New cholesterol drug comes with hefty price tag
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The US Food and Drug Administration last week approved a first-of-a-kind drug that lowers artery-clogging cholesterol more than older drugs that have been prescribed for decades.
The drug from Sanofi and Regeneron Pharmaceuticals Inc offers an important new option for millions of patients at high risk of heart disease. But the drug’s high price tag — US$14,600 per year — is certain to escalate debate about the cost of breakthrough drugs and who should take them.
Praluent is the first in a new class of biotech medications that use a novel approach to lower bad, or LDL, cholesterol. The drugs are considered the first major advance in treatment since the introduction of statin drugs more than 20 years ago, and analysts expect them to generate billions in sales.
But the prospect of introducing highly expensive, injectable drugs for one of the most common medical conditions is drawing concerns from health insurers, doctors and employers. Especially since generic statin pills are now available for as little as a dime a day.
More than 73 million US 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 FDA approved Praluent for two groups of patients at highest risk of heart problems:
— patients with abnormally high LDL cholesterol caused by an inherited condition
— patients with high LDL cholesterol and a history of heart attack, stroke, chest pain and related conditions
Sanofi estimates those groups account for 8 to 10 million patients in the US.
The drug’s US$40-a-day price is even higher than many analyst predictions, which centered on US$10,000 per year. In a recent interview, Sanofi executive Dr Jay Edelberg said the US$14,600-a-year price reflects the “value to the health care system and the value to individual patients.”
He noted that estimated costs for a patient who has suffered a heart attack or similar cardiovascular problem range from US$50,000 to US$119,000 over one year.
But experts say more data is needed to establish if Praluent’s cholesterol-lowering ability translates into fewer heart problems and deaths. Sanofi and Regeneron are conducting an 18,000-patient study to answer that question, but it won’t be complete until 2017. Until then, many experts say new drugs like Praluent should be limited to the highest risk patients.
“What we know so far is that they reduce cholesterol really well, but what we’re not sure about is whether they actually reduce someone’s risk,” said Dr Harlan Krumholz, a Yale University cardiologist.
“I think the wisest thing is to be cautious about their use and reserve them for people who have no other choice.”
An estimated 6.3 million US patients cannot control their LDL levels with statins alone, according to medical surveys. And another 3.3 million are thought to be unable to tolerate statins due to side effects, but there are no formal criteria to identify these patients. As such, experts say more research is needed to define the group.
“I think we need to be clear what qualifies for statin intolerance,” said Dr Neil Stone, a cardiologist at Northwestern University. “What moves you from an inexpensive, generic statin to a very expensive new drug that doesn’t have near the track record of the statin?”
The FDA is scheduled to rule on a similar drug from Amgen by August 27. Pfizer’s entry into the field is expected to launch in 2018 or later.
All three drugs lower low-density lipoprotein, or LDL, cholesterol more powerfully and in a different way than statins. They block a substance called PCSK9, which interferes with the liver’s ability to remove cholesterol from the blood. Adding the new drugs to older statins reduces LDL cholesterol by about 40 percent to 60 percent. Statins alone generally lower levels of the wax-like substance by about 25 to 35 percent.
Statistical analyses published earlier this year suggest patients taking PCSK9 drugs have half the risk of dying or suffering a heart problem as patients receiving statins or older drugs. But definitive studies are still ongoing.
For now, several factors could limit use of the drugs. They must be self-injected by patients, with Praluent dosed every two weeks. Also their price is expected to face pushback from insurers and other companies that manage drug expenses.
Pharmacy benefit manager, CVS Caremark, has warned that if 10 million US patients ultimately take PCSK9 drugs it could result in well over US$100 billion in new drug spending.
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