Journal of Market Access & Health Policy

13 pages, 306 KB

Open AccessPerspective

Safe Staffing Standards for Pharmacy Technicians in Hospital Settings

by Vítor Silva, João José Joaquim, Shane Desselle, Samantha Quaye and Cristiano Matos

J. Mark. Access Health Policy 2025, 13(3), 45; https://doi.org/10.3390/jmahp13030045 - 4 Sep 2025

Pharmacy technicians (PT) are vital to the efficient and safe operation of hospital pharmacy services, fulfilling a range of technical and clinical responsibilities that directly impact patient care. However, increasing healthcare demands have underscored the importance of adequate staffing levels to sustain service [...] Read more.

Pharmacy technicians (PT) are vital to the efficient and safe operation of hospital pharmacy services, fulfilling a range of technical and clinical responsibilities that directly impact patient care. However, increasing healthcare demands have underscored the importance of adequate staffing levels to sustain service quality and safeguard patient outcomes. This perspective paper explores how appropriate staffing levels for PT in hospital settings are essential and important to support safe, efficient care and a sustainable workforce. It compares evidence-informed staffing models, highlights real-world benchmarks, and proposes governance recommendations to guide policies that strengthen pharmacy services. Recommendations are made to inform clinical governance, suggesting that staffing policies, continuous training, and professional development programs are essential to supporting PT effectiveness and retention. The findings advocate for regulated staffing ratios and governance measures to foster an environment where PTs can deliver high-quality care and uphold safety standards within hospital pharmacies. Full article

13 pages, 267 KB

Open AccessArticle

Value-Based Healthcare as a Competitive Strategy—A Multi-Stakeholder Perception Analysis in Portuguese Healthcare

by Filipe Santiago, Filipe Costa, Eduardo Redondo and Cristiano Matos

J. Mark. Access Health Policy 2025, 13(3), 44; https://doi.org/10.3390/jmahp13030044 - 2 Sep 2025

Abstract

Designing an accessible, financially viable healthcare system is a key challenge for society. The value-based healthcare (VBHC) strategic model aims to simultaneously improve the quality of healthcare and the efficiency of health systems. The aim of this research was to describe the perceptions [...] Read more.

Designing an accessible, financially viable healthcare system is a key challenge for society. The value-based healthcare (VBHC) strategic model aims to simultaneously improve the quality of healthcare and the efficiency of health systems. The aim of this research was to describe the perceptions of different stakeholders in the Portuguese health industry about the creation of value and the understanding of VBHC as a competitive advantage. A qualitative study was conducted using the inductive method of Braun and Clarke, designed according to the COREQ criteria. Based on the results of the literature review, a semi-structured script for an interview was created, consisting of eight questions. The initial interview script was based on a thorough narrative literature review and tested with two professionals with practical experience in VBHC. The final version of the semi-structured interview guide consisted of eight open-ended questions. The questions were designed to elicit in-depth, reflective responses, and their neutrality was reviewed to avoid leading language that might introduce bias. As the interviews progressed, minor iterative changes were made to include participant-suggested additions, always maintaining alignment with the research objectives. This iterative process was essential to capture the nuanced perspectives of stakeholders and conformed to COREQ standards for qualitative research. A total of 15 stakeholders in VBHC were interviewed. The interviews were transcribed and coded, and 605 codes were created, divided into subthemes and themes. VBHC implementation faces several challenges, requiring a collaborative effort by the stakeholders involved, to achieve a comprehensive vision of value and appropriate multi-stakeholder alignment. The implementation of VBHC can confer a sustainable competitive advantage, and its adoption as a strategic model will be inevitable in the future. Full article

11 pages, 466 KB

Open AccessArticle

Deploying Experienced Utility in Health Economic Evaluation: A Quantitative Study

by Damien S. E. Broekharst, Sjaak Bloem, Robert J. Blomme, Edward A. G. Groenland, Patrick P. T. Jeurissen and Michel van Agthoven

J. Mark. Access Health Policy 2025, 13(3), 43; https://doi.org/10.3390/jmahp13030043 - 28 Aug 2025

Abstract

Background: Expected utility has been deployed in order to predict health behaviour in health economic evaluation. However, only limited variance in health behaviour is explained by this construct. This limited explained variance is often attributed to the dubious foundational postulates underlying the construct [...] Read more.

