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Cholesterol drug prevents heart attacks — at $14,000 a year

Cholesterol drug prevents heart attacks — at $14,000 a year

WASHINGTON — For the first time, research shows that a pricey new medication called Repatha not only dramatically lowers LDL cholesterol, the “bad cholesterol,” it also reduces patients’ risk of dying or being hospitalized.

Repatha, a man-made antibody also known as evolocumab, cut the combined risk of heart attack, stroke and cardiovascular-related death in patients with heart disease by 20 percent, a finding that could lead more people to take the drug, according to a study presented Friday at a meeting of the American College of Cardiology.

Some doctors hailed the results as major progress against heart disease. In an editorial in The New England Journal of Medicine, Dr. Robin Dullaart, a researcher at the University of Groningen in the Netherlands, called it a landmark study.

Others said they expected more from the $14,000-a-year drug. It was approved in 2015 without evidence that it prevents heart attacks, simply because its cholesterol reductions were so dramatic and promising.

Doctors often recommend that people keep their LDL levels under 100 milligrams per deciliter, and that people at very high risk reduce their LDL under 70.

In the new study, patients with heart disease who combined Repatha with a statin, the most commonly used cholesterol medication, decreased their LDL from 92 milligrams per deciliter to 30. Doctors have rarely seen cholesterol levels that low. Many doctors wondered if such low levels would be dangerous, causing memory problems or dementia due to a lack of cholesterol, said Dr. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic, who was not involved in the new research but has led clinical trials of PCSK9 inhibitors in the past.

Insurers have been reluctant to cover Repatha because of its price and uncertain benefits.

Insurance plans initially reject about 75% of all requests for Repatha, although they eventually approve half, said Dr. Joshua Ofman, senior vice president of global value and access at Amgen, the drug’s manufacturer. Doctors make an average of five requests before getting the medication approved.

In an unusual move aimed at increasing coverage, Amgen on Friday offered a special deal to insurance companies: If they loosen restrictions on coverage, Amgen will refund the medication cost should patients have a heart attack or stroke while taking it.

Although about 5% of patients in the clinical trial had a heart attack or stroke, rates of those problems could be two to three times higher in the real world, where patients are often older and sicker than those in clinical trials, Ofman said.

The refunds would go to insurance companies, not patients, Ofman said. He said insurance companies would have to decide for themselves if they want to refund patients’ out-of-pocket expenses.

The offer isn’t completely unprecedented. Geisinger Health System offers refunds to members who are dissatisfied with their care.

Some health care experts weren’t impressed by Amgen’s offer.

The offer is “a fig leaf covering a massive price,” said Dr. Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center in New York.

Insurance companies would lose money on the offer, Bach predicted, because they would have to pay to treat dozens of patients to prevent one heart attack or stroke.

“It sounds like the patient gets harmed and the payer has its financial risk reduced,” said cardiologist Cam Patterson, chief operating officer at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, who wasn’t involved in the study. “Why not just reduce the price of the drug and make it more broadly available?”

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