For the UK’s National Institute for Health and Care Excellence (NICE) the COVID-19 pandemic and Brexit have created a “global realignment of government and healthcare priorities,” which warrant more agility and flexibility in NICE’s work. In response, NICE launched a five-year strategy on April 19, 2021, which identifies the key challenges in NICE’s work and the strategic pillars where NICE believes it can have the greatest impact over the next five years.
Real-world evidence (RWE) plays a large role in this strategy; here we will summarize NICE’s five-year plan and discuss how RWE will facilitate the changes NICE plans to make.
Overview of NICE’s four strategic pillars for 2021-2026
- Rapid, robust, and responsive technology evaluation
NICE is committed to quickening the pace of high-value technology adoption within the National Health Service (NHS), which will require early and frequent collaboration with the Medicines and Healthcare products Regulatory Agency (MHRA) and the biopharma industry. NICE will proactively identify innovative technologies earlier in the pipeline and develop robust and responsive methods to evaluate these emerging products. Manufacturers can expect to see changes in how they interact with NICE, including more pathways to guidance. For example, there will be different routes to a NICE recommendation depending on the robustness of the evidence base and the type of technology in question, with a focus on greater receptivity to RWE. RWE will be a key area of focus in medical devices and digital health, in rare diseases—where study populations are small and opportunities to participate in randomized controlled trials (RCTs) are limited—and in informing and in evaluating managed access schemes.
- Dynamic living guideline recommendations
NICE is moving from producing full treatment guidelines to a more modular, living approach that will enable rapid updates as new evidence, including RWE, is generated. These living guidelines will use “up-to-date evidence and data on the relative effectiveness” of technologies in order to inform providers’ and patients’ treatment decisions. NICE will gather more input from patients and providers on the top priority areas for updates, with a focus on reducing health inequalities.
- Effective guidance uptake to maximize NICE’s impact
NICE’s guidance does not exist in a vacuum, and it is only relevant if health systems adopt its recommendations. This can be a challenge, as recommendations can be complex and disseminating knowledge takes time, which can be a barrier to guidance uptake. To reduce such barriers, NICE will, for example, develop guidelines in digital formats to meet the needs of different audiences, and it will partner with organizations and patient groups to continually get feedback on implementation efforts and challenges. NICE will also partner with organizations to improve real-world data collection about uptake in order to measure the impact of guidances and the value they create for the health system.
- Leadership in data, research, and science
NICE commits to “developing world-leading capabilities and standards for routinely using real-world data to inform all aspects of [its] work.” To deliver on this strategic goal, NICE will first move from being a “user of research to driving the research agenda” through collaborations with academia, government, and industry partners to address gaps in the knowledge base identified through guidance development. NICE is also investing in furthering the scientific knowledge around the use of RWE in decision-making. As part of this strategy, NICE will develop best practice methods for RWE generation and use, which will be used internally as well as by manufacturers submitting RWE to NICE.
NICE’s five-year strategic plan is ambitious, but necessary in a rapidly changing environment. The COVID-19 pandemic and the speed of innovation has further highlighted the need for agility and flexibility in health care decision-making. This strategic plan showcases the many ways in which RWE can inform and drive efficiencies in the health care system. The continued commitment to RWE builds upon NICE’s statement of intent to use RWE, published in early 2020, and furthers NICE’s interest in playing an active role in generating RWE in addition to receiving it in submissions from manufacturers.