Overall, the changes we’ve proposed aim to enable patients to get faster, equitable access to important new treatments while ensuring the NHS continues to get value for money. We can achieve this in a number of ways, which will include allowing our committees to exercise greater flexibility over how they make decisions about the value of new treatments, as well as over the evidence they consider and how they consider it. In short, the proposed changes are a statement of our commitment to support the introduction of innovative health and care technologies that return additional benefits to the NHS and support the health and well-being of patients.

To drive change, we must first make it as easy as possible for life sciences companies to collaborate with us, so we’re streamlining our processes by, for example, using a simplified singular process for all topics across our health technology evaluation programmes. We’ve also proposed that technical engagement will be an option available within all our guidance development programmes.

‘The changes we’ve proposed will shape the UK marketplace by offering greater decision-making flexibility where it truly counts and builds on several initiatives in which NICE is already involved’

We are adjusting the way treatments for the most severe diseases are considered. This is because evidence has indicated that society places a greater value on health gains from treatments for severe diseases, rather than treatments at the end of life. To accommodate this fairly, we are proposing a new ‘severity modifier’ which will put additional value on treatments for people with severe diseases.

We are also proposing a simplification to the criteria for selecting topics for evaluation under our Highly Specialised Technologies (HST) programme which will help us attain our vision to facilitate fairer access to much-needed treatments for very rare conditions within the NHS. Key to this will be providing a clear vision and aims for the programme while providing clarity in the criteria for routing a topic to the HST programme, for example, a reduction in the number of different criteria that must be met from seven to four.

Britain’s exit from the EU provided an opportunity to showcase the opportunities for life sciences businesses to use the UK as a place to invest in and grow their operations. It’s crucial that we play our role in ensuring the right environment for delivering opportunities and benefits for companies to first launch their products in Britain.

The changes we’ve proposed will shape the UK marketplace by offering greater decision-making flexibility where it truly counts and builds on several initiatives in which NICE is already involved. This includes the joint NICE, Medicines and Healthcare products Regulatory Agency (MHRA), Scottish Medicines Consortium (SMC) and All Wales Therapeutics and Toxicology Centre’s (AWTTC’s) Innovative Licensing and Access Pathway (ILAP) initiative, and the forthcoming NICE and NHS England Innovative Medicines Fund partnership.

We will also continue to move beyond a reliance on randomised control trials as the gold standard and give broader support to real-world evidence based on the experiences of patients. One example of where such an approach can be applied in the future is where medicines lack a comprehensive evidence base. Our appraisal of Tacartus CAR-T treatment for lymphoma at the start of 2021 saw a commercial arrangement agreed between the company and NHS England to provide the therapy at a reduced cost while more data becomes available from the trial and real-life evidence is gathered on the effectiveness of the treatment – meaning NHS patients were among the first in the world to access this groundbreaking innovation. To date, this managed approach has been mostly limited to cancer treatments; however, with the Innovative Medicines Fund on the horizon, we can consider applying this flexibility to a wider range of conditions, if the circumstances are appropriate.

We also recognise there can be inherent challenges in assessing the effectiveness of some treatments. These are notably in conditions affecting children, in rare diseases and in situations where the new treatment is innovative or complex. Gathering enough good quality evidence can often be challenging in these situations, and while the optimum evidence base will always take precedence, our independent committees will be able to exercise a greater degree of flexibility in terms of how they take into account the evidence that is available. This ensures we adopt a measured and proportionate approach to risk, minimising barriers to the availability of important technologies while maintaining value for the NHS.

This review of our methods and processes of health technology evaluation is the first step in our continuing commitment to drive improvements that benefit all the stakeholders involved in and impacted by our work – the NHS, life sciences sector and, ultimately, patients across the country.

As part of this, we are moving away from periodic reviews every four to six years and instead we are moving to an approach that embraces flexibility and agility, reacting to developments in science and the changing health technology assessment landscape.

These changes represent another, albeit significant, step in the continuing evolution of our methods and processes. As we move towards finalised methods and processes, we will share further details on our plans to drive a more transparent and improved evaluation of products, place more value on the real-word experiences of patients using certain medicines and promote innovation to ensure the UK remains an environment within which the life sciences sector can thrive.