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.

Over 50 million people in Europe have more than one chronic disease. This number will increase dramatically in the near future. This will increase health care spending to a staggering 20% of GDP. Multi-morbidity becomes the number one threat to population health and economic sustainability of health care systems. New models of care for multi-morbid patients are urgently needed. Given the diversity of Europe’s health and social care systems there is no single model that fits them all. SELFIE aims to improve patient-centred care for patients with multi-morbidity by proposing evidence-based, economically sustainable integrated chronic care (ICC) models that stimulate cooperation across health and social care sectors and are supported by appropriate financing/payment schemes. SELFIE specifically focuses on multi-morbidity, on generating empirical evidence of the impact of ICC and on financing/payment schemes. It is methodologically innovative by applying Multi-Criteria Decision Analysis. SELFIE develops 5 end-results that are adjustable to different care systems in Europe, including CEE: 1. A taxonomy of most promising ICC models for patients with multi-morbidity; this taxonomy includes a “toolkit” of interventions that policy makers can use to build an ICC model that best fits into their own health and social care system 2. A detailed list of options for different financing/payment schemes to support the implementation of ICC for multi-morbidity 3. A technical document on price-setting of ICC models for patients with multi-morbidity 4. A performance assessment tool to monitor goal achievement; this tool includes new indicators that specifically address the quality of care for patients with multi-morbidity 5. Strategies for implementation and change management Patients, informal and professional caregivers, payers and policy makers are involved right from the beginning to ensure that SELFIE addresses the right questions and pave the pathway for implementation.

Prostate Cancer is the most common cancer in European men. Despite dramatic improvements in early diagnostic and local treatment, one out of five prostate cancer patients will die from their disease. Despite progress in the past years, it remains critical to improve on the present strategy for advanced and metastatic prostate cancer. Within the proposed project, we will evaluate whether intermittent intensified androgen deprivation treatment (iADT) in metastatic prostate cancer is not inferior to continuous treatment in terms of oncological benefit while minimizing side effects and resource utilization and improving patient quality of life. The proposed clinical trial is designed to detect early if iADT has a negative impact on overall survival compared to continuous therapy. If successful, the outcomes of the project will define a new evidence-based standard of care for metastatic hormone sensitive prostate cancer. The proposed research could lead to improved patient survival and quality of life but also improve health system sustainability. This is a multidisciplinary and multistakeholder consortium involving clinical oncologists, surgeons, health economists and patient representatives. The study design was successfully discussed with patients. This action is part of the Cancer Mission cluster of projects on ‘Diagnosis and treatment’.

HTx will create a framework for next generation Health Technology Assessment (HTA) that supports patient-centred, societally oriented, and real-time decision-making for integrated healthcare throughout Europe. HTx will focus on therapeutic areas with high unmet need for which HTA information has to be provided on complex and personalised combinations of health technologies. Based on a select number of relevant case studies, HTx will enhance methods for integrating evidence from RCTs and real-world data (RWD). HTx will also augment statistical and econometric methods for generating robust estimates of effectiveness and cost-effectiveness in order to support relevant HTA decision-making for these complex and personalised combinations of health technologies. HTx will also contribute to improving methods to support personalised treatment advice fitted for sharing with patients and their physicians. This includes the development of statistical and econometric approaches and artificial intelligence/machine learning methods for forecasting treatment effects in specific groups of patients. Simultaneously, in close collaboration with the European Network for HTA (EUnetHTA), HTx will improve synergies between regulatory agencies, HTA bodies and clinical guideline developers. This will include the translation of HTx methods into already existing European guidelines, most prominently those developed by EUnetHTA. HTx will also support initial efforts to discuss reimbursement and funding models that facilitate controlled access to and the pricing of these complex health technologies. Finally, we will evaluate the transferability of HTx results into all EU Member Countries especially in Central and Eastern European (CEE) Countries and promote the dissemination of HTx results to the different European stakeholders with a special focus on the patient community.

Today’s major challenge is to improve efficacy of vaccines to protect the growing ageing population against infectious diseases (ID). The VITAL project aims to address this challenge by assessing the ID burden and mechanisms of immunosenescence to provide evidence-based knowledge on vaccination strategies to establish healthy ageing. Links with existing projects containing data sources combined with novel data acquired through our extensive network of data registries across Europe will result in a database of epidemiology, risk factors and burden of disease of both vaccine-preventable (VP) and potential vaccine-preventable ID. Crucial knowledge on factors that hamper immune responsiveness and in-depth analyses of immune compartments involved in inducing effective immune responses to different vaccines in the ageing host will be gathered. We will identify novel predictive, potentially universal immune profiles of vaccine responses using novel technologies, unique experimental models and (infection) cohorts of elderly subjects in which (bio)markers of frailty have already been identified. Novel strategies to address the problem of immunosenescence will be tested, in particular whether vaccination of middle-aged individuals can maintain proper memory immune responses in the elderly, to improve memory immunity before reaching old age. Using data on epidemiology of VPID and immune responsiveness, novel agent-based models will be developed to build a user- friendly tool to be used by health care professionals for optimal implementation of vaccination strategies for older people and to develop dissemination protocols for the obtained knowledge for the healthcare field. Finally, we will deliver a framework that forms the basis for designing, implementing and regularly updating vaccination schemes for the ageing population. Thereby, VITAL will initiate an important impetus to a more targeted immunization program for the elderly in Europe that will enhance healthy aging.