In July 2015, Praluent (alirocumab) was approved by the FDA as the first drug in a new class known as PCSK9 inhibitors. It was joined by Repatha (evolocumab), which received approval on August 27, 2015. These new injectable medications are the first approvals in a long time that may be as effective as statins—or better—at lowering cholesterol.
For now, Praluent is only approved for use in two types of people with high cholesterol. The first: those who have heart problems caused by a buildup of plaque (atherosclerosis), and who need extra help lowering their cholesterol. It can also be used to treat a form of inherited high cholesterol known as heterozygous familial hypercholesterolemia (HeFH).
Repatha is approved for the same uses, with the inclusion of both types of familial hypercholesterolemia (inherited high cholesterol)—heterozygous (HeFH) and homozygous (HoFH).
This is good news if you have one of these hard-to-treat types of high cholesterol, but be aware. These are new drugs, and they will be very expensive. With the new approvals, prices for both Praluent and Repatha are expected to total more than $14,000 per year.
No word yet on what (if any) assistance programs will be available, or what kind of coverage many insurance companies will offer, but both manufacturers have said they’re committed to patient access and willing to work on cost management.