By Annerose Fischer-Bucher
Since the middle of the year, new preparations for chronic migraine are on the market, mainly offered by three companies in Germany. Among them is a new group of drugs for the treatment of chronic migraine. What about a new biotechnology drug approved? Andrea Nägele, Senior Consultant, Neurological Clinic, Göppingen Christophsbad.
What is a migraine?
Dr. Andrea Nägele: Migraine is a violent attack, usually unilateral, pulsating headache accompanied by nausea and vomiting. It can take between 4 and 72 hours. In contrast to tension headache, it increases during physical activity. Photophobia, noise and sensitivity to odors are other associated symptoms. As there are many types of headache, not every headache, as people like to call it, is a migraine headache.
What types of migraines are there?
We distinguish acute and chronic forms of migraine with some characteristic subtypes, for example, the familial form associated with hemiplegia. The chronic form of migraine is defined as headache for more than 15 days per month.
What does aura mean?
These are symptoms of 5 to 20 minutes in duration, even before the occurrence of headaches. This can be visual disturbances in the form of flickering lights, dots, lines or even feelings of numbness and tingling, which then accompany the headache. A migraine with aura is responsible for about 10 to 15 percent, and those without aura, for 85 percent.
What is the percentage of patients with headaches at your clinic?
About 15-20% of our patients come to us with the headache symptom. Headache may be a concomitant symptom of many neurological conditions, such as cerebral haemorrhage, meningitis, sleep apnea syndrome, or tension-type headache caused by muscle tension. Our daily work and specialty is to recognize the type of headache and treat it specifically.
What is the treatment for chronic migraine?
Until now, beta-blockers, antidepressants, botulinum toxin and epileptic drugs that could affect the frequency of days of headache were available for this group of patients as drug prophylaxis. Only about 20 percent of patients remained with these therapies. Most have to stop the medication because of the side effects.
A prescription drug made from bioengineered antibodies has been approved by the European Medicines Agency (EMA) since July 2018. How does this work?
The new drug specifically for chronic migraine is called Erenumab. It blocks the CGRP receptor (peptides related to the calcium gene). CGRP is launched as a messenger in the meninges. The exact function is not yet known. But it is well known that CGRP sensitizes excess nerves, dilates blood vessels and affects the processing of pain.
How do you rate success?
According to the studies, especially patients with high CGRP level benefit from this new drug. The number of days of headache decreased by half in this group of patients. The erenumab is injected under the skin once a month. Side effects include mild redness at the injection site and mild constipation.
Are you using the new biotechnology drug?
Clear. Patients have a high level of suffering and a significantly reduced quality of life due to the high number of days of headache. Erenumab is so far the only drug approved in Germany. Fremanezumab, galcanezumab and eptinezumab are prone to follow.
What is the difference between
a conventional medicine and a biopharmaceutical?
In a biopharmaceutical, biotechnology agents use genetically modified organisms that form proteins or nucleic acids. They can be programmed to dock in specific cells of the body and therefore are highly efficient and more selective than chemical molecules. So far, these drugs are already used in cancer therapy.
Biotech drugs are laborious to manufacture and are expensive. Will it also be available to patients in health insurance?
If a patient is in the referral group, the cashier pays. The cost is around 6000 euros per year. I suspect that due to the high cost, the refund will be made outside the budget.