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Introducing Core Smart Tags
Introducing Core Smart Tags If you are familiar with Tagging in Nested Knowledge, you know how integral the process of setting up a tagging hierarchy
August 27, 2024
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Introduction
Health Technology Assessment (HTA) has long been a foundational process in global healthcare systems, serving to evaluate the clinical and economic value of medical interventions and guide coverage, reimbursement, and policy decisions. While HTA is practiced globally, the frameworks and standards vary significantly by region—often requiring manufacturers and market access teams to navigate a maze of country-specific processes.
In Europe, however, the landscape is undergoing a major transformation with the rollout of the Joint Clinical Assessment (JCA) under the new EU HTA Regulation. As of early 2025, the JCA mandates a centralized clinical assessment for select high-impact technologies, aiming to streamline duplication across member states. Yet while the goal is harmonization, early feedback from stakeholders highlights new challenges: compressed timelines (just 100 days to final dossier submission), limited manufacturer involvement, and increased complexity, especially in the sheer volume of PICOs (Population, Intervention, Comparator, Outcome frameworks) required. These changes represent both an opportunity and a stress test for global evidence teams.
Here is a video we made that gives an explanation of the role the JCA plays in clinical review: https://www.linkedin.com/posts/nested-knowledge_hta-jca-htar-activity-7260069716319182848-67Io?utm_source=share&utm_medium=member_desktop&rcm=ACoAAD0wtFkBTlTPFtjhG1WC6Y9o0Od3H94xe_Q
As Europe enters this new era of collaborative HTA, geography still matters—regional contexts, payer expectations, and implementation nuances remain diverse. In this article, we explore how Nested Knowledge can help teams manage this complexity and facilitate cross-geographic HTA efforts, whether working within the JCA framework or addressing the decentralized systems still dominant in other markets.
The Geographic Variability of HTA
HTA is not a one-size-fits-all process. In the United States, for example, the system is largely decentralized. Payers, private institutions, health systems, and the Centers for Medicare and Medicaid (CMS) may each conduct their own reviews or commission HTAs through organizations like ICER (the Institute for Clinical and Economic Review). As a result, there is no single, mandated framework, leading to variability in how evidence is gathered, interpreted, and applied. This often leads to redundancy and conflicting outcomes for the same technology.
In Europe, what was once a patchwork of national HTA systems is now transitioning toward a more coordinated model through the Joint Clinical Assessment (JCA)—the formal implementation of the collaborative efforts initially driven by EUnetHTA. Under the JCA framework, a central clinical assessment is conducted for selected health technologies, but this process is anything but one-size-fits-all. Each of the 27 EU member states identifies its own PICOs of interest—defining specific populations, interventions, comparators, and outcomes relevant to their national context. The JCA submission must then address this multitude of PICO frameworks, requiring evidence reviewers to customize their analysis for each country’s needs. While this approach aims to streamline efforts and reduce redundancy, in practice it introduces significant complexity, placing pressure on manufacturers and HTA developers to deliver tailored, multi-faceted submissions under a tight 100-day timeline. Despite these challenges, the JCA marks a significant evolution in the European HTA landscape—one that requires new tools and strategies for success.
In Asia, countries such as Japan, South Korea, China, and Thailand have established their own HTA infrastructures, reflecting a growing commitment to evidence-based healthcare policy. However, the structure, maturity, and influence of HTA vary widely across the region. To promote collaboration and capacity-building, HTAsiaLink—a network of HTA agencies across more than a dozen countries—has emerged as a key initiative. It focuses on sharing best practices, standardizing methods, and improving the transparency of decision-making processes. While this represents a promising step toward regional harmonization, significant differences remain in health system priorities, pricing models, and accepted clinical endpoints. These disparities often require localized assessments, particularly when addressing differing regulatory expectations or economic constraints. As Asian HTA systems continue to evolve and formalize, cross-border collaboration like HTAsiaLink may help pave the way for greater convergence—though the path remains complex.
The Challenges of Fragmented HTA Systems
This global variety in HTA methodology presents three major challenges for organizations working across multiple geographies.
Nested Knowledge’s Solution: A Unified, Customizable Platform for Flexible, Living Systematic Reviews to support HTA
At Nested Knowledge, we are addressing these challenges through a dynamic approach to evidence synthesis and HTA. Our platform allows global teams to build a centralized, continuously updated repository of evidence that can serve multiple HTA submissions. This eliminates duplication of effort while preserving regional adaptability. Structured literature reviews, study data extraction, and meta-analyses are all hosted within an interactive system that supports transparency, traceability, and collaboration.
Moreover, our customizable workflows mean that teams can align their HTA framework with local standards (such as GRADE, EUnetHTA core model, or ICER’s value assessment) without needing to abandon a shared foundation. This dual capability—standardization where it counts and flexibility where it matters—is what enables our partners to pursue truly cross-geographic HTA strategies.
A Real-World Example
Consider a recent case where a multinational life sciences company sought to launch a new oncology therapy across both North America and Europe, including submission under the EU’s new Joint Clinical Assessment (JCA). Traditionally, this would have meant developing separate HTA dossiers tailored to each country, a resource-intensive process that often leads to inconsistent messaging and duplicated effort. But by leveraging Nested Knowledge, the global evidence team took a more strategic, streamlined approach—one specifically designed to meet the complexity of modern HTA, including the PICO-driven requirements of the JCA.
The team began with an umbrella review—a comprehensive evidence synthesis designed to serve as a centralized source of clinical data for multiple geographies. Crucially, even before study screening began, they used PICO and study location prediction to forecast which studies might be relevant to each country’s submission. Throughout the review, they applied Smart Tags to classify studies by PICO relevance and geographic applicability, allowing them to build a flexible evidence base with deep granularity.
To further support JCA readiness, they ran a feasibility network meta-analysis (NMA) using automated data extraction, filtering results by both PICO and country-specific tags. When it came time to prepare submissions targeting specific geographies, they simply copied the umbrella review and excluded studies that didn’t match the local PICOs—quickly generating country-specific dossiers without restarting the entire review process.
This method allowed the team to meet the JCA’s compressed timelines and content demands while maintaining alignment across global submissions. It also gave them the transparency and traceability needed to respond to regulator questions—a critical advantage in the new HTA environment.
Want a step-by-step guide on how to tackle the challenges ahead?
For evidence teams ready to operationalize a cross-geographic HTA strategy, the following guide outlines how to execute a unified systematic literature review (SLR) that satisfies requirements across multiple jurisdictions—supported by the Nested Knowledge platform.
Click here: Executing a Unified SLR for Multi-Regional HTA Submissions: A Practical Guide
Conclusion
As the demand for evidence-based decision-making grows, so does the need for earlier planning, global planning, and efficient approaches to HTA. The old model—duplicating work across borders and navigating a maze of disconnected systems—is no longer sustainable. With Nested Knowledge and our research partners, global health organizations can transform how they conduct HTA: from a fragmented, reactive process to an integrated, proactive strategy that supports faster access, better outcomes, and more equitable global healthcare.
Call to Action
If you’re part of a market access, medical affairs, or health economics team looking to scale your HTA efforts across regions without scaling your workload, Nested Knowledge is ready to help. Contact us to schedule a personalized demo or learn more about our platform.
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Introducing Core Smart Tags If you are familiar with Tagging in Nested Knowledge, you know how integral the process of setting up a tagging hierarchy
