newsletter Archive - ASCERTAIN

ASCERTAIN NEWSLETTER 6

Lena Jessen — Mon, 27 Apr 2026 14:27:49 +0000

Dear readers,

As we enter the final phase of the ASCERTAIN project, this edition highlights key milestones achieved in recent months. We share insights from our consortium meeting in Brussels, present progress on the ASCERTAIN platform and open-access models, and introduce our newly published position papers translating evidence into policy recommendations. In addition, we highlight our work on strengthening security and making specialised health economics knowledge more accessible to patients and the wider public.

Registration is now open for our Final Conference, which will take place on 21 October 2026 in Brussels.

Enjoy reading this newsletter!

Your ASCERTAIN team

GLOBAL MODELS, LOCAL IMPACT: MAKING HTA MORE TRANSPARENT AND ADAPTABLE

Mathyn Vervaart is a health economist and researcher at Oslo University Hospital and the University of Oslo. He holds a PhD focused on methods for handling uncertainty and immature survival data in economic evaluations. His current work centers on model-based cost-effectiveness analyses and the economic evaluation of new health technologies. Previously, he worked as a Senior Adviser at the Norwegian Medical Products Agency (NOMA), where he conducted technology assessments for new pharmaceuticals.

What is a global model, and how does country adaptation work?

A global model is essentially a standardized “master blueprint” used to avoid rebuilding economic models from scratch for every country. Adaptation involves plugging in country-specific data—such as local unit costs, discount rates, or mortality tables—into a fixed structural framework. This ensures that while the underlying logic remains consistent, the results are tailored to local healthcare systems.

What is new in our model?

Our models are developed with a principle of being as open as possible and as closed as necessary. In contrast to many conventional economic models, which are often treated as “black boxes” and are not routinely made available for scrutiny or reuse across Health Technology Assessments (HTAs), our models are built using open-source code in R to support transparency, reproducibility, and adaptability. These are paired with a user-friendly web application that enables both technical and non-technical stakeholders to engage with the models and conduct their own analyses. Where sensitive data or privacy considerations apply, parts of the workflow are maintained within a protected environment. This approach seeks to balance openness with appropriate safeguards, ensuring both broad accessibility and responsible data governance.

What are the main advantages for stakeholders?

For payers and HTA agencies, the main advantages are transparency and comparability—they can trust the results and easily compare outcomes across different jurisdictions. For developers, it increases efficiency, as they can reuse and adapt a validated model rather than reinventing the wheel for every HTA.

What kind of challenges did you face during development?

The main challenge was balancing standardization with flexibility. We had to design core models capable of handling various national rules—such as switching between healthcare and societal perspectives—as well as different technical inputs like survival models and mortality rates. The goal was to offer these options without making the tool overly complex for the user.

How do we ensure quality?

Quality is managed through a dedicated Quality Assurance Framework (QAF). This includes standardized coding practices, version control, and error testing. By moving away from individual spreadsheets and toward a structured codebase, we reduce the risk of calculation errors that often occur in traditional health economic models.

CONSORTIUM MEETING IN BRUSSELS

In April, the ASCERTAIN consortium gathered in Brussels for a two-day meeting marking the transition into the final phase of the project. Bringing together partners from across Europe, the meeting provided an important opportunity to reconnect, align on key priorities, and prepare for the months ahead.

The first day focused on internal collaboration, with partners working intensively on cross-model interactions, validation of the project’s three use cases, and integration of environmental impact considerations. Discussions also addressed preparations for the upcoming final conference, ensuring a strong and impactful conclusion to the project.

On the second day, ASCERTAIN welcomed a diverse group of external stakeholders, including representatives from policy, academia, and healthcare. Through interactive workshops and scenario-based exercises, participants explored how ASCERTAIN’s models and Policy Support Tool can support real-world decision-making. By testing different user perspectives, stakeholders engaged directly with the platform and provided valuable feedback on its usability, relevance, and policy application.

We now look forward to coming together again in October in Brussels for the ASCERTAIN Final Conference.

FINAL CONFERENCE IN BRUSSELS

As the ASCERTAIN project comes to an end, we are pleased to announce that our Final Conference will take place on 21 October 2026 in Brussels.

ASCERTAIN brings together patient representatives, physicians, payers, regulators, and manufacturers to improve the affordability and accessibility of innovative health technologies in Europe. Guided by a comprehensive framework integrating pricing, health technology assessment, and reimbursement, the project has developed open-access, policy-supporting tools to enhance transparency, sustainability, and fairness in health innovation.

This final event will be an opportunity to:

Present and discuss ASCERTAIN’s key findings and policy recommendations;
Showcase the open-access pricing, cost-effectiveness and reimbursement models and the cloud-based platform developed within the project;
Engage with leading experts and stakeholders on the future of equitable access and sustainable pricing in Europe.

More information & registration.

NEW ASCERTAIN POSITION PAPERS: FROM EVIDENCE TO ACTION

As part of our commitment to transparency and policy dialogue, ASCERTAIN has developed a series of concise position papers for Work Packages 4, 5, and 6. These documents present our work in a clear and structured format, making our findings and recommendations accessible to a broad range of stakeholders. Each paper summarises the key review results, sets out concrete evidence-based recommendations, and explains how ASCERTAIN’s tools and activities contribute to addressing the identified challenges.

Check out our three position papers:

ADVANCING ACCESS-BASED PRICING: MODEL DEVELOPMENT AND DISSEMINATION UPDATES

Work Package 4 (WP4) continues to advance the ASCERTAIN pricing work, with major progress on both the medicinal products model and the development of pricing principles for next-generation sequencing (NGS) medical devices.

A draft version of the pricing model for medicinal products was presented and discussed in eight informal online workshops with a wide range of stakeholders. These workshops included payers, industry representatives, an investor, patient advocacy experts, academics, and ASCERTAIN consortium members with expertise in health economics and HTA. Feedback focused on the model’s face validity and its potential practical use across different stakeholder contexts.

In parallel, extensive technical testing took place, including verification of output consistency; translation of the model from Microsoft Excel into R; comparisons with the AIM Fair Price Calculator and Belgian and German net prices; and stress-testing using extreme input values to identify potential errors.

Dissemination activities included a poster presentation at ISPOR Europe in November 2025 and the publication of a scoping review of fair pricing definitions as a preprint on OSF (Open Science Framework).

Finally, a stakeholder survey was prepared and disseminated to inform pricing principles for next-generation sequencing (NGS) in vitro diagnostic (IVD) medical devices in precision cancer care.

ASCERTAIN PLATFORM: FIRST PROTOTYPE AND MODEL INTEGRATION

Our focus is on developing the ASCERTAIN platform, which will serve as a central policy support tool for decision-makers. At the end of 2025, we successfully launched the first prototype. This milestone marks the beginning of an intensive phase where we collaborate closely with other work packages to integrate their models and establish the necessary interconnections.

The work is demanding, as it involves combining multiple technical components to create a scalable and user-friendly application. Our goal is to provide a robust infrastructure that can efficiently run complex health economic models while ensuring an intuitive user experience.

This process is not only technically challenging but also exciting, as it lays the foundation for sustainable use of ASCERTAIN’s results and paves the way for innovative approaches in the assessment and pricing of health technologies.

ENSURING ROBUST SECURITY ACROSS THE ASCERTAIN PLATFORM

As part of our ongoing efforts, we have completed a comprehensive security assessment of the ASCERTAIN platform and the YODA data-sharing platform used by project partners. The assessment, based on technical checklists aligned with the ISO/IEC 27002:2022 standard—an internationally recognised framework for information security controls—marks an important step in strengthening information security and data protection across the project.

Our review confirmed a strong security baseline for both platforms, including anti-malware protection, multi-factor authentication, encryption of data in transit, and a clear separation between development and production environments.

Through this process, we have verified the current security posture and identified areas for further improvement. This work helps ensure that sensitive health data exchanged within ASCERTAIN remains secure, compliant, and protected according to the highest standards.

MAKING SPECIALISED KNOWLEDGE ACCESSIBLE TO A WIDER AUDIENCE

As part of our work in ASCERTAIN, we develop educational materials for patients and the wider public. We are also preparing lay explanations of the models, framework, and online tools, which will be delivered towards the end of ASCERTAIN this year.

Developing such materials involves “translating” specialised knowledge in health economics for a wider audience with little or no background in the field. This means simplifying without losing accuracy, using different types of content and visual aids, breaking down information into small, focused sections, and demonstrating why a particular concept, approach, or evaluation matters. It is a process that involves not only summarising and translating the most relevant information but also navigating different levels of knowledge and values. For example, in our recently published Q&A document on Quality-Adjusted Life Years (QALYs), we worked to understand this health economics concept through the lens of patients’ informational needs. Academic knowledge on QALYs was therefore translated and balanced with patients’ potential interests and values.

For more information on the materials already developed please visit the “For Patients” section on our website.

New ASCERTAIN video series explains how medicines are priced, evaluated and made available in Europe

ASCERTAIN Position Papers on Pricing, Modelling and Reimbursement Now Available

New ASCERTAIN Video Series: How Are Medicines Priced and What Makes a Price Fair?

FINAL CONFERENCE

Join us for our final ASCERTAIN conference in Brussels!

21. October 2026

More info

Don’t miss the latest updates and exciting developments in the world of innovative health technologies. Follow us on LinkedIn and YouTube to stay informed about our mission to enhance affordability and accessibility in healthcare. Join the ASCERTAIN community today and be part of the conversation for a healthier and more equitable future!

Der Beitrag ASCERTAIN NEWSLETTER 6 erschien zuerst auf ASCERTAIN.

