Based on this evidence, the paper outlines recommendations for improving pricing approaches and strengthening the evidence base for access-oriented pricing models. It also explains how ASCERTAIN is translating research findings and stakeholder perspectives into the development of an access-based pricing model that integrates both cost- and value-based determinants.

The work was developed within ASCERTAIN Work Package 4 and led by Gesundheit Österreich GmbH, with contributions from partners across the consortium.

Read the full position paper here.

Der Beitrag New ASCERTAIN Position Paper on Pricing Innovative Health Technologies erschien zuerst auf ASCERTAIN.

What is a model?

The first video introduces health economic models. These are tools used to analyse information and compare different strategies when making decisions about healthcare interventions. The video explains how models help decision-makers assess costs, value for patients and health systems, affordability and broader societal impacts, including environmental considerations. It also shows who uses these models, from regulators and HTA agencies to companies, policymakers, and patient organisations.

Watch video on YouTube.

What is a framework?

The second video focuses on the ACCESS2MEDS framework developed within ASCERTAIN. It explains how a framework brings together different models for pricing, cost-effectiveness, and reimbursement into one structured approach. The video highlights how such frameworks support more consistent, transparent, and well-informed decision-making, particularly in the context of increasing pressure on public health budgets.

Watch video on YouTube.

The journey of a new medicine in the EU

The third video follows the journey of a new medicine from research and development to patient use. It explains the role of the European Medicines Agency, the scientific evaluation process, market authorisation at EU level and the national decisions on pricing and reimbursement that ultimately determine patient access in each country.

Watch video on YouTube.

All three videos are animated, easy to follow, and aimed at helping patients and the wider public better understand how decisions about medicines are made.

You can find these videos and more patient-focused resources on the ASCERTAIN website: https://www.access2meds.eu/for-patients/

Thanks to Myeloma Patients Europe for developing these videos.

Der Beitrag New ASCERTAIN video series explains how medicines are priced, evaluated and made available in Europe erschien zuerst auf ASCERTAIN.

The videos provide clear, accessible explanations of key concepts behind the economics of medicine pricing and reimbursement — making complex ideas understandable for everyone.

What is Reference Pricing?

Maureen Rutten-van Mölken explains how countries determine medicine prices by comparing them with those of similar medicines or across other countries. She highlights the two main approaches — external and internal reference pricing — and the consequences these systems can have for access to medicines, especially in lower-income countries.

Watch now on YouTube.

What is a List Price for a Medicine?

Maureen Rutten-van Mölken discusses why there is no single price for a medicine and what the term list price really means. The video sheds light on how list prices serve as a basis for negotiations and why the debate about making actual (discounted) prices transparent remains controversial.

Watch now on YouTube.

What is a Fair Price?

Carin Uyl-de Groot explores what makes a medicine price fair. Fair pricing means finding a balance: ensuring affordability and access for patients and health systems, while still allowing companies to earn enough to fund innovation and future medical breakthroughs. Pricing policies and regulation are crucial in maintaining this equilibrium.

Watch now on YouTube.

How Do Patients Influence Decisions on Medicine Access?

Carin Uyl-de Groot explains how patient perspectives are increasingly shaping decision-making — from the development of a medicine to its approval and reimbursement. Patient experience provides valuable insights into quality of life, treatment priorities, and real-world outcomes that help guide fairer, more informed access decisions.

Watch now on YouTube.

Thanks to Myeloma Patients Europe (MPE), Maureen Rutten-van Mölken, and Carin Uyl-de Groot for bringing this video series to life.

Der Beitrag New ASCERTAIN Video Series: How Are Medicines Priced and What Makes a Price Fair? erschien zuerst auf ASCERTAIN.

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

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ASCERTAIN Consortium Meeting in Oslo

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ASCERTAIN Website Now Available in 8 Languages

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ISPOR EUROPE 2025

Join partners from the ASCERTAIN project at ISPOR in Glasgow!

09.-12. November 2025

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 5 erschien zuerst auf ASCERTAIN.

Professor Eline Aas representing the ASCERTAIN project (Department of Health Management and Health Economics, University of Oslo, Norway) gave an overview of the ASCERTAIN projects where the is to develop open access models to improve access and affordability of innovative health technologies in Europe. The work in ASCERTAIN address several factors of relevance for the new HTA guidelines for Slovakia, where the work related to cost-effectiveness thresholds is of particular relevance.

Important reflections and contributions were provided by András Incze, Akceso Advisors, Switzerland, Professor Marcin Czech, Warsaw University of Technology Business School, Poland, Professor Zoltán Kaló, Center of Health Technology Assessment, Semmelweis University and Syreon Research Institute, Budapest, Hungary and Bertalan Németh, Syreon Research Institute and Katarína Fedorová, National Institute for Value and Technologies in Healthcare.

Der Beitrag Presentation of New HTA Methodological Guideline for Slovakia at the Ministry of Health erschien zuerst auf ASCERTAIN.

