What Are the U.S. Market Access and Prescribing Hurdles for the Oral Therapies Looming Large on the Horizon for Atherothrombotic Diseases? | Physician & Payer Forum | US | 2015

A Survey of Non-interventional Cardiologists and Managed Care Organization Pharmacy and Medical Directors

Atherosclerosis refers to the thickening of arterial walls due to deposition of plaque; it is the most significant pathology giving rise to cardiovascular disease. In this report, we focus on the clinical manifestations of atherosclerosis in the arteries of the heart, the brain, and the legs. The highlighted atherothrombotic indications are stable coronary artery disease (CAD), history of acute coronary syndrome (ACS), ischemic stroke or transient ischemic attack (TIA), and symptomatic peripheral arterial disease (PAD). All of these diseases are major causes of morbidity and mortality worldwide.

Several antithrombotic options are indicated to address the most important treatment goal in the long-term management of atherothrombotic diseases: the prevention of future atherothrombotic events (e.g., myocardial (re)infarction [MI], stroke, sudden death). Well-established antithrombotic options primarily consist of generic antiplatelet agents such as aspirin, clopidogrel, ticlopidine, and dipyridamole as well as branded antiplatelet agents like Effient (Eli Lilly’s prasugrel), Brilinta (AstraZeneca’s ticagrelor), and Aggrenox (Boehringer Ingelheim’s aspirin/modified-release dipyridamole).

Despite improvements in treatment and management, ischemic event rates and death remain high, and need remains for new therapies that can reduce ischemic complications and mortality. Several antithrombotic agents have recently launched or are in development for atherothrombotic diseases via indication expansions in the United States. Merck’s Zontivity recently launched in the United States for the secondary prevention of cardiovascular events in patients with a history of MI or PAD and no history of stroke or TIA. AstraZeneca is seeking to expand Brilinta’s indications into the post-ACS, PAD, and ischemic stroke/TIA settings. Bayer and Janssen are also seeking to expand the approved indications for their novel oral anticoagulant Xarelto (rivaroxaban) in the CAD, recent ACS, and PAD settings.

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