On May 2, 2019, the Federal Joint Committee (G-BA) adopted the benefit assessment of erenumab in accordance with Section 35a of the German Social Code, Book V (SGB V) . A substantial added benefit was derived from the submitted data only for adult patients who do not respond to, are unsuitable for, or cannot tolerate any of the aforementioned drug therapies/drug classes (metoprolol, propranolol, flunarizine, topiramate, amitriptyline, valproic acid [1] , Clostridium botulinum toxin type A [2] ). "Best Supportive Care (BSC)" was used as the appropriate comparator therapy. Best Supportive Care is defined as the therapy that ensures the best possible, patient-specific, optimized supportive treatment to alleviate pain and improve quality of life. It follows that not only the prior drug therapy is relevant for the added benefit, but also that Best Supportive Care must be considered on an individual basis. Individualized best supportive care (BSC) includes, among other things, information, monitoring of progress and success through documentation of pain progression, behavioral medicine therapies such as relaxation training, biofeedback therapy, cognitive behavioral therapy or stress management, treatment of comorbidities, interventional and neuromodulatory procedures, as well as multimodal pain therapy in accordance with the entry criteria and structural requirements of the OPS code 8-918. BSC must also consider attack therapy and any existing medication overuse headache (MOH) and its appropriate treatment. Erenumab is not approved for the treatment of MOH. According to the German Federal Joint Committee (G-BA), the initiation and monitoring of treatment with erenumab should be carried out by physicians experienced in the diagnosis and treatment of patients with migraine.

[1] According to Annex VI to Section K of the Drug Directive: if treatment with all other approved drugs has been unsuccessful or is contraindicated.

[2] According to the approval, it is only for chronic migraine

Benefit assessment of erenumab according to § 35a SGB V – G-BA decision of May 2, 2019