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[av_heading heading=’WAAW 2022 theme announced ‘ tag=’h3′ style=’blockquote modern-quote modern-centered’ subheading_active=’subheading_below’ show_icon=” icon=’ue800′ font=’entypo-fontello’ size=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” subheading_size=’15’ av-medium-font-size=” av-small-font-size=” av-mini-font-size=” icon_size=” av-medium-font-size-1=” av-small-font-size-1=” av-mini-font-size-1=” color=” custom_font=” subheading_color=” seperator_color=” icon_color=” margin=” margin_sync=’true’ padding=’10’ icon_padding=’10’ headline_padding=” headline_padding_sync=’true’ link=’manually,http://’ link_target=” id=” custom_class=” template_class=” av_uid=’av-kx4q0z2f’ sc_version=’1.0′ admin_preview_bg=”][/av_heading]

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This year’s World of Antimicrobial Awareness Week (WAAW) theme is ‘Preventing antimicrobial resistance together’. It was announced by the Quadripartite organisations, which includes the Food and Agriculture Organisation of the United Nations (FAO), the United Nations Environment Programme (UNEP), the World Health Organisation (WHO), and the World Organisation for Animal Health (WOAH, founded as OIE).

The WAAW takes place every year from 18 to 24 November. The 2022 topic focuses on a One Health approach and inspires collaboration across sectors. AMR is a threat to humans, animals, plants and the environment  and fighting it is a global endeavour. 

Discover more here. 
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[av_heading heading=’Ecraid press release on European response to monkeypox virus outbreak’ tag=’h3′ style=’blockquote modern-quote modern-centered’ subheading_active=’subheading_below’ show_icon=” icon=’ue800′ font=’entypo-fontello’ size=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” subheading_size=’15’ av-medium-font-size=” av-small-font-size=” av-mini-font-size=” icon_size=” av-medium-font-size-1=” av-small-font-size-1=” av-mini-font-size-1=” color=” custom_font=” subheading_color=” seperator_color=” icon_color=” margin=” margin_sync=’true’ padding=’10’ icon_padding=’10’ headline_padding=” headline_padding_sync=’true’ link=’manually,http://’ link_target=” id=” custom_class=” template_class=” av_uid=’av-kx4q0z2f’ sc_version=’1.0′ admin_preview_bg=”][/av_heading]

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Utrecht, 7 July 2022 – Ecraid is assessing its readiness to respond in the event the monkeypox outbreak spreads further in Europe. These preparations are proportionate to the current relatively low risk of this infection for European citizens. Ecraid is currently operating in outbreak response mode 2 (mobilisation) for adults, and in outbreak response mode 1 (preparedness) for children, the second and first of three response modes.

Outbreak

Early May 2022 a multi-country outbreak of monkeypox virus (MPXV) started affecting the United Kingdom (UK), the EU/EEA, Asia, the Americas, and Australia. The virus spreading outside of the known enzootic countries in the African region has been designated clade 3 MPXV. Cases that are thought to be linked to this outbreak have been reported from 31 countries and areas throughout the European region, and other countries. Most recognized infections are in men with high-risk exposure for transmission (men who have sex with men), and disease transmission outside this population is still rare, but there is some concern that expansion of the risk group is possible if the outbreak continues to evolve. The clinical manifestations of clade 3 MPXV infections are usually mild, and most people in the current outbreak have recovered within weeks. More severe disease has been reported in studies from African countries with enzootic presence of monkeypox, with outbreaks with clade 3 MPXV with a case-fatality rate up to 3% in Nigeria. The highest case fatality rates have been reported for children and young adults, as well as immunocompromised individuals.

Treatment for monkeypox is mostly symptomatic. Tecovirimat was approved by the European Medicines Agency (EMA) for treatment of monkeypox throughout the EU on 6 January 2022. Tecovirimat has been authorised under ‘exceptional circumstances’, as it has not been possible to obtain complete information about tecovirimat efficacy and safety in human monkeypox due to the rarity of the disease. Persons with severe disease, immunocompromised patients, children younger than 8 years, and pregnant individuals could be considered for antiviral treatment.

