Issue The establishment of HTA has been an important topic in Europe for many years. The engageme... more Issue The establishment of HTA has been an important topic in Europe for many years. The engagement of HTA agencies, scientists, politicians and many other stakeholders throughout more than 20 years lead to the EU-HTA regulation, which came into force beginning of 2022. Now it is time to prepare for a sustainable European Network for HTA. Description The implementation of HTA in Europe is of high importance of the EU-commission for more than 20 years. Started with the first projects in 1994 (EUR-ASSESS) it needed quite a bunch of different projects and, in the end, three joint actions for finally providing legal ground for HTA with the EU-HTA regulation. This journey seemed a long one. However, referring to the need of addressing the requirements of Health Care of 27 Member States combined with the demand of reliable high methodological quality and applicability, investing all the time and effort for a sustainable European Network of HTA was definitely worthwhile. Joint Scientific Consultation (JSC) and Joint Clinical Assessments (JCA) will play a central role for national HTA and decision making in health care. But for understanding role, content, national uptake and further development of means, products and results of a European Network for HTA it is quite important to get a perception of the development of HTA collaboration in Europe. Based on this the challenge of the EU-HTA regulation and its implementation will be tackled easier. Effects Through provision of the main pillars of the previous EU-HTA collaboration the appreciation and understanding of the differences and complexities behind the HTA processes in the EU-healthcare systems will made aware. Based on this understanding the challenges of the implementation of the EU-HTA regulation will be discussed.
International Journal of Technology Assessment in Health Care, 2023
Objectives Uncertainty is a fundamental component of decision making regarding access to and pric... more 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. Following the 2021 HTAi Global Policy Forum, a cross-sectoral, interdisciplinary HTAi-DIA Working Group (WG) was initiated to develop guidance to support stakeholder deliberation on the systematic identification and mitigation of uncertainties in the regulatory-HTA interface. Methods Six online discussions among WG members (Dec 2021–Sep 2022) who examined the output of a scoping review, two literature-based case studies and a survey; application of the initial guidance to a real-world case study; and two international conference panel discussions. Results The WG identified key concepts, clustered into twelve building blocks that were collectively perceived to define uncertainty: “unavailable,” “inaccurate,” “conflicting,” “not understandable,” “random variation,” “information,” “prediction,” “impact,” “risk,” “relevance,” “context,” and “judgment.” These were converted into a checklist to explain and define whether any issue constitutes a decision-relevant uncertainty. A taxonomy of domains in which uncertainty may exist within the regulatory-HTA interface was developed to facilitate categorization. The real-world case study was used to demonstrate how the guidance may facilitate deliberation between stakeholders and where additional guidance development may be needed. Conclusions The systematic approach taken for the identification of uncertainties in this guidance has the potential to facilitate understanding of uncertainty and its management across different stakeholders involved in drug development and evaluation. This can improve consistency and transparency throughout decision processes. To further support uncertainty management, linkage to suitable mitigation strategies is necessary.
Examining the health technology assessment (HTA) landscape in Europe and globally, the limited in... more Examining the health technology assessment (HTA) landscape in Europe and globally, the limited involvement of HTA bodies in vaccine assessment becomes evident. To a large extent this is because of the role the National Immunization Technical Advisory Groups in providing recommendations for vaccines and immunisation. The role of patients and citizens, given the fact they are important stakeholders in HTA, is well acknowledged, but their involvement remains limited. Issues on how vaccines are developed, including the lack of patient-reported outcomes (PROs) in vaccine research and development, prevent the clearer benefit/risk information to reduce uncertainty. Given the fast-paced approach in comparison to traditional trials and the high level of uncertainty for different population groups, a comprehensive risk communication strategy, is key both for evidence-informed deliberative processes, as well as to ensure the success of vaccination programmes with the best possible outcomes and to overcome vaccine hesitancy. The impact of vaccination or non vaccination extends to families, communities and also has potential psychological consequences of alternative non-vaccine interventions such as lockdowns. Inclusion of such broader impacts may alter both acceptance and willingness-to-pay thresholds for COVID-19 vaccines. Given the lack of a specific legal framework to allow interaction between patients and other stakeholders at both institutional and individual levels, with respect to GDPR, it is vital to ensure interaction and engagement. In a democratic society, it is also important to assure general engagement that will be inclusive and transparent, without exclusion of vulnerable societal groups, that can only be assured by means of communication of scientific advice and regulatory decisions in a language accessible to all, with readily understood terms.
