$14k Price tag on new FDA-approved cholesterol drug raises concerns

“Given the number of people potentially eligible for treatment with the [new class of cholesterol drugs] will number in the millions, the potential overall expenditures by payers are huge,” officials at CVS Caremark warned in a medical journal earlier this year. “The healthcare system has never seen a challenge like this to our resilience in absorbing costs.”

The Food and Drug Administration on Thursday approved Repatha, the second drug in a novel class of powerful cholesterol-lowering medications.

Made by Amgen, Repatha is indicated only for people with extremely high cholesterol levels and those with heart disease who cannot sufficiently lower their cholesterol levels with statins and other therapies. Repatha will cost $14,100 per year.

The high price tag has caused comment among some industry players. Express Scripts Holding Co., the nation’s largest manager of prescription drug benefits, said that up to 10 million people are affected by extremely high levels of high cholesterol, and the new class of drugs to treat them has “the potential to grow over the next several years to become the costliest therapy class our country has seen.”

Industry analysts expect the actual price of Repatha to drop once rebates and other discounts are taken into account. Amgen acknowledged concerns about the drug’s cost, saying that the company would work with payers to provide “innovative pricing programs.”

For now, health insurers and pharmacy-benefit managers probably will require doctors and patients to exhaust other options first or obtain additional lab tests before getting a prescription. Repatha is administered once every two weeks.

Repatha (evolocumab), an injectable drug, works by blocking a protein that interferes with the liver’s ability to remove LDL cholesterol from the blood. In July, the FDA approved Praluent (alirocumab), another injectable drug in the same class of medications.

The new drugs, called PCSK9 inhibitors, have lowered levels of LDL, the dangerous form of cholesterol, by 54 to 77 percent in people already taking other cholesterol-lowering drugs. Some patients in clinical trials have even seen their LDL levels drop into the single digits.

“Repatha provides another treatment option in this new class of drugs for patients with familial hypercholesterolemia or with known cardiovascular disease who have not been able to lower their LDL cholesterol enough with statins,” said Dr. John Jenkins, director of the FDA’s Office of New Drugs at the Center for Drug Evaluation and Research.

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