Methods: The EAs were performed in France, Germany, Spain, Denmark and Switzerland, using decision-analytic models describing AD treatment pathways, as well as resource utilisation and costs associated with the treatment of AD in healthy yet ‘at risk’ newborns who could not be exclusively breastfed. A time horizon of 12 months including six months of formula consumption was applied, with country-specific resource use and costs. In four settings, SF was the main comparator. The outcomes of the EAs were the number of avoided cases and the incremental cost per avoided case (ICER) of AD when comparing subjects who used PHF-W vs. SF. An ICER represents the additional cost for obtaining each additional clinical outcome gained, in this instance each avoided case. Given a lack of significant differences in efficacy between PHF-W and EHF, a cost-minimization approach was used in all settings to compare them. A negative ICER represents savings. Three perspectives were applied: the Ministry of Health (MOH), the family and society.
Results: In the base case analyses selecting PHF-W over SF yielded numbers of avoided cases of AD ranging from 1,653 (Switzerland) to 13,356 cases (France) for respective “at risk” birth cohorts of 22.933 and 185,298 infants. The analyses of PHF-W vs. SF generated ICERs ranging from €801 to €1,343 (MOH), from -€1796 to -€454 (family) and from -€995 to €719 (society). The costs of formula and time loss were the main cost drivers. When comparing PHF-W to EHF in prevention, PHF-W demonstrated savings ranging from €4-€120 million for society, or €1.3-€64 million for the MOH perspective. The robustness of the models and the direction of the results were confirmed by one-way and probabilistic sensitivity analyses.
Conclusions: In five European countries, PHF-W appears to offer a better prevention than SF at a reasonable cost, and at a lower cost than EHF.