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J. Mark. Access Health Policy, Volume 13, Issue 4 (December 2025) – 6 articles

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11 pages, 190 KB

Open AccessOpinion

EU Joint Clinical Assessment: A Framework for Optimising Use with Cost-Effectiveness Decision-Making

by Adam Johns, André Andrade, Sukhvinder Johal and James Ryan

J. Mark. Access Health Policy 2025, 13(4), 52; https://doi.org/10.3390/jmahp13040052 - 9 Oct 2025

Viewed by 213

Abstract

The introduction of the European Union (EU) Joint Clinical Assessment (JCA) under Regulation (EU) 2021/2282 marks a transformative step in harmonizing health technology assessments (HTAs) across EU member states. This article explores the implications of JCA, particularly in oncology, for member states who utilize cost-effectiveness (CE) analysis and health technology developers (HTDs) who produce this evidence. The JCA framework attempts to standardise the assessment of relative clinical effectiveness and safety across the EU to input into national appraisals. Importantly, it excludes economic evaluations that may be required nationally, necessitating HTDs to align their CE models with the JCA PICO (Population/Intervention/Comparator/Outcome) parameters outlined by member states. This article discusses the challenges and opportunities for aligning JCA and CE modelling outcomes, contrasting evidence requirements between JCA and CE frameworks. It highlights the potential increase in complexity due to the diverse comparators in PICO surveys, necessitating the use of indirect comparison methodologies. It further underscores the importance of early communication between HTDs and HTA bodies to ensure timely, relevant, and pragmatic decision-making. By sharing national PICOs upfront to support national evidence generation, the JCA framework’s potential to aid high-quality decision-making and improve patient access to innovative medicines can be maximised. Full article

(This article belongs to the Collection European Health Technology Assessment (EU HTA))

16 pages, 970 KB

Open AccessArticle

Examining State Policies and Administrative Factors as Determinants of Consumer-Reported Unmet Service Needs in Publicly Funded Home- and Community-Based Services in the United States

by Romil R. Parikh, Tetyana P. Shippee, Benjamin Langworthy, Zheng Wang, Stephanie Giordano and Eric Jutkowitz

J. Mark. Access Health Policy 2025, 13(4), 51; https://doi.org/10.3390/jmahp13040051 - 2 Oct 2025

Viewed by 176

Abstract

Access to home- and community-based services (HCBSs) varies substantially between states. Yet, it is unknown how state-level policies and administrative factors impact consumer-reported unmet service needs, an important indicator of HCBS access and quality. Using the National Core Indicators—Aging and Disability Adult Consumer Survey (2016–2019; n = 13,654 community-dwelling older adults, 13 states), we examined associations between unmet HCBS needs with four state-level factors: HCBS spending relative to institutional care spending, HCBS spending per client, percentage of Medicaid beneficiaries in managed care, and Medicaid expansion; and funding program. In the adjusted logistic regression model, the odds of overall unmet HCBS needs were lower with higher percentage Medicaid beneficiaries in managed care (adjusted odds ratio [aOR], 0.92; 95% confidence interval [CI], 0.89–0.96) and Medicaid expansion (aOR, 0.80; 95% CI, 0.73–0.87) but greater with higher HCBS spending relative to institutional care spending (aOR, 1.19; 95% CI, 1.11–1.28). Compared to Medicaid waiver, odds of unmet HCBS needs were significantly lower among consumers in Managed Long-Term Services and Supports (aOR, 0.67; 95% CI, 0.61–0.74) and Program of All-Inclusive Care for the Elderly (PACE; aOR, 0.39; 95% CI, 0.31–0.49). State policies and administrative factors are important place-based determinants of HCBS consumers’ unmet HCBS needs/access; and warrant consideration in HCBS quality assurance and improvement. Full article

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14 pages, 281 KB

Open AccessOpinion

Vaccine Development, Its Implementation and Price Setting: A Historical Perspective with Proposed Ways to Move Forward

by Baudouin Standaert, Oleksandr Topachevskyi and Olivier Ethgen

J. Mark. Access Health Policy 2025, 13(4), 50; https://doi.org/10.3390/jmahp13040050 - 2 Oct 2025

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Abstract

Vaccination has resulted in substantial public health benefits for human populations worldwide since it was first introduced more than a century ago. This article presents an overview of the history of vaccine development, its implementation, and price setting, the latter mainly from a developed world perspective. It considers potential issues and challenges. Over time, vaccine development and production has evolved to a market-driven approach, conducted largely by private commercial entities. The complex processes of identifying potential vaccine targets and developing and producing vaccines at scale have now become more efficient. However, vaccine pricing is an emerging concern. The elements that maximize the overall health benefit of vaccination include high volume, high coverage, and rapid initial implementation to achieve the high coverage with the vaccine as quickly as possible. It therefore requires substantial initial investment. Consequently, the price set for the vaccine should be reasonable to avoid limiting the coverage given the available budget. Suboptimal coverage leads to suboptimal benefit if herd protection is not fully achieved. This may disappoint health authorities and may result in program discontinuation. Conventional cost-effectiveness analysis is therefore not ideally suited to vaccine price setting, as it is based on the concept of ‘more for more’, i.e., higher health gain achieved at a higher reimbursement cost that does not account for limited budgets. Constrained optimization (CO) combines value assessment with constrained budget allocation into one analysis method and may therefore be the better option for vaccine pricing. Full article

