Journal of Market Access & Health Policy

3 pages, 155 KiB

Open AccessEditorial

Joint Scientific Consultation Eligibility Criterion: Hubris or Naïveté

by Mondher Toumi, Bruno Falissard, Laurent Boyer and Pascal Auquier

J. Mark. Access Health Policy 2025, 13(2), 22; https://doi.org/10.3390/jmahp13020022 - 15 May 2025

The eligibility criteria for Joint Scientific Consultation (JSC) raise important questions about the approach taken by the Member State Coordination Group on Health Technology Assessment (HTACG) [...] Full article

18 pages, 1421 KiB

Open AccessArticle

Effects of Primary Healthcare Quality and Effectiveness on Hospitalization Indicators in Brazil

by Bruna Leão Freitas, Maria Luisa de Oliveira Collino Antiga and Flavia Mori Sarti

J. Mark. Access Health Policy 2025, 13(2), 21; https://doi.org/10.3390/jmahp13020021 - 9 May 2025

Abstract

Advances in primary healthcare coverage for the improvement in health outcomes at the population level comprise a major goal of public policies of health, particularly considering increases in hospitalization costs linked to chronic diseases in recent decades. Previous evidence shows the positive effects [...] Read more.

Advances in primary healthcare coverage for the improvement in health outcomes at the population level comprise a major goal of public policies of health, particularly considering increases in hospitalization costs linked to chronic diseases in recent decades. Previous evidence shows the positive effects of access to primary healthcare on hospitalization indicators in high-income countries; however, there is a lack of literature on the subject in Latin American countries. Thus, the present study proposes a quantitative investigation on connections between primary healthcare quality and effectiveness in relation to hospitalization indicators, in addition to the identification of its effects on inequalities in hospitalizations in Brazil. The study was based on an empirical analysis of data from five cross-sectional surveys representative at the population level conducted by the Brazilian Institute for Geography and Statistics (IBGE) in 1998, 2003, 2008, 2013, and 2019. Information on the demographic, socioeconomic, and health characteristics of individuals compatible across surveys were included in the analyses, in addition to data on household and survey characteristics. The statistical analyses were based on the estimation of logistic regression models for the exploration of effects of primary healthcare quality and effectiveness on hospitalizations, inpatient days, and perception of quality of hospital care. Furthermore, the estimation of concentration indexes and their disaggregation allowed to verify trends and determinants of inequalities in hospitalization indicators in Brazil throughout the period. The results indicate that primary healthcare effectiveness is associated with the lower occurrence and frequency of hospitalizations, and a lower length of stay in hospitals. Primary healthcare quality was associated with the perception of higher quality of hospital care. Trends in hospitalization indicators showed reduction in inequalities towards low-income individuals from 1998 to 2013, and primary healthcare quality presented minor influence on inequalities in hospitalizations, inpatient days, and perception of quality of hospital care. Full article

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23 pages, 2678 KiB

Open AccessArticle

Validating the Predictions of a Dynamic Transmission Model Using Real-World Data from a Universal Varicella Vaccination Program in Germany

by Iwona Żerda, Tomasz Stanisz, Tomasz Fundament, Filip Chełmikowski, Wioletta Kłębczyk, Michał Pochopień, Emilie Clay, Samuel Aballéa and Mondher Toumi

J. Mark. Access Health Policy 2025, 13(2), 20; https://doi.org/10.3390/jmahp13020020 - 6 May 2025

Abstract

Dynamic transmission models (DTMs) have been used to estimate various aspects of the public health impact of varicella vaccination programs. The aim of this study was to validate the predictions of a DTM—developed using the typical approach to varicella modeling—using real-world data from [...] Read more.

