Early economic evaluations (EEE) can evaluate the economic potential of new innovative healthcare solutions. We present a methodological framework for EEE in bipolar disorder and use eLi12 as an illustrative case, a new method to estimate 12-h lithium blood levels when blood sampling deviates from the 12-h timing, enabling more flexibility for patients and better data on 12-h lithium levels.

A decision-analytic model evaluated the costs and consequences of eLi12 for the treatment of bipolar disorder from a Danish national healthcare payer perspective, assessing the minimum efficacy threshold where eLi12 would be considered cost-effective compared with standard of care. The primary outcome was net monetary benefit (NMB), and we estimated quality-adjusted life-years (QALYs) assuming a willingness-to-pay threshold of €67,000/QALY gained. Costs associated with bipolar disorder and lithium treatment (e.g. hospitalisations, suicides, lost productivity, implementation costs) were estimated from literature, Danish registries, and expert opinion.

Assuming 28,000 patients with bipolar disorder whereof 10,000 are treated with lithium, a 2.5% reduction in number of hospitalisations and suicides are sufficient for eLi12 to be considered cost-effective within one year of implementation. When using a longer time horizon, allowing more savings to be included and thus considering a smaller improvement to be sufficient, less than 1% improvement by using eLi12 would be sufficient within a three-year time horizon.

EEE can evaluate the health economic potential of new innovative methods, supporting early investment decisions and guiding research. eLi12 can have significant healthcare savings, emphasising the relevance of studying clinical implementation.