Setting the Stage: Why ASCERTAIN Matters

Carin Uyl-de Groot (Erasmus University Rotterdam) opened the meeting with an overview of ASCERTAIN’s mission: to build a public, cloud-based tool that supports fair and sustainable access to IHTs. She highlighted the financial strain on healthcare systems, unequal access across the EU, growing uncertainty in clinical evidence, and the environmental impact of new therapies. The project focuses on three use cases: Precision Cancer Medicine, Cell and Gene Therapy, and Next Generation Sequencing.

Pricing Models to Support Negotiations

Maximilian Salcher-Konrad (Gesundheit Österreich) and Anne Hendrickx (AIM) presented a pricing model combining cost-based elements (e.g. R&D, manufacturing) with value-based factors (e.g. clinical benefit, societal value). Their model, adaptable to different EU contexts, aims to support existing national processes. A key insight: treatment costs can vary significantly based on disease prevalence, a point illustrated through cancer drug scenarios.

Stakeholder Perspectives on Pricing

Contributions from stakeholder organizations enriched the dialogue:

• EAHP emphasized the need for transparent pricing and practical tools for procurement.
• IKK e.V. proposed using the ASCERTAIN model to inform initial benchmark pricing in Germany’s AMNOG process.
• EHA highlighted the growing affordability crisis, citing real-world examples of delayed patient access due to price disputes.

Global Cost-Effectiveness and Reimbursement Models

Eline Aas (University of Oslo) introduced scalable cost-effectiveness models tailored to two user groups: technical experts and decision-makers. Modular structures and flexible parameters were key features to support international use and adaptation.

Tom Belleman (Erasmus University Rotterdam) explained how ASCERTAIN’s reimbursement models will evaluate Managed Entry Agreements (MEAs). These finance- and outcome-based agreements aim to reduce uncertainty and align payment with real-world results.

HTA and Procurement: Practical Needs and Governance

Industry and public stakeholders shared operational perspectives:

• AbbVie Scandinavia advocated for modular tools that are simple and transparent, while noting challenges like confidentiality.
• NoMA (Norway’s HTA body) outlined the value of shared, open-source models for national and cross-border assessments.
• Sykehusinnkjøp stressed the importance of evolving prices based on post-launch data and called for MEAs that genuinely improve access.

ASCERTAIN Policy Support Tool: Designed for Real-World Use

Moritz Mumme and Pascal Wendel (OptiMedis) showcased the upcoming ASCERTAIN Policy Support Tool. Designed for both technical and non-technical users, the platform supports full or partial assessments using the project’s pricing, cost-effectiveness, and reimbursement models. Features include guided workflows, customizable sharing, parameter validation, and AI-assisted support.

Looking Ahead

The Oslo meeting reaffirmed ASCERTAIN’s commitment to transparency, collaboration, and practical impact. The consortium continues to refine its tools with input from diverse stakeholders and invites ongoing participation in user testing and co-creation.

Interested in joining our next development sprint? Contact us to get involved.

Der Beitrag ASCERTAIN Consortium Meeting in Oslo erschien zuerst auf ASCERTAIN.

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.

Der Beitrag ASCERTAIN Website Now Available in 8 Languages erschien zuerst auf ASCERTAIN.

This model, currently in development, builds on AIM’s Fair Pricing Calculator and is designed as a publicly available tool for payers, HTA bodies, healthcare professionals, industry, and patient representatives. Its goal is to balance patient access, the financial sustainability of health systems, and incentives for innovation.

Survey Details

• Deadline: 18 July 2025
• Duration: 10–15 minutes
• Responses are fully anonymous
• Link: ASCERTAIN | Survey on pricing of medicinal products

Your expertise and perspective as part of the pharmaceutical pricing and reimbursement community are essential to shaping a model that is both practical and impactful.

If you have any questions or wish to receive a PDF version of the questionnaire in advance, feel free to contact the ASCERTAIN Pricing Team: xander@eshpm.eur.nl | Maximilian.Salcher@goeg.at | anne.hendrickx@solidaris.be

Thank you for your valuable contribution!

Der Beitrag Take Part in Our Survey on Access-Based Pricing for Innovative Medicines erschien zuerst auf ASCERTAIN.

Speaker

Tom Belleman, PhD candidate at the Erasmus School of Health Policy and Management (ESHPM), Erasmus University Rotterdam, delivered a 45-minute presentation followed by a 30-minute Q&A session.

Now Available Online

If you missed the live session, the full recording is available to watch here:
Watch the webinar on YouTube

About the Speaker

Tom Belleman’s research focuses on cost-effectiveness and market access for innovative health technologies, particularly in oncology. He holds degrees in Biomedical Sciences and Health Economics, Policy & Law.

The webinar was organised by Myeloma Patients Europe (MPE).

Der Beitrag Watch the ASCERTAIN Webinar on Reimbursement Decisions Across Europe erschien zuerst auf ASCERTAIN.

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

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“3 Things About Tiered Pricing” – Transcript

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“3 Things About Pricing Of New Drugs” – Transcript

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“3 Things About Reimbursement” – Transcript

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“3 Things About Cost-Effectiveness” – Transcript

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

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EHA2025 Congress

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

12.-15. June 2025

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ISPOR EUROPE 2025

Join partners from the ASCERTAIN project at ISPOR in Glasgow!

09.-12. November 2025

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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 4 erschien zuerst auf ASCERTAIN.