Dynamic transmission models (DTMs) have been used to estimate various aspects of the public health impact of varicella vaccination programs. The aim of this study was to validate the predictions of a DTM—developed using the typical approach to varicella modeling—using real-world data from a country with a long-term universal varicella vaccination (UVV) program and to assess the sensitivity of the predictions to changes in model input parameters. A compartmental, age-stratified DTM was developed using the settings corresponding to the existing UVV program in Germany. The model-predicted total number of varicella cases followed the same trend as observed in the reported data. The agreement between the simulations’ results and the data was the highest for the age group most exposed to varicella (0–5 years old), while for other age groups, a decline in accuracy was observed. Sensitivity analyses identified the input parameters having a crucial impact on the model’s long-term predictions. The results supported the reliability of the DTM for assessing the impact of varicella vaccination programs over the first decades after their introduction and provided an insight into how certain parameters and assumptions influence the model output and thus require careful evaluation in the studies of future varicella vaccination programs. Full article

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9 pages, 186 KiB

Open AccessPerspective

Towards a Unified European View of Clinical Evidence: What ‘Health Technology Assessment Organizations’ Can Learn from Regulatory Experience

by Karl Broich and Wiebke Löbker

J. Mark. Access Health Policy 2025, 13(2), 19; https://doi.org/10.3390/jmahp13020019 - 28 Apr 2025

Abstract

The harmonization of pharmaceutical regulations within the European Union has been a crucial step towards ensuring high safety standards and efficient access to innovative medicines. The evolution from fragmented national regulations to a unified legal framework has streamlined the marketing authorization process, fostered [...] Read more.

The harmonization of pharmaceutical regulations within the European Union has been a crucial step towards ensuring high safety standards and efficient access to innovative medicines. The evolution from fragmented national regulations to a unified legal framework has streamlined the marketing authorization process, fostered scientific collaboration, and reduced administrative burdens. The establishment of the centralized marketing authorization procedure and the European Medicines Agency (EMA) has played a pivotal role in coordinating regulatory efforts across member states. This article examines the historical developments, regulatory milestones, and the impact of harmonization on pharmaceutical assessments. Furthermore, it explores key lessons learned—including the value of centralized coordination, standardization, capacity and knowledge-sharing, transparency and trust—from the regulatory landscape that could inform the evolving Health Technology Assessment (HTA) framework in the EU. Full article

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

5 pages, 182 KiB

Open AccessEditorial

A New Health Networking Infrastructure on Cancer Is Taking Shape in Europe: A Not-to-Miss Opportunity for the EU Regulatory System

by Paolo Giovanni Casali and Stefano Capri

J. Mark. Access Health Policy 2025, 13(2), 18; https://doi.org/10.3390/jmahp13020018 - 28 Apr 2025

Abstract

At the inaugural EAA convention in Copenhagen (Europe’s Evolving HTA Regulation and Its Relevance for ‘Beating Cancer’, in May 2022), it was suggested that, in the future, the pillars necessary to fully address the problem of cancer should be communicated (i [...] Full article

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

16 pages, 1973 KiB

Open AccessArticle

Workplace Vaccination Against COVID-19 and Seasonal Influenza in the United States: A Modeling-Based Estimation of the Health and Economic Benefits for Employers and Employees

by Ekkehard Beck, Keya Joshi, Darshan Mehta, Stephane Lorenc, Bishoy Rizkalla and Nicolas Van de Velde

J. Mark. Access Health Policy 2025, 13(2), 17; https://doi.org/10.3390/jmahp13020017 - 24 Apr 2025

Abstract

The objectives were to assess the economic burden of COVID-19 and impact of workplace COVID-19 vaccination in the United States (US). An economic model estimated COVID-19 workplace burden (infections, long COVID, inpatient/outpatient care, absent days) with and without vaccination, compared with seasonal influenza [...] Read more.

The objectives were to assess the economic burden of COVID-19 and impact of workplace COVID-19 vaccination in the United States (US). An economic model estimated COVID-19 workplace burden (infections, long COVID, inpatient/outpatient care, absent days) with and without vaccination, compared with seasonal influenza vaccination for context, using Optum’s de-identified Clinformatics^® Data Mart Database. Without workplace vaccination, an average US business (with 10,000 employees), had 18,175 absent days from COVID-19 and lost productivity costs of USD 5.08 million. Implementing COVID-19 workplace vaccination (at 70% coverage) prevented approximately 3132 absent days, saving employers USD 876,453 (lost productivity) and USD 240,633 (medical costs); and saving employees USD 182,196 (medical costs) and USD 198,250 (lost wages) versus no COVID-19 workplace vaccination. The burden and vaccination impact were greater for COVID-19 versus seasonal influenza. Workplace vaccination for COVID-19 and seasonal influenza can have a significant impact for both the employer and employees through averted disease. Full article

