%0 Journal Article %9 ACL : Articles dans des revues avec comité de lecture répertoriées par l'AERES %A Seror, V. %A Cao, C. %A Roussey, M. %A Giorgi, Roch %T PAP assays in newborn screening for cystic fibrosis : a population-based cost-effectiveness study %D 2016 %L PAR00014808 %G ENG %J Journal of Medical Screening %@ 0969-1413 %K Newborn screening ; cystic fibrosis ; PAP assay ; cost-effectiveness ; micro-costing %K FRANCE %M ISI:000378147200003 %N 2 %P 62-69 %R 10.1177/0969141315599421 %U https://www.documentation.ird.fr/hor/PAR00014808 %V 23 %W Horizon (IRD) %X Objectives: To compare the cost effectiveness of adding a pancreatitis-associated protein (PAP) assay to common immunoreactive trypsinogen (IRT) and DNA cystic fibrosis (CF) newborn screening strategies. Methods: Using data collected on 553,167 newborns, PAP cut-offs were calculated based on non-inferiority of the detection rates of classical forms of CF. Cost effectiveness was considered from the third-party payer's perspective using only direct medical costs, and the unit costs of PAP assays were assessed based on a micro-costing study. Robustness of the cost-effectiveness estimates was assessed, taking the secondary outcomes of screening (ie. detecting mild forms and CF carriers) into account. Results: IRT/DNA, IRT/PAP, and IRT/PAP/DNA strategies had similar detection rates for classical forms of CF, but the strategies involving PAP assays detected smaller numbers of mild forms of CF. The IRT/PAP strategy was cost-effective in comparison with either IRT/DNA or IRT/PAP/DNA. IRT/PAP/DNA screening was cost-effective in comparison with IRT/DNA if relatively low value was assumed to be attached to the identification of CF carriers. Conclusions: IRT/PAP strategies could be strictly cost-effective, but dropping DNA would mean the test could not detect CF carriers. IRT/PAP/DNA strategies could be a viable option as they are significantly less costly than IRT/DNA, but still allow CF carrier detection. %$ 056