Hypertriglyceridemia (HTG) is defined as an abnormal concentration of triglyceride in the blood. Classification of serum triglyceride (TG) levels greater than 150 mg/dL as elevated is largely based on prospective observational studies. The prevalence of HTG in the United States is rising, which is occurring parallel to the increase in the incidence of obesity over the past few decades. At the same time, the market for agents treating HTG has become much more dynamic with the launch of newer therapies in 2013 and 2014 that create more options in the treatment of this dyslipidemia subpopulation.
The primary goal of therapy for patients with very high triglycerides (TG ≥ 500 mg/dL) is to lower TG to prevent pancreatitis; meanwhile, high TG levels (≥ 200 mg/dL) are associated with an increased risk for coronary heart disease (CHD). First-line drug therapy for HTG usually consists of fibrates, prescription omega-3 fatty acid drugs (fish oils), and/or niacin-based drugs. Prescription omega-3 fatty acid drugs are gradually gaining popularity in the United States, where until 2013, GlaxoSmithKline’s Lovaza was the only highly purified prescription formulation available. In January 2013 the novel prescription omega-3 fatty acid drug Vascepa (Amarin) launched in the United States for the treatment of very high TG. The U.S. launch of another prescription omega-3 fatty acid drug, Epanova (AstraZeneca), in 2014 will further expand the drug class and add pressure on the branded TG-lowering therapies such as Lovaza, the fibrates, and the niacin-based drugs.
Both Vascepa and Epanova are extensively examined in this report along with two Phase II agents: PRC-4016 (BASF [formerly Pronova]), another oral prescription omega-3 fatty acid and ISIS-ApoCIIIRx (Isis Pharmaceuticals), an antisense oligonucleotide directed against ApoCIII that is delivered once weekly by subcutaneous injection. We analyze the dynamics that will limit or promote market access for new market entrants, employing the results from our survey of 143 clinicians (70 PCPs and 73 specialists) and 30 managed care organization (MCO) pharmacy/medical directors.