NICE manual for technology appraisal and highly specialised technologies updated in England

On December 17, 2025, NICE updated its manual on health technology evaluations. The manual's title changed to “NICE technology appraisal and highly specialised technologies: the manual.”

The introduction was revised to clarify that the manual describes methods and processes for producing technology appraisal and highly specialised technologies guidance on new and existing medicinal products and HealthTech, including medical devices, diagnostics, and digital technologies.

The term "HealthTech" was introduced to encompass medical devices, diagnostics, and digital technologies, alongside medicinal products. The manual clarifies that “health technologies” refers to both medicines and HealthTech unless otherwise specified.

The manual now explicitly states that it applies only to technologies evaluated through NICE’s health technology evaluation programmes and does not cover other NICE programmes, such as clinical guidelines or interventional procedures guidance.

The update reflects a revised approach to evaluating HealthTech compared to traditional medicinal technologies. Key changes include the following:

• For HealthTech assessments, NICE may issue requests for information to companies during scoping where their technologies could be included in, or are otherwise relevant to, the assessment;
• Company evidence submissions are not made for HealthTech evaluations. Instead, companies may be asked to respond to specific requests for information from NICE. Economic models may be submitted as part of these responses;
• A Commercial Liaison Team (CLT) role has been introduced to support earlier alignment of commercial and pricing considerations within the evaluation process. Where a technology appears unlikely to be cost-effective at its initial price, early engagement may be initiated to explore potential pricing or access arrangements. Companies may provide pricing information as part of their response to a request for information and may submit updated costs during consultation on the draft guidance. Outside these points, new or revised prices may not be considered.

See the full details here.

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