[LUM#10] My Dear Migraines
Anne Ducros is a neurologist at the Montpellier University Hospital. As a migraine specialist, she treats patients who often find current medications ineffective. A new antibody-based treatment does exist, but its approval for the French market has been delayed. The reason? Its price is too high.
15% of French people suffer from migraines. This neurological disorder is still poorly understood due to its complexity, involving at least forty genes. For 1% of patients, it takes a severe chronic form. Headache attacks occur more than fifteen days a month and cause—in addition to intense pain—sensitivity to noise and light, nausea, and vomiting, which current medications are not always able to relieve. However, a new treatment could change the lives of these thousands of people.
An initial targeted treatment
A new class of medications specifically designed for migraine. A first. “Until now,” explains Anne Ducros, a neurologist at Montpellier University Hospital and university professor, “we only had nonspecific treatments. We still treat migraine sufferers with antihypertensives, antiepileptics, or antidepressants, even though they are neither hypertensive, nor epileptic, nor depressed. ” These treatments help reduce brain excitability and thus the risk of migraine, but they expose patients to frequent and severe side effects such as drowsiness, difficulty concentrating, fatigue, shortness of breath…
In recent years, however, research has identified the role of a small protein called CGRP. “It’s a small peptide released during attacks by a nerve called the trigeminal nerve, which causes blood vessels to dilate and triggers a cascade of events leading to pain,” explains Anne Ducros. Researchers then developed antibodies capable of targeting and blocking CGRP, thereby halting migraines.
To date, four antibodies that target either CGRP or its receptor have successfully passed clinical trials in patients who did not respond to standard treatments. “At least half of the patients saw a 50% reduction in their attacks; some have virtually none left. And those who did not see an improvement with one type of antibody could very well respond to another,” explains the neurologist.
No side effects
Most importantly, this treatment has no side effects, other than “a slight soreness at the injection site in some people.” Unlike current long-term treatments, which are taken daily as oral tablets, these antibodies are administered to patients via a simple monthly injection.
Simplicity and the absence of side effects are two factors that significantly increase patient adherence to treatment, as Anne Ducros points out: “Studies show that after one year, 80% of patients with chronic migraines are still taking their medication, whereas with conventional preventive treatments, 80% stop taking it.”
These results led to the approval of antibody treatments bythe European Medicines Agency and the Food and Drug Administration, its U.S. counterpart. When the data were submitted to French authorities, they did grant approval for the treatment of severe migraine, but “they determined that there was no improvement in the medical benefit provided, so they are requesting further studies to demonstrate superiority over current treatments.” This makes it impossible for the drug to be released in 2019… So when? No one knows.
A decision that the specialist, in light of published studies, does not understand. “Some of my patients who do not respond to conventional treatments had high hopes. When I tell them they’ll have to wait a little longer, they see it as a real injustice.”
550 euros per injection
This injustice is all the more glaring given that the main obstacle to bringing this new drug to market is primarily its price: 550 euros per injection in the U.S. and Switzerland. This high cost is partly due to the length of the manufacturing process. “It takes five years to set up a production facility for an antibody that can yield a stable, pure, and effective therapeutic product,” explains Anne Ducros.
Today, while French doctors can prescribe these treatments to their patients, the patients must travel to Switzerland to purchase them. “For six injections, they pay 3,200 euros, so for those who can afford it, it works, but for the others… It’s truly a two-tiered healthcare system,” notes the neurologist. Before concluding with a wish—not quite so pie-in-the-sky: “There’s probably room for innovation to produce antibodies more cheaply… For moderately profitable companies.”
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