ASCERTAIN NEWSLETTER 5

Lena Jessen — Fri, 10 Oct 2025 07:44:21 +0000

Dear readers,

Welcome to the fifth edition of the ASCERTAIN newsletter!

As ASCERTAIN progresses, our shared goal remains clear: to make healthcare innovation accessible, affordable, and evidence-based.

This edition highlights how that vision is taking shape. In our interview, Professor Tomas Tesar and Dr Mirjana Huic discuss cost-effectiveness thresholds and the challenge of balancing innovation with equity. Their insights echo ASCERTAIN’s wider mission — ensuring that value assessments reflect both scientific and societal priorities.

At the Stakeholder Day in Oslo, experts from academia, healthcare, policy, and industry came together to refine models for pricing and reimbursement, reinforcing the importance of collaboration across sectors.

Across the work packages, progress continues — from privacy and usability foundations to access-based pricing, global modelling, and preference-sensitive reimbursement approaches. Together, these efforts are building a digital platform to support transparent and flexible decision-making.

Finally, the launch of ASCERTAIN’s multilingual website demonstrates our commitment to openness and inclusion, ensuring that key findings reach stakeholders across Europe.

Enjoy reading this newsletter!

Your ASCERTAIN team

BALANCING INNOVATION AND AFFORDABILITY: PERSPECTIVES ON COST-EFFECTIVENESS THRESHOLDS

Professor Tomas Tesar, Head of the Department of Organisation and Management in Pharmacy at the Pharmaceutical Faculty of Comenius University in Slovakia. He has extensive experience in Health Technology Assessment (HTA) and has been a member of the Reimbursement Committee for Drugs at the Slovak Ministry of Health (MoH) for several years. Tomas Tesar also brings European experience; he was a member of the Executive Board of the EUnetHTA JA3 project and is now a member of the group of experts dealing with pharmaceutical preparations of the European Directorate for the Quality of Medicines in Strasbourg, France.

Mirjana Huic, MD, PhD, specialist in clinical pharmacology and toxicology from the HTA/EBM Center in Croatia, provides external HTA support to UNIBA in specific tasks within the ASCERTAIN project, as an international independent HTA expert.

How does your country decide if a new medicine is “worth the cost,” and do you think the current thresholds are fair for innovative treatments?

Tomas and Mirjana: As we already know, the growing presence of Innovative Health Technologies (IHTs), including medicines, medical devices, and procedures, poses financial challenges for existing healthcare systems, as their potentially high costs strain the limited budgets of healthcare systems and divert resources from other essential services. Many countries use economic evaluations of these IHTs to ensure the cost-effective innovation of healthcare systems. So, to ensure accessibility and affordability of IHTs, an adequate Cost-Effectiveness Threshold (CET) that represents the needs and resources of the country of interest can be essential.
In Slovakia, we have an explicit CET. From 2022, it was stated as follows:
a) 2 × Gross Domestic Product (GDP), if the difference between the gained year of life of standardized quality when using the drug under consideration and the gained year of life of standardized quality when using another medical intervention is greater than 0 and less than 0.33,
b) 3 × GDP, if the difference is 0.33 or more.
If the subject of the assessment is a drug for a rare disease or a drug for innovative treatment, the multiple of the GDP of the Slovak Republic per capita is:
a) 3 × GDP, if the difference is greater than 0 and less than 0.33,
b) 5 × GDP, if the difference is 0.33 or greater and less than 0.5,
c) 10 × GDP, if the difference is 0.5 or more.

What do you think cost-effectiveness thresholds should be based on — for example, the country’s GDP, health budget, or something else?

Tomas and Mirjana: According to the literature, there is no universal “gold standard” for implementing thresholds. Each methodological approach has specific advantages and disadvantages and must be adapted to the national context. Currently, especially in Central and Eastern European (CEE) countries, the country’s GDP per capita for one unit of health (more specifically, quality-adjusted life year – QALY) gain is the most commonly used reference point for establishing the CET.

Some countries adjust the value of the CET in specific contexts to account for unique factors or societal values. These so-called modifiers are intended to ensure that value-for-money assessments align with broader health system goals or societal preferences.
According to the results of the ASCERTAIN questionnaire related to CET, in which participants from various stakeholder groups (patients/patient representatives, HTA bodies, policymakers, healthcare providers/healthcare professionals – HCPs, payers/insurers, citizens and health technology developers) shared their opinions, more than 70% of participants think that CET is important or very important when making reimbursement decisions on innovative health technologies and should be used as a guide to interpreting cost-effectiveness. Around 44% of participants found the combination of demand-side and supply-side approaches appropriate for estimating the CET, and 41% found GDP per capita appropriate for estimating the CET.

In contrast to 52% of participants who think that the CETs should be different for pharmaceuticals and medical devices, experts from the ASCERTAIN Expert Workshop agreed that CETs should be the same for all health technologies (i.e., no discrimination in CET values between pharmaceuticals and medical devices).

What problems do you see when applying these thresholds to expensive or breakthrough medicines?

Tomas and Mirjana: As we already mentioned, to ensure accessibility and affordability of IHTs, an adequate CET that represents the needs and resources of the country of interest can be essential. Multiple CET values based on different factors like relative health gain, disease severity, rarity of disease, and priority disease areas (e.g., oncology/end of life or paediatric diseases) could be the right option. For example, more severe diseases could have a higher threshold than less severe ones, and rare diseases could have a higher threshold than more common diseases. By raising the threshold considered cost-effective for treatment of more severe diseases, decision-makers can recommend more expensive treatments that provide significant benefits to patients with severe conditions. Without such modifiers, these treatments might not meet countries’ criteria for being cost-effective.

In the ASCERTAIN questionnaire related to CET, 76% of participants found modifiers important or very important when making reimbursement decisions on innovative health technologies, more specifically factors such as disease severity, rarity of disease, unmet need, equity, and uncertainty reduction. Only around 25% of participants agreed with the use of the value of knowing and the value of hope as modifiers, but the methodological problem is how to apply them. The same is true for environmental impact.
But sometimes, despite the multiple CET values, the cost the healthcare system is asked to pay is too high in relation to the benefits provided for it to be recommended for routine use. The fastest and only guaranteed way to get expensive or breakthrough medicines, medical devices, and procedures to the patients who need them is for companies to offer a fair price.

How do these thresholds influence patients’ ability to access new treatments in your healthcare system?

Tomas: It is essential to emphasize that the CET, effective from 2022, lacks scientific validity and therefore does not enhance the evidence base for pharmaceutical policy decisions in Slovakia. It negatively affects patients’ access to new treatments. The problem is further amplified by the fact that strategic pricing of innovative therapies is not based on small markets with relatively low purchasing power, such as Slovakia. However, the ASCERTAIN project can significantly influence changes in the CET, which are undoubtedly needed for Slovakia.

What changes could help patients get innovative medicines while keeping healthcare spending under control?

Tomas and Mirjana: As we know, many countries are currently in a transition period, either to establish explicit CETs or to introduce multiple CETs instead of the previous single threshold values or threshold value ranges (i.e., lower and upper threshold values).
Multiple CET values appear as a reflection of recent trends in the development of expensive innovative pharmaceuticals like targeted/personalized therapies, and many countries in transition introduce multiple CETs based on different factors like relative health gain, disease severity, rarity of disease, and priority disease areas (e.g., oncology/end of life or paediatric diseases). But according to CET experts, a balanced approach is needed when using the modifiers. If there are modifiers, the baseline CET needs to be reduced (for example, to 1 × GDP per capita, or in low-income countries, ½ × GDP per capita).

In countries where economic evaluations currently do not play a formal and explicit role in reimbursement decisions, if they decide to go in this new direction, they need to discuss and make further decisions regarding the detailed methods for conducting economic evaluations, whether or not to specify a CET, which method to use, and in which way criteria beyond efficiency (new modifiers) might be considered.

In the ASCERTAIN project, to ensure accessibility and affordability of IHTs and an adequate CET that represents the needs and resources of the country of interest, we hope that we will find additional elements of value beyond the QALY and new methods to estimate CET values that account for these elements, together with an interactive, flexible, publicly available, web-based CET estimation tool.

CONSORTIUM MEETING IN OSLO

On 30 June 2025, the ASCERTAIN Consortium held its Stakeholder Day in Oslo, uniting experts from academia, healthcare, industry, and policy to explore sustainable access to Innovative Health Technologies (IHTs). The meeting focused on refining access-based pricing, cost-effectiveness, and reimbursement models by aligning them with stakeholder needs and expectations.
Opening the event, Carin Uyl-de Groot (Erasmus University Rotterdam) emphasized ASCERTAIN’s mission to create a public, cloud-based platform facilitating equitable access to IHTs — highlighting EU challenges such as system strain, unequal access, clinical uncertainty, and environmental concerns.

Maximilian Salcher-Konrad (Gesundheit Österreich) and Anne Hendrickx (AIM) unveiled a hybrid pricing model integrating cost-based (e.g., R&D, manufacturing) and value-based (e.g., clinical, societal) components, adaptable across EU contexts; treatment costs were shown to differ with disease prevalence. Stakeholder input came from EAHP (emphasizing transparent pricing tools), IKK e.V. (benchmark pricing in Germany), and EHA (highlighting the growing affordability crisis).

Eline Aas (University of Oslo) and Tom Belleman (Erasmus University Rotterdam) presented scalable cost-effectiveness models for diverse user groups and Managed Entry Agreements (MEAs) aligning payment to outcomes, respectively. Industry and public stakeholders, including AbbVie Scandinavia, NoMA, and Sykehusinnkjøp, called for modular, transparent, post-launch adaptive tools and open-source models to facilitate real-world access and procurement.

Lastly, Moritz Mumme and Pascal Wendel (OptiMedis) showcased the forthcoming ASCERTAIN Policy Support Tool. It will support full or partial assessments via guided workflows, parameter validation, and customizable sharing.

