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.

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.

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.

Author

Giulio Galiazzo, Marketing Specialist Chino.io

Chino.io is an Italian cyber security and cloud technology company founded in 2014 with the mission of helping health application developers solve security and privacy law compliance issues when dealing with health sensitive data in the cloud. Chino SRL has created a software development platform called Chino.io. The platform offers developers a set of APIs to store, share and manage sensitive health data securely and fully comply with all data protection laws, including GDPR, ePrivacy and HIPAA.

Role in the ASCERTAIN project: Data management & ethics in WP2.

Der Beitrag Dealing with Data Management and Compliance in ASCERTAIN erschien zuerst auf ASCERTAIN.

On April 12th, PhD student Yancy S Wu presented initial findings from our Structured Expert Elicitation (SEE) project to the CONNECT group, a consortium focused on overcoming barriers in PCM. This was followed by a visit to the Norwegian Medical Products Agency (DMP) on May 2nd, where the ASCERTAIN team engaged with key stakeholders to discuss innovative health technologies and cost-effectiveness modeling. Both events provided invaluable feedback and fostered productive discussions, reinforcing our commitment to integrating diverse perspectives into our research and development initiatives.

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

On April 12th, PhD student Yancy S 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, Yancy S Wu shared findings from ASCERTAIN’s exploration into the use of Structured Expert Elicitation (SEE) 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 sub-groups 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, Yancy S 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

For more information on the Department of Health Management and Health economics from the University of Oslo please visit their website here.

Der Beitrag Insights from Recent Site Visits in Norway erschien zuerst auf ASCERTAIN.