Support Utilisation of Sustainable and TAilored INnovative methods for HTA

Principal investigator: Carlo Federici (CeRGAS) 

Team UB/Cergas: Aleksandra Torbica 

Partners: Universiteit Utrecht (Uu; Coordinator); Erasmus Universitair Medisch Centrum Rotterdam (Emc); Zorginstituut Nederland (Zin); Stichting Radboud Universitair Medisch Centrum (Rumc); Syreon Kutato Intezet Korlatolt Felelossegu Tarsasag (Sri); Fundacion Vasca De Innovacion E Investigacion Sanitarias (Osteba); Getreal Institute (Getreal I); Synapse Research Management Partners Sl (Synapse); Nemzeti Nepegeszsegugyi Es Gyogyszereszeti Kozpont (Nipn); Agenzia Nazionale Per I Servizi Sanitari Regionali (Age.Na.S); Universita Cattolica Del Sacro Cuore (Ucsc); Agencia De Qualitat I Avaluacio Sanitaries De Catalunya (Aquas); Statens Legemiddelverk (Noma); National Institute For Health And Care Excellece (Nice). 

Sponsor: European Union's Coordination and Support Action “Supporting the uptake of innovative Health Technology Assessment (HTA) methodology and advancing HTA expertise across EU” (HORIZON-HLTH-2023-IND-06-01) 

Duration: January 2024 - December 2028 


One of the biggest challenges within the EU is to maintain an innovative, sustainable, and globally competitive health industry while simultaneously ensuring a health care system that guarantees access to innovative treatments for all European citizens and minimising the economic burden to health systems and payors. The most well-known and developed framework that has been used by national, regional, and local decision-makers to make judgements on value is health technology assessment (HTA). HTA is grounded in evidence-based medicine but is dynamic, requiring regular updates in methods to keep up with the latest health technologies and analytical capabilities. The EU 2021/2282 Regulation on HTA (EU HTA-R), that was adopted in 2021, will introduce joint clinical assessments (JCA) of pharmaceuticals and high-risk medical devices that should be used on a national level. In July 2022, a symposium organized as part of the French Presidency of the Council of the European Union, discussed the challenges of methods for HTAs in Europe, and the need for cooperation with the research community to ensure that innovative evaluation methods are properly considered in European joint assessments. Recently published results from the HTx project also demonstrated that EU HTA bodies struggle with the assessment of ‘complicated’ health technologies such as Advanced Therapeutic Medicinal Products (ATMPs) and cancer drugs. Most recently in March 2023, at the first GetReal Institute Annual Conference, results were presented on the difficulties to assess drugs for which only single arm trials were available. Considering that many of those new health technologies are (very) expensive, innovative methods to ensure best value is achieved is crucial. The overall objective of SUSTAIN-HTA is to create a sustainable framework to understand the needs of European HTA bodies for new innovative HTA methods and tools and align those with the development of methods and tools by academic groups (globally, but with a specific focus on EU funded HORIZON and IMI/IHI projects). SUSTAIN-HTA also aims to support the Coordination Group on Health Technology Assessment (HTACG), and in particular, its Subgroup on Methodology, as part of the EU HTA-R. Through the establishment of a continuous horizon scanning tool and a methods observatory, we will contribute to future updates/revisions of HTA methodology supporting improved and more efficient JCA and joint scientific consultations.