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First injectable cholesterol drugs approved
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.”
According to an April 2015 article in Annals of Internal Medicine, PCSK9s decreased LDL cholesterol between 45% to 70%, similar or better than high-dose statin LDL cholesterol reduction.
“PCSK9s work better in combination with statins,” Gleason says. “There is limited, post-hoc study data suggesting a decrease in cardiac events over time with the use of PCSK9 inhibitors.”
The cost of PCSK9 inhibitors will exceed statin and other standard oral therapy. “Treating high cholesterol with statins costs just pennies a day; whereas it’s disappointing Praluent was priced higher than expected at $14,600 per year,” Gleason says.
He stresses the importance of having the right level of utilization management in place to help ensure these drugs are used appropriately, by people who have optimized the available statins and lipid-lowering therapies. Prime’s claims data show 80% of patients aren’t optimizing statin therapy.
Dys agrees. “The agents are intended for a targeted patient population, resistant to standard therapy. Given the specified indication, diagnostic screening may increase-over current practice-in order to guide therapy,” she says.
Prime has developed a drug cost calculator that helps health plans estimate how PCSK9s may affect overall costs (bit.ly/drug-calc).
Tracey Walker is content channel manager for Formulary Watch.