NICE publishes new combined methods and processes manual and topic selection manual

The changes outlined in the manuals will come into effect from 1 February 2022 for new evaluations and will give patients earlier access to innovative new treatments by allowing greater flexibility over decisions about value for money and consideration of a broader evidence base.

The new manuals cover how topics are chosen (topic selection), the steps and stages in each evaluation (processes), and how evidence is collected and considered (methods) and have been produced following one of the largest and most comprehensive reviews of all aspects of NICE’s health technology evaluations ever undertaken.

With extensive involvement from health system partners, industry, healthcare professionals, academia and patients, the changes outlined in the manuals 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.

Key changes included in the manuals are:

• 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. For example, 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 (HST) 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.

  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 that we have made, and which have been incorporated into our new manuals, 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 will now work to identify topics that may need modular updates. Potential topics might include processes to facilitate rapid entry to managed access, and to manage technologies with multiple indications, methods issues for digital, genomic and antimicrobial technologies, and further methods issues, such as the societal value of health benefits in severe diseases and health inequalities.