OBJECTIVES: Despite rapid growth, access/reimbursement of digital health technologies (DHTs) has proven difficult due to lack of clear access guidance or strict evidence generation requirements (e.g., clinical trials). Use of real-world evidence (RWE) has been included in two recently published assessment frameworks (in France and the United States (US), both in 2023). The two frameworks and related appraisals have been analysed to understand how the use of RWE can support access and reimbursement of DHTs.

METHODS: Firstly, the DHT assessment frameworks were analysed in terms of evidence requirements, specifically regarding use of RWE. Secondly, a hand-search of published appraisals following the publication of these frameworks was conducted in June 2024, and retrieved appraisals were reviewed.

RESULTS: In France, PECAN (Prise en charge anticipée des dispositifs médicaux numériques) framework grants temporary reimbursement for innovative DHTs, while companies develop supporting evidence. Alternative methods, including RWE studies are regarded as acceptable evidence for permanent reimbursement. In the US, the Institute for Clinical and Economic Review and the Peterson Health Technology Institute (ICER-PHTI) still prefer RCTs, however high-quality observational studies using an appropriate comparator and patient-relevant outcomes are acceptable.

CONCLUSIONS: The two assessment frameworks provide guidance for reimbursement/access for DHTs and allow use of RWE if studies are robustly conducted. Positive reimbursement decisions can be used in other markets where the two HTA agencies are referenced in decision making.