ASSESS-DHT will increase the adoption of trustworthy and effective Digital Health Technologies (DHT) across Europe, enabling a more coherent digital single market, for health systems and patients to access DHT from all over Europe and giving industry a European market. We will develop a new assessment framework, beyond the existing models, capable of uniform HTA adoption across Europe, addressing new assessment challenges in Digital Therapeutics, AI and telehealth. Our consortium comprises 4 HTA bodies, the European Observatory on Health Systems and Policies, 5 academic and not for profit organisations with expertise in EU Regulation, DHT development and assessment methodologies, data protection, data quality, interoperability and cybersecurity. Patients and health professionals are included through the International Diabetes Federation and European Society of Cardiology. We include the DHT industry through companies with products for us to assess through a formal methodology mimicking actual HTA assessments – 3 as partners, some through an open call and industry-wide consultation via DIGITAL EUROPE. We will engage healthcare payers and ministries through our Advisory Board. We will co-create our overarching assessment framework with specialised pathways for different categories of DHT specified through a novel evidence-based typology. We will cater for phased adoption (going beyond fast track models like DiGA), complex life-cycles, iteratively developed AI, consolidated in a comprehensive HTA assessment manual plus specific guides in topics like cybersecurity. We will develop a sustainable repository containing the ASSESS-DHT framework, pathways and unambiguous criteria, a semantically searchable evidence library, checklists and tools to support companies with evidence generation, evidence of health system value from DHT, and online communities of practice.

Objectives and ambition: Substance use disorder (SUD) is associated with a high global burden of disease, with 5.4% of all disability-adjusted life years lost due to alcohol and illicit drugs. Highly prevalent multimorbidity includes polysubstance use, mental health conditions, and other non-communicable and infectious diseases. Where traditional treatments are insufficient alone, music therapy (MT) is highly engaging and improves motivation and craving, but its long-term effects are unknown. Methodology: In a diverse group of people with SUD across a wide range of age, gender, socioeconomic, and cultural background, a parallel 3-arm assessor-blinded pragmatic multinational randomised clinical trial with embedded exploratory trials and mechanistic studies will determine long-term effects of active music groups (AMG) and music listening groups (MLG) versus treatment as usual (TAU) on addiction severity (primary: 1 year), recovery, and other health and socioeconomic outcomes. Embedded trials will examine short-term effects of individual components of TAU combined with AMG or MLG to determine the best combinations of interventions. Experimental studies will examine mechanisms using neuropsychological tests and brain imaging. With 600 participants in 7 countries randomised, the trial has 80% power on the primary outcome. Patient representatives, HTA bodies, and interventionists have been involved from conception and will ensure feasibility and applicability across Europe. Impact: FALCO will reduce disease burden through innovative, effective, and affordable treatment and will strengthen research and innovation expertise. Recommendations from FALCO will inform intervention delivery across Europe and beyond, leading to increased safety, effectiveness and cost-effectiveness, and improved quality of life for people with SUD. Stakeholders will be involved in communicating findings in all European countries and regions and ensuring that findings are effectively implemented.

CORE–MD will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators, to achieve an appropriate balance between innovation, safety, and effectiveness. A unique collaboration between medical associations, regulatory agencies, notified bodies, academic institutions, patients’ groups, and health technology assessment agencies, will systematically review methodologies for the clinical investigation of high-risk medical devices (Work Package 1), recommend how new trial designs can contribute (Work Package 2), and advise on methods for aggregating real-world data from medical device registries with experience from clinical practice (Work Package 3). Multidisciplinary workshops will propose a hierarchy of levels of evidence from clinical investigations; educational and training objectives for all stakeholders, to build expertise in regulatory science in Europe; and an ethics charter for medical device innovation (Work Package 4). Industry participation will be invited. Specific CORE–MD tasks will advise on optimal statistical methods, the utility of patient-reported outcomes, the conduct of registry trials, clinical criteria for evaluating artificial intelligence as a medical device, and how to evaluate medical devices used in children. The essential principles of medical device trials will be considered jointly with the Good Clinical Trials Collaborative. Links between CORE–MD partners will catalyse sustainable networks for research. The consortium is led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, and involves all 33 specialist medical associations that are members of the Biomedical Alliance in Europe. Final recommendations will be submitted to the Working Group on Clinical Investigation and Evaluation of the European Commission to be considered when developing EU guidance or common specifications.

The variety of innovative technologies with the potential to revolutionize the delivery of health care means that the policy toolbox will need several pricing and payment models, adapted in their design and implementation according to the specific situation. Although there are examples of novel pricing and payment models, the lack of appropriate data infrastructure, legal barriers and unwillingness to adapt current systems often prevent their use. Therefore, the overall objectives of the Health Innovation Next Generation Pricing Models (HI PRIX) project are: i) to map and formulate new pricing and payment schemes that can be used across technology classes, therapeutic areas, setting and healthcare systems/geographies together with a related set of principles that may guide successful adjustment and flexible implementation to the context of use; ii) to investigate the impact on competitiveness, innovation, equity and affordability of a pipeline of contracting modalities for health innovations; iii) to address the challenges and concerns of payers, manufacturers, healthcare professionals, and patients about different models of pricing by sustaining an effective dialogue across stakeholders groups about the trade-offs between affordability, innovation and patient access. Coordinated by Bocconi University, the HI-PRIX Consortium involves 18 partners from 10 European countries, including academic institutions, public authorities, healthcare providers, and independent research organizations. Through theoretical models, quantitative simulation, qualitative research work and case-studies, this three-year project structured around 10 WPs, will generate new evidence on the role of public sector in R&D and indirect medical and environmental costs in pricing and reimbursement determinations, on the pricing dynamics over pharmaceutical products lifecycle, on the impact of policies and incentives on the competitiveness, innovativeness and equity in the healthcare system.