Changes to the way medicines and other health technologies are evaluated for use in the NHS are expected to be approved by the NICE Board today.

The changes, if approved, will come into effect early next month for new evaluations and will give patients earlier access to new treatments by allowing greater flexibility over decisions about value for money and consideration of a broader evidence base. They will also provide greater predictability for industry, greater transparency for stakeholders and enable swift decision making for NICE’s independent committees.

The Board meeting marks the culmination of one of the largest and most comprehensive reviews of all aspects of NICE’s health technology evaluations ever undertaken. It covers how topics are chosen (topic selection), the steps and stages in each evaluation (processes), and how evidence is collected and considered (methods).

With extensive involvement from health system partners, industry, healthcare professionals, academia and patients, the changes signal how NICE is evolving alongside technological advances in healthcare and evidence to continue to deliver excellence for patients, the NHS, and the life sciences industry.

Among the changes expected to be agreed today are:

• Giving additional weight to health benefits in the most severe conditions (a ‘severity modifier’) that will allow for more equitable access to treatments for the most severe diseases, not just those used at the end-of-life. This change has been made because evidence shows that people in the UK highly value health benefits from treatments for the most severe diseases.
• Adopting new approaches to the evidence NICE considers in its assessments. For example, NICE will expand on and improve how it considers real-world evidence from the lived experiences of patients. This will allow NICE to get more insights from people affected by our guidance.
• Allowing more flexibility for NICE’s independent committees in cases where generation of evidence is particularly difficult. Sometimes, research into conditions affecting children, rare diseases or where the new treatment is innovative, or complex can be problematic. While the strongest evidence base will always be required, the proposed changes will allow NICE’s committees to consider uncertainty appropriately and proportionately and to manage the risks to patients and the NHS while preventing inappropriate barriers to valuable innovations.
• Adopting a clearer vision, principles, and routing criteria for treatments for very rare diseases that NICE will evaluate under its Highly Specialised Technologies (HST) Programme. This will improve the efficiency, predictability, and clarity when routing topics to the programme and build upon our ambition to provide fairer access to highly specialised medicines and treatments within the NHS. Key to this is a reduction in the number of different criteria that must be met to enter the HST programme from 7 to 4 and a more explicit acknowledgement of the wider impact on the NHS and the displacement of healthcare resources that occurs when NICE recommends a treatment through the HST programme.
• Earlier engagement with NHS England and NHS Improvement and companies about commercial/managed access proposals, as well as providing greater clarity around the circumstances in which NICE committees can make a managed access recommendation, where NHS patients can receive a treatment while further data is collected on its effectiveness.
• Aligning our methods and processes across different types of evaluation, spanning medicines, medical devices, and diagnostics, to ensure that health technology evaluation is pragmatic, agile, and robust, while also being able to adapt to environmental changes and system partners' requirements.

Professor Gillian Leng CBE, NICE chief executive, said: “Our vision at NICE is to be at the forefront of delivering access for patients in the NHS to valuable, evidence-based innovative medicines, medical devices and diagnostics. The changes being discussed today will provide a robust foundation for our evaluations now and in the future and enable us to continue to lead the way in rapid, independent health technology assessments.

“But they are not the end of the story. In the short term, we will explore the impacts and benefits of the updated methods and processes. We need to ensure they are effectively implemented in order to realise the benefits for NICE, the NHS and the wider stakeholder community, as well as supporting the Government’s wider vision for life sciences.

“Going forward, NICE will adopt a more modular approach to updates to its methods and processes. This will enable us to be more agile and responsive, monitoring, reviewing, and improving our methods and processes into the future, making sure they remain cutting edge as the healthcare landscape continues to evolve.”

NICE has identified potential topics for future modular updates, including:

• Processes to enable rapid entry to managed access agreements, and to manage technologies which are licensed to treat more than one condition.
• Methods issues for digital, genomic, and antimicrobial technologies.
• Further methods issues, such as the societal value of health benefits in severe diseases, health inequalities, quality of life in children and carers, and further support for a comprehensive evidence base.

Helen Knight, programme director in the Centre for Health Technology Evaluation at NICE, said: “We’ve engaged extensively with our stakeholders throughout this process, and we’ve listened to their concerns and taken on board many of their suggestions. I would like to thank all those organisations and individuals who have so generously given their time to help us deliver a blueprint for health technology evaluation that is truly collaborative and one which signals our commitment to making the journey for promising new health technologies even faster, and patient access fairer.”