The meeting reinforced ASCERTAIN’s dedication to transparency, collaboration, and impactful tool development by inviting continued involvement through co-creation and user testing.

ASCERTAIN WEBSITE NOW AVAILABLE IN 8 LANGUAGES

This multilingual launch is an important step toward one of our core goals: making information about affordability, access, and innovation in healthcare understandable and accessible for a broad European audience. By providing translations of our content (including interviews, explanatory videos, and key concepts) we hope to reach stakeholders, patients, and decision-makers in their preferred languages.

Supporting Equal Access

The ASCERTAIN project aims to improve affordability and accessibility of innovative health technologies across Europe. This vision is reflected not only in the tools we develop but also in the way we communicate our findings.

Translating our website into several widely spoken European languages is part of this effort to ensure inclusivity and transparency. It enables more people to follow the progress of the project, understand complex health economic issues, and engage with ASCERTAIN’s work — no matter where they are based.

We’re continuously working to expand the site further. Additional languages and translated materials will be added in the future as part of our commitment to broadening engagement.

For questions or feedback on the translated versions, feel free to get in touch with our communication team.

FROM PRIVACY TO USABILITY: TECHNICAL FOUNDATIONS OF ASCERTAIN TOOLS

CHINO’s team was actively involved in the project’s data management, privacy, and ethics, continuously monitoring the data collected and updating the Data Management Plan (DMP). The team has reviewed and extended the ASCERTAIN Glossary developed under T3.2 to include privacy terms, and has also curated the ACCESS2MEDS website’s Legal Notice, Privacy Policy, and Cookie Policy.

CHINO also worked on the “ASCERTAIN_REQ_Analysis” document, which outlines the requirements for the project tool under development. The focus was on ensuring the tool’s security, compliance, and user-friendliness. The analysis covered aspects related to a smooth user experience that will require extensive testing and optimization. Security is another top priority, with the use of Hypertext Transfer Protocol Secure (HTTPS) for all data transmissions and the use of secure authentication protocols for any login functions.

From a user perspective, the tool will be highly accessible and usable, complying with WCAG 2.1 AA standards and being intuitive for all users, including those who are not technically savvy. Lastly, for data management and compliance, the tool will implement audit logs, ensure data integrity, and guarantee compliance with regulations like GDPR by using data anonymization and obtaining user consent. It has been emphasized that there is a need for 99.9% system uptime and the establishment of clear communication protocols for any planned downtime. Furthermore, regular backups and recovery procedures will be in place to protect critical data.

CROSS-MODEL INTERACTIONS AS AN INTEGRAL PART OF THE ACCESS2MEDS FRAMEWORK

Following up on our work to advance the ACCESS2MEDS Framework, we have initiated a critical phase focused on collecting and synthesizing expert input regarding cross-model interactions. This valuable input was gathered during our recent Consortium Days in Oslo, where project partners engaged in focused discussions. Specifically, we have been gathering insights to inform a definitive decision on how to best operationalize these interactions within the ACCESS2MEDS platform’s toolbox. To this end, an internal discussion forum was created to collect views and opinions from consortium members on how the respective from each model developed within ASCERTAIN can serve as an input in any of the other models. A follow-up discussion based on the obtained views will be held in October. This focused effort is essential to provide clear direction for OptiMedis within Work Package 7 (WP7) and to ensure the upcoming Framework documentation accurately reflects the most effective and integrated approach to our models. By defining these connections clearly, we will significantly enhance the framework’s internal consistency and overall utility for complex policy analysis.

ACCESS-BASED PRICING IN FOCUS: FROM LITERATURE TO STAKEHOLDER PERSPECTIVES

GOEG, AIM, and EUR have been continuing their work on developing an access-based pricing model. The focus concerned targeted literature reviews on the individual price determinants, as well as informal expert and stakeholder interviews to fill gaps not covered by the literature and to answer additional questions that came up during the reviews. These expert interviews provided us with useful information on how to operationalise the price determinants within the pricing model. Moreover, a survey was developed with the aim of eliciting stakeholder views on what price determinants are considered important, how important they are compared to other determinants, and how different kinds of value influence the price of a medicinal product. At the cut-off date, the survey had mostly been finalised and also shared with the ASCERTAIN consortium for further input, but not yet distributed to relevant stakeholders.

In addition, our draft article concerning an analysis of semi-structured interviews with stakeholders regarding relevant determinants for a newly authorised medicinal product’s price, pricing challenges, and innovative pricing approaches was discussed by a fellow researcher at the LOLAHESG Conference in Ermelo, the Netherlands, on 22–23 May 2025. This session not only provided some very useful feedback for the finalisation of the paper but was also met with interest in the project from the present audience.

DEVELOPING GLOBAL MODELS AND DEFINING END-USERS

The work in WP5 is going from developing cost-effectiveness analyses in one setting to the development of global models. In WP5, we work with developing global, open-access (cost-)effectiveness and budget impact models for the three UCs (precision cancer medicine, gene and cell therapy, and genetic profiling). These models are designed with the intention to be fully open access (including R software source with fully commented code) and able to be flexibly adapted through an interactive user interface. Individuals with either non-technical or technical skills will be able to interact with the model. Currently, we have developed models for a single setting and are now planning to expand existing models to accommodate different settings.

During the last period, we have identified two types of end-users:

Level 1 end-users: Users that are able to adapt and parameterise the global, open-access models. Level 1 end-users will need to incorporate clinical, economic, and other input parameters, perform model validation, and inform the estimations of the cost-effectiveness and/or budget impact of an intervention and a comparator.
Level 2 end-users: Users are different types of decision-makers that will use outputs generated by the global, open-access model. Level 2 end-users can interact with the model to vary a selected number of policy-relevant variables, e.g., price, discount rate, time horizon, exchange rate. Level 2 end-users will be dependent on completed models from Level 1 end-users.

During the consortium meeting in Oslo in July, we received input from potential end-users (from the public and private sector), providing useful reflections on the development of the global models. In the next months, we will continue the work with global, open-access models with WP7.

Furthermore, the microcosting study of genomic profiling has been newly published in the Journal of Molecular Diagnostics (Henkel et al). In addition, three cost-effectiveness analyses were presented and discussed at the Nordic Health Economics Study Group Meeting in Oslo.

UNDERSTANDING PREFERENCES ACROSS EUROPE

The work in WP6 advances the development of reimbursement processes by introducing novel cost-effectiveness threshold approaches designed to more accurately reflect societal preferences and address patient priorities. Our recent research combined qualitative and quantitative methods to better understand preferences for healthcare spending prioritisation across Europe. Building on these insights, we aim to develop flexible thresholds that can adapt to disease- and patient-specific characteristics.

This year, we initiated preparatory work for a Discrete Choice Experiment (DCE) to capture independent preferences regarding healthcare spending priorities in the form of modifiers. An initial list of 14 potential cost-effectiveness modifiers was identified through a review of existing literature. These modifiers served as potential attributes for inclusion in the DCE. To ensure the experiment’s efficiency, the number of attributes needed to be reduced. Therefore, the work began with focus groups involving 23 participants in the Netherlands, aimed at further identifying and ranking the most important attributes. This was followed by a short survey with 529 respondents from Bulgaria, the Netherlands, Norway, Slovakia, and Spain to validate and refine these rankings.

We are now in the process of finalising the preparatory phase for the DCE itself. After analysing the results from the focus groups and survey, and following a deliberate phase of internal reflection, we have defined a final set of eight factors that will be included and weighted against each other in the experiment: Severity of Disease, Rarity of Disease, Patient Age Group, Unmet Medical Need, Effectiveness of Treatment, Uncertainty of Treatment Effectiveness, Budget Impact, and Environmental Impact.

The choice experiment will be implemented across eight countries — Austria, Bulgaria, France, Lithuania, the Netherlands, Norway, Slovakia, and Spain — capturing a diverse range of regional and cultural perspectives across Europe. Members of the general public in these countries will be invited to make trade-offs between different attributes, while patient groups will be asked to complete the same experiment. These combined insights will deepen our understanding of cross-country differences in societal preferences, as well as distinctions between the views of patients and the general population. Ultimately, this work will provide a stronger evidence base to guide more transparent, inclusive, and preference-sensitive reimbursement decisions across Europe.

FROM CONCEPT TO IMPLEMENTATION: A DIGITAL PLATFORM FOR EVIDENCE-BASED DECISION-MAKING

We are currently working on the development of a web-based platform designed to support evidence-based decision-making in healthcare — for example, around pricing, cost-effectiveness assessments, and reimbursement schemes. The goal is to create an open, interactive tool that adapts to the needs of different user groups.

At this stage, our focus is on finalizing the user journeys: Together with colleagues from related work packages, we are mapping out how stakeholders such as HTA bodies, policymakers, payers, and patient organizations will interact with the platform. Based on these insights, we are defining the core requirements — both functional and technical — for the system.

This structured and user-centered approach ensures that the platform will be relevant, usable, and well integrated into real-world decision-making processes.

We aim to complete an internal prototype by July 2026. It will serve as the basis for initial testing and stakeholder feedback, leading to further development and refinement.

Presentation of New HTA Methodological Guideline for Slovakia at the Ministry of Health

ASCERTAIN Consortium Meeting in Oslo

ASCERTAIN Website Now Available in 8 Languages

ISPOR EUROPE 2025

Join partners from the ASCERTAIN project at ISPOR in Glasgow!

09.-12. November 2025

More info

Der Beitrag ASCERTAIN NEWSLETTER 5 erschien zuerst auf ASCERTAIN.