12 pages, 499 KB

Open AccessArticle

Balancing Costs and Clinical Outcomes: A Cost-Effectiveness Study of PICC Types Across Chinese Healthcare Settings

by Jia Xu, Hossein Zare, Xia Yan, Herng-Chia Chiu and Renan Castillo

J. Mark. Access Health Policy 2025, 13(4), 49; https://doi.org/10.3390/jmahp13040049 - 29 Sep 2025

Viewed by 193

Abstract

Long-term intravenous therapies often necessitate the use of peripherally inserted central catheters (PICCs). Antimicrobial-coated PICCs have been introduced to minimize central line-associated bloodstream infections (CLABSIs). A decision-analytic cost-effectiveness model was developed from a societal perspective, utilizing real-world data concerning PICC-related complications and costs from Class 3A hospitals and community hospital settings in China. The analysis compared the quality-adjusted life years (QALYs) for patients receiving antimicrobial-coated PICCs versus standard PICCs, with catheter-associated costs included. Incremental cost-effectiveness ratios (ICERs) were calculated in Chinese Yuan (CNY) per QALY gained. Patients with antimicrobial-coated PICCs experienced slightly fewer complication-related events, leading to significantly lower costs for managing complications. In the Class 3A hospital setting, the average total cost per patient was lower with antimicrobial-coated PICCs (CNY 62,800) compared to standard PICCs (CNY 102,900), primarily due to the reduced expenses for treating CLABSIs and related unknown fever. The ICER demonstrated that the coated PICC was the strongest option, showing a negative ICER (cost-saving of approximately CNY 4 million per QALY gained in the base-case Class 3A hospital scenario). In community hospital care scenarios, the cost advantage of antimicrobial-coated PICCs remained. Thus, the antimicrobial-coated PICC strategy was cost-saving, providing equal or improved health outcomes at lower costs in China’s medical center and community hospitals, making it a more efficient choice for long-term vascular access. Full article

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25 pages, 1189 KB

Open AccessReview

Clinical and Economic Evidence Supporting the Value of Fluorescence Imaging of Bacteria in Wound Care

by Jonathan Johnson and Gregory Bohn

J. Mark. Access Health Policy 2025, 13(4), 48; https://doi.org/10.3390/jmahp13040048 - 26 Sep 2025

Viewed by 435

Abstract

Wound infection significantly hinders the healing process. Clinical signs and symptoms (CSS) of infection are used to assess the presence of infection and guide whether to intervene. However, CSS may not be dependable, lacking sensitivity and specificity, and may not accurately reflect bacterial load. The interpretation of CSS can be subjective and can vary between clinicians since they depend on patient characteristics, type of wound, and stage of infection. In addition, conditions such as peripheral vascular disease or diabetes can mask the signs and symptoms of infection. Inaccurate or late diagnosis of infected wounds can be costly to the patient and to healthcare systems. Fluorescence imaging (FLI) provides a safe, objective, highly sensitive approach to detect clinically significant bacterial levels in wounds. This information allows individualized treatment plans and a way to monitor bacterial burden and wound healing longitudinally. This publication reviews the evidence for point-of-care FLI as a means of improving wound identification with a high bacterial burden and the clinical and healthcare economic benefits of earlier and more accurate detection of bacteria. Full article

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6 pages, 197 KB

Open AccessOpinion

Shaping the Future of HTA in Italy: Insights from the Italian Health Policy Forum

by Paolo Sciattella, Roberta Laurita, Chiara Bini, Eugenio Di Brino, Dario Sacchini and Giandomenico Nollo

J. Mark. Access Health Policy 2025, 13(4), 47; https://doi.org/10.3390/jmahp13040047 - 24 Sep 2025

Viewed by 287

Abstract

The implementation of the European (EU) Health Technology Assessment (HTA) Regulation 2021/2282 (EU HTAR) offers many opportunities, aimed at harmonizing HTA procedures and improving access to innovations; it also represents a significant challenge for the European healthcare system. Within the 2024 Health Policy Forum Italy meeting, different actors, stakeholders, and institutions had the opportunity to discuss major criticism and opportunities coming from the EU-HTA Regulation addressing future developments in the healthcare sector. Two groups, EU & Italy Pharmaceuticals and EU-Italy Medical Devices, worked distinctively on the EU HTAR by highlighting key issues that may pose challenges at both European and national levels, proposing potential solutions. The allocation of participants into two groups, according to their affiliation with either the pharmaceutical or the medical device sector, enhances the diversity of professional backgrounds and institutional perspectives, thereby fostering a more comprehensive and informed discussion. The recommendations highlighted by the two groups emphasize the need to promote cooperation among Member States, strengthen training for decision-makers, and develop a monitoring system to evaluate EU HTA’s impact. Full article

(This article belongs to the Collection European Health Technology Assessment (EU HTA))

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