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14 pages, 1840 KiB

Open AccessOpinion

Strengthening the EU Health Technology Assessment Regulation: Integrating National Immunization Technical Advisory Groups for Comprehensive Vaccine Assessments

by Jasmijn Beekman, Adrianne de Roo, Sharon Wolters, Ramesh Marapin, Gabriel Gurgel do Amaral, Evgeni Dvortsin, Sibilia Quilici, Chiara de Waure, Elena Petelos, Maarten Postma and Anna Viceré

J. Mark. Access Health Policy 2025, 13(2), 16; https://doi.org/10.3390/jmahp13020016 - 18 Apr 2025

Abstract

Background: Given their crucial role in vaccine assessment, National Immunization Technical Advisory Groups (NITAGs) should be considered in the Regulation on Health Technology Assessment (EU HTAR) to maximize the benefits of the EU HTAR for vaccines. This review and perspective piece identifies the [...] Read more.

Background: Given their crucial role in vaccine assessment, National Immunization Technical Advisory Groups (NITAGs) should be considered in the Regulation on Health Technology Assessment (EU HTAR) to maximize the benefits of the EU HTAR for vaccines. This review and perspective piece identifies the gaps arising from NITAGs potential lack of involvement and proposes strategies for involving them. Methods: A targeted literature and guideline review was conducted to evaluate NITAGs’ current and future role in relation to the EU HTAR. The impact of the EU HTAR on diverse national HTA frameworks was explored in a three-country case study. Recommendations were developed to leverage strengths and address weaknesses to ensure consistent and cohesive vaccine assessments. Results: The case study revealed potential overlaps between NITAGs and the EU HTAR, particularly regarding horizon scanning and joint scientific consultations. The involvement of NITAGs in national assessments varies, influencing how well joint clinical assessment reports will ultimately align with and be applicable to individual Member States. Conclusions: Stronger consideration of vaccines within the EU HTAR and NITAG involvement can streamline assessments, reduce duplication, and improve alignment between European and national processes. Strategic actions, including capacity building and collaborations between NITAGs, are key in facilitating this process. Full article

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

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3 pages, 164 KiB

Open AccessEditorial

Clinical Trial Validity Guidance from the HTACG: Looking for Chicken Teeth

by Mondher Toumi, Bruno Falissard, Asma Jouini, Samuel Aballéa and Laurent Boyer

J. Mark. Access Health Policy 2025, 13(2), 15; https://doi.org/10.3390/jmahp13020015 - 16 Apr 2025

Abstract

The Member State Coordination Group on Health Technology Assessment (HTACG) guidance on the validity of clinical studies [...] Full article

9 pages, 195 KiB

Open AccessArticle

ARM’s Perspective on the First Joint Clinical Assessments for ATMPs: Challenges and Opportunities on the Path Ahead

by Paolo Morgese, Stephen Majors and Dilip Patel

J. Mark. Access Health Policy 2025, 13(2), 14; https://doi.org/10.3390/jmahp13020014 - 3 Apr 2025

Abstract

Advanced Therapy Medicinal Products (ATMPs) are revolutionising modern medicine. By addressing the root cause rather than the symptoms of disease, ATMPs hold the promise of long-lasting benefits or even cures for severe, genetic, and rare diseases—including rare cancers—for patients with few or no [...] Read more.