Background: Expected utility has been deployed in order to predict health behaviour in health economic evaluation. However, only limited variance in health behaviour is explained by this construct. This limited explained variance is often attributed to the dubious foundational postulates underlying the construct (e.g., absolute rationality, complete information, fixed preferences). Due to these limitations it has been hypothesized that substituting or complementing expected utility with experienced utility may enhance predictions of health behaviour. As this hypothesis has not yet been subjected to empirical scrutiny, this study examines if deployment of experienced utility or expected utility and experienced utility combined enhances predictions of health behaviour relative to expected utility separately. Methods: Online questionnaires were distributed across a panel of Dutch citizens (N = 2550). The questionnaire includes items and scales on sample characteristics, expected utility, experienced utility and health behaviour. Data analysis was conducted by employing descriptive, reliability, validity and model statistics. Results: Experienced utility has a significant direct effect on health behaviour that is stronger than expected utility. Experienced utility also explains more variance in health behaviour than expected utility. Expected utility and experienced utility combined have a significant direct and indirect effect on health behaviour that is stronger than each type of utility separately. Expected utility and experienced utility combined also explain more variance in health behaviour than each type of utility separately. Conclusions: Deploying experienced utility separately or in combination with expected utility in health economic evaluation seems pertinent as it has considerable impact on health behaviour and may provide health economists with an even sturdier foundation for conducting health economic evaluation. Full article

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7 pages, 377 KB

Open AccessOpinion

European Health Technology Assessment Considerations Related to Gene Therapies in Eyecare: The Neovascular Age-Related Macular Degeneration Example

by Kevin Douglas, Gianni Pardhanani, Laetitia Mariani and Maria Chaita

J. Mark. Access Health Policy 2025, 13(3), 42; https://doi.org/10.3390/jmahp13030042 - 27 Aug 2025

Abstract

Gene therapies that induce the body to produce therapeutic anti-vascular endothelial growth factor (anti-VEGF) proteins are an emerging topic related to neovascular age-related macular degeneration (nAMD). Continuous delivery of anti-VEGF protein directly to the target tissue offers the possibility of lifelong efficacy without [...] Read more.

Gene therapies that induce the body to produce therapeutic anti-vascular endothelial growth factor (anti-VEGF) proteins are an emerging topic related to neovascular age-related macular degeneration (nAMD). Continuous delivery of anti-VEGF protein directly to the target tissue offers the possibility of lifelong efficacy without the need for repeated and frequent eye injections. This novel approach could revolutionize patient management through optimizing clinical outcomes while simplifying service delivery. However, such gene therapies are anticipated to face unique challenges related to patients’ access and health technology assessment (HTA), and their integration into real-world eyecare practices. This article presents key elements raised at the European Access Academy (EAA) Fall convention (held in Rome in October 2024) regarding anticipated HTA challenges for gene therapies in nAMD. The important role of HTA and policymakers in ensuring that emerging gene therapies are accessible to all eligible patients is also highlighted. This article mainly focuses on the need for a fit-for-purpose EU HTA framework to address the widely varying utilization of standard of care in nAMD clinical practice, and to incorporate considerations about the long-term durability of gene therapies in nAMD. The importance of integrating real-world evidence (RWE) into the EU HTA framework is also discussed. Full article

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

15 pages, 831 KB

Open AccessArticle

Development of a Work-Related Quality of Life Questionnaire for Medical Doctors (WQMD-9) in Japan: Questionnaire Design and Quantitative Survey

by Miyuki Ezura, Katsuhiko Sawada, Yusuke Takushima, Lida Teng and Ataru Igarashi

J. Mark. Access Health Policy 2025, 13(3), 41; https://doi.org/10.3390/jmahp13030041 - 19 Aug 2025

Abstract

Background: With the ongoing development of game-changing technologies, assessing healthcare provider burden is desirable. This requires developing and evaluating subjective outcome measures, but there is no single scale that measures this burden. We developed a measure of quality of life (QOL) to [...] Read more.

