PAP assays in newborn screening for cystic fibrosis: a population-based cost-effectiveness study. (June 2016)

• Record Type: Journal Article
• Authors: Seror, Valerie; Cao, Caroline; Roussey, Michel; Giorgi, Roch
• Is Part Of: Journal of medical screening. Volume 23:Number 2(2016)
• Page Start: 62
• Page End: 69
• Publication Date: 2016-06
• Subjects: Newborn screening -- cystic fibrosis -- PAP assay -- cost-effectiveness -- micro-costing; Medical screening -- Periodicals; 362.177
• DOI: 10.1177/0969141315599421
• Languages: English
• ISSNs: 0969-1413

Abstract

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.