PCSK9 inhibitors, a new class of injectable cholesterol-lowering drugs, are important breakthrough drugs for patients who need them to control cholesterol. However, if not managed, the high cost of these medications will overwhelm patients and plans, according to one expert.
Praluent (alirocumab) injection, the first PCSK9 to be approved by FDA in July, is priced by the manufacturers Sanofi and Regeneron at $14,600 a year. Another PCSK9 inhibitor, Repatha (evolocumab) from Amgen, is poised for approval this month and is expected to be costly, as well.
“There is no question that PCSK9 inhibitors are a breakthrough for cholesterol management in patients who are unresponsive to statins,” says Adam Kautzner, PharmD, vice president, drug trend & formulary at Express Scripts, who recently presented a webinar on this topic. “However, these medications come with a [high price tag]—as much as 50 times higher than the annual price of the generic statins that are currently being used to treat the majority of these patients. This makes them unsustainable for payers, especially given the large population of patients with high cholesterol.”
Between 8 million and 10 million Americans could receive Praluent, or eventually Repatha, most commonly if they suffer from heterozygous familial hypercholesterolemia (FH) or have had a heart attack or stroke and are unable to lower their LDL cholesterol with statin therapy and diet.
“If these specialty drugs are allowed to broadly replace statins, generic medications that effectively lower cholesterol in most patients for several hundred dollars a year, billions of dollars would be added to the nation’s prescription drug costs,” Kautzner says.