Changes to how medicines and health technologies are evaluated for use in the NHS are expected to be made today by the National Institute for Health and Care Excellence (NICE).
If approved, the changes 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. The changes will come into effect early next month and should provide greater transparency for stakeholders and enable faster decision making by NICE committees.
The NICE Board will meet today to discuss one of the largest 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).
Among the changes expected to be agreed today are a ‘severity modifier’ that will allow more equitable access to treatments for severe diseases, not just those used at the end-of-life.
NICE will also consider adopting new approaches to the evidence it considers in its assessments. For example, NICE will expand on and improve how it considers real-world evidence from the lived experiences of patients. NICE will also aim to give more flexibility to its independent committees in cases where the generation of evidence is difficult. Examples such as conditions affecting children, or rare diseases often means that new treatment are complex and problematic.
Treatments for very rare diseases will be evaluated under NICE’s Highly Specialised Technologies (HST) Programme. It’s hoped that this will enable 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 seven to four.
NICE also wants to engage earlier with NHS England and NHS Improvement, as well as companies, about commercial 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
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.”
Part of NICE’s modular approach that professor Leng mentions include four topics that will need regular assessment. These include processes to enable rapid entry to managed access agreements, and to manage technologies which are licensed to treat more than one condition. NICE will also examine the methods it uses for digital, genomic and antimicrobial technologies. More so, it will examine 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.”