Periodic Reporting for period 1 - SUSTAIN-HTA (Support Utilisation of Sustainable and TAilored INnovative methods for HTA)
Periodo di rendicontazione: 2024-01-01 al 2025-06-30
The healthcare landscape is evolving rapidly, driven by advances in medical science and the digitalisation of health systems. These developments give rise to increasingly complex health technologies, often stretching the limits of conventional HTA methodologies. At the same time, changing regulatory frameworks—particularly those accelerating access to innovation—require assessments earlier in the technology lifecycle, often based on limited evidence. A major development is the EU HTA Regulation, which is reshaping evaluation processes across Europe.
Against this backdrop, the SUSTAIN-HTA project was launched to establish a sustainable framework for identifying the methodological needs of European HTA bodies and aligning them with the development and implementation of innovative methods. A central aim is to ensure the uptake of novel, needs-based methods by upskilling the pan-European HTA workforce and harmonising expertise through a robust education and training framework.
The key objectives of SUSTAIN-HTA are to:
1. Create a continuous horizon-scanning tool (SUSTAIN-HS) to identify the needs of European HTA bodies for new HTA methods and tools.
2. Establish an HTA methods observatory (SUSTAIN-OBS) to identify/track all the relevant new developments in HTA methods and tools based on international published and ongoing scientific research.
3. Facilitate delivery of methods needed by HTA bodies via a sandbox environment (SUSTAIN-SB) and dialogue with academia (SUSTAIN-DIALOGUE).
4. Build an integrated, high-quality training program jointly developed between academics and HTA bodies, supported by a digital platform for knowledge transfer (SUSTAIN-EDU).
5. Initiate a SUSTAIN-HTA fellowship program (SUSTAIN-FP) to support familiarity in daily practice with new HTA methods and tools
6. Maximise long-term impact across stakeholder groups, establishing a platform for training materials and viable business model(s) for project outcomes.
Against this backdrop, the SUSTAIN-HTA project was launched to establish a sustainable framework for identifying the methodological needs of European HTA bodies and aligning them with the development and implementation of innovative methods. A central aim is to ensure the uptake of novel, needs-based methods by upskilling the pan-European HTA workforce and harmonising expertise through a robust education and training framework.
The key objectives of SUSTAIN-HTA are to:
1. Create a continuous horizon-scanning tool (SUSTAIN-HS) to identify the needs of European HTA bodies for new HTA methods and tools.
2. Establish an HTA methods observatory (SUSTAIN-OBS) to identify/track all the relevant new developments in HTA methods and tools based on international published and ongoing scientific research.
3. Facilitate delivery of methods needed by HTA bodies via a sandbox environment (SUSTAIN-SB) and dialogue with academia (SUSTAIN-DIALOGUE).
4. Build an integrated, high-quality training program jointly developed between academics and HTA bodies, supported by a digital platform for knowledge transfer (SUSTAIN-EDU).
5. Initiate a SUSTAIN-HTA fellowship program (SUSTAIN-FP) to support familiarity in daily practice with new HTA methods and tools
6. Maximise long-term impact across stakeholder groups, establishing a platform for training materials and viable business model(s) for project outcomes.
The work performed so far can be outlined against the key objectives:
1. The SUSTAIN-HS tool was established. The first report addressed challenges in relative effectiveness assessment and cost-effectiveness analysis of medicines, drawing on a literature review and input from HTA bodies. An online platform was developed to improve visibility. Future reports will expand to additional HTA domains and technologies.
2. The SUSTAIN-OBS was created. The first report mapped methods from EU-funded projects completed between 2019 and 2024. Future reports will extend coverage to ongoing EU projects and global sources.
3. Work on the SUSTAIN-SB progressed with a proposed study design to assess barriers and facilitators of implementing innovative methods. SUSTAIN-DIALOGUE advanced through a questionnaire circulated among HTA bodies to analyse knowledge infrastructures and collaboration with academia (Deliverable 2.1). A scoping review identified intervention mapping as the guiding framework. Building on Deliverable 2.1 and an initial poll, two surveys—one for HTA bodies and one for academia—were conducted to identify collaboration priorities and challenges.
4. The SUSTAIN-EDU advanced through several activities. HTA expertise was defined via a scoping review, a two-round Delphi with HTA professionals, and validation with early-career professionals and HTA master’s coordinators. This produced a revised version of the Mueller et al. (2020) framework, structured across three expertise levels and validated through workshops and webinars. Training programmes and competencies of doers and users were mapped through a systematic search and outreach to education leads. A survey-based gap analysis identified demand for training in environmental aspects and AI-related methods. Based on these findings, a draft protocol for the first training programme on environmental aspects in HTA was drafted. Minimum criteria for effective training were developed through a desk review of international standards. A protocol for monitoring and evaluation of training impact was also drafted. Specifications for the digital training platform were defined by two task forces, resulting in the LMS Governance Document to guide the next phase.
