PMU72 Digital Health Technology PILOT Evaluation

Abstract

NICE was commissioned by NHS England to conduct an evaluation pilot for digital health technologies (DHTs) during 2019/20. The pilot aimed to produce national NICE guidance on cost saving DHTs, consistent with the policy aims of the forthcoming NHS England funding mandate for MedTech. The pilot evaluation for DHTs was based on the existing NICE medical technologies guidance process and methods which aim to evaluate the clinical effectiveness and economic impact of the technology. The key stages in the evaluation are scoping, evidence submission, evidence review, committee decision-making and guidance publication. The pilot process included some variations suited for DHTs such as a technical assessment, inclusion of digital expert advisers, revision of the evidence submission process and the option of collecting additional data before the committee. The pilot involved the assessment of 5 DHTs chosen by NHS England. Three of the technologies did not obtain regulatory approval within the expected timeframe and had sparse clinical evidence and so the guidance development did not proceed beyond the evidence review stage. Guidance development is proceeding on 2 technologies and will be published later this year. Valuable lessons were learnt about developing NICE guidance on a range of DHTs. Examples include a proposal that regulatory approval should be a pre-requisite for medical technologies guidance development and that splitting the company submission into 2 parts enabled the early identification of topics with insufficient clinical evidence to proceed further to the committee and also reduced the burden on companies. The pilot evaluation project successfully explored the development of NICE’s medical technologies guidance for 5 DHTs. Lessons learnt will be used to update the current NICE medical technologies guidance development process and methods to facilitate routine guidance development for DHTs.