Introduction

Evolocumab (trade name: Repatha) has been approved in Germany since July 2015 for the treatment of hypercholesterolemia or mixed dyslipidemia in adults and teenagers who aren’t able to lower high cholesterol levels enough through other medications and diet.

The human body needs cholesterol to work properly. It is needed to produce certain hormones and is an important building block in cell walls. There are two types:

  • “LDL” cholesterol: “LDL” stands for “low-density lipoprotein.” Cholesterol is transported in this form from the liver to where the body needs it. High levels of LDL cholesterol are associated with a higher risk of cardiovascular disease, which is why it is sometimes referred to as “bad” cholesterol.
  • “HDL” cholesterol: “HDL” stands for “high-density lipoprotein.” In this form, cholesterol is transported back to the liver from the body’s organs and tissues. Because high levels of HDL cholesterol are associated with a lower risk of cardiovascular disease, it is sometimes called “good” cholesterol.

Triglycerides also play an important role. They are found in food and are an important source of energy for our body.

People are considered to have hypercholesterolemia (high cholesterol) if their LDL-cholesterol levels are too high. If their triglyceride levels are too high as well, it is known as mixed dyslipidemia. Left untreated, both conditions can lead to arteriosclerosis, and then to cardiovascular diseases such as coronary artery disease. But these levels aren’t the only thing that determine the risk of cardiovascular disease – other individual factors play a role, too.

Evolocumab helps the liver to break down LDL cholesterol, and is supposed to lower the risk of cardiovascular diseases.

Application

Evolocumab is combined with a low-fat diet. It can also be used together with other lipid-lowering drugs. Evolocumab is injected under the skin using a pre-filled pen (140 mg). This can be done either every two weeks at a dose of 140 mg or once a month at a dose of 420 mg (3 pre-filled pens containing 140 mg each).

Other treatments

The standard treatment is a special diet combined with other lipid-lowering drugs or – if the medication and diet are not enough – medication combined with LDL apheresis. This is a special procedure to remove LDL cholesterol from the blood.

Assessment

In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to look into the advantages and disadvantages of evolocumab compared with the standard treatments for hypercholesterolemia or mixed dyslipidemia in adults.

But the manufacturer did not provide any suitable data with which to do the assessment.

More information

This information summarizes the main results of reviews produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The reviews were commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the reviews and the hearings received, the G-BA passed a resolution on the added benefit of evolocumab (Repatha).