2023-07-20 15:13:15
The Italian Medicines Agency (AIFA) has authorized the reimbursement of the new solution for subcutaneous use (SC) of the drug natalizumab for the treatment of relapsing remitting multiple sclerosis (RMS) in people already being treated with the intravenous (IV) method of administration of the drug. The new solution for subcutaneous injection – informs the American pharmaceutical group Biogen – offers a safety and efficacy profile comparable to the intravenous formulation and makes it possible to reduce the time required for the administration of the treatment by about 49% (equal to over an hour less), to the benefit of people with multiple sclerosis (MS) and of the healthcare facilities where the therapy is provided. Both formulations of natalizumab are to be administered every 4 weeks by a healthcare professional at a dosage of 300 mg. (VIDEO)
Over 15 years of real-world experience in the use of this monoclonal antibody – Biogen points out – have generated a large amount of data in support of the clinical benefits and a well-characterized safety profile. Today, natalizumab is the only highly effective therapy for the treatment of RMS that offers two delivery options, allowing doctors and patients to choose the one that best suits their specific needs.
“Multiple sclerosis – explains Francesco Vacca, national president of Aism (Italian Multiple Sclerosis Association) – is a complex chronic neurological disease that requires personalized management, not only because the symptoms and course vary from person to person, but, in any case, because the management of the disease fits into individual life paths, from which specific needs arise. Life changes radically after the diagnosis, which usually arrives at a young age, between 20 and 40 years, starting from the need to follow a therapeutic procedure. This has an impact on the quality of life, affecting the psychological, relational, social and work spheres. For this reason, among the points highlighted in Aism’s Agenda of Multiple Sclerosis 2025, it is underlined how the continuity of care, with setting, duration of visits and adequate services, are essential aspects for an effective and person-centred care”.
The approval of the new formulation of natalizumab for subcutaneous use – continues the note – is based on data acquired in the Deliver and Refine studies, in which comparability with intravenous administration was demonstrated. “Recently, during the annual Congress of the European Academy of Neurology – observes Luca Massacesi, Department of Neuroscience, Drug and Child Health area of the University of Florence and director of Neurology II of the Aou Careggi in Florence – the results of an unprecedented direct comparison between the subcutaneous administration of natalizumab compared to the intravenous one were presented, carried out in Italy starting from the data of the Refine study on a sample of 99 people with RMS. The analysis demonstrated the non-inferiority of the SC route of administration compared to the EC route. This therapy, available in Europe since 2006 in the intravenous form – recalls the expert – is considered one of the most effective treatments for multiple sclerosis and its use in this disease is now widely consolidated. For this reason, I believe that the results of this study are important for patients and for the doctors who follow them in clinical practice”.
The Sc formulation simplifies access to the therapy which can also be administered in Sm centers that do not have infusion rooms and adequate nursing support. Additionally, where clinically appropriate, the post-infusion observation period of the first 6 doses of the drug may be shortened or even abolished. All this opens up new opportunities for savings and management improvements also for healthcare facilities, remarks Biogen. “The analysis conducted as part of the Easier study, which involved the healthcare personnel of 9 Italian Sm Centers and over 400 patients – reports Luigi Grimaldi, head of UOC Neurology, Istituto G. Giglio Cefalù Foundation in Palermo – shows a reduction in the total time for the provision of treatment of approximately 50% and a decrease in the use of dedicated healthcare resources equal to approximately 76%. Furthermore, the study estimated a reduction of approximately 55% in the active working time of the operator and a reduction in the time spent in the infusion chair by about 60%.These findings therefore open up prospects and opportunities for organizational improvement determined by the release of durable resources and equipment that can be appropriately allocated to other activities, promoting the efficiency of the system, with consequent benefits for patients and their families, who can reduce the time spent in healthcare facilities with a consequent positive impact on the quality of life”.
“Natalizumab is a widely consolidated highly effective therapy, which has contributed to changing the management of multiple sclerosis – comments Matteo Papi, medical director of Biogen Italy – Over 15 years of real-world experience have amply demonstrated the efficacy of this drug in reducing disease activity and today we are proud to be able to make this new therapeutic option available to the Italian MS community, capable not only of reducing the impact of therapy on the life of people with MS, but of allowing organizational improvements and savings in the healthcare facilities involved in the management of therapeutic and care pathways.This approval represents a further step forward in the commitment that we have dedicated for over 40 years to finding new answers, exploring new possibilities and responding to the needs of people living with multiple sclerosis”.
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