ASCERTAIN NEWSLETTER 4

Lena Jessen — Tue, 11 Mar 2025 12:48:25 +0000

Dear readers,

Welcome to the fourth edition of the ASCERTAIN newsletter!

In this issue, we are excited to highlight our efforts to make complex healthcare policies and pricing mechanisms more accessible. Over the past months, our consortium has continued to advance research on pricing models, reimbursement frameworks, and patient engagement —all aimed at improving equitable access to innovative health technologies.

One of our key initiatives has been the “3 Things About” video series, designed to simplify crucial topics such as market access, cost-effectiveness, and reimbursement. In six videos Carin Uyl-de Groot and Frederick Thielen explain “three things you might not know about…”.

In this edition, you will also find updates from our work packages, including progress on the ACCESS2MEDS framework, structured expert elicitation for cost-effectiveness analysis, and our efforts to refine access-based pricing models. Additionally, we showcase the vital role of patient engagement, ensuring that their perspectives remain at the core of our work.

Enjoy reading this newsletter!

Your ASCERTAIN team

MAKING HEALTHCARE COSTS UNDERSTANDABLE: TEACHING, RESEARCH, AND THE ‘3 THINGS ABOUT’ VIDEO SERIES

What is your role at Erasmus University, and how does it relate to health technology assessment?

Frederick: As an assistant professor, my work is divided between teaching and research. Much of my time is dedicated to teaching courses such as HTA, advanced health economic modelling, and pharmaceutical pricing and market access. This covers everything from the fundamentals of how medicine prices are determined to advanced modelling techniques that assess whether new treatments are worth their ever-increasing costs.

In my role as international programme director, I ensure that the curriculum of the European Health Economics and Management (Eu-HEM) Master’s programme remains relevant, up-to-date, and intellectually stimulating for students.

My research at Erasmus University focuses on advanced therapeutic medicinal products (ATMPs) and how to best assess their costs, effectiveness, and environmental impact. Did you know that we often might end up paying for expensive new medication but that the “old” cheaper treatment would have more effective for many patients?

How do you see the value of online videos for learning?

Frederick: From my teaching experience, I know that videos are a great way to facilitate learning and teaching – for both students and teachers. For students, the flexibility of on-demand content allows them to learn at their own pace, re-watch complex concepts, and even speed up playback during boring parts or those they find less challenging. And sometimes people in videos speak soooo slooow. Me included by the way.

For teachers, preparing videos can take more time initially, but it allows for better structuring of content and reduces the need to repeat the same information in every lecture. This frees up time for more interactive discussions, such as Q&A sessions, which enhance the learning experience. Ultimately, it is a win-win situation.

What was it like filming the “3 Things About” series, and what topics can viewers expect to learn about?

Frederick: Filming the series was great fun! The Erasmus Studio at Erasmus University is a fully equipped, professional recording studio, and the team working there is both highly skilled and fun to work with. Have you ever tried warming up your voice by repeatedly saying, “She sells seashells by the seashore”? It is harder than it sounds!

The videos cover key topics related to health economics, including reimbursement, cost-effectiveness, and market access. These are crucial for understanding how healthcare systems make decisions about which treatments to fund and how to allocate limited resources effectively.

Your videos focus on reimbursement, cost-effectiveness, and market access—why are these topics so important for healthcare systems?

Frederick: Healthcare budgets are limited, and new treatments are continuously being developed—often at very high costs. Decisions about reimbursement and market access determine which treatments are available to patients and at what cost to the system. If you look at life expectancy across Europe, you will still find huge differences between countries. Of course, there are many different factors influencing this and many of these factors are harder to influence than others. But how can we sit still when you can buy a happy meal in every European city, but entire European Members States do not have access to life-saving cancer treatments for children?

Cost-effectiveness analysis plays a crucial role in ensuring that healthcare resources are used efficiently. It helps policymakers and insurers assess whether a new treatment provides sufficient benefits compared to existing alternatives, considering both costs and patient outcomes. We can spend money only once. But if we do, it better be for the most effective thing. And maybe we also want to take the health of planet into account.

Without a structured approach to evaluating new treatments, healthcare systems could either overspend on high-cost interventions that provide limited benefit or fail to adopt innovative therapies that could significantly improve patient outcomes. Balancing affordability, effectiveness, and access is key to ensuring sustainable healthcare.

What impact do you hope the series will have on patients and other stakeholders?

Frederick: I hope the series helps to demystify some of the complex economic concepts and make them more accessible to a wider audience. Many people are unaware of the processes that determine whether a new treatment becomes available in their country or why certain medicines are reimbursed while others are not.

For patients, a better understanding of these topics can empower them to advocate for access to necessary treatments but also to understand why access is different between countries. For policymakers and healthcare professionals, the series provides insights into the trade-offs involved in decision-making.

Ultimately, I hope that making these concepts more transparent will contribute to more informed discussions about healthcare funding and the value of medical innovations. And if people want to know, we have a ton of learning material available through our master programmes and at the institute for medical Technology Assessment (iMTA).

CHECK OUT OUR VIDEO SERIES

We are excited to announce the release of the ‘3 Things About’ series. With these six videos we aim to make complex issues more accessible, fostering a deeper understanding of the challenges and opportunities in topics around ASCERTAIN.

In front of the camera are Carin Uyl-de Groot (project coordinator), Professor of Health Technology Assessment, and Frederick Thielen, Assistant Professor of Health Technology Assessment at the Erasmus University Rotterdam. Each of them explains three topics in the format “three things you might not know about…”.

These videos play a key role in the project’s mission to raise awareness and foster dialogue on the affordability and accessibility of health innovations. The videos are now available here on the ASCERTAIN website and social media channels.

Overview of the Videos

3 Things About Market Access
3 Things About Tiered Pricing
3 Things About Pricing of New Drugs
3 Things About Reimbursement
3 Things About Cost-Effectiveness
3 Things About Value of New Cancer Drugs

Watch on YouTube.

SIGNATURES OF LEGAL AGREEMENT AND RELEASE OF THE OPEN ACCESS POLICY

In November 2024, the Consortium achieved an important milestone with the signing of the Joint Controllership Agreement (JCA) between all partners, covering the entire project (D2.4). This followed the previously signed Joint Controllership Agreement among the partners involved in Task 4.1 of WP4 only. The ASCERTAIN Consortium, dedicated to developing open-access tools for healthcare pricing and value assessment, prioritizes data privacy.

The JCA defines that partners actively involved in data processing for specific project tasks act as joint controllers, sharing responsibility for handling personal data. It outlines each partner’s obligations, ensuring compliance with GDPR. The agreement aims to structure data processing responsibilities, considering the joint research purpose, data sharing, open access publication, and adherence to FAIR principles. It specifies which data is collected by whom, how it is shared, and the legal basis for processing (consent or legitimate interests). Data sharing is restricted to partners involved in the same tasks, with aggregated results shared on a common platform and in publications.

All joint controllers have committed to GDPR compliance, implementing necessary measures to protect data subject rights. The JCA also details procedures for managing data subject requests, processor usage, breach notifications, and data protection impact assessments. The final signing of the JCA successfully completed a task initiated at the beginning of 2024.

During the same period, an Open Access Policy was prepared within WP2. This policy was created to outline how the beneficiaries will make their research outputs and resources publicly available. It also establishes principles for sharing research data generated by the ASCERTAIN project, adhering to the FAIR (Findable, Accessible, Interoperable, Reusable) data principles. A dedicated webinar, open to all partners, was held in December.

ADVANCING THE ACCESS2MEDS FRAMEWORK

As part of our ongoing commitment to refining the ACCESS2MEDS Framework, we are continuously updating and improving it. These revisions enhance clarity and readability, strengthen key concepts, and ensure consistency in terminology, aligning with our glossary, which is also regularly updated.

A key focus is making the framework more accessible to all stakeholders by incorporating visual elements—such as graphs, tables, and infographics — alongside streamlined policy insights. Additionally, we are integrating model outputs within the ACCESS2MEDS Toolbox, addressing critical aspects such as pricing models, cost-effectiveness thresholds, and ‘connector’ variables to enhance usability across work packages.

These updates align with core European health values, including universality, equity, and sustainability, while reflecting ongoing developments in EU pharmaceutical legislation and policy frameworks. By reinforcing these connections and improving operationalization, the framework will become an even more robust tool for policy evaluation and decision-making in the pharmaceutical and medical device sectors.

PROGRESS IN DEVELOPING AN ACCESS-BASED PRICING MODEL FOR MEDICINAL PRODUCTS

WP4 has made significant progress in developing a new access-based pricing model for medicinal products. The ASCERTAIN pricing model is structured around the selection of relevant price determinants, i.e., individual components that—taken together—make up a price that aims to ensure access to effective new health technologies. Manufacturers, payers, and other healthcare decision-makers consider different determinants when defining (proposing, negotiating, and setting/regulating) a price for a new health technology. For any given intervention, different determinants for defining a price may become relevant, including some that are linked to the specific health technology.

Over the past six months, we conducted targeted literature reviews on individual price determinants, such as cost and value elements. These reviews have provided a solid foundation for developing a first version of the ASCERTAIN pricing model. Additionally, we continued the analysis of expert interviews that were conducted over the summer of 2024. These interviews have offered valuable insights from a range of stakeholders, including healthcare payers, healthcare professionals, patient organizations, researchers, industry, and investors.

A major milestone was achieved with the successful submission of the first deliverable of this work package. This report describes the research conducted so far and outlines the key principles for the ASCERTAIN access-based pricing model. The deliverable marks a significant step forward in our mission to develop pricing models that balance innovation with patient access.bility, we aim to ensure that health data is managed ethically and securely. This not only builds trust with patients and stakeholders but also paves the way for groundbreaking advancements in health technologies that are both accessible and affordable.