Advanced Therapy Medicinal Products (ATMPs) are revolutionising modern medicine. By addressing the root cause rather than the symptoms of disease, ATMPs hold the promise of long-lasting benefits or even cures for severe, genetic, and rare diseases—including rare cancers—for patients with few or no viable treatment options. At the same time, the inherent complexities of ATMPs pose challenges to traditional HTA frameworks. Unlike conventional treatments, ATMPs are often one-time therapies with a high magnitude of effect. However, their long-term durability remains uncertain at launch. The Joint Clinical Assessment (JCA), under the EU’s Health Technology Assessment (HTA) Regulation, represents a once-in-a-generation opportunity to consolidate the strengths of national HTA processes into a unified framework that accounts for the specificities of ATMPs and streamlines decision-making, cementing Europe’s position as a pioneer in innovative HTA approaches. While concerns remain regarding the suitability of current JCA methodologies for ATMPs, the HTA Regulation continues to bring the HTA ecosystem closer together, with numerous benefits already emerging from EU-wide collaboration on JCAs. This article outlines the HTA challenges posed for and by ATMPs, and ARM’s perspective on the JCA’s implementation. A ‘fit for purpose’ JCA holds the promise to unlocking these therapies’ benefits for individuals across Europe. Full article

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

11 pages, 216 KiB

Open AccessArticle

Healthcare Professionals’ Perceptions About Medical Cannabis in Greece: A Qualitative Study

by Christos Ntais, Yioula Melanthiou and Michael A. Talias

J. Mark. Access Health Policy 2025, 13(2), 13; https://doi.org/10.3390/jmahp13020013 - 2 Apr 2025

Abstract

Background: Medical cannabis continues to generate interest as a potential therapeutic option, yet its acceptance in clinical practice faces challenges, including regulatory barriers, social stigma, and gaps in scientific evidence. Methods: This study explores the perspectives of Greek medical doctors and pharmacists on [...] Read more.

Background: Medical cannabis continues to generate interest as a potential therapeutic option, yet its acceptance in clinical practice faces challenges, including regulatory barriers, social stigma, and gaps in scientific evidence. Methods: This study explores the perspectives of Greek medical doctors and pharmacists on medical cannabis—key stakeholders in its clinical application—through semi-structured interviews with 12 participants from each profession. Results: Medical doctors and pharmacists expressed a range of views on medical cannabis, with many acknowledging its potential while emphasizing the need for rigorous, disease-specific research. Medical doctors highlighted the lack of consistent clinical trials, concerns about drug interactions, and the fine line between medical use and misuse. Pharmacists echoed these concerns, citing regulatory inconsistencies and the need for standardized dosing. Both groups agreed that social stigma and misinformation hinder cannabis adoption, advocating for targeted education and transparent research communication. Participants indicated that regulatory barriers also pose challenges, with calls for harmonized policies and phased market entry approaches. Effective communication strategies, including digital outreach and clear messaging, were suggested to differentiate medical cannabis from recreational use and improve trust among healthcare providers and patients. Participants also highlighted the urgent need for collaboration between policymakers, researchers, and healthcare professionals to establish medical cannabis as a credible therapeutic option. Conclusion: The insights gained provide actionable recommendations to bridge existing gaps and emphasize the need for a responsible, evidence-based approach to the acceptance of medical cannabis as a therapeutic option. Full article

17 pages, 2599 KiB

Open AccessArticle

A Methodological Proposal for Health Technology Assessments: A Case Study on Biosimilar Drugs

by Marilisa Pia Dimmito, Lisa Marinelli, Eleonora Chiara Toto, Giuseppe Di Biase, Ivana Cacciatore, Pierpaolo Toto, Michele Ciulla, Benedetta Monti, Fiorenzo Santoleri, Alberto Costantini and Antonio Di Stefano

J. Mark. Access Health Policy 2025, 13(2), 12; https://doi.org/10.3390/jmahp13020012 - 31 Mar 2025

Abstract

This work proposes a methodological approach that could be useful in multidisciplinary health technology assessments (HTAs). Mathematical models based on real data were used to make predictions for the initial price and actual cost of three classes of biological drugs. Through a comparison [...] Read more.