Background: With the ongoing development of game-changing technologies, assessing healthcare provider burden is desirable. This requires developing and evaluating subjective outcome measures, but there is no single scale that measures this burden. We developed a measure of quality of life (QOL) to address this, focusing on medical doctors (MDs). Methods: Based on Japan’s national statistical distribution of MDs in Japan, we qualitatively interviewed twenty MDs to identify factors that influenced their QOL and another eight MDs to verify the appropriateness and interpretability of the questions. Validity and reliability were evaluated and verified in a quantitative survey of 374 MDs to finalize the questionnaire. Results: Based on our initial research and interviews, we derived nine dimensions and developed the work-related QOL questionnaire for MDs (WQMD-9) accordingly. Correlation coefficients between questionnaire items were 0.3–0.7 and Cronbach’s α was 0.897, confirming the validity and reliability of the questionnaire. Conclusions: The WQMD-9 is an original profile-type scale with nine dimensions and five levels. We expect that as new technologies develop, evaluations of the associated medical treatment will involve measuring the QOL of not only patients but also MDs, and the WQMD-9 will facilitate this process. Full article

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10 pages, 230 KB

Open AccessArticle

Managed Entry Agreements for Pharmaceutical Products in Three Maghreb Countries: Payer and Supplier Perspectives

by Hajer Dahmani, Leila Achour, Maghreb Research Group, Mondher Toumi and Ines Fradi

J. Mark. Access Health Policy 2025, 13(3), 40; https://doi.org/10.3390/jmahp13030040 - 11 Aug 2025

Abstract

Our objective is to describe the experience and challenges of using Managed Entry Agreements (MEAs) in Algeria, Morocco, and Tunisia. We conducted online interviews with key decision-makers in Algeria, Morocco, and Tunisia between March 2021 and December 2023. The questionnaire captured experience with [...] Read more.

Our objective is to describe the experience and challenges of using Managed Entry Agreements (MEAs) in Algeria, Morocco, and Tunisia. We conducted online interviews with key decision-makers in Algeria, Morocco, and Tunisia between March 2021 and December 2023. The questionnaire captured experience with MEAs, types of agreements implemented, and challenges to implementing MEAs. Three, five, and seven participants working, respectively, in the Algerian, Moroccan, and Tunisian pharmaceutical sectors, participated in the interviews. Participants were from the public (8/15) and the private sector (7/15). Only Tunisian respondents reported having dealt with MEAs contracts, such as financial-based agreements (FBAs) related to standard discounts and volume-based price discounts. All respondents were aware of the potential need for structuring contracts differently for expensive medicines. Hurdles in implementing MEAs noted by respondents were mainly related to the absence of a legal framework and the lack of budget allocated for new medicines. Most respondents projected an increase in the use of MEAs to improve reimbursement and access to new, highly priced medicines. Recommendations include strengthening pricing, reimbursement processes, and HTA use. The adoption of FBAs is suggested as a practical initial approach. Full article

15 pages, 1189 KB

Open AccessArticle

Innovative Payment Mechanisms for High-Cost Medical Devices in Latin America: Experience in Designing Outcome Protection Programs in the Region

by Daniela Paredes-Fernández and Juan Valencia-Zapata

J. Mark. Access Health Policy 2025, 13(3), 39; https://doi.org/10.3390/jmahp13030039 - 4 Aug 2025

Abstract

Introduction and Objectives: Risk-sharing agreements (RSAs) have emerged as a key strategy for financing high-cost medical technologies while ensuring financial sustainability. These payment mechanisms mitigate clinical and financial uncertainties, optimizing pricing and reimbursement decisions. Despite their widespread adoption globally, Latin America has [...] Read more.

Introduction and Objectives: Risk-sharing agreements (RSAs) have emerged as a key strategy for financing high-cost medical technologies while ensuring financial sustainability. These payment mechanisms mitigate clinical and financial uncertainties, optimizing pricing and reimbursement decisions. Despite their widespread adoption globally, Latin America has reported limited implementation, particularly for high-cost medical devices. This study aims to share insights from designing RSAs in the form of Outcome Protection Programs (OPPs) for medical devices in Latin America from the perspective of a medical devices company. Methods: The report follows a structured approach, defining key OPP dimensions: payment base, access criteria, pricing schemes, risk assessment, and performance incentives. Risks were categorized as financial, clinical, and operational. The framework applied principles from prior models, emphasizing negotiation, program design, implementation, and evaluation. A multidisciplinary task force analyzed patient needs, provider motivations, and payer constraints to ensure alignment with health system priorities. Results: Over two semesters, a panel of seven experts from the manufacturer designed n = 105 innovative payment programs implemented in Argentina (n = 7), Brazil (n = 7), Colombia (n = 75), Mexico (n = 9), Panama (n = 4), and Puerto Rico (n = 3). The programs targeted eight high-burden conditions, including Coronary Artery Disease, atrial fibrillation, Heart Failure, and post-implantation arrhythmias, among others. Private providers accounted for 80% of experiences. Challenges include clinical inertia and operational complexities, necessitating structured training and monitoring mechanisms. Conclusions: Outcome Protection Programs offer a viable and practical risk-sharing approach to financing high-cost medical devices in Latin America. Their implementation requires careful stakeholder alignment, clear eligibility criteria and endpoints, and robust monitoring frameworks. These findings contribute to the ongoing dialogue on sustainable healthcare financing, emphasizing the need for tailored approaches in resource-constrained settings. Full article

