Rick A. Vreman
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View article: Evolving Recommendations for Patient Populations Among Oncology Medicines: A Quantitative and Qualitative Analysis
Evolving Recommendations for Patient Populations Among Oncology Medicines: A Quantitative and Qualitative Analysis Open
After a medicine has been tested in pivotal trials, regulators, health technology assessment (HTA) organizations, and professional societies make decisions about the patients best served by the medicine. This study assesses how the patient…
View article: Stimulating development of innovative medicines in the European Union: does a new definition for unmet medical need add value?
Stimulating development of innovative medicines in the European Union: does a new definition for unmet medical need add value? Open
The European Commission (EC) has proposed to redefine 'unmet medical need' to steer pharmaceutical innovation and link the definition to incentives and regulatory tools and procedures. A multistakeholder meeting of the Regulatory Science N…
View article: Managed Entry Agreements for High-Cost, One-Off Potentially Curative Therapies: A Framework and Calculation Tool to Determine Their Suitability
Managed Entry Agreements for High-Cost, One-Off Potentially Curative Therapies: A Framework and Calculation Tool to Determine Their Suitability Open
The presented framework provides decision makers with insight into the financial consequences of their chosen payment model under different assumptions. This can aid reimbursement negotiations by clarifying the optimal choice given a thera…
View article: Uncertainty in Long-Term Relative Effectiveness of Medicines in Health Technology Assessment
Uncertainty in Long-Term Relative Effectiveness of Medicines in Health Technology Assessment Open
Uncertainty regarding the long-term effectiveness is an important challenge for HTA bodies. There are large differences in the acceptance of evidence among HTA bodies, which leads to heterogeneity in the inclusion of available long-term ef…
View article: Illustrating the Financial Consequences of Outcome-Based Payment Models From a Payers Perspective: The Case of Autologous Gene Therapy Atidarsagene Autotemcel (Libmeldy®)
Illustrating the Financial Consequences of Outcome-Based Payment Models From a Payers Perspective: The Case of Autologous Gene Therapy Atidarsagene Autotemcel (Libmeldy®) Open
Outcome-based models can mitigate the financial risk of reimbursing atidarsagene autotemcel. This can be considerably beneficial over simple discounts when clinical performance was similar to or worse than predicted.
View article: Agreement about Availability of Alternative Treatments for Innovative Drugs Assessed by the <scp>EMA</scp> and <scp>HTA</scp> Organizations
Agreement about Availability of Alternative Treatments for Innovative Drugs Assessed by the <span>EMA</span> and <span>HTA</span> Organizations Open
The European Medicines Agency (EMA) and European national/regional health technology assessment (HTA) organizations consider the availability of existing treatments when evaluating a new drug. Since disagreement about the availability of a…
View article: Tools for assessing quality of studies investigating health interventions using real-world data: a literature review and content analysis
Tools for assessing quality of studies investigating health interventions using real-world data: a literature review and content analysis Open
Objectives We aimed to identify existing appraisal tools for non-randomised studies of interventions (NRSIs) and to compare the criteria that the tools provide at the quality-item level. Design Literature review through three approaches: s…
View article: Lifecycle HTA: promising applications and a framework for implementation. An HTAi Global Policy Forum Task Force report
Lifecycle HTA: promising applications and a framework for implementation. An HTAi Global Policy Forum Task Force report Open
The 2022 Health Technology Assessment International (HTAi) Global Policy Forum (GPF) established the goal of developing a position statement and framework for lifecycle HTA (LC-HTA), through a Task Force leveraging multi-stakeholder monthl…
View article: An operationalization framework for lifecycle health technology assessment: a Health Technology Assessment International Global Policy Forum Task Force report
An operationalization framework for lifecycle health technology assessment: a Health Technology Assessment International Global Policy Forum Task Force report Open
Operationalization guidance is needed to support health technology assessment (HTA) bodies considering implementing lifecycle HTA (LC-HTA) approaches. The 2022 Health Technology Assessment International (HTAi) Global Policy Forum (GPF) est…
View article: Response to uncertainty management in regulatory and health technology assessment decision-making on drugs: guidance of the HTAi-DIA Working Group – author’s reply
Response to uncertainty management in regulatory and health technology assessment decision-making on drugs: guidance of the HTAi-DIA Working Group – author’s reply Open
Contains fulltext : 301221.pdf (Publisher’s version ) (Open Access)
View article: Perspectives on how to build bridges between regulation, health technology assessment and clinical guideline development: a qualitative focus group study with European experts
Perspectives on how to build bridges between regulation, health technology assessment and clinical guideline development: a qualitative focus group study with European experts Open
Objective Improving synergy among regulation, health technology assessment (HTA) and clinical guideline development is relevant as these independent processes are building on shared evidence-based grounds. The two objectives were first to …
View article: Synergy between health technology assessments and clinical guidelines for multiple sclerosis
Synergy between health technology assessments and clinical guidelines for multiple sclerosis Open
Decision‐making for reimbursement and clinical guidelines (CGs) serves different purposes although the decision‐criteria and required evidence largely overlap. This study aimed to assess similarities and discrepancies between health techno…
View article: Methodological Quality of Retrospective Observational Studies Investigating Effects of Diabetes Monitoring Systems: a Systematic Review
Methodological Quality of Retrospective Observational Studies Investigating Effects of Diabetes Monitoring Systems: a Systematic Review Open
