ASCERTAIN (Affordability and Sustainability improvements through new pricing, Cost- Effectiveness and ReimbursemenT models to Appraise iNnovative health technologies) addresses the need of patients, physicians, payers, regulators, and manufacturers to improve the affordability and accessibility to innovative health technologies (including pharmaceuticals) in Europe. ASCERTAIN aims to enhance current methods of (value-based) pricing, cost-effectiveness modeling, threshold-setting, reimbursement, and payment, to set affordable prices, and to facilitate a cyclic assessment of broader societal benefits including costs and risks. It seeks to find a sustainable balance between access to affordable technologies, the need to stimulate innovation and entrepreneurship, and the need to consider the environmental impact of innovations. Guided by a conceptual framework integrating pricing, health technology assessment and reimbursement/payment, ASCERTAIN will develop open-access, easy to use, policy-supporting tools including (i) pricing models, (ii) value assessment models, and (iii) reimbursement models, which will be adaptable to country-specific conditions. These tools will improve transparency and accountability of decision-making, reduce uncertainty for all stakeholders, reward innovation in areas of high unmet need, accelerate access for patients, and support long-term planning in a sustainable way. Further, these tools will be developed, tested, and validated for three use cases, including precision cancer medicine, cell- and gene therapy, and medical devices (class IIb and III) or in vitro diagnostic (IVD) class D. The multinational, multidisciplinary ASCERTAIN consortium is complemented by an international advisory board consisting of key stakeholders, with whom the policy-supporting tools will be co-created. All tools will be hosted on a cloud-based, publicly accessible, user-friendly platform following open science principles.

Almost 500,000 former childhood cancer patients (CCS) are now living in Europe. Compared to the general population, CCS represent a vulnerable population as they are at an increased risk of developing health problems, known as late effects, resulting in excess morbidity and mortality. Many survivors are unaware of their personal risk for specific late effects, which reduces their ability to manage their own follow-up care. Similarly, their treating healthcare professionals (HCPs) lack information about care required for CCS and access to treatment data from their childhood cancer. The Survivorship Passport (SurPass) is an innovative, digital tool, developed in previous EU-funded projects, that can be used to overcome these knowledge gaps to improve people-centred long-term survivorship care. Importantly, end users (CCS, HCPs) are integral to the research, represented by three key stakeholder networks (PanCare, SIOP Europe, CCI Europe). PanCareSurPass will conduct a robust assessment of the implementation of the SurPass by first conducting a pre-implementation study in six countries (Austria, Belgium, Germany, Italy, Lithuania, Spain) representing three infrastructural scenarios in Europe. Ethical, structural, organisational, economical, national, local, privacy issues, health systems, and particular national circumstances will be taken into account throughout. An Implementation Strategy will be developed and the SurPass will be updated and validated before use in an implementation study in the six countries. The study will look at a range of outcomes including CCS activation and empowerment, CCS/HCP satisfaction with the tool, feasibility and health economics. Based on the results of the study, a Prediction Model will be developed to promote and support future implementation of the SurPass across Europe.

Social Prescribing (SP) is an innovative solution to bridging the gap between primary health care and non-clinical supports and services within the community. SP enables general practitioners who identify health-related social problems to refer patients to a so-called link worker. The link worker provides personalized support and helps these patients to access community resources by addressing any barriers that may exist. SP is an approach to integrate health and social care and strengthen community orientation. SP thereby mitigates the effects of social determinants of health on health outcomes. However, SP has not been tailored to the needs of people in vulnerable situations yet and the effectiveness of SP to improve their access to health and care services remains unknown. The overall objective of SP-EU is to assess the potential of SP to promote and improve access to health and care services for people in vulnerable situations, focusing on three primary target groups: LGBTIQ persons, refugees and first-generation immigrants and older adults living alone. SP-EU follows a mixed-methods approach: SP adaptations will be co-created with the target groups, to adapt them to their specific needs and social contexts. A pragmatic randomized controlled trial will assess the effectiveness of the adapted SP to improve access by randomizing 1,776 patients in eight EU countries to receive SP or care as usual. A qualitative analysis in five European countries will explore enabling and limiting factors to the implementation of SP from different stakeholders’ perspectives. Additionally, we will communicate and disseminate results and translate them into policy action. SP-EU will enable health care systems to implement SP as a scalable, safe, cost-effective and people-centred solution to provide equal access to sustainable care. Thus, SP-EU will enable the transformation of European health care systems to equitable, community-based, people-centred and integrated health care.

