Trends in clinical evidence for digital health applications (DiGa) reimbursed in the German DiGa directory

Skeldon G, Dobson J, Adkins E. Trends in clinical evidence for digital health applications (DiGa) reimbursed in the German DiGa directory. Poster presented at ISPOR Europe; 6-9th November 2022; Vienna: Austria, 2022

OBJECTIVES: In Germany, since 2019, digital health applications (DiGA) are reimbursed by statutory health insurance if they are listed in the DiGA registry. A dedicated HTA process sets reimbursement criteria and provides two listing options: permanent, or provisional with evidence development during a 12-24 month trial period. We aimed to understand the types of DiGAs and clinical evidence submitted and intended for the trial period for DiGAs with permanent and provisional listing.

METHODS: Records for DiGAs listed on the directory website on 08/06/2022 (diga.bfarm.de/de) were reviewed.

RESULTS: 31 DiGAs were listed in the registry: 12 (39%) permanent and 19 (61%) provisional. The most frequent DiGA indications were mental health (n=12, 39%), pain (n=4, 13%), and diabetes (n=3, 10%). Randomized controlled trial (RCT) evidence was available for all DiGAs with permanent listing. For the 19 provisionally listed DiGAs, 14 presented evidence from non-comparative studies, 4 had evidence from an RCT, 1 had a comparative pilot study. All studies intended for the trial period were RCTs. For permanently-listed DiGAs, RCT size ranged from 56–608 patients (mean, 244), duration from 9–48 weeks (mean 24 weeks). For provisionally listed DiGAs, RCT size ranged from 48–261 patients (mean, 214), duration 6–12 weeks (mean 9 weeks); non-RCT size ranged from 20–797 patients (mean, 186), duration 4–48 weeks (mean 17 weeks); intended RCT size ranged from 121–640 patients (mean, 212), duration 6–48 weeks (mean, 16 weeks). DiGA prices are standardized for 90 days of use and ranged from €119–€718 (mean, €440).
CONCLUSION: Digital health technology development has increased rapidly in recent years; however, few have robust clinical evidence to demonstrate a positive healthcare effect. Reimbursement processes that enable early access prior to full clinical trial results being available help speed up availability of these innovative applications.