SINGLE-ARM TRIALS AND STRUCTURED EXPERT ELICITATION (SEE)

The evaluation of cost-effectiveness analyses in WP5 relies heavily on documentation based on single-arm trials. Therefore, we started working on how to document the control arm for these settings. This resulted in our first deliverable for WP5 on methods to establish a comparator in non-RCT data and on the use of expert opinion to reduce uncertainty. A report was successfully submitted in November.

The content of the report focused on the use of structured expert elicitation (SEE) as documentation in HTAs, more specifically in cost-effectiveness analysis. SEE is a valuable method to address data gaps and uncertainties, particularly in economic evaluations where traditional evidence may be limited or unavailable. In the report, we describe the SEE frameworks and tools in combination with a systematic review on applications of SEE in cost-effectiveness analyses. SEE is used as a method in use cases in WP5; therefore, a description of the method and an overview of available applications are of great value in the following work. Based on the report, we will shortly submit a scientific paper on the systematic review.

We have also started a new SEE data collection for a different indication, exploring methodological, practical, and technical features of the SEE framework. SEE interviews are being collected, and we are currently planning for a consensus meeting.

ADVANCING FLEXIBLE AND DYNAMIC REIMBURSEMENT MODELS

Work Package 6 continues to expand the scope of reimbursement frameworks, developing dynamic and cyclic reimbursement procedures that incorporate innovative cost-effectiveness threshold (CET) models to better reflect societal values and patient needs. Building on previous scoping reviews, this phase introduces flexible thresholds that adapt to disease- and patient-specific characteristics, broader societal considerations, and country-specific preferences.

A key component of this work is gathering insights from diverse stakeholders—including patients, citizens, policymakers, healthcare professionals, and insurers—through multi-stakeholder surveys and preference elicitation studies conducted across multiple European countries. These studies explore how value-for-money assessments can be refined to align with evolving health system priorities and societal expectations.

A major step in the next phase for the ASCERTAIN preference study was a series of focus groups held two weeks ago, where participants from the general population shared their views on reimbursing costly, innovative medical treatments. The discussions tackled a fundamental question: When is society willing to pay for expensive new treatments—and when not? Key themes included:

Ethical, economic, and societal factors that should influence reimbursement decisions;
Balancing healthcare budgets with patient access to high-cost treatments;
Broader perspectives on whether healthcare costs should have defined limits.

Participants highlighted the complexity of these decisions, emphasizing that funding choices should not be based solely on economic calculations but must also reflect ethical values and societal priorities. Ensuring sustainability and fairness in healthcare requires continuous engagement with the public, ensuring that decision-making processes align with societal expectations and democratic principles.

Initial findings, drawn from 100 European participants in a multi-stakeholder survey, indicate strong support for expanding cost-effectiveness assessments beyond traditional economic factors. By incorporating patient experiences, societal willingness-to-pay, and ethical considerations into cost-effectiveness threshold frameworks, WP6 aims to establish context-sensitive and adaptable reimbursement strategies. The next phase will refine attribute levels using data from focus groups, literature reviews, and real-world case studies, ensuring a more representative and inclusive approach to pricing and reimbursement decisions. These efforts will contribute to enhancing the ACCESS2MEDS Toolbox, strengthening its ability to support policymakers in designing sustainable, equitable, and transparent health technology reimbursement frameworks.

HOW ASCERTAIN IS INCLUDING THE PATIENT PERSPECTIVE

Patient engagement in research projects with a health policy focus helps ensure that research outcomes align with the views and needs of patients, the ultimate beneficiaries of the tools such projects seek to develop. ASCERTAIN is committed to this principle by giving patients an active and meaningful role in the project from the very beginning.

This is achieved through several means, including the involvement of a European patient organisation, Myeloma Patients Europe (MPE), as a partner in the consortium, actively seeking patient feedback on various research tasks, and including representatives of multiple patient organizations in the project’s Advisory Board.

MPE, an organisation representing the interests of patients with a rare type of blood cancer, multiple myeloma, is involved in nearly all ASCERTAIN work packages. Their role is to promote patient understanding and gather feedback from patients and patient advocates on project results. Additionally, patients and patient advocates at national and European levels can provide their perspectives on pricing, cost-effectiveness, and reimbursement through surveys, interviews, and focus groups. They will also be invited to review ASCERTAIN’s key deliverables, including policy tools and the overarching framework.

Finally, the Advisory Board, which oversees the project’s progress throughout its duration, includes representatives from various patient organizations, such as PNH Global Alliance, Inspire2Live, and the European Sickle Cell Federation, alongside stakeholders from other relevant groups.

If you’re interested in learning more about patient engagement in ASCERTAIN or getting involved, contact us at contact@access2meds.eu.

Note: PNH refers to Paroxysmal Nocturnal Hemoglobinuria.

“3 Things About Market Access” – Transcript

“3 Things About Tiered Pricing” – Transcript

“3 Things About Pricing Of New Drugs” – Transcript

“3 Things About Reimbursement” – Transcript

“3 Things About Cost-Effectiveness” – Transcript

“3 Things About Value of New Cancer Drugs” – Transcript

EHA2025 Congress

Join partners for the 30th EHA Congress, taking place in Milan!

12.-15. June 2025

More info

ISPOR EUROPE 2025

Join partners from the ASCERTAIN project at ISPOR in Glasgow!

09.-12. November 2025

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Der Beitrag ASCERTAIN NEWSLETTER 4 erschien zuerst auf ASCERTAIN.

ASCERTAIN NEWSLETTER 3

Lena Jessen — Tue, 10 Sep 2024 12:52:54 +0000

Dear readers,

At the 4th ASCERTAIN Consortium meeting, held during the European Hematology Association (EHA) Congress in Madrid, we reached an important milestone by presenting 1.5 years of progress to our international advisory board. Our discussions centered around key findings from our scoping reviews and stakeholder inputs on health technology assessments (HTA), pricing, reimbursement, and policy considerations that impact patient access to innovative therapies.

Our consortium delved deeply into the critical issue of fair pricing, exploring innovative valuation methods, especially in single-arm trials. We discussed incorporating the cost of capital and failure rates into R&D expenses and emphasized the need for transparent, adaptable pricing models. The meeting also highlighted the importance of new cost-effectiveness and budget impact models, particularly in light of the evolving EU HTA regulation.

With our policy decision-making tool, ASCERTAIN aims to promote innovation, enhance patient access, and foster sustainable healthcare planning. By testing these tools in areas like precision cancer medicine and CAR-T cell therapies, we plan to provide user-friendly, cloud-based solutions that adhere to open science principles. As we move forward, collaboration and transparency will continue to guide us in advancing equitable access to health technologies worldwide.

In this newsletter, you will find more details on our progress.

Enjoy reading this newsletter!

Your ASCERTAIN team

CONNECTING STAKEHOLDERS FOR BETTER CANCER CARE

What motivated you to start Inspire2Live, and what are its core goals?

Peter: Inspire2Live was founded in 2010 with the aim of connecting patients, researchers, and clinicians to benefit cancer patients and improve the quality of life for patients and their loved ones globally.

How do you connect patients, researchers, and clinicians to foster collaboration and improve cancer treatment and care?

Peter: We are a global network organization with approximately 100 advocates representing all stakeholders in the medical-industrial complex: patients, researchers, clinicians, industry, government, and regulators. We select them based on the topic and their expertise in the initiatives we want to start. These initiatives always contribute to the global patient community and their loved ones. We’re now represented in 42 countries, soon to be 43 with the addition of the Filipinos, including Kenya, Ghana, Nigeria, Argentina, and Brazil.

What strategies do you find most effective in advocating for patients within the healthcare system?

Peter: Cooperation in an open, fair, and equal atmosphere is definitely the most effective. We’re all equal and critical in our conversations. We are all convinced that science is the foundation, and emotions drive us with persistence.

What is your role as an ethical advisor in ASCERTAIN?

Peter: I want to contribute with the attitude: ‘If it’s about us, not without us.’ We are dealing with the interests and risks that patients face. In that situation, it is unethical not to work with patients and not to ask for their opinions. It is unethical when decisions are made without patients. I want to emphasize that and, of course, motivate that.

How do you envision the future of patient advocacy and its impact on healthcare innovation through projects like ASCERTAIN?

Peter: Advocacy, in cooperation with other stakeholders, will drive progress and make a difference. If we truly want healthcare to be patient-focused, we must work with patients and involve them in the decision-making process. ASCERTAIN is important in this process, and in my experience, it works. I sense an open, fair, and equal atmosphere in the project. That will make the difference.

For more information on Inspire2Live please visit www.inspire2live.org

CONSORTIUM MEETING IN MADRID

Throughout three days from June 12th to 14th, the ASCERTAIN Consortium convened in Madrid to advance its project goals and engage with stakeholders. The Consortium Meeting took place during the EHA Congress, which attracted over 18,000 participants from across the healthcare value chain, enhancing visibility and networking opportunities for ASCERTAIN members.

The first day of the meeting focused on exchanging knowledge and incorporating feedback from the Advisory Board members, the Ethics Advisor, and the coordinator of the Horizon Europe project, HI-PRIX. The group discussed key developments in the pharmaceutical and medical device sectors, as well as findings from scoping reviews related to pricing, cost-effectiveness, and reimbursement of innovative health technologies. The participants also explored the development of fair pricing models and structured expert elicitation in cost-effectiveness analysis.

On the second day, the consortium held work package presentations and workshops to further plan project activities. The third day featured the participation of the consortium in the EHA-Patient Joint Symposium at the EHA Congress, which included two panel discussions on unmet medical needs and fair pricing of new medicines in haematology. Consortium and Advisory Board members, including Project Coordinator Carin Uyl-de Groot, Frank Leebeek (EHA), Maximilian Salcher-Konrad (GOEG), and Maria Piggin (PNH Global Alliance), served as panellists in the second panel.

