(ANSA) – BOLOGNA, 03 OCT – (UPDATES AND REPLACES THE 6.21pm SERVICE) Aifa and the Ministry of Health are working to make the preventative drug for syncytial virus respiratory infections available in band A, paid for by the National Health Service but the Regions are pressing: we must act quickly, because the epidemic phase is now around the corner and at present there are no doses for everyone, with the risk of once again creating a scenario of “serious inequality” on the national territory, with regions who have the drug available for a universal campaign and regions who are unable to protect even fragile patients”.
The alarm on the availability of the monoclonal antibody Nirsevimab-Beyfortus comes from a letter sent on September 30, but made public today, to the Minister of Health, Orazio Schillaci, and to the Italian Medicines Agency (Aifa) signed by Raffaele Donini, councilor Emilia-Romagna, as coordinator of the Health Commission of the Conference of Regions and Autonomous Provinces. At the moment, one of the most credible hypotheses would be to include the drug in the immunization calendar. This would allow all children to access the product for free. But now time is running out and the Regions are asking for a quick solution. The pharmaceutical company Sanofi, producer of the monoclonal antibody drug, has meanwhile made it known that, “even in the absence of historical indications on the prevention needs of the individual Regions, it has reserved doses for Italy useful for guaranteeing approximately 75% of the coverage of the entire national birth cohort, based on scientific data on efficacy and epidemiological impact”. Starting in the next few days, Sanofi Italia will start marketing nirsevimab in our country too, starting distribution throughout the country. However, “as communicated to the Institutions, Authorities and Regions, at present and due to the commitments already undertaken”, Sanofi specifies that “it is not in a position to respond to the regional public purchasing procedures in progress and to those that may be announced in the coming weeks, while continuing to make efforts to make additional doses available.”
Respiratory syncytial virus (RSV) can lead to severe cases of bronchiolitis in newborns. Every year, it causes the death of approximately 100,000 children under the age of 5 worldwide. A turning point is represented by the monoclonal antibody which has proven to be able to prevent 90% of hospitalizations and which the ministry has announced it wants to make available free of charge in all regions for the treatment of newborns. This news arrived after a previous circular – which raised a storm – which alerted the Regions in the recovery plan (Lazio, Abruzzo, Molise, Campania, Calabria, Puglia, Sicily), essentially the South, on the opportunity to independently guarantee the administration of the drug.
To date, however, the Regions are once again pressing Aifa and the ministry, especially considering that the epidemic phase – October-March – is practically opening. Donini reports that “to date, many of the regional tenders carried out for the purchase of Nirvesimab have been abandoned because the company declares the unavailability of the drug for universal coverage” and this determines “a scenario of serious inequality on the national territory” . Faced with these “urgent situations”, the Regions ask to “evaluate the activation of an accelerated negotiation by AIFA for the inclusion of the drug in Band A, thus making it accessible to all Regions”. And if this is not possible, they ask to provide for the possibility of attributing “reimbursability to class C drugs purchased by NHS bodies for public health needs”. (HANDLE).
2024-10-04 05:58:26