Migraine presents as a sharp and throbbing pain, lasting hours or days; sometimes it is accompanied by nausea, vomiting, discomfort with light and sounds. It is a disabling disease that has been identified by the World Health Organization as the disease that causes the greatest disability in the age group between 20 and 50, which is the time in life when people are most productive. In our country there are about six million people who suffer from migraine, 12% of the population.
Until recently, people suffering from this disease were treated using drugs developed to treat other diseases such as antidepressants, antiepileptics or antihypertensives: drugs characterized by a moderate effectiveness, but sometimes burdened by intolerable side effects.
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Monoclonal antibodies
Recently, the armamentarium available to migraine specialists has been enriched with an innovative therapeutic approach that involves the use of monoclonal antibodies artificially developed and directed against a particular molecule known as Cgrp (Calcitonin Gene Related Peptide) which when produced in excess by our body can cause inflammation that plays a fundamental role in the genesis of the disease.
This revolutionary treatment has led to a new way of dealing with the disease, because it is able to act on the cause of migraine and therefore manages to prevent it: in the patients treated there has been a reduction in the frequency, intensity and duration of migraine attacks over time. Furthermore, the administration takes place only once a month. All of this has had a huge benefit on the quality of life of our patients.
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The reimbursement
However, the Italian Medicines Agency (Aifa) introduced in July 2020 a series of restrictions on the use of monoclonal antibodies that are supplied at the expense of the national health system. Aifa has in fact bound the reimbursement of the drug by providing for the mandatory suspension of therapy after 12 months of treatment for at least three months. The legislation also provided that the treatment could be resumed if the characteristics that supported the prescribing were reappeared.
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Precisely on the latter issue, as president of the Italian Society of Neurology (Sin), in concert with Professor Paolo Calabresi – president of the Italian Society for the Study of Headaches (Sisc) – and with professor Piero Barbanti – President of the Italian Neurological Association for Research on Headaches (Anircef) – I asked the Agency on 23 April to ask for a joint solution to this regulatory provision, bearing in mind the good of migraine patients who were heavily penalized by this resolution , as they were destined to feel sick again for months without the possibility of being prescribed an effective therapeutic alternative in the reimbursement regime.
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Adult patients
The people we consider suitable for treatment with monoclonal antibodies are in fact adult patients who in the last three months have presented at least eight days of disabling migraine each month (defined as a score of the Midas questionnaire: ≥11), and who have already been treated in an unsuitable way. satisfactory with other migraine prophylaxis therapies. To prescribe antibodies, in fact, we require that the other treatments have not given sufficient results after at least six weeks of treatment; otherwise we require patients to be intolerant or have clear contraindications to at least three previous classes of migraine prophylaxis drugs.
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Furthermore, the suspension of anti-Cgrp antibody therapy after 12 months of treatment imposed by the AIFA did not have univocal scientific data as its foundation, but was decided on the basis of what happened and is happening with the old anti-migraine drugs: an unjustifiable approach, the antibodies being devoid of the plethora of side effects that characterized the old treatments and which therefore made it necessary to suspend treatments that were not very tolerable.
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The observations brought to the attention of AIFA were quickly received and, shortly, patients treated with anti-Cgrp monoclonal antibodies will no longer be forced to wait for the notorious three months of suspension that followed the 12 months of therapy, before to resume specific anti-migraine treatment.
This not only allows people who suffer to breathe a sigh of relief but frees us clinicians from the sense of helplessness and bewilderment we felt when we were forced to suspend, without any apparent scientific or clinical reason, an effective and highly tolerable therapy.
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Finally, the previous AIFA provisions caused problems of social inequality as the treatment with monoclonal antibodies, during the three months of mandatory suspension, could be prescribed in a “non-refundable” regime, thus allowing only patients who could face a disbursement. considerable, the possibility of not interrupting the treatment.
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