This story has been updated to include responses from Amgen, Regeneron, and Sanofi.
A new cholesterol-lowering drug is so expensive, it isn’t worth its potential benefits, according to new research.
PCSK9 inhibitors, the main ingredients in Amgen’s Repatha and Sanofi and Regeneron’s Praluent treatments, were first approved by the Food and Drug Administration in July 2015 for use by patients with a family history of high cholesterol or those who suffered high-cholesterol-induced heart attacks.
The treatment is said to potentially decrease the risk of heart attack and stroke. It’s more effective than fellow cholesterol-lowering medications, ezetimibe and statin. But according to research published in the Journal of the American Medical Association Tuesday, at an average of $14,350 per patient in 2015, its price exceeds the savings from averting cardiovascular events.
If all eligible U.S. citizens between the ages of 35 and 74 years old used the drug, it would increase annual prescription spending by 38% to $125 billion, and health care expenditures by 4% to about $120 billion—a surge, considering U.S. health care costs are currently $2.7 trillion. The drug would also cost each person $423,000 per year of healthy life gained—exceeding the $100,000 threshold that would make a treatment cost effective.
“PCSK9 inhibitors produce impressive reductions in LDL cholesterol and have the potential to reduce cardiovascular events,” wrote Dhruv Kazi, lead researcher for the study in an email to Fortune. “Conclusive studies on how effective they are at reducing heart attacks and strokes are ongoing, with preliminary results available next early next year. The cost of these agents is staggering though—making them not cost-effective for us as a society unless prices come down 70%.”
When a new drug is expensive, it usually indicates treatment of rare conditions or for shorter durations. But the new inhibitors are targeted at a large and growing population of citizens with high cholesterol and atherosclerosis, who will use it for their entire lives. That significantly ramps up the total cost of health care for the nation.
In order for the drug to be cost effective, drugmakers should slash the price of the drug by over two thirds—to $4,536, when patients would be spending about $100,000 to keep themselves healthy, the researchers wrote in the JAMA article.
“The effect on healthcare spending if everyone gets treated should prompt a national conversation about how we balance rewarding pharmaceutical innovation with ensuring that all Americans get the care they need and deserve,” Kazi wrote in his email.
In response to the report, Amgen released a statement: “There have been numerous discussions on the value of PCSK9 inhibitors; this analysis is just one view.”
Sanofi and Regeneron told Fortune in an email that the estimated total cost of the PCSK9 was inflated in the study.
“The analysis is based on total eligible patients, which greatly exaggerates real world use of PCSK9 inhibitors—consider that statins, which are effective, oral and generic, are only used by about half of patients who can benefit,” representatives wrote. “And the entire premise is based on list or wholesale acquisition cost prices, while in reality the vast majority of health plans pay negotiated prices that are significantly lower.”
