Opportunities and barriers for reimbursement of digital therapeutics in Austria: Findings From expert interviews

Abstract

Background: Digital therapeutics (DTx) are software-based interventions that aim to prevent or treat especially non-communicable diseases. Currently, no framework for reimbursement of DTx exists in Austria. The aim of this study was to gather a comprehensive perspective on regulatory considerations of Austrian stakeholders with regard to reimbursement of DTx and to outline strategies for establishing a national reimbursement framework. Methods: Based on a stakeholder analysis, seven semi-structured interviews with Austrian experts from the digital health-related fields medicine, public health, health technology assessment, health industry and social security providers were conducted. Interviews were analyzed according to seven predefined themes. Results: Overall, participants agreed that reimbursement of DTx by the public insurance in Austria is desirable. Prerequisites are (i) a high user and prescriber acceptance of DTx, which must be integrated into a transparent and interoperable Austrian e-Health infrastructure, (ii) a sufficient, risk-based level of evidence for clinical effectiveness, (iii) national authorities that transparently provide evidence-base, indications, contra-indications and potential risks, (iv) adopting European regulations about data security, secondary use of data and use of artificial intelligence and (v) a health-economical evaluation of DTx. Conclusion: A comprehensive national strategy for reimbursing DTx will need to consider technical, scientific and socio-economical requirements, patient safety and liability, secure health data handling and use of artificial intelligence in order to establish a sound framework with equitable access also for socioeconomically disadvantaged persons in order to address the growing burden of non-communicable diseases.