Anne Willemsen, Maureen Rutten-van Mölken, Riam Al Dulaimi, Hedi Schelleman, Wim Goettsch, Lonneke Timmers
{"title":"Preparing for the EU HTA Regulation: Insights from the Dutch Perspective.","authors":"Anne Willemsen, Maureen Rutten-van Mölken, Riam Al Dulaimi, Hedi Schelleman, Wim Goettsch, Lonneke Timmers","doi":"10.3390/jmahp13030035","DOIUrl":"10.3390/jmahp13030035","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":"13 3","pages":"35"},"PeriodicalIF":0.0,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12372018/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144981373","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Deepak A Kapoor, Mark Camel, David Eagle, Lauren C Makhoul, Justin Maroney, Zhou Yang, Paul Berggreen
{"title":"Physician Practice Affiliation Drives Site of Care Cost Differentials: An Opportunity to Reduce Healthcare Expenditures.","authors":"Deepak A Kapoor, Mark Camel, David Eagle, Lauren C Makhoul, Justin Maroney, Zhou Yang, Paul Berggreen","doi":"10.3390/jmahp13030036","DOIUrl":"10.3390/jmahp13030036","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":"13 3","pages":"36"},"PeriodicalIF":0.0,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12371938/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144981405","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Charlotte Graham, Erin Barker, Joe Moss, Emily Gregg, Rachael McCool, Nathalie Largeron, Mélanie Trichard, José Bartelt-Hofer, Maribel Tribaldos
{"title":"Opportunities for and Challenges of Conducting Indirect Treatment Comparisons and Meta-Analyses for Vaccines in Post-EU HTA Regulation Era.","authors":"Charlotte Graham, Erin Barker, Joe Moss, Emily Gregg, Rachael McCool, Nathalie Largeron, Mélanie Trichard, José Bartelt-Hofer, Maribel Tribaldos","doi":"10.3390/jmahp13020031","DOIUrl":"10.3390/jmahp13020031","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":"13 2","pages":"31"},"PeriodicalIF":0.0,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12194800/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144499761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Frank J P van der Hulst, Sanne Huijgen, Anne E M Brabers, Judith D de Jong
{"title":"Exploring Trust in Health Insurers: Insights from Enrollees' Perceptions and Experiences.","authors":"Frank J P van der Hulst, Sanne Huijgen, Anne E M Brabers, Judith D de Jong","doi":"10.3390/jmahp13020029","DOIUrl":"10.3390/jmahp13020029","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":"13 2","pages":"29"},"PeriodicalIF":0.0,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12193822/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144499758","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Health Technology Assessment and Cardiology: A Review of the Present and Future of Innovation.","authors":"Ruben Casado-Arroyo, Lucia Osoro","doi":"10.3390/jmahp13020030","DOIUrl":"10.3390/jmahp13020030","url":null,"abstract":"<p><p><b>Background and Objective:</b> 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. <b>Material and Methods:</b> 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. <b>Results:</b> 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. <b>Conclusions:</b> 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.</p>","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":"13 2","pages":"30"},"PeriodicalIF":0.0,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12194119/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144499760","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ricardo Correia de Matos, Generosa do Nascimento, Adalberto Campos Fernandes, Cristiano Matos
{"title":"Health and Social Care Integration: Insights from International Implementation Cases.","authors":"Ricardo Correia de Matos, Generosa do Nascimento, Adalberto Campos Fernandes, Cristiano Matos","doi":"10.3390/jmahp13020028","DOIUrl":"10.3390/jmahp13020028","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":"13 2","pages":"28"},"PeriodicalIF":0.0,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12194770/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144499759","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Enhancing Patient Engagement in HTA: Using Consensus Research to Overcome PICO Scoping Challenges Under the EU HTAR.","authors":"Emanuele Arcà, Adele Barlassina, Adaeze Eze, Valentina Strammiello","doi":"10.3390/jmahp13020027","DOIUrl":"10.3390/jmahp13020027","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":"13 2","pages":"27"},"PeriodicalIF":0.0,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12194599/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144499757","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rui Santos Ivo, Tiago Rodrigues, Sara Couto, Mariane Cossito
{"title":"The Art of Bridge Building: A Look at the European-Level Cooperation in HTA (EU-HTA).","authors":"Rui Santos Ivo, Tiago Rodrigues, Sara Couto, Mariane Cossito","doi":"10.3390/jmahp13020026","DOIUrl":"10.3390/jmahp13020026","url":null,"abstract":"","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":"13 2","pages":"26"},"PeriodicalIF":0.0,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12193941/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144499764","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Abimbola O Williams, Nicholas Anderson, Young-Gwan Gwon, Wendy Wifler
{"title":"Price Analysis of Systemic Therapies and Transarterial Radioembolization for Treatment of Unresectable Hepatocellular Carcinoma.","authors":"Abimbola O Williams, Nicholas Anderson, Young-Gwan Gwon, Wendy Wifler","doi":"10.3390/jmahp13020025","DOIUrl":"10.3390/jmahp13020025","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":"13 2","pages":"25"},"PeriodicalIF":0.0,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12194767/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144499763","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Tomasz Kluszczynski, Bertalan Nemeth, Magdalena Władysiuk, Marcin Czech, Maria Kamusheva, Nicolae Fotin, Sandra Rose, Tomáš Doležal, Rok Hren
{"title":"Optimizing Patient Access to Orphan Medicinal Products: Lessons from Central and Eastern Europe.","authors":"Tomasz Kluszczynski, Bertalan Nemeth, Magdalena Władysiuk, Marcin Czech, Maria Kamusheva, Nicolae Fotin, Sandra Rose, Tomáš Doležal, Rok Hren","doi":"10.3390/jmahp13020024","DOIUrl":"10.3390/jmahp13020024","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":73811,"journal":{"name":"Journal of market access & health policy","volume":"13 2","pages":"24"},"PeriodicalIF":0.0,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12194612/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144499762","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}