A change in the use of the monoclonal antibody erenumab (Aimovig®)for the prevention of migraine attacks has resulted from the comparative study with topiramate (1). As with other monoclonal antibodies, erenumab was initially only found to offer additional benefit to patients for whom the previously approved drugs were ineffective, not tolerated, or contraindicated as best supportive care. The new assessment is based on the results of the Hermes study (1), which compared migraine prophylaxis with erenumab to that of topiramate in patients with episodic and chronic migraine. The primary endpoint was treatment discontinuation due to adverse events. The secondary endpoint was the proportion of patients with a reduction in monthly migraine days of at least 50%. For both endpoints, erenumab showed favorable results compared to topiramate. While 10.6% of patients treated with erenumab discontinued treatment due to side effects, this figure was 38.9% for patients treated with topiramate. A reduction of at least 50% in the mean number of migraine days per month was observed in 55.4% of patients treated with erenumab, compared to only 31.2% in the topiramate group. Significant benefits of treatment with erenumab compared to placebo were also evident with regard to health-related quality of life.
Based on these results, a new benefit assessment procedure, including price negotiations, was initiated for erenumab. The Federal Joint Committee (G-BA) determined that erenumab offers considerable additional benefit compared to topiramate for migraine patients with at least four migraine days per month who are eligible for conventional migraine prophylaxis. Subsequent negotiations with the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) regarding the reimbursement of erenumab led to new criteria for recognizing prescriptions as special practice treatments. Accordingly, prescriptions of Aimovig® (active ingredient: erenumab) must be recognized as special practice treatments by the review boardfrom April 1, 2022, onwards, in accordance with Section 130b Paragraph 2 of the German Social Code, Book V (SGB V), for the specified patient group, with an additional benefit as determined by the G-BA resolutions of May 2, 2019, and October 21, 2021, starting from the first treatment case, if one of the following conditions is met:
- Adults with at least 4 migraine days per month, for whom therapy with at least one migraine prophylaxis (metoprolol, propranolol, flunarizine, topiramate, amitriptyline or clostridium botulinum toxin type A) has been unsuccessful or not tolerated.
- Adults with at least 4 migraine days per month who for any of the listed active ingredients for migraine prophylaxis. This unsuitability must be documented.
All other prescriptions are expressly excluded from the practice-specific provisions. The instructions in the product information must be followed. Initiation and monitoring of treatment with erenumab should be carried out by physicians experienced in the diagnosis and treatment of patients with migraine. The patient's response must be documented by the physician. Further details regarding appropriate documentation options in practice are described in the section "Efficacy Parameters in the Care Process." For patients who have not shown a response after three months of treatment, subsequent prescriptions are no longer covered by the practice-specific provisions. The regulations concerning practice-specific provisions do not exempt physicians from complying with the requirements of Section 12 of the German Social Code, Book V (SGB V) and Section 9 of the Drug Directive.
Effectiveness parameters in healthcare provision
Continuous monitoring of migraine days per month should be performed during monoclonal antibody treatment. This can preferably be done prospectively using digital applications such as the migraine app (2, 3). The data are continuously documented to enable reliable monitoring of treatment progress. Efficacy can be operationalized by a 50% reduction in migraine days per month. However, the number of days taken with acute medication should also be included in the evaluation analysis. Disability caused by migraine should also be recorded. Suitable instruments for everyday clinical practice include the MIDAS score, the HIT-6 score, or the degree of disability due to headache (GdBK score) in the migraine app. Unlike the MIDAS and HIT-6 scores, the latter does not retrospectively assess functional occupational, social, and familial limitations from memory, but rather determines them prospectively during the course of treatment and continuously evaluates them in aggregated form. A reduction of 30% in migraine-related disability scores with respect to MIDAS and GdBK scores, or a reduction of at least 5 points in the HIT-6 score, can be considered a parameter for effectiveness. In cases of chronic migraine, a reduction of at least 30% in migraine days per month can be considered evidence of effectiveness.
literature
- Reuter U, Ehrlich M, Gendolla A, Heinze A, Klatt J, Wen S, et al. Erenumab versus topiramate for the prevention of migraine – a randomized, double-blind, active-controlled phase 4 trial. Cephalalgia. 2022;42(2):108-18.
