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.

Questions Answered in This Report:

  • Understand clinicians’ (PCPs and specialists) use of currently available HTG therapies. How do clinicians and payers differentiate between the different current therapies? What factors are most influential to physicians when selecting treatment for patients with elevated serum triglycerides? How do physicians’ treatment choices vary with the stage of disease? What market access hurdles (e.g., step therapy) do payers place on the use of current TG-lowering therapies?

  • Explore clinicians’ and payers’ attitudes toward treating HTG as new therapies become available. How do surveyed PCPs and specialists expect to incorporate Epanova, PRC-4016, and ISIS-ApoCIIIRx into clinical practice? Where do they expect these agents to sit in the changing treatment algorithm, and which current TG-lowering therapies are most at risk of losing share? What changes in prescribing practices will be made once branded Epanova and generic Lovaza become available in 2014 and 2015, respectively? What factors will most influence formulary inclusion of these emerging agents? How will MCO reimbursement constraints, including tiering and formulary restrictions, impact the potential patient share of these emerging drugs?

Scope:

This U.S. Physician & Payer Forum investigates payer and physician dynamics that affect prescribing practices for TG-lowering therapies in the United States. The report is based on a survey of 70 primary care physicians (PCPs), 73 specialists (mainly endocrinologists), and 30 pharmacy/medical directors at MCOs that offer commercial health insurance. We analyze current physician and payer insights and practices; perceptions of novel agents in the pipeline; uptake of emerging therapies for high TG, very high TG, and severe TG; and formulary decision making for current and emerging agents, including  Vascepa,  Epanova, Lovaza, AbbVie’s Tricor and Trilipix, PRC-4016, and ISIS-ApoCIIIRx.

Markets covered: United States.

Primary research: Online survey of 70 PCPs, 73 specialists (mainly endocrinologists) and 30 MCO pharmacy/medical directors.

Population segments: HTG patients: borderline TG (150-199 mg/dL), high TG (200-499 mg/dL), very high TG (> 500 mg/dL), and severe TG (> 800 mg/dL).

Author(s): Kate Sullivan

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