BOTOX (Type A botulinum toxin)

Key points

Favourable opinion for reimbursement in the prophylactic treatment of chronic migraine in adult patients who have not responded or are intolerant to other prophylactic migraine treatments.

What therapeutic improvement?

No clinical added value in the therapeutic strategy.

Role in the care pathway?

The management of migraine is based on both the treatment of attacks and, if necessary, the initiation of long-term prophylactic treatment to reduce the frequency of attacks.

The medicinal products used in the treatment of attacks are non-specific migraine treatments (analgesics and nonsteroidal anti-inflammatories) and specific treatments (triptans, mainly and ergot derivatives).

The prevention of the onset of attacks will, first and foremost, take into consideration the identification and avoidance of trigger factors. Thereafter, the initiation of long-term treatment will depend, in particular, on the frequency and intensity of attacks and the resulting disability in terms of quality of life, as well as the prevention of any risk of abuse of medication to treat attacks. The choice of prophylactic treatment is based on the side effects, contraindications, interactions and any concomitant conditions the patient may have. The drugs with an MA in the prophylactic treatment of migraine that are used as first-line treatment are beta-blockers (metoprolol and propranolol) and topiramate. The recent 2021 guidelines issued by the French Society for Migraine and Headache Studies specify the preferential care pathway depending on the episodic or chronic nature of the migraine and position topiramate as a first-line treatment for chronic migraine, since this medicinal product has efficacy data derived from specific studies in this clinical form.

Another three drugs also have an MA for the prophylactic treatment of migraine (pizotifen, oxetorone, flunarizine) but are used as salvage therapies only due to their safety profile, in particular. Other drugs without a marketing authorisation in the prophylactic treatment of migraine are also cited in the national guidelines with a lower level of evidence of efficacy (grade B or C, with the exception of sodium valproate and divalproate, with grade A): anti-epileptic drugs (sodium valproate and divalproate, gabapentin), antidepressants (amitriptyline, venlafaxine), other beta-blockers (atenolol, nadolol, nebivolol, timolol), candesartan, naproxen sodium.

Anti-CGRP antibodies (erenumab [AIMOVIG], galcanezumab [EMGALITY] and fremanezumab [AJOVY]), recently assessed by the Committee, represent alternatives in patients with severe migraine who have at least 8 migraine days per month, with previous failure to at least two prophylactic treatments and without cardiovascular disease.

Alternative therapies, such as relaxation and cognitive and behavioural stress management therapies can also be used in some patients.

Role of the medicinal product in the care pathway

BOTOX (botulinum toxin type A) is a medicinal option for the prophylactic treatment of chronic migraine (presence of headaches at least 15 days per month, including at least 8 migraine days per month) in adult patients who have not responded or are intolerant to other prophylactic oral migraine treatments, in accordance with the characteristics of the patients included in the study.

In the absence of comparative data versus anti-CGRP antibodies, the choice of treatment should be made based on the patient’s characteristics, the efficacy of the drugs and their safety profile, along with the different contraindications.

Special recommendations

Given the specificities of the injection procedure and in accordance with the SPC, the Committee highlights the need to administer BOTOX (botulinum toxin type A) in the context of multidisciplinary global management by specialist physicians already experienced in the use of the toxin in these indications and with appropriate technical facilities.