NICE has produced a single guidance development manual, which describes how NICE conducts itself with each step and stage in its evaluation (NICE's processes) and how NICE collects and considers evidence (NICE's methods). The guidance development manual covers:
- Diagnostic Assessments Programme
- Medical Technologies Evaluation Programme
- Highly Specialised Technologies Evaluation Programme
- Technology Appraisal Programme
As reported by Digital Health Net, NICE has committed to a more modular approach to future updates to its methods and processes, identifying 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.
NICE has also developed a new topic selection manual, setting out how NICE chooses medicines and other health technologies to evaluate.
The changes were intended to streamline and improve the way NICE undertakes health technology evaluation. Of the range of alterations NICE has made on how it evaluates health technologies, key changes include:
- Looking beyond treatments used in palliative care to consider health benefits they may give in other severe conditions.
- Accepting a broader range of evidence to be included in the assessment process, including improving how NICE takes into consideration real-world evidence from patients' lived experiences.
- Permitting more flexibility for NICE's independent committees in cases where evidence generation and collection is difficult, for instance, pediatric conditions, rare diseases or where the new treatment is innovative or complex. NICE's committees will be more enabled to consider uncertainty appropriately whilst managing patient risk, reducing inappropriate barriers to innovations.
- Taking on a clearer vision, principles and routing criteria for very rare disease treatments, which NICE will evaluate under its Highly Specialised Technologies (HST) Programme, to improve the efficiency, predictability and clarity when routing topics to the HST programme, and build upon NICE's ambition to provide fairer NHS access to highly specialised medicines and treatments.
- Advanced engagement with NHS England and NHS Improvement and companies regarding commercial / managed access proposals that allow NHS patients to receive treatment while further data is collected on its effectiveness. The circumstances in which NICE committees can make a managed access recommendation will be made clearer.
- Aligning the methods and processes used across different types of evaluation to make health technology evaluation more pragmatic, agile, and robust, and thereby able to adapt to environmental changes and partner requirements.
The changes came into effect from 1 February for new evaluations. Evaluations that were already underway will continue to use the previous methods and processes.
