Venous thromboembolism (VTE) is a potentially fatal cardiovascular condition characterized by the development of a thrombus in the vasculature. Treatment options for VTE have been largely limited to use of a fast-acting injectable anticoagulant (typically the low-molecular weight heparin [LMWH] enoxaparin [Sanofi’s Lovenox, generics]) and warfarin. However, the commercial potential for novel drugs for VTE is considerable, driven largely by concerns surrounding long-term warfarin use, such as the need for continuous monitoring, variable dose response in patients, and a large number of drug-drug and food-drug interactions.
Several novel oral anticoagulants (NOACs) have been developed as alternatives to warfarin, including the direct factor Xa (FXa) inhibitor rivaroxaban (Bayer/Janssen’s Xarelto); the direct FXa inhibitor apixaban (Bristol-Myers Squibb/Pfizer’s Eliquis); the direct thrombin inhibitor dabigatran etexilate (Boehringer Ingelheim’s Pradaxa); and the direct FXa inhibitor edoxaban (Daiichi Sankyo’s Savaysa). The lack of head-to-head trial data among the NOACs, their contrasting administration profiles, and their varying use in stroke prevention in atrial fibrillation (AF) create an increasingly complex treatment landscape for VTE. Furthermore, the evolving reimbursement landscape and low cost of treatment with the standard therapy of warfarin, coupled with the burgeoning number of available treatment options, will result in increased market access challenges for the NOACs in the VTE treatment setting.
In this report, we analyze the results of our survey of 30 emergency room physicians (ERPs), 70 cardiologists, and 30 managed care organization (MCO) pharmacy or medical directors to examine the dynamics that will limit or promote the NOACs’ market access.