OBJECTIVES:

This study compares and contrasts the reimbursement landscapes of digital health applications (DHAs) in Europe, Japan, and the US.

METHODS:

The reimbursement pathways for DHAs in the US, Belgium, England, France, Germany, Netherlands, Switzerland and Japan were reviewed to determine the maturity of established processes.

RESULTS:

Reimbursement opportunities are most developed in Germany, where the “fast-track” DiGA route has existed the longest and is the quickest process. Belgium recently introduced a DHA-specific national reimbursement framework, however, as only one app is currently reimbursed, it progresses slowly.

In England, DHAs can be certified by the National Health Service but funding decisions are made locally. Similarly, in the Netherlands, although DHA assessment guidance for insurers exists, opportunities are varied and local. In theory, Swiss health insurance offers DHAs reimbursement but no DHA-specific framework exists.

In Japan and France, DHAs can be assessed under the medical device route, though due to their length and complexity each country has approved only one DHA so far. However, an anticipated launch of a fast-access route will rapidly improve reimbursement access in France. In contrast, there are no DHA-specific plans in Japan.

DHAs in the US are reimbursed mostly by commercial payers on a case-by-case basis. CMS has recently included DHAs in a new Level II Healthcare Common Procedure Coding System. It opens the door to federal funding; however, limitations are anticipated due to the “one size fits all” approach.

CONCLUSIONS:

Currently, the extent of the establishment of national reimbursement processes varies significantly between countries. Germany and Belgium can be categorised as “leaders” in the advancement of the DHA reimbursement opportunities while France is a “fast follower”.

The US, Netherlands, Switzerland and the UK can be considered “evolvers” with frameworks being developed but no country-wide reimbursement currently. Japan, with no specific DHA processes, can be considered a “lagger”.