Background: Venous thromboembolism (VTE) in hospitalized medically ill patients is a leading preventable cause of morbidity and mortality in the United States. About half of VTE events occur following discontinuation of standard-duration in-hospital prophylaxis and hospital discharge. The APEX study evaluated Betrixaban for in-hospital to home VTE prophylaxis and is the first FDA approved anticoagulant for in-hospital and extended-duration (35-42 days) prophylaxis of VTE in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE. Our goal was to demonstrate the potential budget impact of VTE prophylaxis over an extended 35-42 day duration for patients who meet the APEX study criteria.

Methods: We developed a dynamic, Excel-based model to estimate the budget impact of extended-duration VTE prophylaxis. Efficacy and safety results were utilized from the 80mg mITT sub-population of the APEX trial. Duration of therapy was based on the median APEX treatment duration: 9 days for enoxaparin and 36 days for betrixaban. Cost of clinical events and drug plus administration were identified through peer-reviewed literature and extrapolated to $2017 using the CPI medical inflation index.

Results: Assuming an institution has 20,000 acute hospitalizations per year, 3,923 patients would be non-surgical patients at ACCP-defined high VTE risk. Including those patients at risk consistent with APEX, 2,458 patients would potentially be eligible for betrixaban. For integrated organizations, drug plus administration cost would be $0.5 million for enoxaparin and $1.4 million for betrixaban. Drug acquisition cost alone would be $1.4 million for betrixaban and $0.2 million for enoxaparin, or an increase of $1.2 million to annual pharmacy spend across settings of care. The total cost of clinical events would be $3.6 million for enoxaparin vs $2.3 million for betrixaban. The betrixaban strategy would result in a savings of 54 VTE events (symptomatic proximal or distal DVT, asymptomatic proximal DVT, non-fatal PE or VTE-related death). Coupled with the drug plus administration costs, the betrixaban strategy results in an overall cost savings of $0.4 million or $182 per patient treated.

Conclusions: In-hospital to home VTE prophylaxis for 35-42 days with betrixaban is highly cost-effective compared to standard-duration enoxaparin for the prophylaxis of VTE.