The drug mepolizumab (trade name: Nucala) has been approved in Germany since December 2015 for the treatment of severe refractory eosinophilic asthma in adults. The drug can be used as an additional treatment if the treatment so far – for instance, with high-dose corticosteroids and long-acting beta2 agonists – is no longer effective enough. Since August 2018, mepolizumab has also been approved for use in children over the age of 6 and in teenagers.
The airways of people with asthma are constantly inflamed. When the mucous membranes of the bronchi come into contact with certain irritants, the airways may contract and become narrow. Symptoms include episodes or "attacks" of wheezing, coughing and shortness of breath that can be treated with a number of medications.
Severe refractory eosinophilic asthma is a type of asthma in which patients – despite receiving treatment – have a high risk of asthma attacks that need to be treated in hospital. Eosinophilic granulocytes are immune system cells. In this type of asthma, patients have an increased number of these cells in their blood and phlegm.
Mepolizumab is injected into the upper arm, the thigh, or the stomach. The dose used depends on the patient’s age:
- Teenagers over the age of 12 and adults receive 100 mg of mepolizumab every four weeks.
- Children over the age of 6 receive 40 mg of mepolizumab every four weeks.
The patients receive individually tailored treatment depending on the type and severity of their asthma. If the treatment isn't effective enough, the dose can be increased or several medications can be combined. In that case, drugs such as corticosteroids, tiotropium bromide, long-acting bronchodilators, or omalizumab are options.
In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether mepolizumab has any advantages or disadvantages for people with severe refractory eosinophilic asthma when compared with the current standard treatments.
But the manufacturer hasn't yet submitted any suitable data – either for children and teenagers or for adults.
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 mepolizumab (Nucala) for children, teenagers and adults.
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Mepolizumab – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A16-03. April 28, 2016. (IQWiG reports; Volume 385).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Mepolizumab – Addendum to Commission A16-03. Dossier assessment; Commission A16-33. June 29, 2016. (IQWiG reports; Volume 407).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Mepolizumab – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A18-58. December 20, 2018. (IQWiG reports; Volume 703)
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