The nation's biggest pharmacy benefits manager has decided to cover two new drugs that lower artery-clogging cholesterol but raise concern over prices that can top $14,000 a year.
Express Scripts said Tuesday that it will pay for prescriptions of Amgen's Repatha as well as Praluent from Sanofi and Regeneron Pharmaceuticals under a few conditions designed to control costs.
The decision comes as soaring drug prices draw criticism from patients, doctors and politicians, as well as insurers and employers that generally pay most of the prescription bill. Praluent and Repatha both stirred worry, in particular, because of their potential to be used by millions of patients.
Praluent and Repatha belong to a new class of drugs called PCSK9 inhibitors, biologic medications that in clinical studies are supposed to lower low-density lipoprotein cholesterol levels by as much as 60% compared with a placebo over a year. The drugs are injected about twice a month.
Such medications have been part of an ongoing debate over the high price of drugs. In an article published in February in Health Affairs, researchers projected the annual cost of those drugs as a chronic therapy to manage high cholesterol could reach $200 billion annually at an estimated price of $10,000 a year.
Praluent was approved in July with Repatha gaining approval a month later.
More than 73 million U.S. adults, or nearly one-third, have high LDL cholesterol, according to the Centers for Disease Control and Prevention. Those patients have twice the risk of heart disease, the leading cause of death worldwide.
The Food and Drug Administration approved both Repatha and Praluent earlier this summer for patients with the highest risk of developing heart problems.
Express Scripts said Tuesday that it negotiated a discount it declined to detail on the prices of those drugs. It will require prior approval from one of its pharmacists before any prescriptions are filled.
That pharmacist will need to see a patient's cholesterol levels first as well as proof that the older statins failed with the patient.
Express Scripts Holding Co. also is requiring the drugmakers to provide rebates if prices climb more than a set amount each year. Express Scripts also has agreed to cover any costs that exceed a certain amount per person, annually.
"We think this is really an innovative approach, and we think it's going to take great care of patients," said Dr. Steve Miller, Express Scripts' chief medical officer.
Express Scripts has been a vocal critic of rising drug prices. But Miller said these new cholesterol drugs are worthwhile because they can make up their cost in the long run by preventing heart attacks, strokes or hospitalizations.
The Express Scripts decision applies to coverage for about 25 million people.
An Amgen spokeswoman said Express Scripts is the first national payer in the United States to decide whether it will cover their new drug.
A spokesman for insurer UnitedHealth Group, which runs a big pharmacy benefits management business, said they have yet to decide on coverage. Another large pharmacy benefits manager, CVS Health, said in August it would not cover the new drugs under its formulary until they have been reviewed by an expert committee.