Although the exact extent of the outbreak remains to be established, these events have triggered an assessment of the level of preparedness of clinical research networks in Europe for possible deployment in case of further spread. The EU has invested in the development of these European clinical networks over many years to ensure preparedness for delivering clinical research in response to new infectious disease outbreaks. These networks include Ecraid: The European Clinical Research Alliance for Infectious Diseases (With the support of funding provided by the EU, Europe is now much better prepared to speed up the processes of clinical research to the extent that findings are generated in real time to inform practice when it is most useful, in the midst of an outbreak, rather than once the threat has passed.

How Ecraid is responding

Information on Ecraid’s response modes and implications can be found here. Activities are planned and conducted in close collaboration with our partner networks (EU-RESPONSE and VACCELERATE) and the European Union and in alignment with those of WHO, ECDC and EMA. The preparations made by Ecraid as part of its mode 1 and 2 responses are briefly summarised below.

Ecraid participates in the MOSAIC study (led by University of Oxford as the sponsor and ANRS/Inserm representant of the sponsor in Europe). This is an observational study of the natural history of monkeypox disease in children and adults. With its collaborative network, Ecraid will identify study sites for participation in MOSAIC in those countries not yet participating. Together with its partners ANRS/Inserm, University of Oxford and UMC Utrecht, the alliance also participates in the preparation of a randomized controlled trial evaluating the effectiveness of tecovirimat. Moreover, Ecraid offers countries access to serology and sequencing capacity in its network (e.g., Erasmus MC).

Through its partners with expertise in pediatric infections (PENTA-ID, UMC Utrecht and Erasmus MC), Ecraid will develop a scientific research agenda in the event that monkeypox infections emerge in children. The first initiatives for preparation have focused on the use of Imvanex in adults and children as Post-Exposure Prophylaxis or Pre-Exposure Prophylaxis. Imvanex is not licensed for children under 18 years but is used off-label for exposed children. There is no standardized protocol for follow-up of these children and the possibilities of a cohort study looking at immunogenicity, break-through infections and adverse events is being explored with several European countries. Study developments will be discussed with EMA, and execution will be aligned with VACCELERATE.

The standing Ecraid Outbreak Mode Committee (Prof. Marion Koopmans of the Erasmus Medical Center in Rotterdam, Prof. Peter Horby of the University of Oxford, Prof. Herman Goossens of the University of Antwerp, Prof. Yazdan Yazdanpanah and Prof. Marc Bonten, University Medical Center) continue to follow the events closely to ensure Ecraid’s clinical research response remains aligned with the risk to health and security of European citizens.

Quotes

Prof. Marc Bonten (UMC Utrecht and CEO of Ecraid): “Ecraid has been established to enhance our capacity in Europe to mount a rapid clinical research response to any new infectious disease threat. Monkeypox may become such a threat, and that’s why we have started preparations for clinical studies now.”

Prof. Yazdan Yazdanpannah (ANRS/Inserm): “Threats related to new emerging pathogens or re-emerging infectious diseases appear regularly and the frequency of their occurrence is increasing. This is again illustrated by the unprecedented and unexpected outbreak of human monkeypox cases across Europe, the Americas, and Australia. A United Europe of Research is key to respond to epidemics/pandemics. Research infrastructures such as Ecraid and its partner networks EU-RESPONSE and VACCELERATE are very important tools of response.”

Prof. Peter Horby (Oxford University): “The unanticipated emergence of monkeypox outside of Africa is a perfect case-study of how threats anywhere can become threats everywhere and exemplifies the need to work as a global community to identify and counter all infectious disease problems, wherever they occur and whomever they affect.”

Prof. Marion Koopmans (Erasmus MC, Rotterdam): “While we do not foresee a surge of monkeypox cases in the near future, preparedness does require scenario thinking and preparing for those scenarios. In Ecraid, we do that for possible trajectories that may evolve if the current public health response does not lead to containment of the outbreak.”

Prof. Herman Goossens (Antwerp University): “The European clinical trial networks, expanded during the COVID-19 pandemic thanks to significant EU funding, are providing the sustainable infrastructures for the response to the monkeypox threat.”

About Ecraid

The European Clinical Research Alliance for Infectious Diseases (Ecraid) is a not-for profit foundation that advances clinical research in the field of infectious diseases by establishing a long-term, financially self-sustainable, clinical research network in Europe. Headquartered in Utrecht, the Netherlands, Ecraid is the first network of its kind in Europe to offer a single point of access to a pan-European clinical research network for infectious diseases and spans 1,100 clinical sites and 900 laboratories across 42 countries. For more information, please visit www.ecraid.eu.