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11 pages, 208 KB

Open AccessReview

Patient Involvement in Health Technology Assessments: Lessons for EU Joint Clinical Assessments

by Anne-Pierre Pickaert

J. Mark. Access Health Policy 2025, 13(3), 38; https://doi.org/10.3390/jmahp13030038 - 28 Jul 2025

Cited by 1

Abstract

Patient involvement in health technology assessment (HTA) processes is increasingly recognized as pivotal for informed, equitable, and patient-relevant health care decision-making. With the implementation of Joint Scientific Consultations (JSCs) and Joint Clinical Assessments (JCAs) under Regulation (EU) 2021/2282, the European Union has a [...] Read more.

Patient involvement in health technology assessment (HTA) processes is increasingly recognized as pivotal for informed, equitable, and patient-relevant health care decision-making. With the implementation of Joint Scientific Consultations (JSCs) and Joint Clinical Assessments (JCAs) under Regulation (EU) 2021/2282, the European Union has a unique opportunity to design harmonized mechanisms that reflect best practices from established HTA systems. This article, drawing on the Acute Leukemia Advocates Network (ALAN)’s comparative analysis of HTA practices across seven countries (Canada, England, Scotland, France, Germany, Spain, and Italy), examines how current patient involvement processes can inform the JCA framework. It identifies opportunities to replicate effective practices and proposes strategies to embed patient voices meaningfully into the JCA process. By prioritizing robust and inclusive patient involvement, the EU can establish a global benchmark for impactful and consistent HTA processes. By leveraging lessons from international HTA systems and prioritizing clear frameworks, early involvement, and capacity building, the EU can set a global standard for meaningful patient participation in HTA processes. ALAN is an independent global network of patient organizations dedicated to improving outcomes for patients with acute leukemia. Full article

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

11 pages, 235 KB

Open AccessArticle

Pivotal Studies for Drugs About to Be Launched for Rare Diseases: Will They Better Support Health Technology Assessment and Market Access than in the Past?

by Claudio Jommi, Marzia Bonfanti, Melissa Guardigni, Andrea Aiello, Andrea Marcellusi, Pier Luigi Canonico, Fulvio Luccini and Chiara Lucchetti

J. Mark. Access Health Policy 2025, 13(3), 37; https://doi.org/10.3390/jmahp13030037 - 25 Jul 2025

Abstract

The designs of clinical trials of drugs for rare diseases are challenged by health technology assessment organisations and payers. Phase II pivotal studies, single-arm or open-label designs, the extensive use of non-final endpoints, and the limited use of patient-reported outcomes (PROs) are the [...] Read more.

The designs of clinical trials of drugs for rare diseases are challenged by health technology assessment organisations and payers. Phase II pivotal studies, single-arm or open-label designs, the extensive use of non-final endpoints, and the limited use of patient-reported outcomes (PROs) are the main points of contention. The evidence on the actual design of these trials is limited, but corroborates the concerns of the above. Our aim is to scrutinise whether the design of pivotal studies of drugs for rare diseases to be launched into the Italian market by 2026 present similar issues. The drugs and the relevant pivotal studies were retrieved from Biomedtracker and US and European clinical trial databases. We identified 154 new drugs for rare diseases. Single-arm designs account for 36% of trials. Almost 50% of randomised control trials (RCTs) are designed using an active comparator and 61% are double-blinded. Primary endpoints are mostly (82%) surrogate. A total of 59% of studies include PROs. Our findings were partially expected (e.g., extensive use of surrogate endpoints) and partially not (e.g., RCTs and an active comparator), considering previous studies on the same topic. Having more head-to-head studies may reduce uncertainty concerning evidence at market launch, but different issues persist, including the still limited role of PROs. Full article

