OBJECTIVES: The emergence of digital medicine (DM) like smart pills, implantable drug delivery or digital therapeutics as a potential tool for efficient and sustained patient monitoring has created a fast-growing product stream offering a new facet of personalised medicine. The drug/device combination brings the involvement of the biopharmaceutical industry much closer to digital wearable technologies enabling real-time monitoring of patient data with respect to drug adherence and behavioural indications. However, there is little knowledge about the evaluation of new digital medicines in Europe.

The study objective is to determine the fundamental criteria with which payers will make reimbursement decisions for DM in the U.K., France and Germany.

METHODS: A systematic literature review was conducted on open-access articles in ScienceDirect, Journal of Market Access and Health Policy and SpringerLink. Due to a small number of initial results, review was expanded to include non-academic grey literature. The review focussed on determining the key payer preferences for an evaluation framework.

RESULTS: Currently, there is no established pathway for reimbursing DM in the three countries. In the UK, NICE will start assessing digital applications as part of NHS’ Improving Access to Psychological Therapies programme. DM access is localised and restricted to pilot studies that indicate Trust-specific funding decisions. In France, accreditation from the government’s Agency for Digital Health is required to work with patient data. In Germany, DM funding comes from the €300 million annual Innovation Fund. Currently, cost effectiveness (UK) and clinical outcomes (France and Germany) recieve highest weightage in reimbursement decision-making for DM.

CONCLUSIONS: The need for a robust evaluation system for DM is increasing as the number of innovative technologies brought to market rise. Currently, evidence requirements lean heavily on establishing DM on par with traditional drugs. But outcomes need to expand to include parameters like physician decision-making, self-management, data security and ethics.