ECRAID PRESS RELEASE
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[av_heading heading=’POC Diagnostics in General Practice: the Effects on Antimicrobial Resistance’ tag=’h3′ style=’blockquote modern-quote modern-centered’ subheading_active=’subheading_below’ show_icon=” icon=’ue800′ font=’entypo-fontello’ size=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” subheading_size=’15’ av-medium-font-size=” av-small-font-size=” av-mini-font-size=” icon_size=” av-medium-font-size-1=” av-small-font-size-1=” av-mini-font-size-1=” color=” custom_font=” subheading_color=” seperator_color=” icon_color=” margin=” margin_sync=’true’ padding=’10’ icon_padding=’10’ headline_padding=” headline_padding_sync=’true’ link=’manually,http://’ link_target=” id=” custom_class=” template_class=” av_uid=’av-kyba6fbz’ sc_version=’1.0′ admin_preview_bg=”][/av_heading]

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In June 2022, VALUE-Dx contributed to a new publication titled ‘The Opportunity of Point-of-Care Diagnostics in General Practice: Modelling the Effects on Antimicrobial Resistance’, that appeared in the open-access journal PharmacoEconomics. The aim of the study was to quantify the investments required for a large-scale rollout of point-of-care (POC) diagnostic testing in Dutch primary care, as well as the impact on antimicrobial resistance (AMR) due to reduced use of antibiotics. 

AMR is a public health threat that is mainly caused by unnecessary use of antibiotics. Community-acquired acute respiratory tract infections (CA-ARTIs) are a major driver of antibiotic consumption in primary care. It is estimated that each year more than 650.000 infections and 30.000 attributable deaths in Europe or 1.27 million deaths worldwide are caused by resistant organisms. 

An individual-based model was developed to simulate CA-ARTI consultations at Dutch GP practices. It compared a scenario where GPs test all CA-ARTI patients with a hypothetical diagnostic strategy to a scenario where the current standard-of-care is continued for the years 2020-2030. Differences in costs and future AMR rates were estimated. 

Results of the study

The results show that improved diagnostics may reduce AMR in the next decade, but that there also are major costs associated. When comparing the current standard-of-care to the diagnostic algorithm, the latter increases the total costs of GP consultations for CA-ARTI by 9% and 19%, when priced at €5 and €10. The hypothetical diagnostic strategy can partly restrain the forecast increase in Streptococcus pneumoniae resistance against penicillins from 3.8 to 3.5% in 2023, albeit with considerable uncertainty.       

Conclusions

The results show that the costs of consultations increase, while antibiotic consumption and AMR decrease when implementing a hypothetical diagnostic strategy for all CA-ARTI patients in primary care. Interventions with limited gains for individual patients, but considerable potential related to antibiotic consumption and AMR, can require novel health-economic methods to assess and communicate the potential benefits related to AMR.   

You can read the publication here. 
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[av_heading heading=’Diagnostics for AMR: Building back better from the COVID-19′ tag=’h3′ style=’blockquote modern-quote modern-centered’ subheading_active=’subheading_below’ show_icon=” icon=’ue800′ font=’entypo-fontello’ size=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” subheading_size=’15’ av-medium-font-size=” av-small-font-size=” av-mini-font-size=” icon_size=” av-medium-font-size-1=” av-small-font-size-1=” av-mini-font-size-1=” color=” custom_font=” subheading_color=” seperator_color=” icon_color=” margin=” margin_sync=’true’ padding=’10’ icon_padding=’10’ headline_padding=” headline_padding_sync=’true’ link=’manually,http://’ link_target=” id=” custom_class=” template_class=” av_uid=’av-kyba6fbz’ sc_version=’1.0′ admin_preview_bg=”][/av_heading]

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The VALUE-Dx project encouraged all relevant stakeholders to partake in a Massive Open Online Course (MOOC) on Diagnostics for AMR: Building back better from the COVID-19 pandemic, developed by the London School of Hygiene & Tropical Medicine in partnership with Becton, Dickinson and Company (BD).

This free three-week course provided valuable insight into how COVID-19 has affected country AMR programmes and how countries can explore the lessons and benefits that the responses to the COVID-19 pandemic hold for AMR. You were able to learn at your own pace with a faculty of leading experts in COVID-19 and AMR and be part of the largest community of AMR professionals on the cutting edge of new information.

