With ever-increasing complexity of novel health technologies, Health Technology Assessment (HTA) methodologies have been evolving rapidly. However, there is now a lack of harmonization on the methodological needs of HTA bodies against the varied methodologies and tools. There is a need for a solution that allows for continuous dialogue between HTA bodies and academia, a solid, unified base for implementation of fit-for-purpose methodologies and long-term upskilling on HTA expertise. SUSTAIN-HTA aims to upskill the pan-European HTA body workforce and harmonise HTA expertise via a robust education and training framework that ensures continuous uptake of novel, need-based HTA methodologies. Aligned to the methodological developments as part of the new EU HTA regulation, the project will set up a mechanism for dialogues and interaction between HTA bodies and academia to regularly assess HTA-bodies’ needs in parallel with a methods observatory that ensures up-to-date knowledge of latest HTA methods. Prioritized methods will be piloted within HTA bodies and, after endorsement, implementation will be supported by a harmonized training and education framework that will be established to upskill the HTA experts. A long-term dissemination and communication structure among all stakeholders will be established to guarantee a feedback loop between HTA needs, methods assessment and associated training needs. Via the collaboration of 5 universities, 7 HTA bodies, 2 SMEs and one non-profit organization, SUSTAIN-HTA brings together extensive experience in (coordinating) previous European funded HTA-related projects including HTx, EHDEN, COMED and GetReEal. With this, SUSTAIN-HTA has the background for establishing sustainable business models that ensures continuity of project outcomes and activities in years beyond the project. SUSTAIN-HTA will support European leadership in the HTA field reach HTA bodies across at least 15 European countries with hundreds of people upskilled.

Europe generates real world health data (RWD) that has the potential to inform the development and evaluation of medicines and medical devices. However, multiple barriers remain that limit the access, analysis, interpretation, and use of RWD, hampering its use. Additionally, the limited uptake of existing guidelines for the generation and use of real world evidence (RWE) adds complexity in the use of RWD to inform decision making. The GREG consortium will leverage the learnings of previous and ongoing key RWE initiatives to fill these gaps by generating, pilot-testing, and disseminating evidence-based guidance and tools for the use of RWE to inform the development and evaluation of medicines, medical devices, and combinations. To achieve these goals, we will work with key stakeholders to iteratively test and improve our guidance and tools, backed by case studies from previous successful and unsuccessful examples. We will engage with the most relevant European RWE initiatives and access the largest network of RWD partners in Europe, namely the European Health Data and Evidence Network (EHDEN) through our partner, the EHDEN Foundation. Additionally, we will provide multi-stakeholder gatherings (including patient and public representatives) to promote the dissemination, adoption, and implementation of RWE for decision-making in Europe. Our public and private partners will co-create use cases working closely with key regulatory and health technology experts in bespoke fora. These will be used initially to evaluate existing guidelines, and later to pilot-test the GREG guidance and tools. Our outputs will include training for all involved stakeholders on the use of our guidance and tools, and practical templates to facilitate regulatory and health technology/payer submissions. Together, these will accelerate access to better medicines and medical devices for European citizens.

