SUSTAIN HTA launched to advance and align innovative HTA methods in Europe

The EU-funded project SUSTAIN HTA with the objective of establishing a sustainable framework to understand the requirements of European HTA bodies regarding novel HTA methods and tools. The project aims to synchronize these needs with the advancements made by academic groups in the creation of HTA methods and tools.

Effective January 2025, the European Regulation on Health Technology Assessment (HTAR; Regulation (EU) 2021/2282) has sparked many long-awaited changes to health technology assessment (HTA) practices in the European Union (EU). By standardizing the evaluation of medicines and medical devices through joint clinical assessments (JCA), this regulation aims to facilitate a more efficient and harmonized HTA process across the EU. JCA also aims leverage the expertise of multiple HTA bodies, improving the quality and consistency of HTA decisions and ultimately speeding up access to innovative technologies for patients.

To advance this new regulation, SUSTAIN-HTA (Support Utilisation of Sustainable and TAilored INnovative methods for HTA) is a new EU-sponsored project, initiated under the Horizon Europe program. This consortium, led by Utrecht University, includes universities, HTA bodies, SMEs, and an NGO, and aims to address high-priority challenges in assessing innovative health technologies, such as advanced therapeutic medicinal products (ATMPs). SUSTAIN-HTA will collaborate closely with the research community and leveraging recent advancements like HTx, EHDEN, COMED, and GetReal. SUSTAIN-HTA also aims to support the methodology subgroup of the Coordination Group on Health Technology Assessment (HTACG), the central governing body established under HTAR tasked with overseeing and coordinating joint efforts on HTA among national and regional HTA bodies within the EU.

In the official press release marking the launch of SUSTAIN HTA, Professor Wim Goetsch (Utrecht University) explained, “SUSTAIN HTA will work with HTA bodies to determine their needs for advancement in HTA methodologies and with leading HTA academics, for instance through large European Horizon HTA Research projects, to bring new methodologies into practical use in HTA. We aim to be an expert, neutral platform that provides balanced information about these new methods while also being a safe harbor to test the new methods in practice and provide training to support widespread implementation.”

Key objectives of SUSTAIN-HTA include:

• Develop a continuous horizon-scanning tool (SUSTAIN HS) to identify emerging needs and challenges related to HTA in the EU.
• Establish an HTA methods observatory (SUSTAIN O85) to continually identify needs and track advancements in HTA methodologies across various domains.
• Create a sandbox environment (SUSTAIN S8) to allow for testing and implementing new and innovative HTA methods in a controlled setting.
• Offer an integrated training program (SUSTAIN EDU) to equip stakeholders with the knowledge and skills necessary to utilize new HTA methods and tools effectively.
• Implement a fellowship program (SUSTAIN FP) to foster expertise in the field of HTA by providing opportunities for focused learning and practical experience with advanced methods.

SUSTAIN-HTA was launched in January 2024 and officially started following a kick-off meeting in February 2024. The project aims to run until the end of 2027.