The U.S. Food and Drug Administration has approved the first of a new class of drugs to treat high cholesterol levels. Praluent is a PCSK9 inhibitor and requires users to inject themselves once a week. While Praluent is considered a breakthrough drug for people with seriously high cholesterol levels, its cost is very high, too: about $14,600 at wholesale per year.
The last big advance in treating high cholesterol levels were the drugs called statins. In comparison, a generic version of a statin costs under $50 per month. More than 73 million Americans have high levels of low-density lipoproteins (LDLs), the type of cholesterol linked to heart disease and stroke. Generally, someone takes drugs to treat cholesterol levels for many years.
The high price of Praluent (the generic name for the drug is alirocumab) is a budget buster, according to Express Scripts Holding Co. Express Scripts is the nation's largest pharmacy benefit manager, a company that administers the drug benefits for health insurance companies and employers. It is also a mail-order pharmacy.
During a discussion with investors, Tim Wentworth, president of Express Scripts, said that Praluent could "wreak financial havoc" for the company's clients. The drug is considered a breakthrough product, but it has the potential of hurting companies that do not proactively manage their drug costs, he said.
Praluent is from Sanofi and Regeneron Pharmaceuticals, Inc. It works by blocking or inhibiting the protein PCSK9, which prevents "bad" LDL cholesterol from being removed from the bloodstream. Another PCSK9 inhibitor from Amgen Inc, called Repatha, is expected to gain U.S. approval next month.
The FDA approved Praluent for two groups of patients, those with abnormally high LDL levels because of a genetic condition and those who have high LDL levels and have had some form of heart disease. Although it has been shown that Praluent can lower LDL levels, it has not been shown that it actually reduces the risk of a heart attack or stroke.