This work proposes a methodological approach that could be useful in multidisciplinary health technology assessments (HTAs). Mathematical models based on real data were used to make predictions for the initial price and actual cost of three classes of biological drugs. Through a comparison of real data, with the data derived through this approach, degree coefficients were formulated to rank the negotiating capabilities of Italian regions. The proposed method could represent a valid means of support for healthcare decisionmakers in planning and reducing pharmaceutical spending, evaluating data, and finding uses for particular medical technologies. This study could be a useful tool for achieving the objectives of HTAs, providing a means of analysis that can be adapted to any data, which may be useful for rationalizing the use of health technologies, reducing waste, and optimally reallocating resources. Full article

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18 pages, 1484 KiB

Open AccessArticle

The Cost-Effectiveness of Avatrombopag Versus Eltrombopag and Romiplostim in the Treatment of Patients with Immune Thrombocytopenia in the UK

by Nichola Cooper, Sebastian Guterres, Michał Pochopień, Koo Wilson, Sam James, Mondher Toumi, Anna Tytuła, Carly Rich and Daniel Eriksson

J. Mark. Access Health Policy 2025, 13(2), 11; https://doi.org/10.3390/jmahp13020011 - 24 Mar 2025

Abstract

Background: Thrombopoietin receptor agonists—romiplostim, eltrombopag and avatrombopag—are commonly used as second-line treatments for immune thrombocytopenia (ITP). Methods: A Markov model was developed to estimate the cost effectiveness of the three TPO-RAs in adults with insufficient response to previous treatment from the perspective of [...] Read more.

Background: Thrombopoietin receptor agonists—romiplostim, eltrombopag and avatrombopag—are commonly used as second-line treatments for immune thrombocytopenia (ITP). Methods: A Markov model was developed to estimate the cost effectiveness of the three TPO-RAs in adults with insufficient response to previous treatment from the perspective of the UK National Health Service (NHS). The model considered the effects of bleeding events, concomitant ITP medications, rescue therapies and treatment related adverse events over a lifetime horizon. Model inputs for effectiveness were based on a network meta-analysis and other published literature on ITP management. Other model inputs included costs (e.g., drug acquisition and administration) and healthcare resource utilisation. Results: Avatrombopag was associated with higher quality-adjusted life-years (QALYs) (10.979) than romiplostim (10.628) and eltrombopag (10.085), producing incremental QALYs of −0.351 and −0.894, respectively. Avatrombopag was associated with lower total costs (GBP £319,334) compared with romiplostim (GBP 406,361 [cost saving of GBP 87,027]) and higher total costs compared with eltrombopag (GBP 313,987 [incremental cost of GBP 5347]). Avatrombopag therefore dominated romiplostim (more effective and less expensive) and was cost-effective versus eltrombopag (incremental cost-effectiveness ratio of GBP 5982 per QALY). Conclusions: Avatrombopag is a cost-effective treatment compared with romiplostim and eltrombopag for the second-line treatment of adults with ITP from the perspective of the UK NHS. Full article

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5 pages, 159 KiB

Open AccessOpinion

Public Health Decision-Maker Perspective on Joint Clinical Assessments in Central European EU Member States

by Gergő Merész, Dávid Dankó and Márk Péter Molnár

J. Mark. Access Health Policy 2025, 13(1), 10; https://doi.org/10.3390/jmahp13010010 - 4 Mar 2025

Abstract

The HTA R introduces provisions that may benefit member states, in particular the opportunity to share national or regional assessment reports, cooperate outside of clinical domains, or use the methodological guidelines on a local level for technologies that are not subject to joint [...] Read more.

The HTA R introduces provisions that may benefit member states, in particular the opportunity to share national or regional assessment reports, cooperate outside of clinical domains, or use the methodological guidelines on a local level for technologies that are not subject to joint assessment. Challenges related to the timelines, differences between assessment scopes, and diverging guidance may jeopardize the full potential of the HTA R in Central European EU member states. However, these are more likely to be related to the commitment and vigilance of local competent authorities. We attempt to address these opportunities and mark some challenges imposed by the application of the HTA R by taking the perspective of public health decision-makers in Central European EU member states. We conclude that the foundations for capitalizing on the opportunities offered by the HTA R are already laid in the region, and we foresee policymakers and payers sharing the responsibility of acting as drivers of change in health policy to reduce the duplication (or multiplication) of efforts by HTDs, as well as to increase the efficient use of HTA bodies’ resources. Full article