- Göbel H, Frank B, Heinze A, Göbel C, Göbel A, Gendolla A, et al. Contemporary medical monitoring of course and success with the migraine app. Pain Medicine. 2020;36(5):28-36.
- Göbel H, Frank B, Heinze A, Zimmermann W, Göbel C, Göbel A, et al. Health behavior of migraine and headache patients when treatment is accompanied by the digital migraine app. Pain. 2019;33(2):147-55.
Over six months ago, I experienced my first migraine with aura.
Since then, I've had constant headaches (on both sides) and approximately 20 migraine attacks (on the left side) per month.
Before that, I averaged maybe 5 to 10 migraine attacks per year, which I managed quite well with rizatriptan.
Unfortunately, it took several weeks to get an appointment with a neurologist.
And unfortunately, the medication I was prescribed, such as topiramate, caused severe side effects including significant visual disturbances, a metallic taste in my mouth, and anxiety, which worsened with increased dosage and persisted long after I stopped taking the medication.
Due to a heart condition (non-compaction cardiomyopathy), I couldn't even try various medications because of the risks.
I even bought a migraine cap for the freezer and tried various other things like a mint roll-on, different types of magnesium, paid attention to various triggers and foods, and did atlas and relaxation exercises.
All of that helped somewhat, but when I received my first 70mg Aimovig injection, the chronic headaches subsided significantly after about a week, and the migraine attacks have decreased so much in recent months that I only had two attacks last month and not even one this month.
The chronic headaches have also only occurred on a few days.
I need to keep an eye on it, but the chronic headaches slowly return about three weeks after the injection. At least that's how it was last month and this month. Therefore, I took the next injection a week earlier.
I don't have any long-term experience yet, but so far, Aimovig has been an absolute blessing for me.
I usually don't tolerate many medications well and then have to choose between suffering and suffering.
So far, I've tolerated Aimovig very well. I also have no problems with the injection site, but I follow the instructions and take it out of the refrigerator 30 minutes before use.
I've been taking Aimovig for two months, and it started working after 14 days. I haven't had any headaches since!! And that's after having headaches 25-30 days a week. Other symptoms like fatigue and mood swings have also disappeared. I am so incredibly grateful for this medication.
Hello everyone!
I think I also had migraines as a child, like my mother. They were always dismissed as tension headaches.
Then, 10 years ago, my best friend died of the flu at the age of 47, quite suddenly, and that seems to have triggered something in me, because from then on I had headaches almost 2-3 times a week and went from doctor to doctor. No one could help me until my orthopedist suggested I see a neurologist.
The doctor then diagnosed me with migraines. The triptans helped, but I had over 10 migraine days a month and wanted to try alternatives. None helped. Then, in 2023, I was prescribed Aimovig 70 mg, and now I've gone from 10 triptans a month to a maximum of 2. I hope that this antibody won't cause any long-term damage. Are there any studies on this?
I'll be 60 next year and, of course, I hope that the migraines will eventually stop on their own. :-) Best wishes to all those affected!
Hi :-) I can also only report positive experiences with Aimovig migraine medication :-) I often had headaches as a child (from about age 6) – which later turned out to be migraines. As a teenager (from age 16), I went from doctor to doctor to finally get rid of these awful pains. Whenever something was coming up – long school days, birthdays, trips, special events, you know… my head would be pounding. While others were out partying or having fun, I was stuck in bed :-( I sometimes had migraines for 3-6 days straight, which was really awful. I tried everything that doctors and acquaintances/friends prescribed/recommended. Nothing helped – well, my sumatriptan combined with 600 mg ibuprofen sometimes helped – if I was lucky – but not always. Then my neurologist prescribed the Aimovig migraine pen. First with 70 mg and then, after about a year, with 140 mg. Initially, the number of migraine days decreased significantly. Now I've been using the pen at this dosage for at least 5 years and only very, very rarely get migraines or even headaches. At most, once every 4 months, and then only for one day – and then I usually don't take any pills, but try to let it go away on its own. So, this thing is... Really GREAT :-)
I have suffered from severe migraines since childhood (over 50 years), lasting 3-4 days several times a month with severe nausea and vomiting. I tried various preventative treatments, but it only got worse. For the past 3 years, I have been taking Aimovig and am almost symptom-free. I no longer need medication; I have my life back
I've had migraines with and without aura for many years.
