Join Nested Knowledge at ISPOR EU 2024: AI-Powered Solutions for the HTAR Era

Jeff Johnson

Nested Knowledge at ISPOR EU 2024: AI-Powered Solutions for the HTAR Era

As we approach ISPOR Europe 2024 in Barcelona on November 17th, we stand at a fascinating intersection of regulatory evolution and technological innovation. This conference comes at a crucial time, just months before the implementation of the EU Health Technology Assessment Regulation (HTAR) – a transformative change in how health technologies are evaluated across the European Union. While policy makers have spent the past three years laying the groundwork for the coming harmonization of health technology assessment, we at Nested Knowledge have also been hard at work developing tools to help our users meet a number of the associated challenges head-on.

The Path to 2025: Parallel Evolution

The Regulatory Journey

The EU Health Technology Assessment Regulation (HTAR) entered into force in January 2022, initiating a crucial three-year preparatory phase. During this time, the European Commission has been methodically building a framework for horizon scanning and Joint Clinical Assessment (JCA). The aim of this new regulatory framework is to unify and codify the previously voluntary efforts of individual member states in an effort to streamline the process, reducing the overall burden on HTA bodies and the industry.

Nested Knowledge’s Innovation Timeline

With an eye on work of the European Commission, and while lending an ear to our current user’s needs, we’ve been developing and refining AI-powered workflow solutions specifically designed to meet the demands of the type systematic evidence synthesis:

Core Smart Tags & RoboPICO: Our automated PICO extraction and hierarchy-building tools achieve over 80% recall in identifying key study elements, helping teams rapidly scope and organize their evidence base.
Robot Screener: As published in multiple validation studies at ISPOR US in Atlanta, Robot Screener has improved recall over human reviewers and delivers 45-50% time savings in Dual Screening workflows.
Custom Smart Tag Recommendations: Our advanced extraction tools leverage Large Language Models while maintaining full data provenance and human oversight.

Meeting the Challenges Posed by New Regulation

The transition to mandatory Joint Clinical Assessments in January 2025 presents several key challenges for manufacturers:

Challenges	Solutions
Unknown PICOs: Assessors will have limited prior knowledge of which PICOs will be selected before Scope of Evaluation, but we do know that PICOs must be inclusive, meaning that the nature of all member states will be reflected in the final selection, even if the final list will be compressed.	Horizon Scanning: Our Search Exploration tools and Core Smart Tags help predict likely PICOs and scope evidence requirements ahead of time.
Workload Uncertainty: The unknown number of finalized PICOs makes resource planning difficult. We do not yet know how PICOs will be winnowed to produce a more optimized list, so it is vital to stay nimble.	Best Practice, Mapped to Software: Our “living SLR” approach enables teams to set up AI-assisted reviews in advance, making it easier to update when final PICOs are received.
Tight Timelines: Manufacturers face a compressed 100-day window to assemble HTA dossiers after receiving final PICOs.	Collaboration, Scaled: Our integrated workflow combines screening, tagging, and extraction, critical appraisal and reporting to streamline evidence consolidation and allow teams to operate as efficiently as possible.

Why Use AI?

How can we be so sure that AI is the answer? While it is true that few HTA bodies have released statements regarding the responsible use of AI in evidence synthesis, our recommended approach at Nested Knowledge aligns closely with the guidance published in NICE’s recent position statement. By building our software in close collaboration with our core customer base, we are laser focused on three key principles: human oversight, methodological transparency, and data provenance. Central to all three is our commitment to augmentation, not replacement. Our AI tools are designed to support and enhance the work of researchers, with preliminary determinations offered as recommendations for human confirmation. This alignment with NICE’s emphasis on human oversight ensures that all AI-driven processes in evidence synthesis remain reliable and accountable, bolstering trust in the results. Methodological transparency is another pillar of our approach. We provide full disclosure of our AI methods, making our processes easily accessible and understandable. By publishing validation results, we allow users to see the performance metrics and limitations of our tools, supporting informed use and fostering an environment of open and reproducible science. This transparency addresses NICE’s concerns about “black-box” AI systems and enables users to make evidence-based decisions with confidence. Finally, we place a strong emphasis on data provenance. Each AI-generated insight we provide is traceable back to its original source documentation, ensuring accuracy and accountability. This practice allows researchers to verify AI outputs and strengthens the credibility of synthesized data. By ensuring a clear, traceable link from insights to source materials, Nested Knowledge not only adheres to NICE’s guidelines but also raises the standard for responsible AI use in evidence synthesis, helping researchers meet stringent compliance and quality standards.

Visit Us at ISPOR EU 2024

After you attend Session 200b, “Ready, Set, Go: The Last Sprint for the EU HTAR,” stop by our booth, #501. We’d be happy to demonstrate how our AI-augmented platform can help organizations prepare for the new regulatory landscape. We’ll showcase our existing AI tools, workflow solutions, and visualization tools to help you get a head start.

Looking Forward

As we enter this new era of harmonized European HTA, the combination of regulatory clarity and technological innovation offers an unprecedented opportunity to streamline evidence synthesis while maintaining the highest standards of quality and transparency. We invite ISPOR attendees to connect with us to discuss how our platform can help your organization prepare for the challenges and opportunities ahead. Whether you’re concerned about meeting tight timelines, managing uncertain workloads, or ensuring compliance with new regulations, our AI-augmented solutions are designed to help you succeed in the HTAR era. We’ll also be demonstrating a brand new feature we’re launching in conjunction with ISPOR: automated AI search. This feature will allow you to generate an entire search strategy complete with a properly formatted query by just entering a research question. Stop by and check it out! For a demonstration of our platform or to discuss your specific needs, visit us at ISPOR EU 2024 or contact us.

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