Journal of Market Access & Health Policy

9 pages, 1004 KiB

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

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 KiB

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 KiB

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 KiB

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

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 KiB

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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5 pages, 165 KiB

Open AccessEditorial

The Art of Bridge Building: A Look at the European-Level Cooperation in HTA (EU-HTA)

by Rui Santos Ivo, Tiago Rodrigues, Sara Couto and Mariane Cossito

J. Mark. Access Health Policy 2025, 13(2), 26; https://doi.org/10.3390/jmahp13020026 - 28 May 2025

Abstract

Health technology assessment (HTA) is a methodological and a scientific evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing health technologies and to inform real-world decisions [...] Full article

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

12 pages, 521 KiB

Open AccessArticle

Price Analysis of Systemic Therapies and Transarterial Radioembolization for Treatment of Unresectable Hepatocellular Carcinoma

by Abimbola O. Williams, Nicholas Anderson, Young-Gwan Gwon and Wendy Wifler

J. Mark. Access Health Policy 2025, 13(2), 25; https://doi.org/10.3390/jmahp13020025 - 27 May 2025

Abstract

Systemic therapy (ST) and transarterial radioembolization (TARE) are widely used treatments for advanced-stage hepatocellular carcinoma (HCC). This study quantified the significant variability in treatment costs for unresectable HCC from payer and provider perspectives. An Excel-based price analysis model was developed to estimate the [...] Read more.

Systemic therapy (ST) and transarterial radioembolization (TARE) are widely used treatments for advanced-stage hepatocellular carcinoma (HCC). This study quantified the significant variability in treatment costs for unresectable HCC from payer and provider perspectives. An Excel-based price analysis model was developed to estimate the prices of ST and TARE over a 21-month time horizon using 2015–2021 data. Median prices were calculated from Medicare Average Sales Price (ASP), provider Wholesale Acquisition Cost (WAC), and Average Wholesale Price (AWP). Sensitivity analyses evaluated price fluctuations associated with a ±10% variation in treatment duration. ST prices demonstrated marked variability across perspectives, with the median ASP at $175,625, WAC at $198,719, and AWP at $262,892. However, TARE prices were stable, ranging from $21,594 to $24,052. Sensitivity analyses revealed that treatment duration variation resulted in price changes of $35,000–$50,000 for ST, compared with ~$5000 for TARE. The variability in ST pricing was driven by treatment duration and drug-specific pricing mechanisms, particularly immunotherapy-based regimens, which accounted for the higher cost range. Conversely, TARE’s consistent pricing is attributed to standardized procedural costs. Substantial variability exists in ST prices compared with the consistent costs of TARE, underscoring the economic advantage of TARE in appropriate clinical contexts. Full article

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15 pages, 2129 KiB

Open AccessArticle

Optimizing Patient Access to Orphan Medicinal Products: Lessons from Central and Eastern Europe

by Tomasz Kluszczynski, Bertalan Nemeth, Magdalena Władysiuk, Marcin Czech, Maria Kamusheva, Nicolae Fotin, Sandra Rose, Tomáš Doležal and Rok Hren

J. Mark. Access Health Policy 2025, 13(2), 24; https://doi.org/10.3390/jmahp13020024 - 26 May 2025

Abstract

This study examines patient access to orphan medicinal products (OMPs) in Central and Eastern Europe (CEE) over the past five years, focusing on seven countries: Bulgaria, Czechia, Hungary, Poland, Romania, Slovakia, and Slovenia. While these jurisdictions have undergone rapid healthcare transformations, significant disparities [...] Read more.

This study examines patient access to orphan medicinal products (OMPs) in Central and Eastern Europe (CEE) over the past five years, focusing on seven countries: Bulgaria, Czechia, Hungary, Poland, Romania, Slovakia, and Slovenia. While these jurisdictions have undergone rapid healthcare transformations, significant disparities in OMP access persist compared to Western Europe. This study aimed to address this gap by identifying barriers and enablers to optimize patient access to OMPs in a sustainable and equitable manner. A mixed-methodology approach was utilized, combining systematic literature reviews, in-depth interviews, and advisory board insights. Perspectives were gathered from a wide range of stakeholders, including policymakers, payers, academia, industry associations, and patient advocacy groups. Additionally, the study incorporated data from CEE-specific initiatives to triangulate findings and evaluate barriers, enablers, and best practices in OMP access. The analysis identified sub-optimal OMP access across most CEE countries, marked by prolonged delays and lower reimbursement rates compared to Western Europe, with Slovenia and Czechia as notable exceptions. Key barriers include limited awareness, inadequate health technology assessment (HTA) frameworks, insufficient financing mechanisms, underutilization of novel access schemes, and fragmented patient engagement. Conversely, enablers include the presence of rare disease policies, OMP-specific HTA frameworks, and patient-inclusive decision-making processes. Full article

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19 pages, 584 KiB

Open AccessArticle

Streamlining Endoscopy Cleaning: The Impact of a New Detergent on Time and Water Use

by Joshua Hicks and Mutsa Mutowo

J. Mark. Access Health Policy 2025, 13(2), 23; https://doi.org/10.3390/jmahp13020023 - 16 May 2025

Abstract

Reprocessing reusable flexible endoscopes is resource-intensive and involves high water consumption. This study evaluated the impact of replacing a standard detergent with EndoPreZyme™, a novel detergent, at Blackpool Teaching Hospitals NHS Foundation Trust. We assessed manual cleaning times, water usage, costs, and technician [...] Read more.

Reprocessing reusable flexible endoscopes is resource-intensive and involves high water consumption. This study evaluated the impact of replacing a standard detergent with EndoPreZyme™, a novel detergent, at Blackpool Teaching Hospitals NHS Foundation Trust. We assessed manual cleaning times, water usage, costs, and technician experiences. A direct observational time system analysis was conducted over two one-week periods to record technician tasks before and after implementing EndoPreZyme™, allowing for the omission of the final rinse after manual cleaning. Technician surveys captured user experiences during the transition. The results showed that removing the final rinse after manual cleaning reduced water consumption by 25 litres per endoscope, resulting in an estimated saving of 725,000 L annually. The average manual cleaning time decreased from 13 min 10.2 s to 11 min 10.7 s—a reduction of 1 min 59.5 s per endoscope (15%). This efficiency gain translated to approximately 962.9 fewer technician hours being required annually for manual cleaning. Cost analysis revealed a slight per-endoscope cost reduction (GBP 4.88 vs. GBP 4.90). Technicians reported improved productivity, reduced workload, and an awareness of water conservation. These findings demonstrate that EndoPreZyme™ supports NHS sustainability goals by decreasing water usage and enhancing operational efficiency in healthcare delivery. Full article

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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

Abstract

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 Collection 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 Collection 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 Collection 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 Collection 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

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