The National Institute for Health and Care Excellence’s (NICE) board is expected to approve changes to the way medicines and other health technologies are evaluated for use in the NHS.

The changes, if approved, are being considered at the conclusion of one of the largest and most comprehensive reviews of all aspects into NICE’s health technology evaluations. NICE believes these proposed changes will give far greater flexibility over decisions about value for money and consideration of a broader evidence base.

As well as providing greater predictability to the industry and supporting quick decision making for NICE’s independent committees, the changes would also give patients earlier access to innovative new treatments.

The changes that are expected to gain approval include:

  • Giving additional weight to health benefits in the most severe conditions to allow for more equitable access to treatments, and not just those used for end-of-life care.
  • Adopting new approaches to the evidence NICE considers in assessments, allowing them to gain more insight from people affected by its own guidance.
  • Allowing more flexibility for NICE’s independent committees in instances where generating evidence is tricky. The strongest evidence base will always be required, but the proposed changes allow the committees to consider uncertainty appropriately and proportionately. It will also prevent inappropriate barriers to valuable innovations.
  • Adjusting the principles and routing criteria for treatments for very rare diseases to be evaluated under NICE’s Highly Specialised Technologies (HST) Programme.
  • Earlier engagement with NHS England and NHS Improvement and companies on commercial access proposals, as well as improved clarity on when committees can make a managed access recommendation.
  • Aligning the methods and processes used across different types of evaluation so that health technology evaluation is pragmatic, agile and robust and able to adapt to environmental changes and partner requirements.

Gillian Leng, NICE chief executive, said: “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.”

Modular approach for future updates

NICE has also committed to a more modular approach to future updates to its methods and processes. It has already identified potential topics for future modular updates, including methods issues for digital, genomic and antimicrobial technologies; processes to enable rapid entry to managed access agreements; as well as further methods issues such as health inequalities and the societal value of health benefits in severe diseases.

Leng continued: “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.”

If the changes are passed, they would come into effect early February for new evaluations, while ongoing evaluations will continue to use current methods and processes.

NICE has had extensive involvement from health system partners, industry, healthcare professionals, academia and patients, over the proposed changes being discussed. It opened a public consultation for the changes back in August 2021, where it sought feedback on the changes being considered.

Helen Knight, programme director in the Centre for Health Technology Evaluation at NICE, concluded: “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.”