A5004254550- Pharmaceutical Economics and Policy
- Health Systems, Economic Evaluations, Quality of Life
- Biosimilars and Bioanalytical Methods
- Pharmaceutical studies and practices
- Biomedical Ethics and Regulation
- Healthcare cost, quality, practices
- Genomics and Rare Diseases
- Ethics in Clinical Research
- Intellectual Property and Patents
- Patient-Provider Communication in Healthcare
- Statistical Methods in Clinical Trials
- Pharmaceutical industry and healthcare
- Digital Mental Health Interventions
- Patient Satisfaction in Healthcare
- Mobile Health and mHealth Applications
- Healthcare Policy and Management
- Biotechnology and Related Fields
- Healthcare Quality and Management
- Liver Disease Diagnosis and Treatment
- Monoclonal and Polyclonal Antibodies Research
- Innovation Policy and R&D
- Telemedicine and Telehealth Implementation
- HER2/EGFR in Cancer Research
- Science, Research, and Medicine
- Health and Medical Research Impacts
KU Leuven
2017-2025
European Medicines Agency
2025
Stanford University
2024
Despite the benefits biosimilars offer in terms of cost savings and patient access, healthcare professionals patients have been reluctant to use them. Next insufficient understanding trust biosimilars, questions about switching nocebo effect when using clinical practice. In addition, clear motivation may be lacking among these stakeholders. This study aims provide recommendations on how improve biosimilar both a practical level based insights from (physicians, hospital pharmacists, nurses),...
Beyond evaluation and approval, European national regulators have a key role in providing reliable information on biosimilars the science underpinning their development, use.This study aims to (i) review biosimilar guidance provided by EMA medicines agencies (ii) explore stakeholder perspectives of enabling acceptance use biosimilars.This consists comparative regulatory position statements across medicine (n = 32) qualitative interviews with stakeholders Europe 14).The analysis showed that...
Background: In Europe, off-patent biologicals and biosimilars are largely procured by means of tender procedures. The organization design tenders may play a key role in the evolving biosimilar market, currently, it is not fully elucidated how for designed if approaches aligned with sustaining market competition societal savings healthcare systems over long term. This study aims to (i) explore implementation procedures (ii) identify learnings sustainable from purchasers suppliers, (iii)...
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, Ireland that aims to address sustainable access medicines. In view of soon-to-be-implemented EU HTA Regulation, insights experiences from stakeholders could provide possible transferable learnings. Therefore, this research (i) identify opportunities faced...
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 understand stakeholders' views regarding appropriate UMN criteria and incentives, EC developed a survey launched it public consultation between September December 2021. This study aims assess on policy revisions proposed by EC, particularly those definition UMN, its incentives...
Background At the European level, several regulatory measures (ie, priority medicines (PRIME) scheme, accelerated assessment, conditional marketing authorisation and under exceptional circumstances) are in place with aim to expedite process for targeting unmet medical needs (UMNs). However, potential impact of these on subsequent decisions regarding market access at national ultimately if making use supporting reach patient earlier, remains unclear. Objectives This study seeks (1) assess...
Objective: Patients have unique insights and are (in-)directly affected by each decision taken throughout the life cycle of medicinal products. Patient preference studies (PPS) assess what matters most to patients, how much, trade-offs patients willing make. IMI PREFER was a six-year European public-private partnership under Innovative Medicines Initiative that developed recommendations on use PPS in medical product decision-making, including regulatory evaluation This paper aims summarize...
Background: Countries are struggling to provide affordable access medicines while supporting the market entry of innovative, expensive products. This Perspective aims discuss challenges and avenues for balancing health care system objectives access, affordability innovation related in Belgium (and other countries). Methods: focuses on R&D, regulatory approval phases, with particular attention oncology medicines, precision orphan advanced therapies, repurposed generics biosimilars. The...
Biosimilar medicines have been on the European market for 15 years. Despite extensive and positive experience with biosimilars across Europe, their uptake remains limited in Belgium. One of possible factors limiting clinical practice is inadequate understanding lack trust among patients. This study aimed to assess level knowledge perceptions about biosimilar Belgian patients ambulatory care.
Abstract Background With the approval of biosimilars for subcutaneously administered products, such as adalimumab, etanercept and insulin, become increasingly available in ambulatory care. Little is known about knowledge attitudes healthcare providers who are charge dispensing prescribing this context. This study aims to assess perception among community pharmacists physicians. Methods Belgian ( n = 177) physicians 30) were surveyed on their knowledge, experience with dispensing/prescribing...
Electronic informed consent (eIC) may offer various advantages compared to paper-based consent. However, the regulatory and legal landscape related eIC provides a diffuse image. By drawing from perspectives of key stakeholders in field, this study aims inform creation European guidance framework on clinical research.Focus group discussions semi-structured interviews were conducted with 20 participants six stakeholder groups. The groups included representatives ethics committees, data...
Changes in the clinical trials landscape have been driven by advancements digital technology. The use of electronic informed consent to inform research participants and obtain their electronically has potential improve participant–researcher interactions over time, facilitate trial participation, increase efficiency conduct. A personalized platform that enables long-term with team could function as a tool empower participant engagement trials. However, significant challenges persist impeding...
Abstract Aims Decision‐makers still predominantly focus on the perspective of non‐patient stakeholders, which may deviate from unique heart failure (HF) patients. To enhance patient‐centred decision‐making, there is a need for more patient‐based evidence derived directly patients themselves. Hence, this study aimed to understand (i) HF patients' unmet medical needs and preferred treatment outcomes; (ii) risk tolerance; (iii) their information needs, uncertainties satisfaction towards...
Background: By improving the affordability and accessibility of biologicals, biosimilar competition provides important benefits to healthcare systems patients. In Belgium, uptake is limited compared other European markets. Whereas countries have initiated structured introduction or switching plans, no such framework guiding principles are yet available in Belgium. Objective: This study aims develop recommendations that can inform policy action Belgium on use, especially context switch...
With the growing availability of biosimilars on global market, clinicians and pharmacists have multiple off-patent biological products to choose from. Besides competitiveness product's price, other criteria should be considered when selecting a best-value biological. This article aims provide model facilitate transparent selection in medicines segment.The presented was developed basis established multicriteria decision analysis tools for rational medicine selection, ie, System Objectified...