Highlighting the importance of collaboration between different initiatives, Carmen Sanges, member of the Advisory Board and part of the coordination team of the T2EVOLVE Horizon Europe Project said: “The T2EVOLVE consortium is primarily focused on accelerating the development and accessibility of CAR-T therapy across Europe. What I’d really like to see from ASCERTAIN is a synergistic approach in HTA and reimbursement schemes, particularly in collaboration with T2EVOLVE and others. Now is the time for collaboration across Europe, as we aim to harmonise efforts.”

Photo: OptiMedis

CHECK OUT OUR NEW PROJECT BROCHURE

In this brochure, we highlight ASCERTAIN’s methodology for creating sustainable health technologies and its impact on key stakeholders in healthcare. Dive into the innovative approaches we are taking to revolutionize healthcare access and outcomes.

Click here to read the brochure

EXPLORING PERSPECTIVES ON FAIR PRICING OF PHARMACEUTICALS

Building on efforts reviewing the literature on pricing models for new health technologies over the past year, WP4 dove deeper into understanding the key concepts of fair pricing for pharmaceuticals. Over the past couple of months, the WP4 team conducted a series of expert interviews with payers, health care professionals, patient experts, HTA bodies, researchers, industry, and investors from across Europe. These interviews provided valuable insights into how different stakeholders perceive fair pricing, highlighting the diverse considerations to balance innovation and affordable patient access. Additionally, we consulted with the ASCERTAIN advisory board to identify key aspects of fair pricing that should be prioritised in our research. This consultation was instrumental in refining our approach and ensuring that our work remains relevant for the needs of decision makers.

Findings from literature reviews as well as early findings from expert interviews were shared and discussed at the ASCERTAIN consortium meeting in June, fostering a collaborative environment for further exploration and refinement of our ideas. Moreover, we had the opportunity to present the results of our review on fair pricing at two scientific conferences: the EHA Congress 2024 in Madrid and EuHEA 2024 in Vienna. These presentations not only showcased our progress but also facilitated valuable feedback and discussions with the wider scientific community, helping to shape the future direction of our research.

INSIGHTS FROM SITE VISITS IN NORWAY

Stakeholder feedback from the CONNECT group and the Norwegian Medical Products Agency

On April 12th, PhD student Yansi Wu at the University of Oslo (ASCERTAIN Work Package 5) presented initial findings from our Structured Expert Elicitation (SEE) project to the CONNECT group. CONNECT is a public-private consortium aimed at driving the implementations of precision cancer medicine (PCM) by addressing key obstacles (e.g., single-arm trials) and piloting novel solutions (e.g., SEE). This meeting unites representative stakeholders from the Norwegian university hospitals, pharmaceutical and technology companies (Association of Pharmaceutical Industry in Norway), patient organizations (the Norwegian Cancer Society), and the Norwegian HTA agency (the Norwegian Medical Products Agency).The study was partly funded by CONNECT and is a collaboration with Oslo Economics.

During this meeting, Yansi shared findings from ASCERTAIN’s exploration into the use ofSEE in evaluating the cost-effectiveness of selpercatinib for non-small cell lung cancer (NSCLC) patients in Norway. Given an increasing reliance on single-arm trials within PCM, SEE holds potential in offering alternative methodologies of effectiveness evaluation, an endeavor that could significantly impact decision-making processes within PCM. The presentation focused on SEE as a viable tool in the pilot case of selpercatinb for NSCLC and its potential to aid healthcare economic evaluations.

We received invaluable feedback and suggestions from the patient representatives, the industry, and the HTA agency. The patient organizations were concerned about the transparency and credibility of SEE. They were particularly interested in understanding which experts contribute to our elicitations, how these individuals are selected, and their levels of expertise. This insight encourages us to ensure that our SEE framework is both open and structured to earn trust and support from patient groups eagerly awaiting new PCMs.

Similarly, the industry and the HTA agency showed great interest in the structural integrity and validity of the model we presented. They sought clarity on the conclusions drawn from our project and were curious about SEE’s potential role in real-world applications. Their perspective is crucial as they prioritize tangible outputs that can influence healthcare decision-makings.

Overall, aligned with the overarching goal of the ASCERTAIN project, the CONNECT meeting was a cornerstone event for gaining direct input from diverse stakeholders. It offered us diverse perspectives on how to tailor further development of our project to meet the needs and expectations from the industries, HTA agencies, and patent groups.

Decision-makers, mingling and productive discussions – our site visit to DMP

Stakeholder engagement visit to the Norwegian Medical Products Agency on May 2nd, 2024
ASCERTAIN aims to meet the needs of patients, physicians, manufacturers, regulators, and payers. A recent site visit to the Norwegian Medical Products Agency (DMP – Direktoratet for medisinske produkter) provided a great opportunity for the Oslo team to exchange knowledge with health authorities and decision-making stakeholders on their needs and perspectives on our project.

The afternoon started with mingling followed by an introductory round of all participants from DMP, the Norwegian Hospital Procurement Trust (NHPT), and the ASCERTAIN team from the University of Oslo. Afterwards, DMP and NHPT presented their organizational structure and gave a brief spotlight on some of their recent work with clinical subgroups in assessments. Eline Aas then gave a general introduction to the ASCERTAIN project and to the specific tasks conducted by the Oslo team. She introduced the concept of use cases, which was then illustrated in presentations by two of ASCERTAIN’s PhD students in Oslo. First, Pia Henkel presented her project on next-generation sequencing-based diagnostics in oncology. Subsequently, Yansi Wu presented his project on structured expert elicitation and single-arm trials applied to non-small cell lung cancer. Especially the timing of the expert elicitation assessment sparked a lively discussion on the challenges related to single-arm trials in health technology assessment. Our presentations were rounded off by Emily Burger, who introduced our quality assurance framework for ASCERTAIN cost-effectiveness modeling. Based on previously sent-out questions, the audience then shared their thoughts on the needs and challenges of assessing innovative health technologies, and on the concept of global models.

Our two main takeaways from this discussion are as follows. First, improving access, one of ASCERTAIN’s main objectives, was not always understood as access to products, but also as access to high-quality decisions. Second, the idea of global models was perceived positively, especially when enabling decision-makers to work with data inputs rather than finished models. Overall, we received both critical and encouraging feedback on our work. The productive discussions helped us to better understand the perspective of healthcare decision-makers and payers involved in health technology assessment. As such, we aim to conduct more of these visits and discussions with decision-makers in other countries, and continuously implement their insights into our work.

Photo: Emily Burger

DEALING WITH DATA MANAGEMENT AND COMPLIANCE IN ASCERTAIN: ETHICAL AND SECURE DATA USE IN HEALTH RESEARCH

Effective data management is a cornerstone of modern health research, especially when addressing privacy and compliance with ethical standards. In the digital health ecosystem, where data flows rapidly and innovations are constantly emerging, ASCERTAIN is committed to ensuring that data handling is both ethical and secure. Our mission to improve the affordability and accessibility of innovative health technologies in Europe is underpinned by rigorous data management practices that adhere to EU Ethics and Data Protection guidelines, including the GDPR (General Data Protection Regulation), which harmonizes data privacy laws across Europe.

The Importance of Ethical Data Management

Ethical data management is not just a regulatory requirement but a moral obligation. It ensures that patients’ sensitive health information is treated with the utmost respect and confidentiality. Within ASCERTAIN, we prioritize the dignity and rights of individuals by implementing strict protocols for data collection, storage, and analysis. These protocols are designed to safeguard personal data, ensuring that it is used solely for the intended research purposes and that individuals’ privacy is never compromised.

Adhering to EU Data Protection Regulation

The GDPR, officially known as REGULATION (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement, has been applicable across all EU member states since May 25, 2018, and sets the standard for data protection in Europe. At ASCERTAIN, compliance with GDPR is integral to our operations. We ensure that all personal data is processed lawfully, transparently, and for a specific purpose. Consent from data subjects is obtained whenever required, and they are informed about how their data will be used, stored, and shared.

Our legal consortium partners provide continuous assistance to ensure that the collection and further processing of personal data for the purposes of the research and innovation action remain at all times compliant with the provisions of the GDPR and applicable national data protection laws, especially with regard to data storage and transmission, automated processing, de-identification methods, access restrictions, and technical and organizational security measures.

Data Sources:

Interviews and questionnaires
Cancer registries
Medical records
Literature reviews

To protect individuals’ privacy, data used in the project is de-identified and aggregated.

Ensuring Secure Data Sharing and Analysis

Data sharing is vital for advancing health research but must be done securely. ASCERTAIN employs state-of-the-art encryption methods to protect data during transmission and storage. Our data management systems are designed with multiple layers of security to prevent unauthorized access and ensure data integrity.

When sharing data with research partners or stakeholders, we use secure channels and ensure that all parties adhere to the same stringent data protection standards. Data sharing agreements clearly outline the responsibilities of each party and the protective measures to be taken.

Fostering a Culture of Responsibility

Beyond technical measures, fostering a culture of responsibility among the team members is crucial. This ensures that everyone involved in the project understands their role in maintaining data security and upholding ethical standards.

Conclusion

In the fast-evolving digital health ecosystem, the ASCERTAIN project is committed to navigating the complexities of data management and compliance with diligence. By adhering to EU Ethics and Data Protection guidelines, implementing robust security measures, and fostering a culture of responsibility, we aim to ensure that health data is managed ethically and securely. This not only builds trust with patients and stakeholders but also paves the way for groundbreaking advancements in health technologies that are both accessible and affordable.

