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.
Questions Answered in This Report:
- Understand physicians’ use of currently available VTE therapies. How do ERPs and cardiologists differentiate between the different lead-in injectable anticoagulant therapies? What are the key considerations for both physician groups when selecting VTE agents, and how does treatment differ for different subpopulations of VTE patients (i.e., DVT, PE, and VTE due to cancer)? What restrictions (e.g., step therapy) do payers place on the use of current VTE agents?
- Explore physicians’ and payers’ attitudes toward treating VTE as new therapies become available. How do surveyed physicians expect to incorporate Eliquis, Pradaxa, and Savaysa into clinical practice? Where do they expect these agents to sit in the changing treatment algorithm, and which current VTE therapies are most at risk of losing share? What factors will most influence formulary inclusion of these emerging agents? How will MCO reimbursement constraints, including tiering and formulary restrictions, affect the potential patient share of these emerging drugs? Are data demonstrating a reduction in bleeding relative to warfarin an advantage in the eyes of payers for Eliquis and Savaysa, and, conversely, is the absence of such data a hindrance for Xarelto and Pradaxa?
- Examine physicians’ and MCO PDs’ receptivity to therapies that do not require a lead-in injectable anticoagulant. How do physicians expect to incorporate such agents into clinical practice should they reach the market? How will they affect the use of standard therapies? What, if any, will be the impact on the other emerging NOACs that do have a lead-in injectable anticoagulant? What restrictions will MCO PDs/MDs impose for those agents that also require a lead-in injectable anticoagulant?
This U.S. Physician & Payer Forum investigates payer and physician dynamics that affect prescribing practices for therapies for VTE in the United States. The report is based on a survey of 30 emergency room physicians, 70 cardiologists, and 30 pharmacy/medical directors at MCOs that offer commercial health insurance. We analyze current physician and payer insights and practices; perceptions of the NOACs in the pipeline; uptake of emerging therapies for DVT, PE, and VTE due to cancer; and formulary decision making for current and emerging agents, including Bayer/Janssen’s Xarelto, Bristol-Myers Squibb/Pfizer’s Eliquis, Boehringer Ingelheim’s Pradaxa, Daiichi Sankyo’s Savaysa, Sanofi’s Lovenox, and Aspen’s Arixtra.
Markets covered: United States.
Primary research: Online survey of 30 emergency room physicians, 70 cardiologists, and 30 MCO pharmacy or medical directors.
Population segments: DVT, PE, VTE due to cancer.