OBJECTIVES: The Raoul Wallenberg Australian Pregnancy Register (APR) was established in 1999 to collect, analyse and publish data on the risks to babies exposed to Anti-seizure medications (ASMs) and to facilitate possible quality improvements in management care over time. It is one of a few prospective observational pregnancy registers of ASMs that has been established around the world. No study has examined the cost-effectiveness of such registers. Here we aimed to evaluate the clinical and economic impacts of the APR from both societal and healthcare system perspectives.

METHODS: Using decision analytic modelling, we estimated the effectiveness (prevention of adverse pregnancy outcomes) and costs (costs of adverse pregnancy outcomes and the register itself) of the APR over a 20-year time horizon (2000-2019). The adverse outcomes were stillbirth, birth defects and induced abortion. All cost data were derived from published sources. The health and cost impacts were then extrapolated to the total target Australian epilepsy population. In the base-case analysis, the comparator was referred to the Register data from 1998 to 2002. The outcomes of interest were the return of investment (ROI) for the APR and incremental cost effectiveness ratio (ICER) in terms of cost per adverse outcome avoided.

RESULTS: Over the 20-year time horizon, the ROI from the APR from a societal perspective was AU$3,474 (i.e. every dollar spent on the program resulted in a return of AU$3,474). Over this time, it was estimated that there were 9,609 adverse pregnancy outcomes avoided, and healthcare and societal costs were reduced by AU$191milion and AU$13.8 billion, respectively. Hence from a health economic point of view, the APR was dominant (health and cost saving). This conclusion was stable to sensitivity analyses.

CONCLUSIONS: The APR represents excellent value for investment for Australian being not only health saving, but also cost saving from a societal and a healthcare perspective.