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

12 pages, 763 KiB

Open AccessArticle

Ensuring the Efficiency and Effectiveness of Joint Clinical Assessment in National HTA Decision-Making: Insights from the 2024 CIRS Multi-Stakeholder Workshop

by Ting Wang and Neil McAuslane

J. Mark. Access Health Policy 2025, 13(1), 9; https://doi.org/10.3390/jmahp13010009 - 3 Mar 2025

Abstract

Background: This study explored the readiness and strategic considerations of companies and key stakeholders for the implementation of the Joint Clinical Assessment (JCA) under the European Health Technology Assessment Regulation (HTAR). It examined the implications of the JCA process for jurisdictional submission strategies, [...] Read more.

Background: This study explored the readiness and strategic considerations of companies and key stakeholders for the implementation of the Joint Clinical Assessment (JCA) under the European Health Technology Assessment Regulation (HTAR). It examined the implications of the JCA process for jurisdictional submission strategies, and decision-making across Europe. The study aimed at identifying key measures for an efficient and effective JCA process to enable national rollout. Methods: A survey was conducted with international pharmaceutical companies, followed by a multi-stakeholder workshop that expanded on the findings. The survey and workshop focused on key areas such as time to market, submission strategies, and the role of JCA in national decision-making processes. Descriptive and qualitative analyses were performed to identify recommendations for measuring and improving the JCA process. Results: 13 companies responded to the survey, respondents were generally prepared for the JCA process (readiness rated 6–7/10), but concerns persist about timeline uncertainties and timely JCA report delivery. In the short term, success for the HTAR from the company perspective is measured by positive recommendations across EU jurisdictions. Long term, the focus shifts to aligning HTA methodologies and evidence requirements across the EU. Establishing metrics to assess the efficiency and effectiveness of the JCA is a key step in the HTAR’s ongoing learning journey. To enhance the efficiency of the JCA process, a list of metrics is recommended for continuous improvement, as well as establishing training programs to strengthen member states’ capabilities, fostering open dialog for sharing technology-specific insights, and creating open-source tools to support companies. Additionally, research should be conducted to understand agencies’ expectations of the JCA and how they will use its reports, grouping agencies by archetype to identify trends. A key recommendation is the development of a product-based scorecard to evaluate JCA submissions and reviews from various perspectives, ensuring the process meets stakeholders’ needs and can be effectively utilized in national decision-making. Conclusions: The JCA process offers a significant opportunity to streamline HTA decision-making across Europe. This study highlights several key measures and consideration for its successful rollout, including the need for clearer communication about the role of JCA in national decisions, measurement of rollout time components, and the development of quality evaluation frameworks. A collaborative, iterative approach, where stakeholders continually refine the system, will be essential for its effectiveness. Addressing these challenges will enable the JCA to enhance efficiency, consistency, and ultimately improve access to treatments for patients. Full article

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

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14 pages, 255 KiB

Open AccessPerspective

The Integration of Social and Health Sectors in Scotland: An Analysis from the Prism of Different Public Policy Models

by Ricardo Correia de Matos, Generosa do Nascimento, Adalberto Campos Fernandes and Cristiano Matos

J. Mark. Access Health Policy 2025, 13(1), 8; https://doi.org/10.3390/jmahp13010008 - 27 Feb 2025

Abstract

The integration of health and social care has been a key focus in Scotland, driven by demographic changes, rising healthcare costs, and the need for more efficient service delivery. The Public Bodies (Joint Working) (Scotland) Act 2014 sought to formalise this integration by [...] Read more.