The creation of a European Health Data Space is one of the six strategic priorities for the newly elected European Commission. The European Health Research and Innovation Cloud (HRIC) will be one of the future cornerstone pieces for this area. HealthyCloud will deliver a Strategic Agenda including a Ready-to-implement Roadmap for the HRIC ecosystem. The Strategic Agenda will incorporate the consolidated feedback of a broad range of stakeholders: the European Commission, the Member States and regional, national, European and international relevant initiatives. These agents will be invited to be part of the HealthyCloud’s Stakeholders’ Forum, designed to facilitate the dialogue among them and the Consortium, and to act as an umbrella to bring together similar efforts in specific domains. HealthyCloud has been organized around four fundamental objectives that cover 1) interactions with stakeholders to ensure their voices are included as part of the Strategic Agenda; 2) the inclusion of Ethical, Legal and Societal aspects in the design of the future HRIC ecosystem; 3) the sustainable access, use and re-use of health-related data considering a progressive adoption of the FAIR principles; and 4) the technological solutions in terms of computational facilities and mechanisms to enable distributed health data analysis across Europe. The project is driven by two real-world use-cases (Cancer and Atrial Fibrillation) to ensure that propositions by domain-specific and technological experts are technically and ethically sound and legally compliant. The ultimate goal is to propose an ecosystem that builds and reinforces the trust of patients and citizens in the use of their health data for research. HealthyCloud is a 30-month project that brings together 21 organizations with broad and yet complementary expertise, including 5 Research Infrastructures (ELIXIR, ECRIN, EATRIS, BBMRI and Euro-BioImaging) and 3 Joint Actions (InfAct, iPAAC and eHAction) related to health research.

Antimicrobial resistance (AMR) is of great public health concern, causing numerous losses of lives worldwide and threatening to reverse many of the considerable strides modern medicine has made over the last century. There is a need to stratify antibiotic and alternative treatments in terms of the actual benefit for the patient, improving patient outcome and limit the impact on AMR. High quality, effective and appropriate diagnostic tests to steer appropriate use of antibiotics are available. However, implementation of these tests into daily healthcare practice is hampered due to lack of insight in the medical, technological and health economical value and limited knowledge about psychosocial, ethical, regulatory and organisational barriers to their implementation into clinical practice. VALUE-Dx will define and understand these value indicators and barriers to adoption of diagnostics of Community-Acquired Acute Respiratory Tract Infections (CA-ARTI) in order to develop and improve health economic models to generate insight in the whole value of diagnostics and develop policy and regulatory recommendations. In addition, efficient clinical algorithms and user requirement specifications of tests will be developed fuelling the medical and technological value of CA-ARTI diagnostics. The value of diagnostics will be tested and demonstrated in a unique pan-European clinical and laboratory research infrastructure allowing for innovative adaptive trial designs to evaluate novel CA-ARTI diagnostics. Close and continuous interaction with the VALUE-Dx multi-stakeholder platform provides for optimal alignment of VALUE-Dx activities with stakeholder opinions, expert knowledge and interests. A variety of dissemination and advocacy measures will promote wide-spread adoption of clinical and cost-effective innovative diagnostics to achieve more personalized, evidence-based antibiotic prescription in order to transform clinical practice, improve patient outcomes and combat AMR.