Isabelle Huys
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View article: Toward Regulatory Convergence and Streamlined Biosimilar Development: Recommendations from an International Qualitative Study
Toward Regulatory Convergence and Streamlined Biosimilar Development: Recommendations from an International Qualitative Study Open
View article: Public perception and willingness to accept somatic gene therapy: A Belgian survey study
Public perception and willingness to accept somatic gene therapy: A Belgian survey study Open
Background Genetic disorders affect millions worldwide, yet fewer than 10% of patients currently receive effective treatment. While gene therapies offer significant promise, their clinical translation is hindered by technical, regulatory, …
View article: Correction: Patients’ Needs and Preferences for Cardiac Pacemaker Implantation: A Qualitative Study on Disease and Medical Device Characteristics to Inform a Quantitative Preference Study
Correction: Patients’ Needs and Preferences for Cardiac Pacemaker Implantation: A Qualitative Study on Disease and Medical Device Characteristics to Inform a Quantitative Preference Study Open
View article: Preferences for gene therapy in Duchenne muscular dystrophy: insights from patient and caregiver interviews and attribute development
Preferences for gene therapy in Duchenne muscular dystrophy: insights from patient and caregiver interviews and attribute development Open
Background Duchenne muscular dystrophy (DMD) is an X-linked degenerative muscle disease with no curative treatment available to date. The current long-term use of corticosteroids is associated with severe adverse effects. With the progress…
View article: Future-Proofing European Pharmaceutical Regulatory and Market Access Practices Based on EU Learnings from the COVID-19 Pandemic: Insights from Multi-Stakeholder Interviews
Future-Proofing European Pharmaceutical Regulatory and Market Access Practices Based on EU Learnings from the COVID-19 Pandemic: Insights from Multi-Stakeholder Interviews Open
Introduction During the COVID-19 pandemic, regulatory and market access actions were taken to expedite the market entry of COVID-19 medicines. This study aims to (i) capture multi-stakeholder views on these actions, and (ii) provide recomm…
View article: Barriers to adoption of biosimilar insulins in Europe: A mixed‐methods study
Barriers to adoption of biosimilar insulins in Europe: A mixed‐methods study Open
Background Despite the introduction of biosimilar insulins to improve affordability and enhance patient access, their adoption remains limited in Europe. Objectives This study aims to (i) provide an up‐to‐date overview of EMA‐approved insu…
View article: Advanced therapy medicinal products are coming of age: A pipeline analysis of the clinical trial landscape
Advanced therapy medicinal products are coming of age: A pipeline analysis of the clinical trial landscape Open
Advanced therapy medicinal products (ATMPs) are a unique class of biological medicines that are based on cells, genes, or tissues. Searching four databases, this analysis identified 2008 trials that investigated ATMPs and characterised the…
View article: Patients’ Needs and Preferences for Cardiac Pacemaker Implantation: A Qualitative Study on Disease and Medical Device Characteristics to Inform a Quantitative Preference Study
Patients’ Needs and Preferences for Cardiac Pacemaker Implantation: A Qualitative Study on Disease and Medical Device Characteristics to Inform a Quantitative Preference Study Open
View article: The effectiveness and user preferences of two tactile breathing devices in reducing stress in stressed individuals: A mixed methods study
The effectiveness and user preferences of two tactile breathing devices in reducing stress in stressed individuals: A mixed methods study Open
View article: Criteria to evaluate unmet health-related needs of persons living with rare diseases and their caregivers: rapid literature review and stakeholder consultations
Criteria to evaluate unmet health-related needs of persons living with rare diseases and their caregivers: rapid literature review and stakeholder consultations Open
Background Rare diseases affect small populations but present unique challenges in access to healthcare and social support. The needs of patients and their caregivers extend beyond medical treatments, impacting various aspects of their liv…
View article: Disparities in access to gene therapy in the European Union: ethical and regulatory challenges
Disparities in access to gene therapy in the European Union: ethical and regulatory challenges Open
