA bodies requires careful attention to methodological considerations and early planning. Broader RWE integration that reflects patient journeys is needed. Expanding the HTA Coordination Group guidance can unlock RWE’s full potential in supporting EU JCA submissions.
Pediatric pneumonia remains a major cause of morbidity and mortality in low- and middle-income countries (LMICs), imposing both health and financial burdens. While the clinical aspects of pediatric pneumonia are well-studied, less attention has been paid to its economic implications for households, particularly regarding out-of-pocket (OOP) expenditure. This paper synthesizes current evidence from Kenya, India, Bangladesh, and Vietnam and introduces a proposed econometric framework designed to identify cost determinants and model policy interventions. The framework integrates microeconomic data, identifies cost determinants, and models the effects of clinical and policy factors (e.g., intensive care, vaccination, insurance coverage) on household expenditures. Simulated results illustrate potential findings from such an approach. Existing studies show substantial variability in hospitalization costs, with OOP payments ranging from US$30 to US$250 per episode, often exceeding 20% of monthly household income. Econometric modeling using generalized linear models (GLMs) and difference-in-differences (DiD) can disentangle the impact of hospital practices, disease severity, and policy interventions. Simulated regression results demonstrate that length of stay, intensive care admission, and absence of insurance significantly increase household costs, while pneumococcal conjugate vaccine (PCV) introduction reduces both admissions and financial burden. Hospitalization for pediatric pneumonia imposes significant OOP costs on households in LMICs. An econometric framework provides rigorous tools to estimate cost drivers, evaluate policy impacts, and guide equitable health financing reforms.
Activism exposes individuals to sustained harassment, threat and psychological strain in contexts marked by discrimination and weak institutional protection. For LGBTQ communities, public engagement frequently increases vulnerability to both offline and digital harm, with cumulative consequences for mental health. Using the Balkans as a case example, this perspective sees activist mental health through a public health and health policy lens, framing distress not as an individual coping failure but as an outcome of structural barriers and minority stress processes, including inadequate legal protection, limited access to culturally competent mental health care and insufficient accountability for platform-mediated harm. This article highlights the population-level implications of unaddressed structural stressors, like burnout, disengagement and reduced sustainability of civil society participation, by situating activist mental health within broader questions of health system performance, access to care and governance. Upstream policy responses that strengthen institutional protection, ensure equitable access to mental health services and promote safer digital environments would address these challenges, positioning activist mental health as a critical public health policy issue.
The aim of the present study was to compare the cost-effectiveness of 3DMorphic’s spinal 3DFusion Lumbar (3DFL) cages versus Off-The-Shelf (OTS) cages for patients undergoing lumbar interbody fusion in an Australian healthcare setting. 3DFL cages differ from generic OTS cages in that they are Patient-Specific Interbody Cages (PSICs). While several studies have discussed the clinical benefits of PSIC versus OTS cages, no studies have evaluated the cost-effectiveness of this technology. Without a direct randomised controlled trial between the two implant categories, an indirect treatment comparison was performed. The indirect comparison was informed by a clinical trial of 3DFL cages, the Australian Spine Registry and an analysis of reoperation rates for patients undergoing spinal fusion in an Australian cohort. In conclusion, the PSICs were demonstrated to be clinically superior to OTS cages as measured by Health Related Quality of Life (HRQoL) and reoperation rates. The cost-utility analysis demonstrated that 3DFL cages were cost-effective compared to OTS cages in an Australian healthcare setting.