15 pages, 1045 KB

Open AccessArticle

Physician Practice Affiliation Drives Site of Care Cost Differentials: An Opportunity to Reduce Healthcare Expenditures

by Deepak A. Kapoor, Mark Camel, David Eagle, Lauren C. Makhoul, Justin Maroney, Zhou Yang and Paul Berggreen

J. Mark. Access Health Policy 2025, 13(3), 36; https://doi.org/10.3390/jmahp13030036 - 24 Jul 2025

Abstract

The continued migration of physicians from independent practice to affiliation with larger entities has garnered significant scrutiny. These affiliation models include hospitals and health systems, payers and corporate entities, and management services organizations, which may or may not be private equity (PE)-backed. Data [...] Read more.

The continued migration of physicians from independent practice to affiliation with larger entities has garnered significant scrutiny. These affiliation models include hospitals and health systems, payers and corporate entities, and management services organizations, which may or may not be private equity (PE)-backed. Data on the impact of different physician affiliation models on cost of care is limited. We examined the relationship between provider affiliation model, site of care (SOC), and cost of care for certain high-volume procedures in procedure-intensive specialties for both Medicare and commercial insurance. We found that hospital-affiliated physicians are least likely—and PE-affiliated physicians are most likely—to provide care in lower-cost settings. For both Medicare and commercial insurance, SOC contributes meaningfully to procedure unit price, which is consistently greater in hospital-based settings. These findings suggest that the physician affiliation model and associated SOC cost differentials contribute materially to healthcare expenditures. As the Medicare cost differentials are set by statute and regulations, strategies such as site-neutral payments are needed to mitigate the monetary impact of historical and future physician practice migration. Full article

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19 pages, 424 KB

Open AccessArticle

Preparing for the EU HTA Regulation: Insights from the Dutch Perspective

by Anne Willemsen, Maureen Rutten-van Mölken, Riam al Dulaimi, Hedi Schelleman, Wim Goettsch and Lonneke Timmers

J. Mark. Access Health Policy 2025, 13(3), 35; https://doi.org/10.3390/jmahp13030035 - 24 Jul 2025

Cited by 1

Abstract

The European Health Technology Assessment (HTA) regulation (HTAR) came into effect in January 2025 and impacts the HTA process in all European Member States. Member States must give due consideration to the joint clinical assessment (JCA) report. This may require adaptations at the [...] Read more.

The European Health Technology Assessment (HTA) regulation (HTAR) came into effect in January 2025 and impacts the HTA process in all European Member States. Member States must give due consideration to the joint clinical assessment (JCA) report. This may require adaptations at the national level. This paper describes the anticipated changes to the Dutch national HTA process and how the Dutch National Health Care Institute (Zorginstituut Nederland, ZIN) prepared for this, because sharing experience between Member States can be of general interest for future expansion of the EU HTAR. ZIN’s implementation activities were facilitated by a project-governance structure and by a continuous gap analysis of the current national assessment and appraisal process of medicinal products, resulting in a concrete action plan. The implementation of the HTAR has two major implications for ZIN’s HTA process, namely that the scoping phase starts much earlier and that the JCA report is the starting point for the national assessment. Gaps, challenges and issues were identified in the categories: information and knowledge, IT and template, communication and stakeholder engagement, capacity and resources, and financial aspects. Based on a thorough and well-defined implementation plan, ZIN is ready to implement the HTAR in national HTA processes and to take on (co-)assessor roles for JCA of medicinal products in 2025. Full article

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

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11 pages, 496 KB

Open AccessArticle

An Estimation of the Economic and Environmental Impact of Inhaler Devices Switch for Non-Clinical Reasons in COPD and Asthma: The Case for Spain

by Oriol Solà-Morales, Joan B Soriano, Míriam Solozabal-Coll and Jose Vicente Galindo

J. Mark. Access Health Policy 2025, 13(3), 34; https://doi.org/10.3390/jmahp13030034 - 17 Jul 2025

Abstract

In respiratory patients, limited adherence to and misuse of devices hinder the effectiveness of inhalation therapy. Switching inhalers for non-clinical reasons poses a risk of deterioration of respiratory disease and/or promotes poor adherence to therapy. The objective of this work was to explore [...] Read more.

