Erenumab for migraines: According to the IQWiG reference to considerable additional benefits for certain patients

Successful as a prophylaxis when other drug therapies have been exhausted

Erenumab, the first drug in a new class for migraine prophylaxis, was launched in Germany in November 2018. The Institute for Quality and Efficiency in Health Care ( IQWiG ) has now conducted an early benefit assessment to determine whether erenumab additional benefits . Data submitted by the manufacturer show that erenumab can reduce the burden of migraines in patients for whom other previously used prophylactic drugs have failed or were not suitable.

The manufacturer only submitted data for episodic migraine, not for chronic migraine. However, since this classification is based solely on the number of pain days and the boundaries between episodic and chronic migraine are blurred, the IQWiG (Institute the indication of considerable added benefit to be limited to episodic migraine.

This class of drugs switches off the messenger substance CGRP

Unlike acute treatment, there have previously been no specific medications for migraine prophylaxis. While a number of medications are now available, these were all developed for other conditions, such as high blood pressure, depression, or epilepsy.

CGRP ( calcitonin gene-related peptide in the development of migraines . However, it took decades to develop a drug that CGRP without serious side effects.

Erenumab is the first representative of a new class of drugs that has now reached market maturity. Its mechanism of action involves inhibiting CGRP

The dossier contains data for one of three patient groups

The Federal Joint Committee ( G-BA ) has distinguished between three groups of patients, each experiencing at least four migraine days per month. The distinguishing criterion is whether, and if so, which type of prophylactic medication they have previously received.

However, the manufacturer's dossier only contains data for one group, namely patients for whom the previously approved active substances for migraine prophylaxis, including valproic acid and Botox (Clostridium botulinum toxin type A), had failed or for whom they were not suitable, for example due to intolerance.

As an appropriate comparator therapy, the G-BA Best supportive Care ” ( BSC for this group , i.e. the best possible, individually optimized treatment, such as psychotherapy or relaxation techniques.

Only patients with episodic migraine were included

The data from 193 patients cited by the manufacturer in the dossier come from the randomized controlled trial LIBERTY , on which the approval is also based. Over a period of 12 weeks, participants received either a monthly subcutaneous injection of erenumab or a placebo, each supplemented by BSC ( ).

Eligible participants were those with between four and 14 headache days per month (episodic migraine) and for whom at least two, but no more than four, prophylactic medications had already failed. Patients with chronic migraine, who according to the classification suffer from headaches on 15 or more days per month, are not included LIBERTY

Fewer migraine days, less impairment

As the analysis of these data shows, the number of headache days was reduced by at least half in significantly more participants in the erenumab group than in the placebo group. This also applies to the number of migraine attacks, which can each last several days.

The results also favor erenumab with regard to the "general impairment" caused by headaches and the "impairment of activity".

In contrast, no or no relevant differences were found in "physical function," "work productivity," health status, and side effects. The endpoint not assessed at all in LIBERTY

The only criterion is the number of headache days

Erenumab has been approved for both episodic and chronic migraine. Furthermore, the study results need not be limited to episodic migraine, as the use of a 14-day period to differentiate between episodic and chronic migraine lacks any medical or other substantive justification in the literature. Moreover, the participants in the LIBERTY study within the transitional range between episodic and chronic migraine.

Overall, IQWiG additional benefit of erenumab for the prophylaxis of migraine

The G-BA decides on the extent of the added benefit

The dossier assessment is part of the early benefit assessment under the Act on the Reform of the Market for Medicinal Products ( AMNOG ), for which the (G-BA) is responsible. After publication of the dossier assessment, the G-BA a consultation process and makes a final decision on the extent of the added benefit.

an overview of the results of the IQWiG You can also find easily understandable information on the IQWiG