INITIATING DEVELOPMENT OF THE ASCERTAIN POLICY SUPPORT TOOL: A PATH TOWARDS INCLUSIVE AND EFFECTIVE HEALTHCARE INNOVATIONS

The ASCERTAIN project stands at the forefront of addressing critical healthcare challenges in Europe. By focusing on affordability, accessibility, and sustainability of innovative health technologies, ASCERTAIN seeks to create a balanced ecosystem that benefits patients, healthcare providers, payers, regulators, and manufacturers alike. One of the pivotal components of this project is the development of the ASCERTAIN Policy Support Tool (PST), which aims to revolutionize healthcare decision-making processes through advanced data analytics, data modelling, and user-friendly interfaces.

Setting the Stage for Development

Our journey towards creating the ASCERTAIN Policy Support Tool begins with a comprehensive requirements analysis phase. This phase is crucial as it ensures that the tool will meet the diverse needs of all stakeholders involved. Stakeholder analysis and user story development are integral parts of this phase, capturing the goals, desired outcomes, and expectations from various user groups. In our requirement analysis process, we examine several critical components to ensure a comprehensive understanding of the project. We start by assessing the functionality and features, such as login systems and data input forms, followed by evaluating the user interface (UI) and user experience (UX) design to ensure a seamless and accessible user journey. Our review includes the technological stack, focusing on both front-end and back-end technologies, and we scrutinize security measures like encryption and authentication (where required). Performance and scalability are tested to ensure the website handles traffic efficiently. Additionally, we check for compliance with industry standards such as GDPR regulations. During this initial analysis phase, we gather valuable feedback from partners within the consortium to refine our approach. Later stages and beta releases will involve external evaluators to further enhance the project’s effectiveness and user satisfaction.

Fast Prototyping for Visual Understanding

Adopting a fast prototyping principle, we aim to create visual representations of our progress and gather feedback continuously. This approach will help us refine the tool iteratively, ensuring it aligns with user expectations and technical feasibility. The first Use Case we focus on is the development of the Fair Pricing Calculator to help stakeholders calculate a fair price for medicines, considering factors like R&D costs, market competition, production costs, and therapeutic value. It will enable users to estimate medicine prices and compare them to current or negotiated prices. The tool will focus on transparency in R&D costs, innovation, and pricing mechanisms, and include options for adjusting prices by country based on purchasing power.

A Collaborative Effort

The development of the ASCERTAIN tool is a collaborative effort. Our multidisciplinary consortium, complemented by an international advisory board, will co-create the policy-supporting tools. This collaborative approach ensures that the tools developed are relevant, effective, and practical for real-world applications.

Future Steps

As we move forward, the next steps include the iterative development of the tool’s frontend and backend, rigorous evaluation of the models and functionalities, and consecutive refinement based on user feedback. The ultimate goal is to create a publicly accessible, web-based ASCERTAIN PST that supports data storage, visualization, and interactive analysis, thereby empowering stakeholders to make informed and effective healthcare decisions.

By meticulously analyzing stakeholder requirements and leveraging advanced technologies, we are on the path to creating a tool that will significantly improve decision-making in healthcare policy and practice. Stay tuned as we continue to make strides in this exciting journey towards a more affordable, accessible, and sustainable healthcare system.

Image: Nuromedia

European Public Health Week: GÖG-Colloquium

Greener pharmaceuticals: policies for an environmentally sustainable pharmaceutical system.

Erasmus University Rotterdam Interviews Carin Uyl-de Groot on ASCERTAIN

“Everyone is entitled to the best treatment, no matter where you live”

Presentation of AIM’s Fair Price Model to the Belgian Parliament

Solidaris closes its petition for fair drug prices with more than 50,000 signatures.

EAA Spring Convention: Discussions on EU Market Access

The EAA Spring Convention, themed ‘Finding the Right Balance,’ was held at Erasmus Universiteit Rotterdam.

ISPOR Europe 2024

Join global healthcare leaders as they convene at ISPOR Europe 2024, the leading global conference in Europe for Health Economics and Outcomes Research (HEOR), 17 -20 November, for discussion and dissemination of the latest trends in healthcare. This must-attend event provides you with dedicated opportunities to network with your peers, HEOR experts, and thought leaders and to discuss with a global audience how we establish, incentivize, and share value sustainable for health systems, patients, and technology developers.

17 – 20 November 2024

More info

Der Beitrag ASCERTAIN NEWSLETTER 3 erschien zuerst auf ASCERTAIN.

ASCERTAIN NEWSLETTER 2

Lena Jessen — Wed, 27 Mar 2024 09:50:48 +0000

Dear readers,

Six months have passed since our last newsletter, and a lot has happened.

In this second issue of the ASCERTAIN newsletter, we are pleased to present an interview with Maria Piggin, founder and chair of the PNH Global Alliance. Maria Piggin talks about the Alliance’s mission and the challenges faced by patients with rare diseases such as paroxysmal nocturnal haemoglobinuria (PNH). Their commitment to patients highlights the urgent need for affordable and sustainable healthcare solutions.

We are also pleased to present our animated video! Discover ASCERTAIN innovative approach to tackling inequalities in access to health technologies. Learn how ASCERTAIN seeks to improve affordability and sustainability while fostering innovation and addressing environmental impacts.

Meet our Advisory Board shines a spotlight on the diverse group of experts leading the ASCERTAIN project. Their collective expertise and insights are invaluable as we work to develop innovative models for accessibility and equity in healthcare.

In our Updates on our work section, we provide a comprehensive overview of the latest developments and milestones of the ASCERTAIN project. From setting the agenda at our consortium meeting to advancing precision medicine and addressing inequalities in access to next-generation sequencing tests, we are making great progress towards our goals.

Learn more about our latest webinar on the fundamentals of drug pricing in Europe. Find out about the processes and policies that influence the pricing of medicines and their impact on patients and healthcare systems.

In the News & Events section you will find a review of ISPOR 2023 and the 6th European CAR T-CELL Meeting. You can also find out which events we will be attending next.

Enjoy reading this newsletter and happy Easter!

Your ASCERTAIN team

ADVOCATING FOR ACCESS: MARIA PIGGIN DISCUSSES THE MISSION OF THE PNH GLOBAL ALLIANCE

What does the PNH Global Alliance do?

Maria Piggin: It is a non-profit organisation that brings together 9 PNH patient groups from 8 different countries across the globe with a shared vision for PNH patients globally to have access to optimal care and treatment, achieved through collectively advocating on behalf of all PNH patients with various stakeholders. We also lobby relevant stakeholders to assist individual patients where we can with access to treatment or trials and provide guidance and support to patients in countries where no patient organisations exist.

Can you share your personal experiences or the experiences of those you represent about the impact of high drug prices in the treatment of PNH?

Maria Piggin: My homeland of New Zealand is one of approximately 80% of countries which does not currently have access to available effective treatments for PNH due to their prohibitive cost. I was lucky that my dual citizenship in the UK meant I could access PNH treatment once this became necessary however this is a privilege most are not afforded. Untreated PNH has a risk of death or serious life-changing complications. Very soon, some PNH patients will be taking a tablet twice a day whilst others continue to be at risk of death without access to any effective treatments.

To what extent do you believe that affordable access to innovative therapies can significantly improve the lives of PNH patients and their families?

Maria Piggin: It is more than a belief, it is a fact. Untreated PNH patients are at high risk of blood clots and other serious life-changing complications. The improved quality of life of patients treated with innovative PNH therapies (of which there are 3 licensed in Europe and 4 licensed in the US not including biosimilars) also expands to the quality of life of their carers and families. It enables both patients and carers to start working (or work more), start studying or take on caring responsibilities for dependants and therefore reduce the burden on the healthcare system and the State to support them.

Why do you participate in ASCERTAIN as an advisory board member?

Maria Piggin: Representation by the PNH Global Alliance on ASCERTAIN was important to bring the perspectives of those with our ultra-rare disease which is in a privileged situation i.e. with a number of licensed innovative treatments (as well as biosimilars) and more in development but which treatments are only available to few patients globally due to the prohibitive cost and no clear solution for this situation to change anytime soon. Therefore, the need for new models of pricing is imperative for the PNH global patient community.

What actions or changes do you think could help improve access to life-saving treatments for rare diseases like PNH?

Maria Piggin: New pricing models are welcome as well as systemic revision of the medicines licensing and health technology assessment (HTA) processes to ensure there is affordable and sustainable access to innovative medicines for patients. I look forward to the outcomes of the ASCERTAIN project.

For more information on PNH Global Alliance please visit www.pnhglobalalliance.org

MEET OUR ADVISORY BOARD

The ASCERTAIN Advisory Board comprises a diverse group of experts from various sectors of the healthcare industry, including patient advocacy, academia, pharmaceutical industry, and policy-making. Their collective expertise and insights contribute to guiding the ASCERTAIN project towards achieving its objectives of developing innovative models for healthcare accessibility and equity. With backgrounds spanning patient advocacy, medical research, healthcare policy, and investment, the Advisory Board members bring a wealth of experience and perspectives to the table. Through collaboration and strategic guidance, they play a crucial role in shaping the direction of the project, ensuring that it remains relevant, impactful, and aligned with the needs of stakeholders across the healthcare ecosystem.

Antonella Cardone emphasizes, “Accessibility and time to access innovative treatments for cancer patients means more than quality of life. It means surviving or not a cancer diagnosis.” Yannis Natsis highlights the urgency, stating, “ASCERTAIN is about one of the elephants in the room: the high prices of some new treatments. It is encouraging that ASCERTAIN will test ways and foster some creative thinking to help better prepare us for what is coming our way.”

Get to know all advisory board members here.

