Within Trial Cost Analysis of Flares from the BLISS-SC Clinical Trial Evaluating the Use of Subcutaneous Belimumab for the Treatment of Systemic Lupus Erythematosus

Trial description: Belimumab is a B-lymphocyte stimulator-specific inhibitor indicated for the treatment of adult subjects with active, autoantibody-positive SLE who are receiving standard therap. Flares are a key manifestation of SLE and are associated with increased disease activity, poor subject outcomes, and significant burden. Results from the BLISS-SC trial have shown that SC belimumab plus standard therapy compared with placebo plus standard therapy is associated with statistically significant reductions in flares. The healthcare economic information may quantify the economic impact associated with the reduction in flares. However, this information needs to be timely in order to be valued and deemed relevant by decision-makers. Thus, a retrospective, economic analysis from the payer perspective of the United States (US) healthcare system will be conducted using trial data from the BLISS-SC trial. The aim of this study is to apply updated unit costs of treating flares to the flare events observed in the BLISS-SC trial to compare the flare costs between the SC belimumab plus standard therapy and placebo plus standard therapy groups. A cross-sectional study design using the most recent calendar year (2016) available in the claims data will be employed for assessing unit cost per flare episode. This year will be termed as the index year and the year prior to it will be the pre-index period, and will be used to identify subjects with active SLE disease. The study duration included data from the 01 January 2015 through 31 December 2016, which will be used for the claims analysis.