Digital Health Value Assessment Frameworks: An International Landscape

OBJECTIVES: The nuances of digital health technologies (DHTs) necessitate tailored value assessment frameworks (VAFs) to ensure appropriate evaluation. In September 2023, ICER and PHTI published a VAF to support assessment of DHTs in the USA. The objective of this research is to compare the ICER-PHTI framework with other national VAFs to support understanding of its position in the landscape.

METHODS: Targeted searches were conducted to identify relevant frameworks specifically tailored to support the value-based evaluation of DHTs. Assessment criteria detailed in each VAF were extracted to enable comparisons of frameworks across data security, usability, clinical and economic value domains.

RESULTS: VAFs from the USA, Germany, France, UK, Finland and Australia were analyzed; all included a requirement for DHTs to adhere to data privacy laws, and submission of safety and clinical efficacy evidence. However, evidence requirements, including the need for a randomized controlled trial, vary; Germany and UK VAFs were also the only to specifically reference acceptance of real-world evidence. The ICER-PHTI VAF details budget impact model (BIM) methodologies, whilst the UK VAF notes both BIM and cost-effectiveness modelling requirements; all other VAFs do not report HE modelling requirements. Consideration of health inequalities, environmental sustainability and DHT usability were also inconsistent across countries.

CONCLUSIONS: Requirements related to data security, clinical efficacy and safety represent universal value domains considered by current national VAFs. However, HE modelling requirements vary between countries. The ICER-PHTI framework covers a broad range of domains, including BIM requirements, suggesting a robust VAF. Only the UK VAF considers more domains by employing two complimentary frameworks to support DHT evaluation (Evidence Standards Framework/Digital Technology Assessment Criteria); other countries could consider this model to ensure robust value assessment of DHTs. Differences between national VAFs may introduce country-specific complexities for DHT adoption, which could be mitigated by manufacturers developing evidence to meet the most robust VAFs.