WATCH OUR ANIMATED VIDEO ABOUT THE PROJECT

Discover how ASCERTAIN is tackling inequalities in access to healthcare technologies with our latest animated video and listen to Carin Uyl-de Groot! Learn about the project’s mission to improve affordability and sustainability while promoting innovation and considering environmental impacts.

Click here to watch the video on YouTube.

SETTING THE AGENDA: CONSORTIUM MEETING IN JANUARY 2024

The ASCERTAIN Consortium met online on January 16-17 to advance project work and discuss key findings. Participants included ASCERTAIN’s Advisory Board, European Commission representatives, and various stakeholders. Highlights of the meeting included a keynote by Yannis Natsis on the EU pharmaceutical revision, insights from a fair pricing review, updates on the ACCESS2MEDS Framework, and findings from scoping reviews on pricing methods.

During discussions on pricing methods for new health technologies, participants emphasized the need for fairness and effectiveness. They highlighted the oversight of not considering the cost of capital in pricing equations and suggested integrating it into research and development (R&D) costs. Additionally, there were discussions on capturing the long-term value of curative treatments and the importance of adopting a lifetime approach to pricing models.

The conversation then shifted to cost-effectiveness and budget impact models, with a focus on mandatory trial updates and incorporating additional data under new EU Health Technology Assessment (HTA) regulations. Participants also discussed optimizing pricing models to reduce complexity and increase transparency, emphasizing collaboration and transparency to achieve equitable access and fair pricing worldwide.

Concerns about medical device availability and pricing were addressed, with calls for safety and transparency in product evaluation. Participants agreed on the importance of viewing medicines as global public goods, stressing equitable access and fair pricing. In conclusion, the discussions underscored the multifaceted nature of pricing methods and the importance of ongoing dialogue and collaboration to develop fair, transparent, and effective pricing models for innovative health technologies.

The meeting highlighted the critical need for ongoing dialogue, collaboration, and transparency to ensure fair and effective pricing models for innovative health technologies, ultimately striving for equitable access and improved healthcare outcomes.

We are currently reviewing and analysing the literature on these topics, as well as conducting interviews regarding fair pricing. The initial results will be shared with our Advisory Board in June at the EHA2024 Hybrid Congress!

EXPLORING FAIR PRICING IN HEALTHCARE TECHNOLOGIES

As part of a multi-step approach to developing new pricing models in this Work Package, we reviewed how others have previously defined “fair pricing” for health technologies. We found four core themes that were commonly included in existing definitions of fair pricing for new pharmaceuticals: prices should be affordable to health systems and patients, linked to the costs for developing and producing them, reflect value, and provide companies with appropriate profits. While these core themes were common across existing definitions, we noticed that stakeholder groups, such as health care payers, patient organizations, and industry, among others, emphasized different aspects. Notably, factoring the environmental impacts of health technologies into pricing was not mentioned in any of the definitions.

Another important finding was that none of the definitions focused on fair pricing for medical devices. This lack of definitions suggests that more work is needed to understand how prices for specific devices are derived and perceived, and how they impact on health systems and patient access to these technologies. In ASCERTAIN, we will focus on pricing for a specific type of in-vitro diagnostic devices, next-generation sequencing.

The review findings were presented as a poster at ISPOR Europe in Copenhagen on 14 November 2023 and the abstract was published in the conference supplement in Value in Health.

BASICS OF MEDICINES PRICING IN EUROPE

On 7th of March 2024 Myeloma Patients Europe (MPE) held an introductory webinar on the topic of medicine pricing in Europe. The main speaker was Sabine Vogler, Director of the WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies and Head of Pharmacoeconomics Department, Austrian National Public Health Institute. The webinar provided foundational knowledge on the basics of drug pricing (with a focus on high-cost branded medicines) and the processes and policies that influence it. Aimed at patients, patient advocates and the general public, the presentation was given in accessible language with clear real-world examples.

The webinar gathered high interest, with 152 registered participants and 82 unique viewers. Questions from the audience focused on pricing models used by European countries and the implications for rare diseases, cooperation among EU Member States and the role of the EU in pricing and reimbursement practices. The feedback received after the webinar was very positive with participants appreciating the clarity of the explanations. The event was live for registered participants but was also recorded and disseminated by MPE, ASCERTAIN and other partners.

The webinar forms part of a wider engagement strategy for ASCERTAIN, designed to inform and involve patients, patient advocates and other relevant stakeholders in the project. The next topic of focus will be a webinar on the EU HTA regulation and the implications for patients across Europe. Please message racovita@mpeurope.org if you have any questions!

Click here to watch the webinar on YouTube.

ADVANCING PRECISION MEDICINE: FRAMEWORK DEVELOPMENT AND EXPERT ELICITATION

We are currently working on developing a general framework for WP5. The framework includes building blocks, pilot model analyses, and a quality assurance framework for the three Use Cases: precision cancer medicine, gene/cell therapy, and whole genome sequencing. These will ultimately inform and guide the development of the three global models.

The building blocks and quality assurance framework that underpin the model development processes consist of several components relevant for all three Use Cases, such as data collection and management, standardization of coding practice, verification, and validation.

Pilot case selection and model development are currently underway. For example, we have selected the pilot case for the precision cancer medicine Use Case and are currently building a pilot model for precision cancer medicine with a single-arm trial design.

More specifically, we are evaluating the use of expert elicitation, following the framework suggested by Bojke et al (2022) to inform the relative treatment effect. The analysis is based on a phase 1/2 study LIBRETTO-001, including patients with RET-fusion positive non-small-cell lung cancer (NSCLC) treated with selperatinib (we are also doing a second analysis on RET-mutant thyroid cancer).

With co-funding and collaboration with the public-private network CONNECT and collaboration with Oslo Economics on conducting the interviews with clinicians, we are evaluating expert elicitation as a source of documentation in cost-effectiveness analysis (CEA).

The CEA results from the phase 1/2 study with expert elicitation will be compared and validated with the CEA results based on documentation from the phase 3 studies (LIBRETTO-431 and LIBRETTO-531). The phase 3 study was a randomized controlled trial enabling validation of the expert elicitation. We are currently working on the analyses.

ADDRESSING DISPARITIES IN ACCESS TO NEXT-GENERATION SEQUENCING (NGS)-BASED TESTS

Developing Flexible Models for Pricing, Cost-Effectiveness, and Reimbursement

Considering the relevant differences in pricing, health technology assessment (HTA), and reimbursement of pharmaceuticals and medical devices, including in vitro diagnostic (IVD) medical devices, the ASCERTAIN project aims to develop new flexible models for pricing, cost-effectiveness, and reimbursement that can contribute to the accessibility of different innovative technologies, as well as to health equity.

Identification and Selection Process

In the first year of the ASCERTAIN project, the identification and selection of medical devices applied in oncology (for use in WP5) were provided by targeted searches on relevant organisational websites (e.g., regulatory bodies like the FDA, HTA bodies, notified bodies), scientific literature (systematic reviews and clinical guidelines), and grey literature. This process included the involvement of different stakeholder organisations at the EU level (patient organisations, HTA bodies, healthcare providers, payers, and manufacturers), using online questionnaires or email correspondence, and discussion with clinical experts. The NGS-based tests, specifically the whole group of Targeted panel sequencing tests, were selected as IVD medical devices, including companion diagnostics, in indications related to solid tumors (e.g., colorectal cancer) and hematologic malignancies (e.g., acute leukemia/myelodysplasia).

Assessment and Recognition of Benefits

Currently, an appropriate, fit-for-purpose assessment framework for such tests is lacking. However, different potential benefits of the NGS-based tests are recognized, such as delivering the right treatment for the right patients, delivering benefits to healthcare systems and payers, as well as broader societal impact (e.g., added value of knowing for patients, relatives, and the community; more efficient use of healthcare system resources; helping direct future areas of research).

Challenges in Availability and Reimbursement

In many European countries, there are restrictions on the availability and reimbursement of such tests. In 2021, the uptake of NGS-based tests is highly varied, ranging from 0% in Slovakia to more than 50% in Denmark and the Netherlands. Additionally, in several countries, there is no link between precision medicine and matched biomarker test approval.

Future Directions

With this in mind, ASCERTAIN partners will develop appropriate flexible HTA frameworks and generalizable pricing and reimbursement models that enable country-specific adaptations. These models will reflect the various stakeholder perspectives involved in the adoption of NGS-based tests in the healthcare system.

ENHANCING DATA SECURITY MEASURES

During recent months we have dedicated efforts to collecting data across various tasks and ensuring the security of the infrastructure responsible for hosting and processing this data for the project’s objectives. Numerous calls were conducted with partners to develop distinct data flow diagrams and assist them in correctly completing them.

In addition to these efforts, several meetings were held to initiate the definition of the architecture and technical security measures for the infrastructure crucial for upcoming project developments.

Subsequently, following discussions with the EUR Data Steward and upon request from the EUR ethical committee, an updated (intermediate) version of the Data Management Plan was released in January 2024. This version contains the latest updates relevant to the progress of the project.

ASCERTAIN at the 6th European CAR T-Cell Meeting in Valencia

A catalyst for collaborative advances in cancer immunotherapy.

ASCERTAIN at ISPOR 2023 in Copenhagen

Navigating Challenges in Health Economics and Outcomes Research

EAA SPRING COVENTION

Join partners from ASCERTAIN project the EAA SPRING CONVENTION 2024 in Rotterdam.

18 – 19 April 2024

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5TH PPRI CONFERENCE

Ensuring access to affordable medicines through innovative policies

Organisers: WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies, Pharmacoeconomics Department at the Austrian National Public Health Institute (Gesundheit Österreich GmbH)

25 – 26 April 2024 in Vienna

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Der Beitrag ASCERTAIN NEWSLETTER 2 erschien zuerst auf ASCERTAIN.