A5051137041- Health Systems, Economic Evaluations, Quality of Life
- Pharmaceutical Economics and Policy
- Pharmaceutical industry and healthcare
- Biosimilars and Bioanalytical Methods
- Pharmacovigilance and Adverse Drug Reactions
- Healthcare cost, quality, practices
- Pharmaceutical studies and practices
- Dementia and Cognitive Impairment Research
- Biomedical Ethics and Regulation
- Delphi Technique in Research
- Healthcare Policy and Management
- Statistical Methods in Clinical Trials
- Peripheral Artery Disease Management
- Acute Ischemic Stroke Management
- Patient-Provider Communication in Healthcare
- Economic and Financial Impacts of Cancer
- Clinical practice guidelines implementation
- Consumer Market Behavior and Pricing
- Innovation Policy and R&D
- Lung Cancer Treatments and Mutations
- Meta-analysis and systematic reviews
- Radiology practices and education
- Diversity and Career in Medicine
- Biotechnology and Related Fields
- Quality and Safety in Healthcare
National Institute for Health and Care Excellence
2016-2024
University of York
2023
University of Maryland, College Park
2023
Utrecht University
2011-2017
Erasmus University Rotterdam
2011-2016
Erasmus MC
2012
In-Q-Tel
2012
Pharmo Institute
2011
There is growing interest in using observational data to assess the safety, effectiveness, and cost effectiveness of medical technologies, but operational, technical, methodological challenges limit its more widespread use. Common models federated networks offer a potential solution many these problems. The open-source Observational Medical Outcomes Partnerships (OMOP) common model standardises structure, format, terminologies otherwise disparate datasets, enabling execution analytical code...
- As per the EMA definition, adaptive pathways is a scientific concept ftor development of medicines which seeks to facilitate, through patient access promising addressing high unmet need prospectively planned approach products medical in Europe sustainable way. This review reports findings activities undertaken by ADAPT-SMART consortium identify enablers and explore suitability managed entry agreements for Europe. We found that during 2006-2016 outcomes-based were not commonly used with...
The silent pandemic of antimicrobial resistance (AMR) is a global issue needing prompt attention. A comprehensive one-health approach across human and animal health, agriculture the environment needed to solve this, addressing overuse antibacterials, course, optimising measures for preventing controlling infection. We also need robust pipeline new antibacterials. However, current inadequate several companies with antibacterials have gone bankrupt due low sales, leading 'broken market'. To...
We analyzed the cost-effectiveness of International Conference on Harmonisation (ICH) E14 guideline that requires a thorough QT/QTc (TQT) study for all drugs under development. compared two pharmacoeconomic scenarios: health effects and costs resulting from implementing ICH ("regulation" scenario) vs. not ("no regulation" scenario). used dynamic population model to calculate prototype QT-prolonging antipsychotic drug entering US European markets. The incremental ratios regulation no were...
Conditional marketing authorization (CMA) in the European Union (EU) is an early access pathway for medicines that show promising therapeutic effects, but which comprehensive data are not available. Using a mixed quantitative-qualitative research design, we evaluated how CMA has been used of oncology period 2006 to 2013. We compared full authorization, granted based on less data. However, this accompanied by significantly longer assessment times and consensus among regulators about...
This study assessed whether five Health Technology Assessment (HTA) bodies in Europe were more negative about drugs with a Conditional Marketing Authorization (CMA) that are approved without controlled studies compared to CMA based on studies. The HTA recommendations categorized into positive, restricted, and negative. A total of 92 available for 27 drugs. Thirty 62 (48%) 17 30 (57%) the studies, respectively. Overall, only 12 (13%) positive. In all jurisdictions, between data comparable,...
Regulatory agencies and other stakeholders increasingly rely on data collected through registries to support their decision-making. Data from are a cornerstone of post-marketing surveillance for monitoring the use medicines in clinical practice. This study was aimed at gaining further insight into European Medicines Agency's (EMA) requests new registry studies using existing review experience gained conduct.European Public Assessment Reports were consulted identify products which request...
Health technology assessment (HTA) is increasingly informed by nonrandomized studies, but there limited guidance from HTA bodies on expectations around evidence quality and study conduct. We developed recommendations to support the appropriate use of such based a pragmatic literature review workshop involving 16 experts eight countries as part EU's Horizon-2020 IMPACT-HTA program (work package six). To ensure processes remain rigorous robust, should demand clear, extensive structured...
ROADMAP is a public-private advisory partnership to evaluate the usability of multiple data sources, including real-world evidence, in decision-making process for new treatments Alzheimer's disease, and advance key concepts disease pharmacoeconomic modeling.ROADMAP identified patient outcomes stakeholders
Sophie Cooper, Jacoline Bouvy and colleagues discuss the challenges that histology independent cancer drugs will pose for NICE NHS
We analyzed the cost-effectiveness of all Periodic Safety Update Reports (PSURs) submitted for biologicals in Europe from 1995 to 2009 by comparing two regulatory scenarios: full regulation (PSUR reporting) and limited (no PSUR reporting, but other parts pharmacovigilance framework remain place). During this period, reporting resulted detection 2 out a total 24 urgent safety issues biologicals: (i) distant spread botulinum toxin (ii) edema/fluid collection associated with off-label use...
Medicines with one seller and many buyers: strategies to increase the power of payer Andrew Rintoul colleagues argue that collaboration transparency market buyers who face a monopoly H ealth system budgets increasing pressures from ageing populations, epidemiological transitions, technological innovation.One area for find savings is in questioning whether price they negotiate medicine fair.This challenge high prices particularly acute medicines are available single source, where there no...
Adaptive pathways for medicines have gained momentum and, in Europe, adaptive recently been introduced into the European Medicines Agency (EMA) processes after a successful 2-year pilot. Although concept, as initially proposed, contained several elements that would required regulatory reforms, program has developed more pragmatic scope (Box 1). In this article, we explore main challenges and opportunities pose from health technology assessment (HTA) perspective.
Objective To assess the cost-effectiveness of endovascular treatment against intravenous thrombolysis (IVT) when varying assumptions concerning its effectiveness. Methods We developed a health economic model including hypothetical population consisting patients with ischemic stroke, admitted within 4.5 h from onset, without contraindications for IVT or intra-arterial (IAT). A decision tree and life table were used to 6-month lifetime costs (in Euros) effects in quality-adjusted years alone,...
The aim of this study is to provide a comprehensive overview the outcomes marketing authorisation applications via mutual recognition and decentralised procedures (MRP/DCP) assess determinants licensing failure during CMDh referral procedures.All MRP/DCP Co-ordination group for Mutual Decentralised procedures-human (CMDh) period from January 2006 December 2013 were analysed. Reasons starting scored. In addition, survey under pharmaceutical companies was performed estimate frequency prior...
Purpose The aim of this study was to determine the outcomes and timing within product life cycle all benefit-risk reassessment procedures for marketed products that were completed by committee medicinal human use during 2001–2012. Methods A cohort referral (Article 20, Article 31, 36, 107 procedures) which issued an opinion between 1 January 2001 31 December 2012 created. European Medicines Agency website Dutch Evaluation Board used collect data. Results There a total 73 reassessments...