Background Retrospective observational studies (ROSs) have been frequently used to investigate treatment effects of diabetes monitoring systems (DMS), i.e. medical devices to monitor blood glucose. However, due to quality concerns, the fin…
View article: The Beneluxa Initiative domain task force health technology assessment: a comparison of member countries’ past health technology assessments
The Beneluxa Initiative domain task force health technology assessment: a comparison of member countries’ past health technology assessments Open
Objective This study aimed to compare assessments between Beneluxa Initiative member countries’ assessments and identify alignments and divergences. Methods A retrospective comparative analysis was performed that investigated (i) number an…
View article: Uncertainty management in regulatory and health technology assessment decision-making on drugs: guidance of the HTAi-DIA Working Group
Uncertainty management in regulatory and health technology assessment decision-making on drugs: guidance of the HTAi-DIA Working Group Open
Objectives Uncertainty is a fundamental component of decision making regarding access to and pricing and reimbursement of drugs. The context-specific interpretation and mitigation of uncertainty remain major challenges for decision makers.…
View article: When Reality Does Not Meet Expectations—Experiences and Perceived Attitudes of Dutch Stakeholders Regarding Payment and Reimbursement Models for High-Priced Hospital Drugs
When Reality Does Not Meet Expectations—Experiences and Perceived Attitudes of Dutch Stakeholders Regarding Payment and Reimbursement Models for High-Priced Hospital Drugs Open
This study aimed to identify the current experiences with and future preferences for payment and reimbursement models for high-priced hospital therapies in the Netherlands, where the main barriers lie and assess how policy structures facil…
View article: OP11 Differences And Similarities In Past Health Technology Assessments In Beneluxa Initiative Countries
OP11 Differences And Similarities In Past Health Technology Assessments In Beneluxa Initiative Countries Open
Introduction Conducting joint health technology assessments (HTA) is one of the main goals of the Beneluxa Initiative. To strengthen this collaboration, this study aimed to assess similarities and differences between past assessments of Be…
View article: PP111 Reimbursement And Payment Models: A Survey Of Stakeholders’ Current Experiences And Future Outlook Within The Dutch Policy Setting
PP111 Reimbursement And Payment Models: A Survey Of Stakeholders’ Current Experiences And Future Outlook Within The Dutch Policy Setting Open
Introduction The constant evolution of high-priced hospital drugs with large uncertainties are increasingly challenging the sustainability of many healthcare reimbursement systems. Consequently, more attention is paid to exploring innovati…
View article: PP37 A Systematic Review of Machine Learning and Statistical Models For Predicting Coronary Heart Disease In Diabetic Patients
PP37 A Systematic Review of Machine Learning and Statistical Models For Predicting Coronary Heart Disease In Diabetic Patients Open
Introduction Risk prediction models, using either machine learning or statistical algorithms, can act as inputs of a cost-effectiveness model when predicting costs and effectiveness of an intervention. This systematic review has two object…
View article: OP89 The CE-Signal, A New Simplified Health Technology Assessment Method To Determine Whether Interventions Are Cost-Effective
OP89 The CE-Signal, A New Simplified Health Technology Assessment Method To Determine Whether Interventions Are Cost-Effective Open
Introduction Conducting a cost-effectiveness analysis (CEA) is resource consuming, and therefore the Dutch National Health Care Institute (ZIN) only performs those for interventions with a high budget impact. Sometimes, cost-effectiveness …
View article: Cost-effectiveness of clopidogrel versus ticagrelor in patients of 70 years or older with non-ST-elevation acute coronary syndrome
Cost-effectiveness of clopidogrel versus ticagrelor in patients of 70 years or older with non-ST-elevation acute coronary syndrome Open
Background/Introduction In older patients with non-ST-elevation acute coronary syndrome (NSTEMI) the POPular AGE trial clopidogrel showed superiority to ticagrelor in reducing bleeding risk and non-inferiority in net clinical benefit (all-…
View article: Outcome-based reimbursement in Central-Eastern Europe and Middle-East
Outcome-based reimbursement in Central-Eastern Europe and Middle-East Open
Outcome-based reimbursement models can effectively reduce the financial risk to health care payers in cases when there is important uncertainty or heterogeneity regarding the clinical value of health technologies. Still, health care payers…
View article: Do Health Technology Assessment organisations consider manufacturers’ costs in relation to drug price? A study of reimbursement reports
Do Health Technology Assessment organisations consider manufacturers’ costs in relation to drug price? A study of reimbursement reports Open
Introduction Drug reimbursement decisions are often made based on a price set by the manufacturer. In some cases, this price leads to public and scientific debates about whether its level can be justified in relation to its costs, includin…
View article: Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America
Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America Open
Objectives. To map the timing and nature of regulatory reliance pathways used to authorize COVID-19 vaccines in Latin America. Methods. An observational study was conducted assessing the characteristics of all COVID-19 vaccine authoriza…
View article: Delayed payment schemes in Central-Eastern Europe and Middle-East
Delayed payment schemes in Central-Eastern Europe and Middle-East Open
The need for innovative payment models for health technologies with high upfront costs has emerged due to affordability concerns across the world. Early technology adopter countries have been experimenting with delayed payment schemes. Our…
View article: Cost-effectiveness of clopidogrel vs. ticagrelor in patients of 70 years or older with non-ST-elevation acute coronary syndrome
Cost-effectiveness of clopidogrel vs. ticagrelor in patients of 70 years or older with non-ST-elevation acute coronary syndrome Open
Objective The POPular AGE trial showed that clopidogrel significantly reduced bleeding risk compared with ticagrelor without any signs of an increase in thrombotic events. The aim of this analysis was to estimate the long-term cost-effecti…