Gene therapies represent a significant advancement in modern medicine, offering potential cures for untreatable genetic disorders. However, equitable access to these innovative therapies remains a critical ethical challenge within the Euro…
View article: Defining the role of pragmatic clinical trials in cancer clinical research: outcomes of a collaborative workshop hosted by the European Organisation for Research and Treatment of Cancer
Defining the role of pragmatic clinical trials in cancer clinical research: outcomes of a collaborative workshop hosted by the European Organisation for Research and Treatment of Cancer Open
View article: Caregivers and multidisciplinary team members’ perspectives on shared decision making in Duchenne muscular dystrophy: A qualitative study
Caregivers and multidisciplinary team members’ perspectives on shared decision making in Duchenne muscular dystrophy: A qualitative study Open
Background As new therapies for Duchenne muscular dystrophy (DMD) are entering the market, shared decision making (SDM) will become increasingly important. Therefore, this study aimed to understand (1) Belgian stakeholders’ knowledge and p…
View article: Comparative valuation of longstanding and novel treatments for sickle cell disease: a multinational MCDA study
Comparative valuation of longstanding and novel treatments for sickle cell disease: a multinational MCDA study Open
View article: Towards implementing new payment models for the reimbursement of high-cost, curative therapies in Europe: insights from semi-structured interviews
Towards implementing new payment models for the reimbursement of high-cost, curative therapies in Europe: insights from semi-structured interviews Open
Background New ways of reimbursement for high-cost, one-shot curative therapies such as advanced therapy medicinal products (ATMPs) are a growing area of interest to stakeholders in market access such as industry representatives, legislati…
View article: Unmet medical needs definition and incentives: stakeholders perspectives on the reform of the EU pharmaceutical legislation
Unmet medical needs definition and incentives: stakeholders perspectives on the reform of the EU pharmaceutical legislation Open
Introduction The 2020 pharmaceutical strategy for Europe stressed that rethinking regulatory policies to foster innovation in disease areas with unmet medical needs (UMN) is one of the European Commission’s (EC) priority areas. To understa…
View article: Do European regulatory measures accelerate national market access in Belgium? A retrospective analysis of medicines centrally authorised between 2015 and 2020
Do European regulatory measures accelerate national market access in Belgium? A retrospective analysis of medicines centrally authorised between 2015 and 2020 Open
Background At the European level, several regulatory measures (ie, priority medicines (PRIME) scheme, accelerated assessment, conditional marketing authorisation and authorisation under exceptional circumstances) are in place with the aim …
View article: Evolution of Eligibility Criteria in Inflammatory Bowel Disease Clinical Trials: A Clinical Trial Databank Analysis
Evolution of Eligibility Criteria in Inflammatory Bowel Disease Clinical Trials: A Clinical Trial Databank Analysis Open
Background Eligibility criteria in clinical trials have been criticised for being overly restrictive without clinical justification. Objective We aimed to investigate the types, evolution, and current status of eligibility criteria in clin…
View article: PD72 Are Patient Experience Data Currently Embedded In Reimbursement Decision-Making? An Analysis Of Belgian Reimbursement Documents
PD72 Are Patient Experience Data Currently Embedded In Reimbursement Decision-Making? An Analysis Of Belgian Reimbursement Documents Open
Introduction Stakeholders in the drug life cycle recognize the importance of integrating patient experience data (PED) into healthcare decision-making. PED includes patient input, patient reported outcomes (PROs), patient reported experien…
View article: OD28 Towards Implementing New Payment Models For The Reimbursement Of High-Cost, Curative Therapies: Insights From Semi-Structured Interviews
OD28 Towards Implementing New Payment Models For The Reimbursement Of High-Cost, Curative Therapies: Insights From Semi-Structured Interviews Open
Introduction In response to the intricate challenges posed by high-cost, one-shot curative therapies, this study explores what hinders the wide implementation of innovative payment schemes across Europe. Drawing insights from the Belgian s…
