A change in the use of the monoclonal antibody erenumab (Aimovig ® ) in the prevention of migraine attacks has resulted from the comparison study with topiramate (1). As with the other monoclonal antibodies, erenumab was initially only found to have an additional benefit for patients for whom the previously approved drugs as best supportive care were not effective, tolerated or contraindicated. The new assessment is based on the results of the Hermes study (1), which compared migraine prophylaxis with erenumab and topiramate in patients with episodic and chronic migraine. The primary study endpoint was treatment discontinuations due to side effects. The proportion of patients with a reduction in monthly migraine days by at least 50% served as a secondary endpoint. Erenumab showed favorable results compared to topiramate for both target parameters. While 10.6% of erenumab-treated patients discontinued treatment due to side effects, 38.9% of topiramate-treated patients discontinued treatment. An improvement rate of at least 50% in the mean migraine days per month was seen in 55.4% of the patients treated with erenumab; in the topiramate group, a corresponding treatment result was only seen in 31.2%. There were also significant benefits of treatment with erenumab compared to placebo in terms of health-related quality of life.

Based on these results, a new benefit assessment procedure including price negotiations for erenumab was initiated. The G-BA found a considerable additional benefit of erenumab compared to topiramate for migraine patients with at least four migraine days per month who are eligible for conventional migraine prophylaxis. The subsequent negotiations with the National Association of Statutory Health Insurance Funds regarding the reimbursement of erenumab led to new criteria for the recognition of the regulation as a practice peculiarity. According to this, the prescriptions of Aimovig ® (active ingredient: erenumab) from April 1st, 2022 according to Section 130b Paragraph 2 SGB V by the testing body in the listed patient group have an additional benefit according to the G-BA resolution of May 2nd, 2019 and October 21st, 2021 from the first case of treatment to be recognized as a practice peculiarity if one of the following conditions exists:

  • Adults with at least 4 migraine days per month in whom therapy with at least one migraine prophylaxis (metoprolol, propranolol, flunarizine, topiramate, amitriptyline or Clostridium botulinum toxin type A) was unsuccessful or was not tolerated.
  • Adults with at least 4 migraine days per month who are not suitable for any of the active ingredients mentioned The unsuitability must be documented.

All other regulations are expressly not included in the practice specificity. The specifications of the specialist information must be taken into account. Treatment with erenumab should be initiated and monitored by physicians experienced in the diagnosis and treatment of patients with migraine. The patient's response must be documented by the doctor. Further details about corresponding documentation options in practice are described in the section “Effectiveness parameters in care provision”. For patients who have not shown a response after three months of treatment, the follow-up prescription is no longer covered by the practice specificity. The regulations on the specific nature of the practice do not exempt doctors from complying with the requirements of Section 12 SGB V and Section 9 of the Medicines Directive.

Effectiveness parameters in the care process

Continuous recording of migraine days per month should be carried out continuously during the use of monoclonal antibodies. Preferably, this can be done prospectively using digital applications such as the migraine app (2, 3). The data is continuously aggregated and analyzed to enable reliable progress and success monitoring. The operationalization of effectiveness can be achieved via a 50% reduction in migraine days per month. However, the number of days taken for acute medications should also be included in the evaluation analysis. The disability caused by the migraine should also be recorded. Instruments suitable for everyday practice include the MIDAS score, the HIT-6 score or the degree of disability due to headaches (GdBK score) in the migraine app. In contrast to the MIDAS and HIT-6 scores, the latter does not record functional professional, social and family limitations retrospectively from memory, but rather determines them prospectively during the course of treatment and continuously evaluates them in aggregate form. A reduction in migraine-related disability scores by 30% in relation to the MIDAS and GdBK score or by at least 5 points in the HIT-6 score can be viewed as a parameter for effectiveness. If you have chronic migraine, a reduction in the number of migraine days per month by at least 30% can be considered proof of effectiveness.

literature

  1. 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.
  2. Göbel H, Frank B, Heinze A, Göbel C, Göbel A, Gendolla A, et al. Contemporary medical progress and success monitoring with the migraine app. Pain medicine. 2020;36(5):28-36.
  3. 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.