EMGALITY

First assessment.

Favourable opinion for reimbursement 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 (patients having had a myocardial infarction, unstable angina, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), stroke, deep-vein thrombosis (DVT) or other serious cardiovascular risk).

Unfavourable opinion for reimbursement in the rest of the MA indication.

What therapeutic improvement?

No clinical added value in the management of migraine.

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 their frequency.

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.

In the absence of contraindications, beta-blockers (propranolol and metoprolol), are the first-line treatments to be favoured. Treatment should be initiated as monotherapy, at low doses that are progressively increased. In the event of contraindication or intolerance to beta-blockers, topiramate is an alternative with a demonstrated efficacy. 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 recommendations with a lower level of evidence of efficacy (grade B or C): anti-epileptic drugs (sodium valproate and divalproate, gabapentin), antidepressants (amitriptyline, venlafaxine), other beta-blockers (atenolol, nadolol, nebivolol, timolol), candesartan, naproxen sodium.

Erenumab (AIMOVIG), the first anti-CGRP antibody assessed by the Committee in 2019, is an alternative in patients with severe migraine and at least 8 migraine days per month, with previous failure to at least two prophylactic treatments and without cardiovascular disease (patients having had a myocardial infarction, stroke, TIA, unstable angina or coronary artery bypass graft (CABG)).

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

EMGALITY (galcanezumab) is a medicinal option to be favoured in patients with severe migraine and at least 8 migraine days per month, with previous failure to at least two prophylactic treatments and without cardiovascular disease. In other clinical situations, including patients with fewer than 8 migraine days per month, previously untreated or with previous failure to only one alternative, as well as patients with severe cardiovascular disease, EMGALITY (galcanezumab) has no role in the care pathway.