26P Cost-Effectiveness Review of the 21-GENE Breast Cancer Test

Abstract

ABSTRACT Oncotype DX® (ODX) is a validated 21-gene assay that allows personalised treatment decisions in early-stage, node negative, ER+ breast cancer. The cost-effectiveness of ODX has been assessed in multiple studies and European data has been presented recently. Study objective was to review the consistency of methods and findings from all available studies. The electronic database Pubmed and a selection of congress databases were searched to identify publications describing cost-effectiveness analyses of ODX. Searches were limited to those published in the English language between January 2001 and January 2012. All records were screened for inclusion in the review. The methodological quality of selected publications was assessed using the 35 items methodological checklist from Drummond et al. Five published health economics analyses and 6 abstracts were identified. The studies were carried out in multiple countries (US (2), Canada (2), Japan, Israel, Singapore, UK, Germany, France and Hungary and used a Markov modeling approach based on data from a large multicentre trial (e.g. NSABP B-20) to make estimates of long-term outcomes, and assess the cost-effectiveness of using the ODX recurrence score in patients classified as having a high or low risk of distant recurrence using other methods of assessment. All studies were carried out in the perspective of the healthcare payer. Study comparators, costs, characteristics of the population receiving the test and impact of using the ODX results on treatment decisions were adapted to each individual country clinical practice explaining the large range of cost-effectiveness results from these studies. In the US and France, using ODX was shown to be cost-saving when in one of the Canadian studies, it was cost-effective (incremental cost-effectiveness ratio of $64,063 per QALY gained). When looking at the methodological quality of studies, they generally scored well however posters, as expected scored lower than the full scale articles. Published literature to date is of good methodological quality and consistently supports the cost-effectiveness of using ODX in the various settings. Further analyses should be carried on to assess the budget impact of funding ODX and to include a broader perspective of the costs. Disclosure J.A. Plun-Favreau: Juliette Plun-favreau is an employee of Genomic Health. All other authors have declared no conflicts of interest.