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 board from 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 aggregated and analyzed to enable reliable monitoring of treatment progress and success. Efficacy can be operationalized by a 50% reduction in migraine days per month. However, the number of days taken for 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

  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 monitoring of course and success 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.