OBJECTIVES:

The aim of this study was to compare health technology assessment and reimbursement of digital therapeutics in France, Germany and the UK.

METHODS:

Digital therapeutics (DTx) are rarely differentiated from other digital health technologies (DHTs) such as telemedicine and connected care. Submissions in NICE, CNEDiMTS and BfArM DiGA directories were searched systematically to identify DHTs. Interventions were classified as DTx based on the Digital Therapeutics Alliance definition.

RESULTS:

In France, DHTs are assessed by CNEDiMTS, using the same process as for all other medical devices. Most DHTs monitored cardiovascular conditions using implantable devices (89%). Of those that met the DTx definition (2%), CNEDiMTS concluded one intervention had insufficient evidence, one provided moderate additional benefit and one provided minor additional benefit.

In May 2020, Germany introduced a reimbursement process specific to DHTs, via BfArM. Of the assessments completed, 30% achieved reimbursement, 7% had a negative outcome and 63% of applications were withdrawn. All reimbursed products met the DTx definition; most were psychiatry interventions (53%). 29% of reimbursed products achieved permanent listing on the DiGA directory and demonstrated an improvement of health status.

In 2020, NICE established a pilot project for assessing DHTs in the UK; medical technology Zio XT was the first product assessed using this framework. Assessments of 2 DTx are currently in progress (Sleepio and myCOPD). A targeted search also identified NICE advice (a form of evidence summary rather than formal reimbursement assessment) for 14 psychiatry DTx.

CONCLUSIONS:

Germany has reimbursed the most DTx, reflecting the alignment between the DTx definition and BfArM’s assessment criteria for DiGA products. France has assessed very few DTx and the assessment of DTx by NICE is less well defined than in France or Germany. The assessment routes in these two countries are expected to evolve and become more distinct as DTx become more common.