For the last five years, they've been extremely severe.
I've tried many things to alleviate the sometimes intense attacks:
oral pain medication, then triptans, then Botox, and now Aimovig 70mg every four weeks.
After the third injection, the attacks decreased from 18-20 days to just 12 a month.
I'm absolutely thrilled.
The very severe migraine attacks with nausea and vomiting have also lessened.
Since I've been so successful, I don't want to increase the dose to 140mg just yet.
I'll wait a few more weeks, in consultation with my doctor. I hope to achieve even more pain-free (migraine-free) days every day. Every pain-free day is a gift!
I've had migraines with aura since I was 20. It wasn't until I was over 50 that I finally found real help (with a competent neurologist; unfortunately, I'd had two bad experiences before) after triptans stopped providing relief. She prescribed Aimovig. I took it for six months and had fantastic results: I felt full of energy, the pain was gone, and I only had mild headaches with aura in addition to the migraine cycles I used to get – a great success. Unfortunately, I had to discontinue the therapy due to side effects, which haven't completely disappeared even now (over a year later), but are milder. (I had cramping muscle pain and ankle pain, etc.
I was initially desperate at the thought of having to live without Aimovig, but thankfully there were alternatives (Emgality). I tolerate this better, with fewer side effects and no increase in pain. From 10-15 days of severe migraines to now just a few days of mild migraines in a year, which is how long I've been taking the new injection. Both medications were effective, and I am incredibly grateful for that; I have a life again, not just suffering!)
I'm already on my sixth Aimovig injection. Since starting treatment with this medication, I haven't had any severe migraine attacks.
Sometimes I have pain that's more like a headache. For that, an Ibuprofen 400 or sometimes a Naratriptan is enough, and it works quickly.
I can enjoy pain-free weekends again.
I've already had six injections. Before, I had up to 10 attacks a month, some of which left me completely incapacitated. Now, I have headaches for an average of 5 days a month, but they're easily manageable – either with an ibuprofen 400 or 600 mg tablet, or sometimes a naratriptan, which takes effect within an hour. Life is so much more worth living!! Finally, pain-free weekends again.
First I was on Aimovig 70mg.
My migraine days went from up to 12 to 2.
After about 7 months, I was back to 6 migraine days. With Aimovig 140mg, it went down to zero.
After 4 months, however, I was back to 2-3 migraine days. Everything is better than before. The pain is more bearable and the nausea isn't always present.
I'm 57 years old and have had diagnosed migraines since I was 21. Before puberty and from age 19 to 21, they were simply "bad headaches"... In addition to hormonal migraines, I developed cervical migraines due to unstable cervical vertebrae (I'm hypermobile). I often experience migraines with aura. Depending on work stress, I had migraines up to five days a week for many years. Exercise with a heart rate above 140 also immediately triggers a migraine. I was significantly overdosed on pain medication. Besides migraines, I have other problems (MCAS, various intolerances, osteoarthritis, tinnitus, lipedema/lymphedema) and am now on early retirement. I live a very disciplined life to avoid pain: no alcohol, no trigger foods, no events with light and noise, and my "exercise" is limited to dog walks, cycling, and swimming. Hormonal migraines are largely "gone" due to my age, but despite my best efforts, I still get cervical migraines or migraines with aura 2-3 times a week. My treatment of choice so far has been triptans, first sumatriptan (which causes severe nausea), now Maxalt orodispersible tablets, combined with 800 mg ibuprofen or 2 Thomapyrin Intensiv tablets when needed. It usually reduces the pain. I'm managing the nausea quite well now; it's there, but I rarely vomit. Even so, I'm always exhausted on those days, my mind is sluggish, and I have to exert myself for everything. I call them "wasted days." In between, I recover from the migraine days and the necessary medication.
After three consecutive migraine days, I received my first Aimovig 70 mg injection last Tuesday and had 8 days of NOTHING!!! And real energy!! All day long. It was completely surreal. Today I did get another migraine with aura, but it wasn't as severe. The eight days before were truly wonderful. My doctor said it could take up to three injections for the medication to be fully effective, and I might even need the full 140 mg dose. I'm really hoping for many more days full of energy. I'd completely forgotten what it felt like.
Two weeks ago I received my first Aimovig 70 mg injection. Since then I haven't had a migraine. I feel like a different person!!