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

Publish date: February 2015

Login to access report

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 (, 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.

Questions Answered in This Report:

  • Prescribing of antithrombotic therapies. What percentage of patients are treated with the various existing antithrombotic agents across the different atherothrombotic indications in question? What is the extent of off-label prescribing across each disease? What are the most important factors that dictate prescription of antithrombotic agents by non-interventional cardiologists?

  • Coverage and tiering of antithrombotic therapies. How are the various approved treatments and off-label products positioned in MCOs’ drug benefits in terms of coverage tiers, and which are more likely to be excluded from coverage now and in the next 12 months? What are the most important factors that dictate favorable tier placement of antithrombotic agents by MCO pharmacy directors (PDs)/medical directors (MDs)?

  • Potential of emerging antithrombotic therapies. How willing are clinicians to incorporate Zontivity, Brilinta, and Xarelto into their treatment strategies for different atherothrombotic diseases? What are clinicians’ general impressions of these drugs? What is the extent of patient share that these therapies can capture in the different atherothrombotic disease populations? What are the factors that may limit uptake of these antithrombotic agents? What is the extent of coverage that can be expected of emerging antithrombotic agents according to MCO PDs/MDs?

Scope:

This U.S. Physician & Payer Forum report contains insights from a survey of 101 non-interventional cardiologists and 30 MCO pharmacy and medical directors (25 PDs and 5 MDs) regarding the current management and future treatment of atherothrombotic diseases.

Markets covered: United States.

Primary research: Online survey of 101 non-interventional cardiologists and 30 MCO directors.

Author(s): Joseph Dwyer, Ph.D., M.Res.