OBJECTIVES

: The FDA defines the scope of digital health as mobile health, health information technology, wearable devices, telehealth and telemedicine, and personalized medicine. According to an IQVIA report, the number of digital health apps available on iTunes and Google Play nearly doubled between 2015 and 2017. Japan's HTA agency will be launched in an environment where digital interventions are becoming increasingly prevalent; Japan’s and other Asian HTA bodies will need to develop processes to appraise digital interventions.

Question: How are digital health interventions obtaining access and reimbursement in France, Italy and the UK; and what factors led to their success?

METHODS

: An analogue analysis of the access pathways of three digital health interventions in Europe was conducted via desk research. A set of selection criteria was developed and used to select six interventions. After initial review, three were shortlisted for a deep dive analysis. These were: Diabeo (for diabetes), Monsenso (for mental illness) and SmartInhaler (for respiratory diseases).

RESULTS

: Diabeo was assessed by CNEDiMTS in France and is being funded as part of a national digital health experiment. Professionals using the service were also provided funding to facilitate the use of the app. Monsenso is being trialled by an NHS Trust in the UK. SmartInhaler was recommended by NICE in a MedTech innovation briefing. Yet none were guaranteed reimbursement. All three have been tested in clinical trials.

CONCLUSIONS

: There is no single, defined pathway for access and reimbursement of digital interventions in the countries assessed. However, HTA agencies have shown willingness to engage with digital interventions and local providers are keen to trial them if they show promise either in improving outcomes or efficiency of care. Asian HTA agencies can use these case studies to develop their own guidance.