2023-09-19 18:58:55
After the subcutaneous formulations, the Italian Medicines Agency (Aifa) recently recognized the reimbursement of eptinezumab, the first monoclonal anti-Cgrp (peptide related to the calcitonin gene) monoclonal antibody for intravenous administration for the prophylaxis of migraine in adult patients. This new formulation “has some relevant specificities: it allows administration in 30 minutes, 4 times a year, i.e. once every 3 months (12 weeks)”. This was underlined by Piero Barbanti, director of the Unit for treatment and research on headaches and pain, Irccs San Raffaele Rome, associate professor of Neurology, San Raffaele University, Rome and president of the Italian Association for the fight against headaches (Aic) , who spoke at the event ‘Migraine: new perspectives for the patient between innovation, research and regulatory opportunities’, organized by Lundbeck Italia today in Rome.
The new formulation “has a particular rapid onset of the prophylactic effect – highlights the neurologist – which can be correlated to the peculiar pharmacokinetic profile due to the intravenous route of administration, and a preventive effect sustained over time. Its preventive effectiveness has been proven both for episodic or chronic migraine, in the presence or absence of excessive use of analgesics and failure of previous preventive anti-migraine therapies”. Furthermore, “the favorable tolerability and safety profile of eptinezumab – adds Barbanti – has also been proven in the long term, as the data show, up to 2 years from the start of treatment”.
According to data from the World Health Organization (WHO), “migraine – underlines Paolo Calabresi, director of the UOC Neurology, full professor of the Institute of Neurology, Fondazione Policlinico Gemelli Irccs and past president of the Italian Headache Study Society (SISC ) – represents the third most frequent pathology and the second most disabling. It affects approximately 14-15% of adults with a prevalence 3 times higher in women and also younger groups. Despite its impact being very high from every point of view ( human, social and economic), still today it is defined as an invisible pathology”.
The pathophysiology of migraine is complex. “However – specifies Alessandro Padovani, full professor of Neurology at the University of Brescia and elected president of the Italian Society of Neurology (Sin) – the central role of the activation of the trigemino-vascular pathways, which causes the release of vasodilatory substances, is now clear , proinflammatory and neuropeptides which have become the main targets in the treatment of the pathology. In fact, in recent years, drugs have been developed that act on the Cgpr peptide. Monoclonal antibodies and gepants neutralize the Cgpr or block its receptor and, consequently, act by antagonizing a mechanism central in the pathogenesis of migraine. Thanks to these drugs and the use of botulinum toxin, a new era has opened in the field of headaches, creating the conditions for precise and personalized treatments for the prevention of migraines, with improved effectiveness and the safety and tolerability profile”.
Episodic migraine – recalls a note – is a neurological disease with a high risk of becoming chronic if not treated adequately. When it occurs in chronic form it involves serious disability, high costs and risk of excessive use of symptomatic drugs. “The consequences of inadequate therapy, highlighted by the Italian Migraine Registry – Barbanti specifies – are health nomadism; frequent, but useless specialist visits (an average of 18 different specialists for those who have at least 25 days of migraine per month); diagnostic tests not necessary or incorrect in 95% of cases, of which 8-9 times out of 10 are the responsibility of the National Health Service”.
In this scenario, Italy has taken an important step forward with Law 81/2020, which recognized chronic primary headache as a social disease. “Headache – states Lara Merighi, national coordinator of Al.Ce. Group Italia Cirna Foundation Onlus – affects, often from an early age, the life of those who suffer from it. Even today, however, 3 years after the law, people expect average 8 months for a visit with an expert and there is an unsatisfied therapeutic need and a strong disparity in access between patients, due to the few reference centers” and a “staff shortage” which aggravates “intra-health mobility -regional”.
Migraine – continues the note – is associated with a greater global economic burden due to the loss of work productivity and increased healthcare costs. “Looking at Italy – reports Francesco Saverio Mennini, Research Director Eehta of Ceis, Faculty of Economics, University of Rome Tor Vergata and president of the Italian Society of Health Technology Assessment (Sihta) – the literature data estimate an overall annual cost per patient equivalent to approximately 11,300 euros, higher than patients with diabetes (approximately 8,300) or patients with chronic renal failure (7,000-9,600 euros). The annual direct cost of those with the chronic form is 4.8 times higher than that of those who suffer from it episodically (2,037 against 427 euros). The days of reduced production capacity account for 64.6% of the total indirect costs”.
“We are proud – comments Tiziana Mele, managing director of Lundbeck Italia – to be able to offer patients a new therapeutic solution now available in Italy and the result of Lundbeck’s tireless commitment to research in the field of neuroscience. However, we want to be alongside these people and of their loved ones at 360 degrees, and for this reason we support awareness campaigns and provide services and tools to support the therapeutic path” such as the “Patient Support Program for patients undergoing therapy with eptinezumab, a pilot project which will initially involve the headache centers of Lombardy Developed with the support of a board of clinicians, psychologists, representatives of patient associations, it is aimed at increasing the empowerment of people with migraines through a counseling process”.
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