NICE is introducing a new HealthTech program in England

On February 7, 2025, the National Institute for Health and Care Excellence (NICE) published a manual for a new HealthTech program and launched a consultation. The HealthTech program will combine the former Medical Technologies Evaluation, Interventional Procedures, and Diagnostic Assessment programs. It will produce two types of guidance: Interventional Procedures guidance and HealthTech guidance.

• HealthTech guidance will cover non-medicine technologies, such as diagnostics, medical devices, and digital technologies, including artificial intelligence. The program will make recommendations based on the assessment of the clinical and cost-effectiveness of HealthTech products;
• Interventional Procedures guidance is relevant for procedures that involve making an incision, puncture, or entry into a body cavity or using ionizing, electromagnetic, or acoustic energy. Recommendations are made based on assessing the efficacy and safety of new, significantly modified, or established procedures. However, it is mentioned that where cost is considered in guidance, interventional procedures (including those with existing NICE Interventional Procedures guidance) can be assessed in HealthTech guidance or other NICE guidelines.

A life cycle approach is being introduced (applicable for HealthTech and interventional procedures):

Early use

• For HealthTech guidance, the approach focuses on HealthTech products that meet national NHS needs. It rapidly assesses products early in the lifecycle or with limited use in the NHS, and further evidence is needed to support wider use;
• For Interventional Procedures guidance, new or significantly modified procedures can also be conditionally recommended during the evidence-generation period to confirm their safety and efficacy, provided clinical and system risks are adequately addressed.

For routine use

• For HealthTech guidance, the approach considers HealthTech products that address a national NHS need and may be suitable for routine, widespread use in the NHS based on assessments of their clinical and cost-effectiveness or cost comparisons;
• For Interventional Procedures guidance, procedures are recommended when sufficient evidence supports their safety and efficacy, allowing healthcare professionals to consider them a viable option.

For existing use

• The application of HealthTech guidance relies on assessing existing, widespread HealthTech products within the NHS. This informs commissioning and procurement choices, and the relevant process is outlined in the Late Stage Assessment (LSA) manual.

The deadline for comments submission is March 6, 2025.

See the full details here.

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