OP05.10: A global landscape analysis of reimbursement policies for prenatal cell‐free DNA testing in public healthcare systems

Le résumé fourni par la source

With strong evidence supporting the use of cell-free DNA (cfDNA) testing to screen for fetal trisomy 21 in the general prenatal population, professional guidelines now recommend offering this testing clinically. The goal of this work was to explore how these guidelines are being instituted globally by studying the coverage of cell-free DNA testing in national and regional public health systems. Public policy statements, public policy recommendations and ongoing evaluation projects published in the clinical literature and available on public websites were reviewed. Information related to the scope of testing and integration into public healthcare programs was compiled. We identified fifteen countries with policies to provide healthcare coverage for cfDNA testing and at least four countries with policies pending. The coverage is nationwide in eight and on a regional or local basis in seven. Trisomy 21 is the primary focus; however, most policies also include trisomies 13 and 18. Currently, there is no published public policy covering conditions beyond these except for research purposes on temporary basis. Two countries provide first-line screening to all women, one (Belgium) as part of public policy and the other (The Netherlands) on a research basis. The remaining countries provide screening contingent on another method of risk assessment, most commonly first trimester combined screening, with different risk thresholds employed. A number of other countries are in the process of developing policies, which are expected to be published soon. Public health coverage of cfDNA testing has expanded rapidly over the last five years but is heterogeneous. Different thresholds are employed for offering testing and are not necessarily consistent with published studies and guidelines. Access differs not only between countries but also between different regions in the same country. Cost calculations are generally included in policies and are an important driver in implementation. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.

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