• You learned about diagnostic technology innovations and diagnostic capacity increases developed in response to the COVID-19 pandemic and how they can be applied to the AMR response.
• You learned about the importance of quality and data systems for AMR diagnostics and AMR data sharing to strengthen surveillance and reporting, and opportunities for professional development as part of a culture of continuous learning.
• You got the opportunity to join discussion forums to share your knowledge and views with colleagues and benefit from the experiences of other learners from around the world.

How can the COVID-19 pandemic help us defeat Antimicrobial Resistance?

Having the latest data for COVID-19 allows policy makers, clinicians, and the public to do their part in the fight against this pandemic. Many countries still lack sufficient data on antimicrobial resistance (AMR) trends to develop national and local treatment guidelines and policies. “Without data, you are just a person who has another opinion…with data, you can convince people there is an issue”, says Dr. Amal Saif Al-Maani, AMR expert from Oman.

In addition, we have made numerous investments in science, diagnostic testing capacity, and innovations in data systems we can leverage to do better with AMR before it’s too late. “Now is the time to learn more about the diagnostic technology innovations and diagnostic capacity increases that developed in response to COVID-19, and how they can be applied to the AMR response”, says Professor Rosanna Peeling, Director and Chair of Diagnostics at the International Diagnostics Centre at the London School of Hygiene and Tropical Medicine.

COURSE SYLLABUS

Week 1 – Updates on the AMR response and the impact of the COVID-19 pandemic

Week 2 – Better diagnosis, surveillance and reporting for AMR

Week 3 – Building back better for a robust and sustainable AMR response
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[av_heading heading=’VALUE-Dx supported participation in Ecraid webinar’ tag=’h3′ style=’blockquote modern-quote modern-centered’ subheading_active=’subheading_below’ show_icon=” icon=’ue800′ font=’entypo-fontello’ size=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” subheading_size=’15’ av-medium-font-size=” av-small-font-size=” av-mini-font-size=” icon_size=” av-medium-font-size-1=” av-small-font-size-1=” av-mini-font-size-1=” color=” custom_font=” subheading_color=” seperator_color=” icon_color=” margin=” margin_sync=’true’ padding=’10’ icon_padding=’10’ headline_padding=” headline_padding_sync=’true’ link=’manually,http://’ link_target=” id=” custom_class=” template_class=” av_uid=’av-kx4q0z2f’ sc_version=’1.0′ admin_preview_bg=”][/av_heading]

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The VALUE-Dx project encouraged all relevant stakeholders to attend the Ecraid educational webinar “Clinical case discussion: How clinical trials inform antibiotic stewardship”, organized by VALUE-Dx partners ERS and ESCMID. The webinar took place on 19 January, 2022 from 13:00–14:30 CET.

The aim of this webinar was to provide an overview of data from clinical trials in the management of complicated urinary tract infections and pneumonia, and how this information may be incorporated into stewardship activities.

Following the webinar, participants were able to discern the relevance of microbiological tests and their interpretation for the aetiological diagnosis of pneumonia, and the evidence-based principles for antibiotic treatment of complicated UTIs and community-acquired pneumonia.

About Ecraid

The European Clinical Research Alliance for Infectious Diseases – Ecraid – advances clinical research in the field of infectious diseases by establishing a long-term, financially self-sustainable, clinical research network in Europe. This network encompasses more than 2,000 sites in 40+ European countries. It includes primary care settings (general practitioners), hospital settings (emergency rooms and intensive care units), paediatric care settings, clinical laboratories, and long-term care facilities. The VALUE-Dx project and clinical studies are at the heart of the Ecraid network.
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[av_heading heading=’IMI Mid-Term Review meeting ‘ tag=’h3′ link_apply=” link=’manually,http://’ link_target=” style=’blockquote modern-quote modern-centered’ size=” subheading_active=’subheading_below’ subheading_size=’15’ margin=” margin_sync=’true’ padding=’10’ color=” custom_font=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” av_uid=’av-kwlx1b9j’ custom_class=” admin_preview_bg=”][/av_heading]

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VALUE-Dx’s Mid-Term Review meeting was held on 13 October 2021 and brought together VALUE-Dx’s Executive Board members, IMI’s Scientific Officer and three external reviewers to monitor and discuss project progress.
In a full day remote meeting, Executive Board members presented progress and achievements to date as well as planned activities for the coming months and years. Constructive and very interactive Q&A sessions provided the expert panellists with detailed project information. While the reviewers’ consensus report is confidential, the experts concluded that VALUE-Dx will likely provide results with significant immediate or potential impact in the years to come. Concrete suggestions and recommendations to further enhance the output of the project will be implemented.

