FDA approves cholesterol drug with $15,000 yearly price tag

A newly approved drug that has been hailed as a breakthrough treatment for high cholesterol is causing sticker stock across the healthcare industry.

The injectable treatment, Praluent, is the first of a powerful new class of drugs proven to lower cholesterol. It also carries a list price of $14,600 a year — nearly twice what analysts had been expecting.

While the newly approved drug is far from the most expensive on the market, it has potential for widespread use: It could be used by millions of people who have been unable to treat their high-cholesterol with existing — and cheaper — drugs.

Within minutes of the official notice from the Food and Drug Administration, health insurance companies were already raising concerns about unsustainable costs.

“While the FDA’s focused guidance recognizes the safety and effectiveness of this treatment for certain patients, the exorbitant price raises concerns as to whether consumers and the health system can sustain the long-term cost,” said the interim CEO of America’s Health Insurance Plans, Dan Durham.

“Breakthrough treatments such as Praluent hold tremendous medical promise for certain patients, but its price tag makes us question how long the health system can sustain these costs for patients managing chronic conditions over several years,” John Rother, president of the National Coalition on Health Care, said in a statement.

The drug would benefit at least 8 million people who have genetic conditions that prevent the current class of drugs known as statins from lowering their cholesterol levels, according to Regeneron Pharmaceuticals.

Those drugs, which are extremely common and are available in generic versions, can cost as little as a few dollars per month.

“Many patients today do not achieve recommended levels despite lifestyle modifications and treatment with statins,” said Dr. Christopher Cannon, a Harvard University professor who helped lead clinical trials for the drug.