Introduction

Cladribine (trade name: Mavenclad) has been approved in Germany since December 2017 for adults with relapsing-remitting multiple sclerosis.

Multiple sclerosis (MS) is a chronic and incurable inflammatory disease of the central nervous system in which the body’s immune system damages nerve pathways in the brain and the spinal cord. This condition can cause abnormal sensations, fatigue, arm and leg pain, partial paralysis, dizziness and trembling. MS often comes in episodes, with symptom-free intervals between acute phases. This type is called relapsing-remitting multiple sclerosis (RRMS). If many attacks occur within a short time, it is referred to as highly active multiple sclerosis.

The disease is usually treated with interferon beta or glatiramer acetate to start off with. Drugs such as fingolimod, glatiramer acetate and interferon beta slow down damage to the nerve cells by affecting the immune system. The drug cladribine decreases the lymphocyte count, which is supposed to reduce the frequency of flare-ups.

Application

Cladribine is available in the form of 10 mg tablets. The dose is determined based on the person’s body weight. Depending on the amount of tablets needed, the drug is taken on 4 or 5 consecutive days during the first week of the first and second months of treatment. This is repeated after 12 and 13 months.

Other treatments

Several drugs are available for treating highly active or rapidly evolving RRMS, depending on earlier treatment, the course of the disease and other factors. These drugs include interferon beta, alemtuzumab, natalizumab, fingolimod, and glatiramer acetate.

Assessment

In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to look into the advantages and disadvantages of cladribine compared with the standard treatments for people with highly active relapsing-remitting multiple sclerosis.

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 cladribine (Mavenclad).