The sets of slides that were presented during the meeting are available on the Members Area of the VALUE-Dx website.
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[av_heading heading=’PRUDENCE and ADEQUATE-Paediatric officially kicked off’ tag=’h3′ link_apply=” link=’manually,http://’ link_target=” style=’blockquote modern-quote modern-centered’ size=” subheading_active=’subheading_below’ subheading_size=’15’ margin=” margin_sync=’true’ padding=’10’ color=” custom_font=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” av_uid=’av-kvawz4i3′ custom_class=” admin_preview_bg=”][/av_heading]

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On 17 and 18 September 2021, an online Network Training meeting has officially kicked off PRUDENCE, a clinical trial aiming to assess effectiveness of CA-ARTI diagnostics in terms of both reductions in antimicrobial prescribing, and patient recovery.

During this meeting, the sites were trained by the study team on all the aspects of the trial, from patient recruitment to performance of the diagnostic test and completion of the eCRF. Specifically, the LAB-Net team (the laboratory network within COMBACTE and Ecraid) has trained the long term care facilities (LTCF) on sample collection and management for the Microbiology-Biomarker study embedded in PRUDENCE. After almost a year’s delay due to the COVID-19 pandemic, this online session represents finally the start of PRUDENCE.

ADEQUATE-Paediatric aims to assess the impact of rapid syndromic diagnostic testing in patients with ARTI at the emergency department. As of 1 October 2021, nine patients were enrolled in ADEQUATE-Paediatric and four (Germany, Switzerland, Greece, and Spain) of the six sites were trained by the study team during virtual site initiation visits (SIVs).
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[av_heading heading=’Health Economic Analyses of Diagnostics: Guidance on Design and Reporting’ tag=’h3′ link_apply=” link=’manually,http://’ link_target=” style=’blockquote modern-quote modern-centered’ size=” subheading_active=’subheading_below’ subheading_size=’15’ margin=” margin_sync=’true’ padding=’10’ color=” custom_font=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” av_uid=’av-kvl1lcgr’ custom_class=” admin_preview_bg=”][/av_heading]

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Over the past decades, policy makers in the healthcare sector have tried to control the rising costs of pharmaceuticals in different ways. To assess the value of diagnostic interventions in clinical practice, cost-effectiveness analyses can be used; however, we previously identified some gaps in the design and reporting of these studies. Compared with pharmaceutical interventions, assessing the cost effectiveness of diagnostic strategies can be more challenging, as various diseases or treatment options may be important to consider. The new VALUE-Dx publication provides eight recommendations on the reporting and design of CEAs of diagnostics, which can be used in addition to more general guidelines.

The first recommendation is to specify the target population of the test, including the symptoms patients experience and other relevant determinants that may influence the clinician when diagnosing patients. Clearly state whether the aim of the intervention is to screen, diagnose or monitor patients. The second recommendation is to specify the clinical setting in which the clinician operates, and where the diagnostic test is performed. Next to that you should specify the diagnostic algorithm, including clinicians’ decision processes (decision to perform the test), the diagnostic tests (including brand, type and frequency), and the relevant treatment options (the outcome of the diagnostic algorithm). It is also important that the assessed time horizon should be similar to the time horizon over which costs and consequences of treatment following the diagnostic process are typically evaluated.

The fifth recommendation is to include either QALYs or DALYs when assessing the cost effectiveness of diagnostics. Consider the economy (or diseconomy) of scale related to collecting, transporting and performing more (or fewer) tests on the same equipment, as opposed to a fixed price per test. Use an efficiency frontier to visualize the incremental costs and outcomes of the different strategies, if several diagnostic algorithms are assessed simultaneously. Finally, define the perspective of the economic evaluation and identify which payers are included in the budget impact analysis. Calculate the budget impact of implementing the assessed diagnostic algorithm within the overall clinical care pathway and consider setting-specific reimbursement regulations

These recommendations can be used in addition to other, more general, recommendations, such as the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) or the reference case for economic evaluation by the international decision support initiative. Although we expect the issues raised in the paper to be generalizable to diagnostics or all disease areas, some issues relevant for specific disease areas may not have been included. However, this research could be used as a starting point for a follow-up project to further develop diagnostic-specific guidelines or a reference case for diagnostic CEAs.

