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European citizens made it clear in 2024 that healthcare should be the EU’s top priority for shaping the future of Europe. This sentiment reflects the escalating health challenges facing the region, driven by ageing populations, rising chronic d...

Objective: The perspective applied in Health Technology Assessment (HTA) has recently been presented as a central methodological debate in HTA. Beyond expected effects on patients’ health and quality of life, health technologies can affect broa...

Pulmonary arterial hypertension (PAH) and cancer share high mortality and complex prognoses. Due to PAH’s rarity, these parallels may be underrecognized by healthcare stakeholders. This study explored similarities between PAH and cancer across...

Bone conduction hearing implant systems (BCHIs) are established treatments for patients with conductive or mixed hearing loss or single-sided deafness when conventional hearing aids are unsuitable. This study evaluated the cost-effectiveness of the a...

Introduction: [¹⁸F]-DCFPyL (Piflufolastat [¹⁸F]) is a prostate-specific membrane antigen (PSMA)-targeted position emission tomography (PET) radiotracer for detecting the biochemical recurrence (BCR) of prostate cancer (PCa). This study evaluates its...

Objectives: This study explores the feasibility and value of integrating structured patient input into the PICOS (Population, Intervention, Comparator, Outcome, Study design) scoping process for Joint Clinical Assessments under the EU Health Technolo...

Background: The objective of this work was to support the implementation of the European Health Technology Assessment Regulation (EU HTAR) and optimize performance of the evolving EU HTA system. Therefore, an inclusive multi-stakeholder framework of...

This perspective provides an in-depth analysis of the role and tasks of Notified Bodies (NBs) under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). It explores the conformity assessment process and highlights typical is...

The PICO framework determines the scope of the Joint Clinical Assessment (JCA) under the EU HTA Regulation (EU HTAR), with PICO consolidation being a critical final step of the scoping process. Due to limited clarity on how consolidation works in pra...

Patient access to innovative care for complex conditions like schizophrenia remains limited by systemic, clinical and policy-level barriers. Cognitive impairment associated with schizophrenia (CIAS) illustrates how critical symptom domains are often...

Background: Interactions between healthcare professionals and medical technology companies on social media are central to understanding how variations in knowledge spillover and innovation performance vary. Aim: This study investigates how social med...

In the process of determining whether a health technology should be covered by healthcare systems, patients and their representatives were initially excluded from both evaluations and decision-making. In Europe, direct dialogue between patient organi...

The regulation of new medicine prices must balance financial sustainability with equitable access to innovation. Value-Based Pricing (VBP) strategies seek to align drug prices with their clinical and societal impact. The Pharmaceutical Innovativeness...

Hard-to-heal wounds are a major burden to healthcare systems. Electrical stimulation therapy (EST) is known to improve clinical outcomes, but cost-effectiveness analysis is lacking. The aim was to explore the cost-effectiveness of EST with standard o...

This study aimed to determine the relative efficacy of bevacizumab gamma (an ophthalmic formulation of bevacizumab) versus alternative interventions relevant to the treatment of neovascular age-related macular degeneration (nAMD) in the United Kingdo...

Objective: This confirmatory survey aimed to verify the criterion-related validity and reliability of the final version of the Medical Doctors’ Work-Related Quality of Life Questionnaire (WQMD-9), following partial revision of its content. This...

There remains a persistent lack of patient-centered evidence on insurance reform and real-world experiences of patients with chronic disease. This study gathered insights around insurance design from chronic disease beneficiaries. This mixed-methods...

Copay accumulator (CA) and copay maximizer (CM) programs in the United States, which prevent manufacturer copay assistance from counting toward deductibles or out-of-pocket (OOP) maximums, are increasingly used, raising concerns about costs and outco...

Background: Stakeholders’ perception plays a crucial role in shaping pharmaceutical strategies. Stakeholders are groups interested in pharmaceutical companies’ success and outcomes. Stakeholders’ perceptions are multifaceted and imp...

Type 2 diabetes (T2D) constitutes a major health problem, reaching alarming rates over the last decades, especially due to contemporary lifestyle and associated obesogenic environments, as well as the aging population. Diabetes not only causes social...

The introduction of the European Union (EU) Joint Clinical Assessment (JCA) under Regulation (EU) 2021/2282 marks a transformative step in harmonizing health technology assessments (HTAs) across EU member states. This article explores the implication...

Access to home- and community-based services (HCBSs) varies substantially between states. Yet, it is unknown how state-level policies and administrative factors impact consumer-reported unmet service needs, an important indicator of HCBS access and q...

Vaccination has resulted in substantial public health benefits for human populations worldwide since it was first introduced more than a century ago. This article presents an overview of the history of vaccine development, its implementation, and pri...

Long-term intravenous therapies often necessitate the use of peripherally inserted central catheters (PICCs). Antimicrobial-coated PICCs have been introduced to minimize central line-associated bloodstream infections (CLABSIs). A decision-analytic co...

Wound infection significantly hinders the healing process. Clinical signs and symptoms (CSS) of infection are used to assess the presence of infection and guide whether to intervene. However, CSS may not be dependable, lacking sensitivity and specifi...

The implementation of the European (EU) Health Technology Assessment (HTA) Regulation 2021/2282 (EU HTAR) offers many opportunities, aimed at harmonizing HTA procedures and improving access to innovations; it also represents a significant challenge f...

Introduction: Market access, pricing, and reimbursement of digital health technologies (DHTs) in Europe are significantly challenged by regulatory fragmentation and various assessment methodologies. Understanding the challenges and priorities of tech...

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 unders...

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...

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...

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 dir...

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...

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 Dece...

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, o...

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...

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 u...

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 servic...

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. Thi...

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 the...

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 effective...

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 (...

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 p...

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 innovat...

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, ne...

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 coord...

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 i...

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 [...]

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 pr...

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 jurisdi...

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 Fou...