In respiratory patients, limited adherence to and misuse of devices hinder the effectiveness of inhalation therapy. Switching inhalers for non-clinical reasons poses a risk of deterioration of respiratory disease and/or promotes poor adherence to therapy. The objective of this work was to explore the impact of device changes for non-clinical reasons on clinical outcomes (primary) and costs (secondary), including carbon emissions in Spain. After a comprehensive literature search, the increased use of resources following worsening outcomes was apportioned using Spanish cost data and following the recommended pathways for care. We calculated the cost of re-training these patients and attributed carbon emissions in metric tons of CO₂ equivalent (tCO₂eq) to the excess resource use. In Spain, the impact of uncontrolled switching for non-clinical reasons in COPD has an annual estimated cost of EUR 923/patient, leading to an excess annual expenditure of more than EUR 216 million. For asthma patients, the annual impact is almost EUR 263/patient, representing an additional EUR 118 million excess annual expenditure. The environmental consequence of both conditions can be equated to almost 45 thousand tCO₂eq. Training all these patients on the new device would cost around EUR 35 million and would generate an extra impact reduction of about 2.6 thousand tCO₂eq in carbon emissions levy. Full article

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4 pages, 168 KB

Open AccessEditorial

EU-HTA Guidance for Clinical Validity: Misconceptions and Flawed Processes

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

J. Mark. Access Health Policy 2025, 13(3), 33; https://doi.org/10.3390/jmahp13030033 - 15 Jul 2025

Abstract

This review of the scope of the European Health Technology Assessment (EU HTA)’s guidance on clinical trial validity in its randomized controlled trials (RCTs) highlights several key issues that undermine its practical application and effectiveness, including misconceptions, errors, and inconsistencies [...] Full article

21 pages, 615 KB

Open AccessArticle

The PICO Puzzle: Can Public Data Predict EU HTA Expectations for All EU Countries?

by Karolin Eberle, Lisa-Maria Hagemann, Maria Katharina Schweitzer, Martin Justl, Jana Maurer, Alexandra Carls and Eva-Maria Reuter

J. Mark. Access Health Policy 2025, 13(3), 32; https://doi.org/10.3390/jmahp13030032 - 26 Jun 2025

Abstract

With the European Union (EU) Health Technology Assessment (HTA) regulation, Joint Clinical Assessments (JCA) are now required for oncological and advanced therapy medicinal products. The JCA assessment scope is determined through the PICO framework (Population, Intervention, Comparator, Outcome). Given the tight JCA timelines, [...] Read more.

With the European Union (EU) Health Technology Assessment (HTA) regulation, Joint Clinical Assessments (JCA) are now required for oncological and advanced therapy medicinal products. The JCA assessment scope is determined through the PICO framework (Population, Intervention, Comparator, Outcome). Given the tight JCA timelines, Health Technology Developers (HTD) must anticipate PICO elements early to prepare dossiers effectively. This study investigates whether PICO can be predicted across EU member states using publicly available information. A systematic literature review was conducted to identify relevant peer-reviewed articles. Additionally, an extensive search of publicly available HTA documents, including reports, methodological guidelines, submission templates, and market access information was performed across 29 European countries. Relevant information for PICO anticipation was extracted. For many member states, a wealth of relevant information is publicly accessible: 66% have HTA reports publicly available, 79% have HTA methodological guidelines, 69% have dossier templates, and 100% have market access status lists. Between countries, the requirements for population and outcomes are largely aligned, making comparator the central element in PICO anticipation. PICO can be anticipated reliably based on public information. HTDs must be prepared to adjust their strategies as national procedures adapt, ensuring alignment with both current and emerging EU and national requirements. Full article

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

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9 pages, 1004 KB

Open AccessPerspective

Opportunities for and Challenges of Conducting Indirect Treatment Comparisons and Meta-Analyses for Vaccines in Post-EU HTA Regulation Era

by Charlotte Graham, Erin Barker, Joe Moss, Emily Gregg, Rachael McCool, Nathalie Largeron, Mélanie Trichard, José Bartelt-Hofer and Maribel Tribaldos

J. Mark. Access Health Policy 2025, 13(2), 31; https://doi.org/10.3390/jmahp13020031 - 11 Jun 2025

Cited by 2

Abstract

The dynamic nature of infectious diseases introduces inherent challenges to the design of vaccine clinical trials, which consequently makes vaccine indirect treatment comparisons (ITCs) and meta-analyses (MAs) more challenging compared with regular pharmaceuticals. However, comparisons of efficacy and safety between vaccines are being [...] Read more.