The Gravitate-Health mission is to equip and empower citizens with digital information tools that make them confident, active, and responsive in their patient journey, specifically encouraging safe use of medicines for better health outcomes and quality of life. It is our vision that engagement of citizens in their own health can only be achieved with access to actionable, understandable, relevant, reliable and evidence-based information that meets their specific needs, health context, and literacy level. This project's ambition is to provide a key piece to advance this vision: the Gravitate Lens (G-lens), which focuses (but does not conceal or filter) approved electronic product information (ePI) content, and offers a route for patients to access trustworthy, up-to-date information that better meet their individual needs. Gravitate-Health is an integrated digital health information project. The principle objective is to demonstrate how use of an integrated, digital, user-centric health information solution with two-way communication could enable tangible improvements in availability and understanding of health information from a set of trusted sources, starting with regulator-approved medicinal product information (e.g. package leaflet content) and EHR-IPS (International Patient Summary). The secondary objectives are to demonstrate that the improved availability and understanding of health information from trusted sources translate to higher levels of adherence to treatment, safer use of medication (Pharmacovigilance), better health outcomes and quality of life, and to develop new and deeper insights into how use of available health information can be optimized to act as effective risk minimization measures. The project allows for efficient and timely development of the G-lens, provides testing grounds for new services and an evaluation framework to test the efficiency, efficacy and safety of Gravitate-Health services. Our main outputs will be an open source digital platform supporting G-lens functionally, demonstrated in a number of testing scenarios, and a White Paper with recommendations on realistic strategies to strengthen access, understanding and future use of digital services like ePIs as a tool for Risk Minimization. The Gravitate-Health is a public – private partnership with 45 members from Europe and the US, co-led by University of Oslo (coordinator) and Pfizer (industry lead), funded by the Innovative Medicines Initiative (IMI) – a joint undertaking of the European Commission, the European Federation of Pharmaceutical Industries and Associations (EFPIA), IMI Associated Partners.

This innovation action will give a powerful impulse to implementation of ISO IDMP (ID of Medicinal Products) standards in EU Member States drug databases, supporting safe cross-border ePrescription/eDispensation and effective pharmacovigilance. Once EU-interoperable data on medicines taken by patients become available, further benefits will accrue through better health data for improved clinical decision support, patient empowerment, public health and clinical research. New opportunities will arise for pharma industry, software developers, SMEs providing smart apps and others, thereby fostering their innovation capacity and competitiveness. The many challenges still to be faced on this road will be tackled by a powerful consortium assembling all relevant actors, with critical mass for impact throughout the EU. After 10 years of development, the IDMP suite of standards is ready for implementation. Though some isolated implementation work has started, the time is now ripe for a more concerted effort towards large-scale implementation, contributing to this global interoperability endeavour and delivering benefits to EU citizens. Project ambition centres on conversion of key regulatory and clinical processes to use IDMP. These information value chains must be converted over their full length from data input to data repositories to data usage. Project work spans all three areas, focussing on the most challenging, the implementation of EU and national SPOR (substances, products, organisations, referentials) data bases, including establishing an EU Substance Reference System (EU-SRS). Such information is fundamental to cross-border ePrescription where safe dispensation may require reliable identification of substances in available products. 19 countries are represented, including 26 national Drug and eHealth Agencies. Stakeholders are involved through their associations. Duration is 4 years, budget € 21 m, with requested funding € 19 m.

The overall goal of the Big Data for Better Outcomes (BD4BO) programme is to facilitate the use of ‘big data’ to promote the development of value-based, outcomes-focused healthcare systems in Europe. To fully exploit the transformative potential of big data, consideration will need to be taken of the use of detailed personal and biological information across the spectrum of care delivery, starting from the development of innovative medicines and treatments, to market access and adoption, diffusion, and use in healthcare systems by providers and patients. This paradigm shift requires shared understanding and standards among healthcare stakeholders including patients, providers, payers, regulators, policy makers, pharmaceutical industry, and academia. OBJECTIVES The proposed Coordination and Support Action (CSA) will establish an enabling platform that brings together these stakeholder groups across the BD4BO programme to ensure quality and consistency of individual projects in line with the overarching programme objective. Our consortium therefore aims to promote the use of big Data for better Outcomes, policy Innovation and healthcare system Transformation (DO->IT). Accordingly, we will: • Define a programme strategy that ensures quality, consistency and sustainability of health outcomes related activities across individual BD4BO projects. • Integrate, synthesise, and manage knowledge from all BD4BO projects, making it easily accessible via a single knowledge exchange platform. • Act as pivotal point of collaboration, stakeholder engagement and communication for all BD4BO projects. • Provide transparency and enable the use of patient health data and human biological samples for research purposes by developing minimum data privacy standards for Informed Consent Forms (ICFs) and supporting materials for use by individual BD4BO disease-specific projects and more widely in the Research and Development (R&D) sector.