Health Technology Assessment (HTA)

Health technology assessment (HTA) is the process by which the clinical- and cost-effectiveness of a new treatment or intervention, as well as its broader impact on patients and health systems, is evaluated to determine whether it represents sufficient value to justify adoption and funding.

HTA requirements vary considerably across jurisdictions. Agencies such as NICE, G-BA, HAS and CADTH each operate within distinct deliberative frameworks, apply different evidence standards and weigh clinical and economic data in different ways. For medical device and diagnostics companies, the challenge is compounded by the fact that device evidence bases are typically thinner than those available for pharmaceuticals — fewer randomised controlled trials, shorter follow-up periods and limited health economic data. Navigating this landscape requires a clear understanding of what each agency expects to see, how deliberative committees interpret evidence and where submissions most commonly fail. The introduction of the EU HTA Regulation, with its joint clinical assessments, is adding a further layer of complexity to an already demanding environment.

I advise medical device and life sciences companies on HTA strategy, submission planning and evidence alignment across jurisdictions. This includes preparing evidence packages for NICE evaluations and NHS procurement, developing local trust-level business cases and ensuring that clinical and economic evidence is structured to meet the specific requirements of the relevant assessment process.