Celebrating its 25th anniversary, NICE hosted a conference looking back at its progress and ahead to future challenges. Spanning health technology assessment (HTA), real-world evidence (RWE), and artificial intelligence (AI), the event highlighted NICE’s unwavering commitment to equitable healthcare access in England and Wales.
Key Achievements
- Rigour, Transparency, Independence: NICE’s robust methods have earned the trust of the public, policymakers, and international stakeholders.
- Reducing Inequalities: Initially met with scepticism, NICE has proved instrumental in closing regional care gaps and broadening treatment access.
- Global Benchmark: Its HTA framework is now a leading reference point for other health systems worldwide.
- Adaptability: NICE’s swift response during COVID-19 demonstrated its capacity to stay relevant in an ever-changing healthcare landscape.
Here is an overview of the main highlights from NICE’s conference, reflecting some of its evolving processes and current priorities:
NICE embraces evolving HTA processes and tools to tackle HTA challenges
NICE is continuously evolving its processes, and is keen to promote the early dialogue with industry and ensure proactive collaboration ensures potential uncertainties—like cost-effectiveness for gene therapies—are identified earlier, smoothing out the appraisal process
There’s concern that treatments for “rare but not ultra-rare” diseases may fall between HTA frameworks (STA vs. HST). In response, NICE is committed to reviewing negative decisions and staying informed about developments in countries like Germany and France to spot any technology adoption trends or differences. It was note that if other markets are adopting treatments that NICE has not, they would consider the potential need to re-evaluate its processes and decisions in the future.
Meanwhile, NICE’s “HTA Innovation Lab” offers a low-risk setting to try out new methods, separate from formal appraisals. This “sandbox” approach is designed to help NICE accommodate disruptive technologies—like AI-based diagnostics or cell and gene therapies—while refining its processes at the same time
NICE recognises role of real-world evidence (RWE) in MedTech HTA and advises early engagement prior to evidence generation
There is growing recognition that RWE must play a stronger role in HTA, especially in MedTech. MedTech faces additional challenges in evidence generation compared to medicines; for instance, increasing regulations, inability to blind, complexity and software updates, and lack of national funding post-approval. NICE emphasised on the use of its RWE framework which serves a practical guidance for designing high-quality studies. Manufacturers are encouraged to seek scientific advice and early engagement with NICE to ensure studies meet expectations.
NICE’s new centralised approach to prioritisation of guidance topics
NICE’s prioritisation board uses six domains—budget impact, system impact, population impact, evidence quality, health inequalities, and environmental sustainability—to decide which topics proceed to guidance development.
Topics that fall short may still receive NICE support for further evidence generation or be referred to external bodies. Workforce requirements and constraints are increasingly acknowledged as a real-world barrier or enabler of adoption
Beyond clinical and cost-effectiveness, manufacturers must create a strong value proposition across multiple domains to improve the chances of progressing to full guidance development. In addition, manufacturers must consider how their product fits into current workflows and whether it helps ease, or adds to, existing pressures.
Artificial intelligence (AI) is changing drug development, from discovery to HTA preparation, but clear rules and strong evidence are still needed
NICE has expressed their commitment to supporting innovative AI in healthcare, insisting on safety, efficacy, and cost-effectiveness underpinned by continuous evidence generation. So far, it has evaluated six AI tools—mainly in diagnostics—and granted conditional recommendations to enable early adoption while data continues to build. Collaboration between clinicians, payers, and manufacturers remains essential to refine these technologies in real-world settings.
Meanwhile, manufacturers must tackle AI-specific challenges, including the need for transparent disclosure of AI-driven methods. NICE is aware that companies are already using generative AI for dossiers and economic modelling; but it was highlighted that while they welcome such innovation, transparency is critical for responsible implementation. NICE was the first HTA body to issue a position statement on AI in evidence generation. With this, NICE aims to guide both industry and other HTA bodies towards a more collaborative approach, ensuring AI-based advances truly benefit patients and health systems alike.