Changes to the way medicines and other health technologies are assessed 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 further assessments and will give patients faster access to new treatments by allowing greater flexibility on decisions about value for money and taking. taking into account a larger database. They will also provide greater predictability for the industry, greater transparency for stakeholders, and enable rapid 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 health technology assessments ever undertaken. It covers how topics are chosen (topic selection), the stages and stages of each assessment (process), and how evidence is collected and considered (methods).
With broad involvement from healthcare system partners, industry, healthcare professionals, academia and patients, the changes show how NICE is evolving alongside advancements in healthcare technology and evidence to continue to deliver excellence to patients, the NHS and the life sciences industry.
Among the changes expected to be agreed today are:
- Giving extra weight to health benefits in the most severe conditions (a “severity modifier”) that will allow more equitable access to treatments for the most serious conditions, not just those used at the end of life. This change has been made because evidence shows that people in the UK place great importance on the health benefits of treatments for the most serious conditions.
- Adopt new approaches to the evidence that NICE considers in its reviews. For example, NICE will develop and improve the way it considers real-world evidence from the lived experiences of patients. This will allow NICE to obtain more information about the people affected by our advice.
- Allow more flexibility for independent NICE committees in cases where producing evidence is particularly difficult. Sometimes research on conditions affecting children, rare diseases or when the new treatment is innovative or complex can be problematic. Although the strongest evidence base is always required, the proposed changes will allow NICE committees to appropriately and proportionately consider uncertainty and manage risks to patients and the NHS while avoiding inappropriate obstacles. to valuable innovations.
- Adopt a clearer vision, principles and referral criteria for treatments for very rare diseases that NICE will assess under its Highly Specialized Technologies (HST) programme. This will improve efficiency, predictability and clarity when bringing subjects into the program and build on our ambition to provide more equitable access to highly specialized 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 program from 7 to 4 and a more explicit recognition of the wider impact on the NHS and the shift in healthcare resources that is occurring when NICE recommends treatment. through the HST program.
- Earlier engagement with NHS England and NHS Improvement and businesses on commercial/managed access proposals, as well as greater clarity on the circumstances in which NICE committees can make a managed access recommendation, where patients in the NHS may receive treatment while additional data is collected on its effectiveness.
- Align our methods and processes across different types of assessment, spanning drugs, medical devices and diagnostics, to ensure that health technology assessment is pragmatic, agile and robust, while being able to adapt to environmental changes and system partner requirements.
Professor Gillian Leng CBE, Chief Executive of NICE, said: “Our vision at NICE is to be at the forefront of NHS patient access to innovative and valuable medicines, medical devices and diagnostics. , based on evidence. The changes discussed today will provide a solid foundation for our current and future assessments and allow 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 that they are actually implemented in order to realize the benefits for NICE, the NHS and the wider stakeholder community, as well as supporting the government’s broader vision for life sciences.
“Going forward, NICE will take a more modular approach to updates to its methods and processes. This will allow us to be more agile and responsive, to monitor, review and improve our methods and processes in the future, ensuring they remain at the forefront of technology as the care landscape healthcare continues to evolve.
NICE has identified potential topics for future modular updates, including:
- Process to enable rapid entry into managed access agreements and to manage technologies that are permitted to address more than one condition.
- Methods issues for digital, genomic and antimicrobial technologies.
- Other methods issues, such as the societal value of health benefits in critical illness, health inequalities, quality of life for children and caregivers, and additional support for a comprehensive database.
Helen Knight, Program Director at NICE’s Center for Health Technology Assessment, said: “We have engaged extensively with our stakeholders throughout this process, and we have listened to their concerns and considered many of their suggestions. I would like to thank all the organizations and individuals who have given so generously of their time to help us develop a plan for health technology assessment that is truly collaborative and signals our commitment to further accelerate the journey to promising new health technologies, and more equitable patient access.