OBJECTIVES: Digital health technologies (DHTs) are increasingly being assessed by regulatory bodies. Few DHTs to-date have undergone formal health technology assessment (HTA), resulting in limited analogues to compare evidence requirements between HTA bodies. To improve transparency, a comparative review of the evidence requirements of Germany’s BfArM and UK’s NICE was conducted.

METHODS: A search of an international database of extracted HTAs (HTA Accelerator) was conducted in July 2022. HTAs were restricted to assessments of DHTs intended for patients with depression undertaken by NICE and BfArM. Data extractions included the evidence under assessment, agency critique and outcome.

RESULTS: A total of 9 and 4 DHTs assessed by NICE and BfArM, respectively, since 2018 were reviewed. For both agencies, the evidence generation plan must include a well-designed study, ideally conducted in local clinical setting, with the population and comparator studied in the RCT reflecting the intended positioning in current treatment pathway. Real world evidence was often required by NICE, which was not required by any of the reviewed BfArM assessments. EQ-5D appears to be a good scale to have for NICE. Therapeutic content is not assessed by BfArM beyond the positive care effect, while NICE assesses content using current practice. The economic assessment is limited to a cost analysis quantifying the budget impact for the NHS. Previous NICE recommendations in the UK often require the company to collect local data on its use, while BfArM provides immediate reimbursement with no requirements for data collection on costs.

CONCLUSIONS: Evidence generation planning to support local reimbursement decisions for DHTs should include locally collected data on their use in the form of a robustly designed RCT to be successful for NICE and BfArM. Additionally, data describing the impact on local resources is needed for NICE and might benefit price negotiation in Germany.