Read the full article
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[av_heading heading=’Point-of-care diagnostic testing (POCT) improves the quality of antibiotic prescription’ tag=’h3′ link_apply=” link=’manually,http://’ link_target=” style=’blockquote modern-quote modern-centered’ size=” subheading_active=’subheading_below’ subheading_size=’15’ margin=” margin_sync=’true’ padding=’10’ color=” custom_font=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” av_uid=’av-ksioskw8′ custom_class=” admin_preview_bg=”][/av_heading]

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In August 2021, the VALUE-Dx Consortium has published a new article in the journal Health Economics Review on the use of point-of-care diagnostic testing for improved antibiotic prescription.

Antimicrobial resistance (AMR) is one of the top 10 global public health threats facing humanity. Antibiotics have been over-prescribed to treat infectious diseases and have generated antimicrobial resistances that reduce their effectiveness. Point-of-care diagnostic testing (POCT) can improve the quality of antibiotic prescription with the aim of reducing AMR.

In order to understand whether this recommendation is valid, the VALUE-Dx researchers created a theoretical economic model to determine under which conditions the expected benefits of using POCT to guide antibiotic prescription are greater than for empiric prescription. The researchers considered the interaction of a group of physicians who express differing levels of uncertainty when prescribing with a firm selling a diagnostic device, and analysed the firm’s pricing policy and the physicians’ prescribing decisions. The physicians were allowed to internalize the external costs of antimicrobial resistances.

The results showed that the use of POCT reduces the number of antibiotic prescriptions. The reduction in antibiotic prescriptions is higher when physicians internalise the costs of antimicrobial resistances. Physicians with relatively high levels of uncertainty use POCT as they are uncertain about the right treatment for a large proportion of patients. Physicians with low levels of uncertainty prefer to prescribe empirically. The segmentation in the population of physicians regarding the uptake of POCT depends on the distribution of levels of uncertainty across physicians. For each test, the firm charges the marginal production costs of the inputs needed to administer the test, and makes its profit from the sales of the testing devices.

From a theoretical perspective, these findings corroborate the fact that POCT improve the quality of antibiotic prescription and reduce the number of prescriptions. Nevertheless, their use is not always recommended as empiric therapy may be preferred when uncertainty is low.

Read the full article
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[av_heading heading=’VALUE-Dx investigates HTA, Reimbursement and Pricing of Diagnostic Tests for CA-ARTI’ tag=’h3′ link_apply=” link=’manually,http://’ link_target=” style=’blockquote modern-quote modern-centered’ size=” subheading_active=’subheading_below’ subheading_size=’15’ margin=” margin_sync=’true’ padding=’10’ color=” custom_font=” av-medium-font-size-title=” av-small-font-size-title=” av-mini-font-size-title=” av-medium-font-size=” av-small-font-size=” av-mini-font-size=” av_uid=’av-knr9eayp’ custom_class=” admin_preview_bg=”][/av_heading]

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In January 2021, the VALUE-Dx project produced a report that aims to map policies related to Health Technology Assessment (HTA), pricing and reimbursement of diagnostics for CA-ARTI in Europe.

The study indicates that the overall level of policy implementation in pricing and reimbursement for diagnostics is rather low. In addition, it is shown that HTA as a supportive tool to inform pricing and reimbursement decisions at national levels is rarely used in the study countries. Diagnostics for CA-ARTI constitute a valuable instrument to ensure rational antibiotic prescribing and thus to tackle antimicrobial resistance (AMR). Pricing and reimbursement policies, supported by HTA, can contribute to patient access and uptake of health products, such as diagnostics for CA-ARTI. Further research will be conducted in the course of the VALUE-Dx project.

In its fight against AMR, VALUE-Dx seeks to investigate the economic value, policies and innovative funding models. One of the goals of Work Package 5 is to review and analyze the current policy environment in Europe and identify good practices for the assessment of diagnostics.

The successful implementation and long-term viability of rapid diagnostic testing does not solely depend on developing, selling, and marketing these kind of medical devices. It is also important to demonstrate the economic value – especially from a long-term societal perspective – and to incentivize the uptake of rapid diagnostic tests through appropriate policies with regards to pricing, reimbursement (funding), and HTA.

Read the report
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