The Austrian Institute for Health Technology Assessment (AIHTA) completed the research project “Framework for reimbursement decisions of digital health technologies (mHealth) and its (retrospective) application on selected examples”. The report was published in the middle of December 2020.
The aim of the project was to test the applicability of the currently available frameworks on digital health applications, based on international experience. A systematic literature search in four databases and a survey of the International Network of Agencies for Health Technology Assessment (INAHTA) members was conducted to identify assessment frameworks, and six assessment frameworks were selected as examples and analyzed. A manual search was performed to identify already reimbursed digital health applications; for eleven digital health applications, the published studies were identified. A hand search was conducted to describe the strategies and regulations of several countries in dealing with digital health applications.
The results showed that suggestions for study designs were described in four of six analyzed frameworks. Risk classification of the digital health application and aspects of artificial intelligence were considered in one of six analyzed frameworks. Only for two of the 11 selected digital health applications, the present study design met the evidence standards of the NICE framework. Belgium, France, the Netherlands, England, and Germany have different strategies for the regulation and reimbursement of digital health applications. Recent developments in these countries show that there are efforts to find regulations at the national level.
In conclusion, there is a great heterogeneity of assessment frameworks, especially in regard to risk classification and technology-specific aspects such as data protection and artificial intelligence. Only the Evidence Standards Framework of NICE offers a precise classification into defined risk classes with correspondingly required study designs. The published evidence of digital health applications show differences in the choice of study designs. Controlled studies with comparisons of the standard of care are not always available but are more frequent in recent (ongoing) studies.
The full details in German can be found here and here.
This news is just one of about 300 market access news collected by our team in the subscription services "HTA Alerts” and “Reimbursement Alerts” every two weeks from more than 80 organizations. Access our paid subscription services to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news).
Not ready for a subscription service? Subscribe to our free-of-charge newsletter delivered every second week to get updates about key reimbursement developments in Europe (10-12 news every two weeks).