A new class of cholesterol drugs that can reduce hard-to-manage LDL cholesterol levels by as much as 60% has come on the market this year. This class of cholesterol drugs is called PCSK9 inhibitors. Two PCSK9 inhibitors were recently approved by the FDA: adlirocumab (Praluent) and evolocumab (Repatha).
How do PCSK9 inhibitors work?
PCSK9 inhibitors are distinct from all other types of cholesterol drugs on the market such as statins, fibrates and cholesterol absorption inhibitors. PCSK9 is a protein that binds to LDL receptors in the liver. These receptors remove LDL cholesterol from the blood, but when one of these proteins binds to the receptor, it is destroyed and can no longer perform this function. By blocking PCSK9, this is prevented and the liver can clear more LDL cholesterol from the blood. Because they work differently, PCSK9 inhibitors can also be taken along with other cholesterol drugs such as statins to further lower cholesterol levels.
Who can benefit from PCSK9 inhibitors?
These drugs will be especially helpful to people with familial hypercholesterolemia (FH) that causes LDL levels to be as high as 300-400 mg/dL. Familial hypercholesterolemia is a genetic disorder that causes high LDL levels. Individuals with FH have mutations in their LDLR genes causing unusually high LDL levels. Because it is genetic, this type of hypercholesterolemia normally isn’t well controlled with traditional cholesterol drugs, but PCSK9 inhibitors have been shown to reduce these levels down to 100mg/dL. These drugs are also prescribed to those with clinical atherosclerotic cardiovascular disease caused by blocked arteries.
“They are a major advance in our ability to lower LDL,” said Dr. Sekar Kathiresan in reference to the new PCSK9 inhibitor medications in an article published by Harvard Health. Dr. Kathiresan is Director of Preventive Cardiology at Massachusetts General Hospital.
How much do these new drugs cost?
The cost is the downside. That and the fact that PCSK9 inhibitors have to be injected. Repatha and Praluent cost around $14,000 wholesale, and the cost to the patient is around $1200 per month. Most patients will need to get the injection once every two weeks. In some cases, patients are prescribed Repatha injections once per month, but they will require three injections at once, so the cost is not any lower. Fortunately, the cholesterol medications produce noteworthy results and they are covered by insurance companies. Repatha and Praluent manufacturers also have patient assistance programs that can significantly lower copay costs.