A new cardiac drug that could reach the U.S. market in the next few years could set off another cascade of tens of billions of dollars in additional healthcare costs, the Financial Times has reported.
The drug, known as Praulent, was approved by an advisory panel of physicians within the Food and Drug Administration (FDA) and could receive full approval by the agency in the coming months, according to the Financial Times.
Praulent is known as a PCSK9 inhibitor. It can be used to reduce levels of LDL cholesterol by as much as 60 percent in ways statins cannot. Clinicians may prescribe the drug when statins do not work or patients can't tolerate them, or for patients who have already had a heart attack or a stroke.
A one-year regimen of Praulent is expected to cost about $10,000 a year. Although that is relatively modest compared to other specialty drugs, the size of the patient pool could drive up healthcare costs by $16 billion a year, according to the Financial Times.
"If this class proves to be as safe and effective as trials suggest, then they could become the biggest class in all of pharmaceuticals, although that would take years to accomplish," Steve Miller, M.D., chief medical officer at Express Scripts, told the Financial Times.
Specialty drugs such as Gilead's Harvoni, which is used to treat patients with hepatitis C, cost up to $1,000 per pill and is considered a significant factor in pushing up both pharmaceutical prices and healthcare costs in the past couple of years. Spending on hepatitis C went from less than $300 million in 2013 to more than $4.5 billion annually. As a result, the pharmaceutical sector is coming under greater pressure to reduce prices.
There is one potential stumbling block in the widepsread adoption of Praulent: The FDA panel suggested for now the agency limit the drug's use to patients with a particular genetic disorder, heterozygous familial hypercholesterolemia, until further testing is done to ensure it is safe for use with other patients, Bloomberg News reported.