A potent new class of low density lipoprotein (LDL) cholesterol-lowering drugs called PCSK9 inhibitors are the first specialty drugs to treat high cholesterol. PCSK9 inhibitors are expected to cost more than statins, and some are raising questions about how health plans, employers and members will afford the drugs’ high price tag.
There are two emerging drugs in this category: Sanofi and Regeneron’s Praluent (alirocumab), which was approved on July 24 for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol; and evolocumab (Repatha, Amgen).
In June, an FDA Advisory Committee also recommended approval of Repatha for a rare disease called homozygous familial hypercholesterolemia. This drug is projected for final approval by the end of August.
These drugs act by preventing the protein PCSK9 from interfering with the liver LDL removal process, allowing more LDL cholesterol removal from the blood, says Patrick Gleason, PharmD, FCCP, BCPS, at Prime Therapeutics.
“Unlike traditional statins, which are oral medicines and have inexpensive generic alternatives, PCSK9 inhibitors are self-injected monoclonal antibodies that can be administered every two weeks to once monthly,” Gleason says. “Praluent is labeled for every two-week dosing. Evolocumab [Repatha] is also anticipated for every two-week dosing with a potential one monthly dosing to be FDA approved at a later date.”
“This class provides an additional treatment option for patients resistant to statin plus/minus current therapy,” says Rabiah (Bea) Dys, PharmD, executive director, clinical program development, at Comprehensive Pharmacy Services.
According to Gleason, PCSK9 inhibitors could treat the more than 600,000 Americans with familial hypercholesterolemia (FH). FH is a major risk factor for cardiovascular disease if not controlled, and it often cannot be managed with traditional statins. “With Praluent, the FDA agreed that PCSK9 inhibitors are an important breakthrough therapy for people living with this condition,” he says. “The FDA is less certain the PCSK9 inhibitors will benefit people who have not already had a cardiovascular event.”