The dynamic nature of infectious diseases introduces inherent challenges to the design of vaccine clinical trials, which consequently makes vaccine indirect treatment comparisons (ITCs) and meta-analyses (MAs) more challenging compared with regular pharmaceuticals. However, comparisons of efficacy and safety between vaccines are being frequently required in vaccine decision making due to a low number of head-to-head clinical trials in the vaccine landscape. The introduction of the European Union Health Technology Assessment (HTA) Regulation (EU HTAR) aims to harmonize HTA efforts across Europe. However, the EU HTAR could also escalate existing challenges for conducting vaccine MAs and ITCs. Such challenges include generating efficacy evidence in time for Joint Clinical Assessment (JCA), incorporating high levels of heterogeneity due to infectious disease-specific characteristics, and tackling a high number of PICOs per submission—likely driven by heterogeneity in the available data and differences in national vaccine calendars. Opportunities to tackle these challenges include introducing a stepwise approach to vaccine assessment in JCA, best-practice recommendations for conducting/interpreting vaccine MAs and ITCs, and condensing the number of PICOs to create larger ‘catch-all’ ITC networks. This perspective article explores these challenges and opportunities further. Full article

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

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10 pages, 768 KB

Open AccessReview

Health Technology Assessment and Cardiology: A Review of the Present and Future of Innovation

by Ruben Casado-Arroyo and Lucia Osoro

J. Mark. Access Health Policy 2025, 13(2), 30; https://doi.org/10.3390/jmahp13020030 - 9 Jun 2025

Abstract

Background and Objective: Innovation is a key enabler of patient-centered care in cardiology, with new medical devices and digital health technologies offering the potential to improve outcomes and efficiency. However, the evaluation of these innovations poses challenges for clinicians, regulators, and procurement stakeholders, [...] Read more.

Background and Objective: Innovation is a key enabler of patient-centered care in cardiology, with new medical devices and digital health technologies offering the potential to improve outcomes and efficiency. However, the evaluation of these innovations poses challenges for clinicians, regulators, and procurement stakeholders, particularly within the complex European healthcare landscape. This review aims to explore the current state of health technology assessment (HTA) for cardiology-related medical devices in Europe, offering a clinical perspective. Material and Methods: Three independent scoping reviews were conducted following the PRISMA-ScR guidelines. Keywords included “innovation”, “health technology assessment”, and “cardiology”. The search was supplemented by the relevant literature on European HTA policies, regulatory directives, and emerging technologies. Results: The review identified three central themes: (1) the evolving role of clinicians in HTA processes, (2) the integration of innovative technologies such as digital tools and artificial intelligence within HTA frameworks, and (3) the considerable variation in HTA practices and policies across EU member states. Conclusions: HTA in Europe is undergoing a transformation, with increasing emphasis on interdisciplinary collaboration and frameworks that support innovation. While the goal of harmonization across the EU remains a work in progress, new regulatory efforts, such as the HTA Regulation (HTAR), offer promising avenues for aligning clinical practice with evidence-based assessment and reimbursement decisions. Full article

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

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19 pages, 1200 KB

Open AccessArticle

Exploring Trust in Health Insurers: Insights from Enrollees’ Perceptions and Experiences

by Frank J. P. van der Hulst, Sanne Huijgen, Anne E. M. Brabers and Judith D. de Jong

J. Mark. Access Health Policy 2025, 13(2), 29; https://doi.org/10.3390/jmahp13020029 - 9 Jun 2025

Abstract

Managed competition is a key driver in healthcare systems in countries like Germany, Switzerland, and The Netherlands. Trust in health insurers is vital but currently low in The Netherlands. This may be due to perceptions regarding profit motives, negative experiences, media coverage, and [...] Read more.

Managed competition is a key driver in healthcare systems in countries like Germany, Switzerland, and The Netherlands. Trust in health insurers is vital but currently low in The Netherlands. This may be due to perceptions regarding profit motives, negative experiences, media coverage, and a lack of understanding of insurers’ roles. This study explores how enrollees perceive health insurers and how the aforementioned factors contribute to these perceptions. Semi-structured interviews were conducted with 17 participants from the Nivel Dutch Health Care Consumer Panel in March and April 2023. Data were analysed using Braun and Clarke’s six-step method for inductive thematic analysis. Participants generally view health insurers positively in terms of managing finances and ensuring care accessibility. However, some perceive insurers as profit-driven and prioritising cost reduction over individual needs, leading to dissatisfaction. Negative experiences and media coverage also shape these perceptions. Participants believe that insurers should ensure care accessibility and quality, distribute costs fairly, provide guidance, and prioritise preventive measures. To foster trust, insurers should communicate their non-profit status and use of benefits, increase transparency in purchasing decisions, and maintain clear communication about payment obligations. Enhancing communication about their contributions to healthcare and raising awareness of their broader roles may also help build trust. Full article