The integration of health and social care has been a key focus in Scotland, driven by demographic changes, rising healthcare costs, and the need for more efficient service delivery. The Public Bodies (Joint Working) (Scotland) Act 2014 sought to formalise this integration by restructuring governance and service provision to improve coordination between health and social care sectors. Despite these efforts, challenges remain in fully achieving the intended outcomes of the integration. This study analysed Scotland’s integrated health and social care through the theoretical frameworks of public choice, institutionalism, and functionalism. The objective was to examine policy drivers, structural mechanisms, and governance implications, providing insights into the broader impact of integrated care reforms. A qualitative research approach was employed, synthesising data from peer-reviewed literature, government publications, and policy documents. The findings on integration were systematically examined through the lens of each public policy model, allowing for a nuanced analysis of how Scotland’s approach to integration aligns with and diverges from these frameworks. A literature search was performed on PUBMED, Google Scholar, and Scottish government portals. While integration improved coordination and service delivery in some areas, limitations in funding allocation, workforce distribution, and governance autonomy limited its overall success. Scotland’s integrated care model demonstrates potential benefits in reducing service fragmentation and improving patient-centred care; however, persistent challenges such as funding constraints, workforce shortages, and governance conflicts indicate that integration alone is not sufficient to resolve systemic healthcare inefficiencies. This study provides a perspective on Scotland’s health and social care integration, offering valuable lessons for other European countries facing similar demographic and healthcare challenges. Full article

21 pages, 1392 KiB

Open AccessReview

Healthcare Resource Utilization (HCRU) and Direct Medical Costs Associated with Long COVID or Post-COVID-19 Conditions: Findings from a Literature Review

by Elżbieta Łukomska, Krzysztof Kloc, Malwina Kowalska, Aleksandra Matjaszek, Keya Joshi, Stefan Scholz, Nicolas Van de Velde and Ekkehard Beck

J. Mark. Access Health Policy 2025, 13(1), 7; https://doi.org/10.3390/jmahp13010007 - 12 Feb 2025

Abstract

Approximately 10–20% of individuals suffering from COVID-19 develop prolonged symptoms known as long COVID or post-COVID condition (LC). This review aimed to assess healthcare resource use (HCRU) and healthcare costs associated with LC. Because LC is not clearly defined and often remains undiagnosed, [...] Read more.

Approximately 10–20% of individuals suffering from COVID-19 develop prolonged symptoms known as long COVID or post-COVID condition (LC). This review aimed to assess healthcare resource use (HCRU) and healthcare costs associated with LC. Because LC is not clearly defined and often remains undiagnosed, studies reporting on long-term follow-up of individuals with a COVID-19 diagnosis were also included. Among the 41 publications included, 36 reported on HCRU and 16 on costs. Individuals with LC had significantly elevated HCRU and healthcare costs vs. controls without a COVID-19 diagnosis over ≥15 months, with a 7.6–13.1% increase in total healthcare costs per person per month as assessed by difference-in-difference analysis. Among studies that did not specifically refer to LC, having a COVID-19 diagnosis was associated with a significant 4–10% increase in long-term total HCRU over 6–8 months and a 1.3- to 2.9-fold relative increase in total healthcare costs over 6 months. Due to the heterogeneity of the included studies, high-quality evidence is needed to better understand the economic burden of LC. In the absence of effective treatments, prioritizing the prevention of acute COVID-19, e.g., through vaccination, may be crucial for preventing LC and the associated long-term HCRU and medical spending. Full article

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17 pages, 1547 KiB

Open AccessArticle

Avoiding Error and Finding the Right Balance in European Health Technology Assessments: Insights Generated by the European Access Academy

by Elaine Julian, Tom Belleman, Maria João Garcia, Maureen Rutten-van Mölken, Robin Doeswijk, Rosa Giuliani, Bernhard J. Wörmann, Daniel Widmer, Patrick Tilleul, Ruben Casado Arroyo, Valentina Strammiello, Kate Morgan, Marcus Guardian, Michael Ermisch, Renato Bernardini, Fabrizio Gianfrate, Stefano Capri, Carin A. Uyl-de Groot, Mira Pavlovic and Jörg Ruof

J. Mark. Access Health Policy 2025, 13(1), 6; https://doi.org/10.3390/jmahp13010006 - 10 Feb 2025

Abstract

Background: We examined four potential challenges for the implementation of the European Union (EU) Regulation 2021/2282 on Health Technology Assessment (EU HTAR): interaction with the European Medicines Agency (EMA), expert input, the interface of European health technology assessment (EU HTA) joint procedures with [...] Read more.

