22-24 - The future of health technology evaluation

At NICE, our five-year strategy clearly sets out our vision to anticipate, recognise and respond to future changes to ensure constant improvements to health and well-being. This means putting robust evidence at the heart of health and care decision -making, whilst working with industry partners to foster innovation.

With that goal in mind, and as technologies advance, so too must our methods of evaluation. The speed at which the COVID-19 pandemic gripped our health and care systems demanded a new type of response – one that required swiftness, flexibility and adaptation to an ever-changing situation. We rose to meet this demand, and the pandemic provided a catalyst for the type of change we already knew we needed to make.

We’re an international leader in health technology evaluation and we need agile methods and processes to remain at this forefront. This will help shape the future, and it is something we want all life sciences companies to be a part of.

The proposed changes would see patients receive innovative new treatments sooner by allowing greater flexibility over decisions about their cost-effectiveness. This means that NICE will be able to support the introduction of valuable innovative technologies, bringing health benefits for patients and good value to the NHS. At the same time, we will remain robust, efficient and able to meet the challenges of advancing health technology.

So, what are the key changes that will directly impact the life sciences sector? Firstly, we want to make it easier for companies to work with us, so we’re streamlining our processes and being clearer about how we make decisions.

When it comes to topic selection, we need to be better at reflecting the real priorities of the NHS. As part of the proposed changes, one panel of experts will decide what treatments, medical devices and interventional procedures and diagnostics we assess. This will ensure consistency, allow for more transparent decision-making and enable us to achieve a better balance between pharma and medtech topics.

In another significant change we are also looking to simplify the criteria for rare disease evaluation. This will build upon our vision to facilitate access to valuable treatments for very rare conditions within the NHS. Our proposals include removing the criteria that a condition being treated must be chronic or severely disabling and considering the impact and additional benefits such technologies can provide.

We are also aligning our process and methods across all of our evaluation programmes to make better use of available evidence, place appropriate value on a wider range of technologies and speed up our approach in a way that works for companies. These changes include clarification about when NICE can make a recommendation for managed access where there isn’t a case for routine use, and consultations will be removed or shortened in certain instances to support this.

Currently, our committees can recommend higher cost treatments that support people in their last months of life which tends to apply to late-stage cancer treatments. However, evidence shows that society places greater value on health gains from treatments for very severe diseases over other treatments.

Therefore, we are proposing that a new ‘severity modifier’ will be introduced, putting more weight on treatments for people with any severe disease. As part of this we will be working closely with research partners to further understand how much the impact of placing greater value on the benefits achieved from new treatments for severe diseases would be on health funding elsewhere in the NHS and whether the level we currently use is appropriate.

As we have now left the European Union, it is more important than ever that while we are defining a new offer for companies we are clear about the benefits for them to launch their products in the UK market. The proposed updates will shape the UK environment as the place to make a first product submission by offering greater decision-making flexibility where it truly counts and build on a number of initiatives in which NICE is already involved, including the joint NICE/MHRA/Scottish Medicines Consortium Innovative Licensing and Access Pathway (ILAP) and the forthcoming NICE/NHS England Innovative Medicines Fund (IMF).

NICE sits at the crossroads between ensuring the NHS gets the best value out of the products it uses and promoting innovation by supporting the UK life sciences sector through regulation, health technology evaluation and patient access.

We have always been committed to working closely with companies to deliver timely access. Over recent years, we have completed multiple CAR-T treatment evaluations, with the latest being Tacartus at the start of 2021. NHS patients have been among the first in the world to access this groundbreaking treatment while real-world evidence is being gathered on their experience and its effectiveness. To achieve this, a commercial agreement was put in place with the company to provide the therapy at a reduced cost while evidence is collated. To date, this approach has been limited to cancer treatments through the Cancer Drugs Fund, however, in changing approach, we will now apply this flexibility to a wider range of conditions.

Another benefit the sector will see is the broadening of types of evidence considered beyond gold-standard randomised controlled trials. New flexibility will mean real-world evidence from patients’ lived experiences will be taken into account, ensuring we are accepting and reviewing the evidence and data that is most relevant for any given disease area.

We know that in some cases, such as rare diseases, children’s diseases and innovative or complex treatments, conducting research to evidence the true benefits of some treatments can be challenging. As part of the consultation, we acknowledge this uncertainty, and while evidence bases should still aim to be as strong as possible, all our committees will continue to act with more flexibility to take these situations into account.

We have already held multiple webinars to discuss the proposed changes and are taking into account the valuable feedback that has been provided by the sector to date. One of the main themes raised so far has been when and how we will implement these new processes and methods. We are currently developing a systematic approach to this, working with key stakeholders and keeping them informed throughout the consultation to ensure the best course of action can be agreed.

As part of this, we will need to design systems to oversee, prioritise, schedule and develop modular updates – and again, stakeholders will play an essential role in shaping this to be the best it can be.

This consultation is the first step, and there are many more updates to come around – for example, methods for considering drugs with multiple indications, health inequalities and genomics. We are moving away from a cycle of updating our approaches every four to six years, and instead committing to a new approach that will allow us to evolve and react as emerging science and methods do.

Taken together, our proposals aim to achieve fair, transparent and robust evaluation of products, increased opportunities to use real-world evidence as part of acceptance of a more comprehensive evidence base, and the support needed to ensure the UK is the most attractive place for life sciences companies to innovate, succeed and grow.