Introduction

Selexipag (trade name: Uptravi) has been approved in Germany since May 2016 for adults with pulmonary arterial hypertension (high blood pressure). The drug can be combined with other blood-pressure-lowering (antihypertensive) medications.

The right side of the heart pumps blood that is low in oxygen through the pulmonary artery into the lungs. The blood picks up oxygen in the lungs and then travels through the pulmonary vein to the left side of the heart. From here, oxygen-rich blood is pumped into the body. This part of the blood circulatory system is called pulmonary circulation. In pulmonary arterial hypertension, the pulmonary (lung) vessels are narrowed, increasing blood pressure within the pulmonary circulation. This makes it harder for the heart to pump blood through the lungs. As a result, there is more strain on the heart, less oxygen is absorbed by the lungs, and too little oxygen reaches the body. This type of high blood pressure is usually caused by another heart or lung condition.

There are four stages of pulmonary arterial hypertension (PAH):

  • Stage I: Patients have increased pulmonary blood pressure, but have no symptoms during normal physical activities.
  • Stage II: During physical activity, patients have symptoms such as trouble breathing, exhaustion, chest pain or feeling faint. These symptoms stop when resting.
  • Stage III: Even light physical activity causes severe symptoms, but there are no symptoms at rest.
  • Stage IV: Symptoms occur even at rest and physical activity is severely limited. There is also a risk of heart failure.

Selexipag is an option for people with stage II or III pulmonary arterial hypertension. The drug aims to widen the blood vessels and to decrease the strain on the heart.

Application

The drug is available in tablet form in several doses, ranging from 200 mg to 1,600 mg. Treatment should start with 200 mg twice a day and can then be individually increased every week to up to 1,600 mg per day.

Other treatments

For people with pulmonary arterial hypertension, the standard treatment is what is known as optimized drug treatment. The exact type of individual therapy will depend on whether it is an initial treatment or which treatments have been tried before. The therapy is individually adjusted by the doctor.

Assessment

In 2016, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to look into the advantages and disadvantages of selexipag compared with the standard treatments for people with pulmonary arterial hypertension.

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

More information

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