Background: We examined four potential challenges for the implementation of the European Union (EU) Regulation 2021/2282 on Health Technology Assessment (EU HTAR): interaction with the European Medicines Agency (EMA), expert input, the interface of European health technology assessment (EU HTA) joint procedures with those within Member States, and the management of conflict of interest. This research aims to explore how to address these challenges in a balanced manner and prioritise key actions for effective collaboration in the context of the EU HTA. Methods: The methodology included a pre-convention survey among relevant stakeholders as well as working groups and the plenary ranking of discussion outcomes at the European Access Academy (EAA) Spring Convention 2024. Results: In the survey, 65.5% of respondents indicated that experts are currently not sufficiently included in the upcoming joint scientific consultations and clinical assessments; only 37.9% suggested that the EU HTA joint procedures would accelerate national appraisal decision-making, and 58.6% believed that the principles of ‘transparency’ and ‘competency’ are balanced in the EU HTA position on conflict of interest. The top priority action points identified in the working groups were the involvement of the best available expertise, the early and inclusive involvement of experts, strengthened early scientific dialogue, and the fostering of the political willingness/financial support of EU Member States to increase capacities. Conclusions: The key topics identified were an approach to conflict of interest that balances transparency obligations and the need for expertise, strengthens the involvement of clinical and patient experts, intensifies early interaction between the EMA and EU HTA, and increases the involvement of the EU Member States. Full article

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

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3 pages, 656 KiB

Open AccessEditorial

Agenzia Italiana del Farmaco (AIFA): Developments and Strategy in a Transitioning European HTA Landscape

by Robert Nisticò

J. Mark. Access Health Policy 2025, 13(1), 5; https://doi.org/10.3390/jmahp13010005 - 5 Feb 2025

Abstract

The Agenzia Italiana del Farmaco (AIFA) is the national public body that regulates medicines for human use in Italy [...] Full article

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

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9 pages, 220 KiB

Open AccessCommunication

Musculoskeletal Magazine Advertising Focuses on White Individuals and Overlooks Minority Consumers

by Wei Shao Tung, Kelsey A. Rankin, Robert John Oris, Adithi Wijesekera and Daniel H. Wiznia

J. Mark. Access Health Policy 2025, 13(1), 4; https://doi.org/10.3390/jmahp13010004 - 4 Feb 2025

Abstract

Introduction: Demographic disparities in musculoskeletal (MSK) health exist in the US. Racial representation in advertising has been shown to influence consumer behavior and buying patterns. Direct-to-consumer advertising that does not target a racially diverse audience may exacerbate MSK disparities by failing to reach [...] Read more.

Introduction: Demographic disparities in musculoskeletal (MSK) health exist in the US. Racial representation in advertising has been shown to influence consumer behavior and buying patterns. Direct-to-consumer advertising that does not target a racially diverse audience may exacerbate MSK disparities by failing to reach minorities. We explore the hypothesis that minorities are underrepresented in direct-to-consumer MSK advertisements in this cross-sectional analysis. Methods: Using magazines from four databases, eight health-related magazine types were selected and advertisement categories were established. Racial distribution was analyzed using Pearson’s Chi-squared and Chi-squared tests. Fisher’s Exact test was used when >20% of cells had expected frequencies <5. Significance was set at α = 0.05. Results: Of the advertisements featuring at least one model, 68.5% featured a white-presenting model, followed by 17.6% with a black model. Further, 92.7% of advertisements were monoethnic or monoracial with an overrepresentation of white models (p < 0.001). Black models were overrepresented as athletes (p < 0.001) and underrepresented in advertisements for pain relief (p < 0.001). Hispanic/Latinx and Asian models were underrepresented across all advertisement categories (p < 0.001). Discussion: The causes of musculoskeletal health disparities are multifactorial. One potential influence is adjacent industries such as MSK health-related advertisements. When controlling for US population demographics, white models were overrepresented and minority race models were underrepresented, demonstrating racioethnic disparities in MSK advertising. Improving the racial and ethnic diversity of models within MSK advertisements may serve to improve patient perceptions of orthopaedic products and services and improve MSK disparities. Full article

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