Nav: Home

Erenumab in migraine: Indication of considerable added benefit for certain patients

February 07, 2019

Erenumab was the first drug of a new drug class for the prophylaxis of migraine to enter the German market in November 2018. In an early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined whether erenumab has an added benefit. As the data presented by the drug manufacturer showed, erenumab can reduce the burden from migraine in those patients for whom other substances used for prophylaxis have failed or have not been an option.

The manufacturer presented data only for episodic, but not for chronic migraine. However, since this classification is only based on the number of pain days with an unclear distinction between episodic and chronic migraine, IQWiG does not consider the indication of considerable added benefit to be limited to episodic migraine.

Drug class blocks CGRP transmitter

In contrast to acute treatment, there had been no specific drugs for prophylaxis of migraine so far. A range of drugs have been available for a long time, but they all have been developed for other conditions, such as hypertension, depression or epilepsy.

It has long been known that a transmitter called calcitonin gene-related peptide (CGRP) plays a key role in the development of migraine. But it took decades before a drug was developed that blocks CGRP without having major side effects.

Erenumab is the first drug of a new drug class that became ready for the market. Its mechanism of action consists in inhibiting the function of the CGRP receptor in the brain.

Dossier contains data for one of three patient groups

The Federal Joint Committee (G-BA) differentiated three groups of patients, who all have at least four migraine days per month. They were differentiated by whether the patients have received prophylactic medication and, if any, by the type of prophylactic medication.

However, the company's dossier contained data for only one group, i.e. patients for whom the drugs approved for prophylaxis of migraine up to then, including valproic acid and Botox (clostridium botulinum toxin type A), have failed or for whom these were not an option, e.g. due to intolerance.

The appropriate comparator therapy specified by the G-BA was best supportive care (BSC), i.e. the best possible therapy optimized for the individual patient, such as psychotherapy or relaxation techniques, for example.

Only patients with episodic migraine were included

The data from 193 patients used by the company in the dossier were from the randomized controlled trial LIBERTY. Over a period of 12 weeks, the study participants received either subcutaneous erenumab injections once a month or placebo, each in addition to BSC.

Eligible patients had migraine for four to 14 days per month (episodic migraine), and had been treated unsuccessfully with between two and four preventive medications. Patients with chronic migraine, who, according to the classification, have a headache for at least 15 days per month, were not included in the LIBERTY study.

Fewer migraine days, less impairment

The analysis of these data showed that notably more participants in the erenumab group than in the placebo group had a 50% or greater reduction in the number of headache days. This was also shown for the number of migraine attacks, which can last several days.

The results regarding "general impairment" from headache and "activity impairment" were also in favour of erenumab.

In contrast, there were no differences or no relevant differences regarding "physical functioning", "work productivity", health status and side effects. The outcome "quality of life" was not recorded at all in the LIBERTY study.

Number of headache days as the only criterion

Erenumab was approved for both episodic and chronic migraine. The study results also do not have to be restricted to episodic migraine as the literature provides no medical or other substantive justification for the value of "14 days" to distinguish episodic from chronic migraine. In addition, the participants in the LIBERTY study were in the transition period between episodic and chronic migraine.

Overall, IQWiG therefore sees an indication of a considerable added benefit of erenumab for the prophylaxis of migraine.
-end-
G-BA decides on the extent of added benefit

The dossier assessment is part of the early benefit assessment according to the Act on the Reform of the Market for Medicinal Products (AMNOG) supervised by the G-BA. After publication of the dossier assessment, the G-BA conducts a commenting procedure and makes a final decision on the extent of the added benefit.

More English-language information will be available soon (Sections 2.1 to 2.7 of the dossier assessment as well as easily understandable information on informedhealth.org). If you would like to be informed when these documents are available, please send an e-mail to info@iqwig.de.

Institute for Quality and Efficiency in Health Care

Related Migraine Articles:

Both too much, too little weight tied to migraine
Both obesity and being underweight are associated with an increased risk for migraine, according to a meta-analysis published in the April 12, 2017, online issue of Neurology®, the medical journal of the American Academy of Neurology.
Examining whether migraine is associated with cervical artery dissection
A new study published online by JAMA Neurology examines whether a history of migraine is associated with cervical artery dissection (CEAD), a frequent cause of ischemic (blood vessel-related) stroke in young and middle-age adults, although the causes leading to vessel damage are unclear.
Migraine associated with higher risk of stroke after surgery
Surgical patients with a history of migraines have a greater risk of stroke and readmission to hospital, finds a study published by The BMJ today.
Migraine as a risk marker for stroke and heart attack
A team of researchers led by Professor Tobias Kurth, Head of the Institute of Public Health at Charité -- Universitätsmedizin Berlin, has now been able to establish the following: female migraine patients have a higher risk of stroke or heart attacks than women without migraine.
Are drops in estrogen levels more rapid in women with migraine?
Researchers have long known that sex hormones such as estrogen play a role in migraine.
Migraine drugs underused
New research shows that more migraines could be safely treated with drugs that are known to constrict blood vessels.
Managing migraine during pregnancy and lactation
According to doctors at Wake Forest Baptist Medical Center, medications and treatments long considered safe to treat pregnant women with migraines may not be.
Children who are emotionally abused may be more likely to experience migraine as adults
Children who are emotionally abused may be more likely to experience migraines as young adults, according to a preliminary study released today that will be presented at the American Academy of Neurology's 68th Annual Meeting in Vancouver, Canada, April 15 to 21, 2016.
Migraine triggers may all act through a common pathway
Migraines can be triggered by a variety of factors, including stress, sleep disruption, noise, odors, and diet.
A new marker for migraine?
Researchers may have discovered a new marker found in the blood for episodic migraine, according to a study published in the Sept.

Related Migraine Reading:

Best Science Podcasts 2019

We have hand picked the best science podcasts for 2019. Sit back and enjoy new science podcasts updated daily from your favorite science news services and scientists.
Now Playing: TED Radio Hour

Digital Manipulation
Technology has reshaped our lives in amazing ways. But at what cost? This hour, TED speakers reveal how what we see, read, believe — even how we vote — can be manipulated by the technology we use. Guests include journalist Carole Cadwalladr, consumer advocate Finn Myrstad, writer and marketing professor Scott Galloway, behavioral designer Nir Eyal, and computer graphics researcher Doug Roble.
Now Playing: Science for the People

#529 Do You Really Want to Find Out Who's Your Daddy?
At least some of you by now have probably spit into a tube and mailed it off to find out who your closest relatives are, where you might be from, and what terrible diseases might await you. But what exactly did you find out? And what did you give away? In this live panel at Awesome Con we bring in science writer Tina Saey to talk about all her DNA testing, and bioethicist Debra Mathews, to determine whether Tina should have done it at all. Related links: What FamilyTreeDNA sharing genetic data with police means for you Crime solvers embraced...