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14 pages, 262 KB

Open AccessPerspective

Health and Social Care Integration: Insights from International Implementation Cases

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

J. Mark. Access Health Policy 2025, 13(2), 28; https://doi.org/10.3390/jmahp13020028 - 5 Jun 2025

Cited by 1

Abstract

The integration of health and social care is increasingly recognized as essential to address population ageing, the rise in chronic diseases, and persistent health inequities. Across Europe, diverse models have been developed to improve service coordination, resource efficiency, and person-centered care. This paper [...] Read more.

The integration of health and social care is increasingly recognized as essential to address population ageing, the rise in chronic diseases, and persistent health inequities. Across Europe, diverse models have been developed to improve service coordination, resource efficiency, and person-centered care. This paper aims to explore international experiences in integrating health and social care, identify common strategies and challenges, and provide insights to inform policy development in countries where integration remains incipient, with a focus on Portugal. A qualitative comparative approach was employed. A systematic literature review was conducted across PUBMED, MEDLINE, and Google Scholar, including peer-reviewed articles, policy reports, and government documents. Thematic analysis was used to identify integration models, enablers, and barriers across different countries. Different models reveal that joint governance, pooled funding, strong community involvement, and digital innovation are key enablers of integration. However, common challenges persist, including fragmented governance, inconsistent implementation, and financial sustainability. In Portugal, structural separation between the health and social sectors continues to limit strategic alignment. Successful integration depends on political commitment, shared vision, and active stakeholder collaboration. European models offer adaptable lessons for Portugal and similar systems, especially regarding intersectoral coordination and preventive care. Integrating health and social care is vital for building resilient, equitable systems. Portugal must adopt a cohesive national strategy; strengthen local implementation; and embrace person-centered, sustainable solutions to ensure long-term impact. Integrating the health and social sectors is indispensable in navigating the ever-evolving healthcare landscape and promoting holistic well-being. Full article

15 pages, 1306 KB

Open AccessOpinion

Enhancing Patient Engagement in HTA: Using Consensus Research to Overcome PICO Scoping Challenges Under the EU HTAR

by Emanuele Arcà, Adele Barlassina, Adaeze Eze and Valentina Strammiello

J. Mark. Access Health Policy 2025, 13(2), 27; https://doi.org/10.3390/jmahp13020027 - 2 Jun 2025

Abstract

The evolving landscape of Health Technology Assessment (HTA) in Europe, shaped by the implementation of the new EU HTA Regulation (HTAR), places an emphasis on engaging all stakeholders, including patients, in collaborative evidence generation. Yet integrating patients’ perspectives into critical processes like PICO [...] Read more.

The evolving landscape of Health Technology Assessment (HTA) in Europe, shaped by the implementation of the new EU HTA Regulation (HTAR), places an emphasis on engaging all stakeholders, including patients, in collaborative evidence generation. Yet integrating patients’ perspectives into critical processes like PICO scoping remains a challenge, with concerns around subjectivity, representativeness, and methodological robustness. This opinion paper examines the complexities of patient engagement in HTA, highlighting both the opportunities for patients to make meaningful contributions and the barriers that stand in the way. We propose a framework that employes the Delphi panel methodology to (1) foster scientific validity and increase transparency in patient contributions, (2) establish a structured and consistent patient engagement framework, and (3) and understand European patients’ perspectives while promoting collaboration among EU countries. By facilitating iterative feedback and fostering agreement among diverse groups of patients and caregivers contributing with their expertise, consensus methods like Delphi panels can help refine PICO criteria, align diverse stakeholders’ expectations, and increase the relevance of HTA outcomes. A study is now underway to evaluate the feasibility and value of using the modified Delphi panel methodology for patient engagement in PICO scoping. The authors propose that embracing patient engagement through carefully designed consensus frameworks could enhance the legitimacy and completeness of HTA processes, driving more patient-centered decision making across Europe. Full article

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

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