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This statement describes the interim methods and processes to support the approach to late-stage assessment (LSA) launched in October 2023. It describes the changes to NICE's existing methods and processes, and should be read alongside the relevant sections of NICE's health technology evaluations manual.
LSA aims to assess technologies that are in widespread or established use in the NHS to inform commissioning and procurement decisions. This will support clinical practitioners, managers and commissioners to use NHS resources as effectively as possible, to ensure patient and system benefits are maximised, and to secure value for money. Over time, technologies in use often undergo continuous or incremental innovation and adaptation but there is limited consistency in how these are valued and recognised. LSA aims to assess which technologies in a category represent value for money and whether price variations are justified by the incremental differences and advancements.
The approach outlined in this statement is iterative and may change to fit the needs of the project. Learnings from the initial assessments will inform the final design of LSA which will then be published in a final manual following consultation.
Both patients and healthcare professionals can benefit from choice of technology. But more choice can make it difficult to identify the right technology, for the right patient, at the right price. The Medicines and Healthcare Regulatory Agency (MHRA) has over 3 million different technologies registered for use in the UK, with around 500,000 regularly used in the NHS. Many technologies claim to be innovative without substantial differences to other technologies in the same category. Meanwhile, other technologies with clear advantages are overshadowed by the overwhelming variety of options available. This can create barriers for new, more beneficial technologies to enter the market. It makes it challenging for the UK healthcare system to choose from a diverse range of technologies in a way that maximises patient and system benefit, and value for money.
Adopting a new or alternative technology can require wider changes, such as additional user training, patient education and clinical expertise. The resources needed to implement these can be significant, and the system only has a finite capacity to make changes. The high numbers of technologies available and low levels of technology switching have impacted the ability to have the right technology in the right place, for the right price (see Lord Carter's 2016 report on productivity in NHS hospitals).
LSA will inform procurement and commissioning decisions by assessing if the value added by incremental innovation offered by the technologies within a category justifies the price variation. This will include capturing the product features most relevant to patients or user, and NHS healthcare providers, and evaluating how they impact clinical and non-clinical outcomes and user preferences. These product features can include basic product specifications and features that add value. This will help procurement services and commissioners to make well-informed decisions and ensure that effective technologies are available for use while maintaining choice in the system.
Existing procurement and commissioning decisions and frameworks will contribute to the scoping and decision-making process.
LSA will use a predetermined price range for a category of technologies, to promote the consideration of overall resources available to the NHS. The price range can take into account broader NHS considerations such as the predicted net budget impact, government policy and procurement strategies. This price range will determine whether technologies represent a good option for patients and clinicians and value for money for the NHS.
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