“The 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 that we are making 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.” Gillian Leng, NICE Chief Executive January 20, 2022
Key changes being implemented by NICE
- Giving additional weight to health benefits in the most severe conditions to allow more equitable access to treatments for these conditions, not just to treatments used at the end-of-life.
- Adopting new approaches to the evidence NICE considers in its assessments. E.g., NICE will expand on and improve how it considers real-world evidence from the lived experiences of patients.
- Allowing more flexibility for NICE’s independent committees in cases where its particularly difficult to generate enough evidence. Sometimes, research into conditions affecting children, rare diseases or where the new treatment is innovative or complex can be problematic. The changes will allow NICE’s committees to consider uncertainty appropriately 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 Programme. This will improve the efficiency, predictability and clarity when routing topics to the programme and build upon NICE’s ambition to provide fairer access to highly specialised medicines and treatments within the NHS.
- Earlier engagement with NHS England and NHS Improvement and companies about commercial/managed access proposals that allow NHS patients to receive a treatment while further data is collected on its effectiveness. There will also be greater clarity around the circumstances in which NICE committees can make a managed access recommendation.