What are PCSK9 Inhibitors?

The Food and Drug Administration recently approved two products in a new class of cholesterol-lowering drugs known as PCSK9 Inhibitors. This class of drugs reduces the amount of low-density lipoprotein cholesterol (LDL-C), or “bad cholesterol,” by improving the liver’s ability to remove LDL-C from the blood.1,2 High cholesterol levels leads to heart attacks, strokes, and other cardiovascular diseases.

Praluent® (alirocumab) injection, manufactured by Sanofi-Aventis US and Regeneron, was the first PCSK9 approved on July 24, 2015, and is indicated for use in addition to diet and maximally tolerated statin therapy in adults with heterozygous familiar hypercholesterolemia (HeFH) or patients with clinical atherosclerotic cardiovascular disease, such as heart attacks or strokes, who require additional lowering of LDL-C.3

Repatha™ (evolocumab) injection, manufactured by Amgen, was approved on August 27, 2015, and is indicated for use in addition to diet and maximally tolerated statin therapy in adults with heterozygous or homozygous familial hypercholesterolemia (HoFH), or patients with clinical atherosclerotic cardiovascular disease, such as heart attacks or strokes, who require additional lowering of LDL-C.4

What Do These Drugs Cost?

Praluent and Repatha are currently priced at $14,600 and $14,100 per year, respectively, compared to costs ranging from $96 to $2,700 per year for commonly prescribed generic and brand-name statins.8

What is Familial Hypercholesterolemia?

Familiar hypercholesterolemia (FH) is an inherited genetic disorder that results in very high levels of LDL-C and can cause heart attacks and other cardiovascular disease at very early ages, including childhood.5

Heterozygous FH occurs when the FH gene is inherited from one parent, meaning the patient has one FH gene and one normal gene. HeFH is characterized by very high LDL-C and a family history of high cholesterol, heart disease, or stroke, and affects approximately one in 250 people. Homozygous FH results if both parents have FH and a patient inherits the FH gene from each of them. Approximately one in one million people worldwide has HoFH. HoFH is rare, but is much more severe and characterized by extremely high levels of LDL-C and symptoms potentially occurring in childhood.6

Current Treatment Recommendations

The current recommended treatment of high cholesterol, which subsequently prevents and treats cardiovascular events, includes lifestyle modifications of diet and exercise and drug therapy with statin drugs, such as simvastatin (Zocor®) and atorvastatin (Lipitor®).7 While results of clinical studies have thus far shown that PCSK9 Inhibitors are safe and effective, long-term safety has not been established and care should be utilized in prescribing these high-cost drugs.

EmpiRx Health’s Position

Due to the lack of long-term safety and efficacy data, accompanied with the high costs of these drugs, EmpiRx Health will not immediately place the PCSK9 Inhibitors on our formularies and exclude coverage as we await further studies and guidance to be established.

 


Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

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