Issue The establishment of HTA has been an important topic in Europe for many years. The engageme... more Issue The establishment of HTA has been an important topic in Europe for many years. The engagement of HTA agencies, scientists, politicians and many other stakeholders throughout more than 20 years lead to the EU-HTA regulation, which came into force beginning of 2022. Now it is time to prepare for a sustainable European Network for HTA. Description The implementation of HTA in Europe is of high importance of the EU-commission for more than 20 years. Started with the first projects in 1994 (EUR-ASSESS) it needed quite a bunch of different projects and, in the end, three joint actions for finally providing legal ground for HTA with the EU-HTA regulation. This journey seemed a long one. However, referring to the need of addressing the requirements of Health Care of 27 Member States combined with the demand of reliable high methodological quality and applicability, investing all the time and effort for a sustainable European Network of HTA was definitely worthwhile. Joint Scientific Consultation (JSC) and Joint Clinical Assessments (JCA) will play a central role for national HTA and decision making in health care. But for understanding role, content, national uptake and further development of means, products and results of a European Network for HTA it is quite important to get a perception of the development of HTA collaboration in Europe. Based on this the challenge of the EU-HTA regulation and its implementation will be tackled easier. Effects Through provision of the main pillars of the previous EU-HTA collaboration the appreciation and understanding of the differences and complexities behind the HTA processes in the EU-healthcare systems will made aware. Based on this understanding the challenges of the implementation of the EU-HTA regulation will be discussed.
International Journal of Technology Assessment in Health Care, 2023
Objectives Uncertainty is a fundamental component of decision making regarding access to and pric... more 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. Following the 2021 HTAi Global Policy Forum, a cross-sectoral, interdisciplinary HTAi-DIA Working Group (WG) was initiated to develop guidance to support stakeholder deliberation on the systematic identification and mitigation of uncertainties in the regulatory-HTA interface. Methods Six online discussions among WG members (Dec 2021–Sep 2022) who examined the output of a scoping review, two literature-based case studies and a survey; application of the initial guidance to a real-world case study; and two international conference panel discussions. Results The WG identified key concepts, clustered into twelve building blocks that were collectively perceived to define uncertainty: “unavailable,” “inaccurate,” “conflicting,” “not understandable,” “random variation,” “information,” “prediction,” “impact,” “risk,” “relevance,” “context,” and “judgment.” These were converted into a checklist to explain and define whether any issue constitutes a decision-relevant uncertainty. A taxonomy of domains in which uncertainty may exist within the regulatory-HTA interface was developed to facilitate categorization. The real-world case study was used to demonstrate how the guidance may facilitate deliberation between stakeholders and where additional guidance development may be needed. Conclusions The systematic approach taken for the identification of uncertainties in this guidance has the potential to facilitate understanding of uncertainty and its management across different stakeholders involved in drug development and evaluation. This can improve consistency and transparency throughout decision processes. To further support uncertainty management, linkage to suitable mitigation strategies is necessary.
Examining the health technology assessment (HTA) landscape in Europe and globally, the limited in... more Examining the health technology assessment (HTA) landscape in Europe and globally, the limited involvement of HTA bodies in vaccine assessment becomes evident. To a large extent this is because of the role the National Immunization Technical Advisory Groups in providing recommendations for vaccines and immunisation. The role of patients and citizens, given the fact they are important stakeholders in HTA, is well acknowledged, but their involvement remains limited. Issues on how vaccines are developed, including the lack of patient-reported outcomes (PROs) in vaccine research and development, prevent the clearer benefit/risk information to reduce uncertainty. Given the fast-paced approach in comparison to traditional trials and the high level of uncertainty for different population groups, a comprehensive risk communication strategy, is key both for evidence-informed deliberative processes, as well as to ensure the success of vaccination programmes with the best possible outcomes and to overcome vaccine hesitancy. The impact of vaccination or non vaccination extends to families, communities and also has potential psychological consequences of alternative non-vaccine interventions such as lockdowns. Inclusion of such broader impacts may alter both acceptance and willingness-to-pay thresholds for COVID-19 vaccines. Given the lack of a specific legal framework to allow interaction between patients and other stakeholders at both institutional and individual levels, with respect to GDPR, it is vital to ensure interaction and engagement. In a democratic society, it is also important to assure general engagement that will be inclusive and transparent, without exclusion of vulnerable societal groups, that can only be assured by means of communication of scientific advice and regulatory decisions in a language accessible to all, with readily understood terms.
Risk of COVID-19 epidemic resurgence with the introduction of vaccination passes, 2021
Many countries hit by the COVID-19 epidemic consider the introduction of vaccination passes. So f... more Many countries hit by the COVID-19 epidemic consider the introduction of vaccination passes. So far, no thorough impact assessment of vaccination passes and of lower restrictions for their holders has been conducted. Here, we propose the VAP-SIRS model that accounts for susceptible, infected, and recovered subpopulations, also within the group of vaccinated pass holders. The model accounts for imperfect vaccination effectiveness, revaccinations and waning immunity. Different restrictions for pass holders and the rest of the population result in different scenarios of the epidemic evolution, some of which yield unfavourable COVID-19 dynamics and new waves. We identify critical variables that should be considered by policymakers and show how unfavourable outcomes can be avoided using adaptive policies. In particular, while pass holders could initially be allowed large freedoms, the gradual loss of immunity will require either increased restrictions for pass holders, or accelerated revaccination. In the long-term, common restrictions for both the pass holders and the rest of the population will have to be kept to avoid epidemic resurgence. Such minimum required restrictions depend on vaccination effectiveness, revaccination rate, waning rate and fraction of never-vaccinated population, and, for realistic combinations of these parameters, range between 29% and 69% reduction of contacts.
Uploads
Papers by Elena Petelos