OBJECTIVES: Digital Health Technologies (DHT) are rapidly evolving and Health Technology Assessment (HTA) bodies are developing frameworks to assess their benefits for healthcare systems. In 2018, NICE published the Evidence Standards Framework (ESF) for DHT assessments. Lack of regulatory framework and transparent evidence requirements for combination DHTs [cDHT] (medical device/treatment with an app/software) means their access route remains unclear. An analysis was conducted to determine how compliant recent cDHTs submissions have been with ESF.

METHODS: A search of the HTA Accelerator^TM was conducted on 28^th March 2023. HTAs were restricted to assessments of device interventions published since 2019, subsequently filtered by cDHTs. Data extractions included submitted evidence, agency critique and recommendations. Evidence was then compared against ESF guidance.

RESULTS: A total 74 assessments were identified. Based on the criteria above, were retrieved for analysis, amongst which only two received a positive recommendation. All assessments included a systematic review of clinical evidence and head-to-head comparative data (observational or randomised controlled trial data). RWE is a requirement under ESF; however, it was included only in two assessments. Four assessments included a cost-effectiveness model and a cost minimisation model. However, only two assessments included a budget impact model, although this is a requirement under ESF. Patient involvement in the design of the DHT is also required but was only pursed by two sponsors. Other requirements (transparency about requirements for deployment; strategies for communication, consent and training processes, etc.) were sporadically provided.

CONCLUSIONS: Most of the evidence requirements were met; however, specific DHT requirements were not submitted, including local RWE to demonstrate applicability to UK practice. Main criticism from the Committee referred to lack of improved efficacy, RWE and long-term data. Key factors for positive recommendation identified were improved efficacy/non-inferiority to current practice and cost-effective use of healthcare system resources.