5. Work on SUSTAIN-FP included drafting eligibility and selection criteria, surveying partners to identify potential hosts and participating HTA bodies, and establishing a review committee. Preparations are underway to award fellowships.
6. Work on maximising long-term impact focused on developing an actionable business model. Input was gathered through workshops and an online survey. Business model scenarios were discussed within the consortium and refined in Deliverable 5.4 which outlined two options: establishing an independent legal entity or joining an existing one. A second survey in April 2025, targeting consortium and advisory group members, showed strong support for joining an existing entity. The results led to an updated plan for Deliverable 5.5 due at project end.
Cross-cutting efforts also supported the objectives. A taxonomy was developed to standardise terminology and establish a common language. The SUSTAIN-HTA Network, Expert Forum, and Stakeholder Forum were created as channels for stakeholder engagement. A review of HTA methods manuals, EU HTA guidance documents, and selected HTA reports, together with qualitative input from HTA bodies, informed a gap analysis (Deliverable 1.6). A two-stage prioritisation process was also initiated. The first stage developed criteria through consultation with HTA bodies, which will guide the selection of methods and tools for testing in SUSTAIN-SB.
1. The SUSTAIN-HS tool was established. The first report addressed challenges in relative effectiveness assessment and cost-effectiveness analysis of medicines, drawing on a literature review and input from HTA bodies. An online platform was developed to improve visibility. Future reports will expand to additional HTA domains and technologies.
2. The SUSTAIN-OBS was created. The first report mapped methods from EU-funded projects completed between 2019 and 2024. Future reports will extend coverage to ongoing EU projects and global sources.
3. Work on the SUSTAIN-SB progressed with a proposed study design to assess barriers and facilitators of implementing innovative methods. SUSTAIN-DIALOGUE advanced through a questionnaire circulated among HTA bodies to analyse knowledge infrastructures and collaboration with academia (Deliverable 2.1). A scoping review identified intervention mapping as the guiding framework. Building on Deliverable 2.1 and an initial poll, two surveys—one for HTA bodies and one for academia—were conducted to identify collaboration priorities and challenges.
4. The SUSTAIN-EDU advanced through several activities. HTA expertise was defined via a scoping review, a two-round Delphi with HTA professionals, and validation with early-career professionals and HTA master’s coordinators. This produced a revised version of the Mueller et al. (2020) framework, structured across three expertise levels and validated through workshops and webinars. Training programmes and competencies of doers and users were mapped through a systematic search and outreach to education leads. A survey-based gap analysis identified demand for training in environmental aspects and AI-related methods. Based on these findings, a draft protocol for the first training programme on environmental aspects in HTA was drafted. Minimum criteria for effective training were developed through a desk review of international standards. A protocol for monitoring and evaluation of training impact was also drafted. Specifications for the digital training platform were defined by two task forces, resulting in the LMS Governance Document to guide the next phase.
5. Work on SUSTAIN-FP included drafting eligibility and selection criteria, surveying partners to identify potential hosts and participating HTA bodies, and establishing a review committee. Preparations are underway to award fellowships.
6. Work on maximising long-term impact focused on developing an actionable business model. Input was gathered through workshops and an online survey. Business model scenarios were discussed within the consortium and refined in Deliverable 5.4 which outlined two options: establishing an independent legal entity or joining an existing one. A second survey in April 2025, targeting consortium and advisory group members, showed strong support for joining an existing entity. The results led to an updated plan for Deliverable 5.5 due at project end.
Cross-cutting efforts also supported the objectives. A taxonomy was developed to standardise terminology and establish a common language. The SUSTAIN-HTA Network, Expert Forum, and Stakeholder Forum were created as channels for stakeholder engagement. A review of HTA methods manuals, EU HTA guidance documents, and selected HTA reports, together with qualitative input from HTA bodies, informed a gap analysis (Deliverable 1.6). A two-stage prioritisation process was also initiated. The first stage developed criteria through consultation with HTA bodies, which will guide the selection of methods and tools for testing in SUSTAIN-SB.
The project delivered outputs that strengthen the methodological foundations and capacity of HTA in Europe. A structured system was created to identify HTA bodies’ needs and catalogue emerging innovative HTA methods. The SUSTAIN-HTA Network was established to enable structured discussions among HTA bodies, ensuring their priorities informed the project’s work. Existing and potential collaboration models between HTA bodies and academia were mapped. A validated competency framework was also developed to define the knowledge and skills required for HTA doers and users, complemented by a mapping of current training provision, identification of gaps, and minimum criteria for effective training. Together, these results enable more coordinated, need-driven method development and implementation, strengthen stakeholder dialogue, and provide a foundation for workforce development. Further progress will require sustained coordination with HTA bodies, academia, and training providers, and mechanisms to maintain engagement and resource access beyond the project period.