On May 2, 2019, the Federal Joint Committee (G-BA) decided on benefit assessment of erenumab in accordance with Section 35a SGB V. respond to any of the drug therapies/active ingredient classes mentioned (metoprolol, propranolol, flunarizine, topiramate, amitriptyline, valproic acid [1], Clostridium botulinum toxin type A [2 ] ) , are not suitable for them or cannot tolerate them. “Best Supportive Care (BSC)” was used as the appropriate comparative therapy. Best Supportive Care is defined as therapy that ensures the best possible, patient-specific, optimized supportive treatment to relieve pain and improve quality of life. It can be deduced from this that not only the previous drug therapy is relevant for the additional benefit, but also the best supportive care must be taken into account individually. The Best Supportive Care, which is tailored to each individual case, includes, among other things, information, progress and success monitoring through documentation of the pain progression, behavioral medicine therapy procedures such as relaxation training, biofeedback therapy, cognitive behavioral therapy or stress management, treatment of comorbidities, interventional and neuromodulating procedures, as well as multimodal pain therapy according to the entry criteria and structural specifications of the OPS code 8-918. As part of the BSC, attack therapy and any existing medication overuse headache (MÜK) and its appropriate treatment must also be taken into account. Erenumab is not approved for the treatment of MOH. According to the G-BA, treatment with erenumab should be initiated and monitored by doctors who are experienced in the diagnosis and treatment of patients with migraine.
[1] According to Appendix VI to Section K of the Medicines Directive: if treatment with all other approved medicines was unsuccessful or is contraindicated.
[2] According to the approval only for chronic migraines
Benefit assessment of erenumab according to Section 35a SGB V - G-BA review from May 2, 2019
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