Introduction

This guide describes the methods and processes that NICE follows when evaluating HealthTech products and interventional procedures. The methods and processes are designed to produce robust guidance for the NHS in an open, transparent and timely way, with appropriate contribution from stakeholders. Organisations invited to contribute to health technology evaluation should read this guide in conjunction with the NICE-wide topic prioritisation process. This sets out the process for identifying, prioritising and routing new guidance topics and updates to existing NICE guidance.

The NICE HealthTech programme combines the former NICE Diagnostics Assessment programme, Interventional Procedures programme and Medical Technologies Evaluation programme.

To avoid duplication, this guide refers to the existing evaluation manual (NICE health technology evaluations: the manual) for methods and processes that remain the same. This guide sets out the new approaches in the HealthTech programme including further detail for clarity. Section 1 covers process (except for guidance that focuses on HealthTech products in existing use, which is currently set out in the late-stage assessment (LSA) interim methods and process statement). Section 2 covers methods (except for guidance that focuses on HealthTech products in existing use, which is currently set out in the LSA interim methods and process statement, and interventional procedures guidance which can currently be found in NICE's interventional procedures programme manual).

HealthTech products and interventional procedures can offer significant benefits to patients, such as a quicker diagnosis, faster recovery, and reduced risk. They also have the potential to improve efficiency and reduce costs, such as by streamlining patient flow, tailoring treatments to an individual, and reducing hospital admissions.

The HealthTech programme provides 2 types of guidance: HealthTech guidance and interventional procedures guidance.

HealthTech guidance

HealthTech is often used interchangeably with 'medtech'. For NICE guidance, HealthTech includes non-medicine technologies. This means diagnostics, medical devices and digital technologies including artificial intelligence. Examples include technologies, techniques, strategies and pathways that help diagnose, monitor, prognose, predict or symptomatically screen for health conditions, and technologies that treat, manage or prevent a health condition.

Recommendations are made based on assessment of clinical and cost effectiveness of HealthTech products.

When multiple technologies that can be used for the use case, or use cases, being assessed in a guidance topic are available to the NHS, they will be assessed in 1 piece of guidance. When only 1 technology is available, guidance will be produced for a single technology. It is expected that most HealthTech assessments will be for multiple technologies.

Interventional procedures guidance

Interventional procedures involve making an incision, a puncture or entry into a body cavity, or using ionising, electromagnetic or acoustic energy.

Recommendations are made based on assessment of the efficacy and safety of new, significantly modified or established procedures. Although some interventional procedures can involve implanting or using a health technology, the guidance and recommendations are about the procedure.

Lifecycle approach

The approaches taken to develop guidance, and the types of recommendation made, reflect what stage a technology or procedure is at in the lifecycle.

For early use

This approach considers HealthTech products that could address a national NHS unmet need. It rapidly assesses products early in the lifecycle (but that have appropriate regulatory approval for use in the UK) or that have limited use in the NHS and need further evidence to support wider use. Technologies considered for early use can be conditionally recommended for use while further evidence is generated during the evidence generation period. This enables early access to promising new technologies for patients. Conditional recommendations are for a fixed period of time and the technologies will be reassessed for routine use using the evidence generated.

For interventional procedures guidance, new or significantly modified procedures can be conditionally recommended for use while more evidence is generated to check if they are safe and efficacious.

For routine use

This approach considers HealthTech products that address a national NHS unmet need and may be suitable for routine widespread use in the NHS. Recommendations are based on assessment of clinical and cost effectiveness, or cost comparison.

For interventional procedures guidance, a recommendation that the procedure can be used is made if there is enough evidence on the safety and efficacy of the procedure for healthcare professionals to consider it as an option.

For existing use

This approach considers HealthTech products that are already in established use within the NHS, to inform commissioning and procurement decisions. Process and methods for this are currently in the LSA interim process and methods statement.