View article: Mitigating the Nocebo Effect in Biosimilar Use and Switching: A Systematic Review
Mitigating the Nocebo Effect in Biosimilar Use and Switching: A Systematic Review Open
View article: Development and Characterization of a Human Mammary Epithelial Cell Culture Model for the Blood–Milk Barrier—A Contribution from the ConcePTION Project
Development and Characterization of a Human Mammary Epithelial Cell Culture Model for the Blood–Milk Barrier—A Contribution from the ConcePTION Project Open
It is currently impossible to perform an evidence-based risk assessment for medication use during breastfeeding. The ConcePTION project aims to provide information about the use of medicines during lactation. The study aimed to develop and…
View article: EU-US data transfers: an enduring challenge for health research collaborations
EU-US data transfers: an enduring challenge for health research collaborations Open
View article: Patient preferences for inflammatory bowel disease treatments: protocol development of a global preference survey using a discrete choice experiment
Patient preferences for inflammatory bowel disease treatments: protocol development of a global preference survey using a discrete choice experiment Open
Background As the therapeutic landscape for inflammatory bowel disease (IBD) continues to expand, a need exists to understand how patients perceive and value different attributes associated with their disease as well as with current and em…
View article: Opportunities and Challenges in Cross-Country Collaboration: Insights from the Beneluxa Initiative
Opportunities and Challenges in Cross-Country Collaboration: Insights from the Beneluxa Initiative Open
National pricing and reimbursement agencies face growing challenges with complex health technologies, prompting European policy advancements. Beneluxa is a cross-country collaboration involving Belgium, the Netherlands, Luxemburg, Austria,…
View article: Heart failure patients' perspectives on treatment outcomes and unmet medical needs: A qualitative preference study
Heart failure patients' perspectives on treatment outcomes and unmet medical needs: A qualitative preference study Open
Aims Decision‐makers still predominantly focus on the perspective of non‐patient stakeholders, which may deviate from the unique perspective of heart failure (HF) patients. To enhance patient‐centred decision‐making, there is a need for mo…
View article: Implementing the EU HTA regulation: Insights from semi-structured interviews on patient expectations, Belgian and European institutional perspectives, and industry outlooks
Implementing the EU HTA regulation: Insights from semi-structured interviews on patient expectations, Belgian and European institutional perspectives, and industry outlooks Open
Introduction: The goal of the Health Technology Assessment (HTA) Regulation 2021/2282 is to establish a more harmonized HTA framework, fostering member states cooperation and enabling equal patient access to innovative health technologies …
View article: An Inclusive Civil Society Dialogue for Successful Implementation of the EU HTA Regulation: Call to Action to Ensure Appropriate Involvement of Stakeholders and Collaborators
An Inclusive Civil Society Dialogue for Successful Implementation of the EU HTA Regulation: Call to Action to Ensure Appropriate Involvement of Stakeholders and Collaborators Open
Objectives: Stakeholder involvement has long been considered a success factor for a joint European health technology assessment (HTA) process, and its relevance is now anchored in the EU HTA Regulation’s (EU HTAR) legislative wording. Ther…
View article: Patients’ knowledge, preferences, and perspectives about data protection and data control: an exploratory survey
Patients’ knowledge, preferences, and perspectives about data protection and data control: an exploratory survey Open
Background: In the European Union, the General Data Protection Regulation (GDPR) plays a central role in the complex health research legal framework. It aims to protect the fundamental right to the protection of individuals’ personal data,…
View article: Comparing Discrete Choice Experiment with Swing Weighting to Estimate Attribute Relative Importance: A Case Study in Lung Cancer Patient Preferences
Comparing Discrete Choice Experiment with Swing Weighting to Estimate Attribute Relative Importance: A Case Study in Lung Cancer Patient Preferences Open
Introduction Discrete choice experiments (DCE) are commonly used to elicit patient preferences and to determine the relative importance of attributes but can be complex and costly to administer. Simpler methods that measure relative import…