Bronchiolitis, life-saving treatment for newborns 'only for some regions'. Then the half-reverse

It is alert for the respiratory syncytial virus epidemic season among toddlers and infants, which can cause severe forms of bronchiolitis that last year caused 15,000 hospitalisations, including 3,000 in intensive care, and 16 deaths.

The Ministry of Health's note warning that the monoclonal antibody Nirsevimab, a drug that reduces hospital admissions by 90%, will only be available free of charge in the Regions with accounts in order and not in those with a recovery plan, namely Latium, Abruzzo, Molise, Campania, Calabria, Apulia and Sicily. A decision that provoked a storm of reactions and convinced the ministry to make an immediate half-retreat, evaluating the inclusion of the drug among those free of charge borne by the SSN and therefore for everyone.

The Ministry of Health has in fact initiated contacts with Aifa, the Medicines Agency, in order to make the monoclonal antibody Nirsevimab against the respiratory syncytial virus in children, which can evolve into even severe cases of bronchiolitis, available in all regions, at the expense of the National Health Service and therefore at no cost to citizens.

The clarification came from the ministry itself, after a previous circular - dated 18 September - had alerted the regions in the recovery plan, mainly in the south, to the opportunity to independently guarantee the administration of this drug, even though it is not included in the LEA (Essential Levels of Care). In fact, the note stated that 'the regions in the healthcare deficit recovery plan (Lazio, Abruzzo, Molise, Campania, Calabria, Apulia and Sicily) cannot currently guarantee the administration of the monoclonal antibody,' because, the note explained, 'it is an extra-LEA service,' i.e. outside the essential levels of care. While the remaining regions can guarantee it 'only on condition that financial coverage is guaranteed with resources from the autonomous regional budgets'.

In the new circular to the Regions, again signed by the director general of the Health Planning Directorate, Americo Cicchetti, it is in fact clarified that 'in consideration of the possible profiles of territorial inequity in access to therapies based on the monoclonal antibody Nirsevimab-Beyfortus, used for the treatment of respiratory syncytial virus infections (VRS) in paediatric age, resulting from the application of the note of 18/09/2024, the Ministry has already initiated the appropriate discussions with the Italian Drug Agency and the Directorate General for Prevention of the undersigned Ministry, in order to ensure fair and timely access for patients to all approved therapies that show adequate profiles of appropriateness, safety and efficacy throughout the country'. The problem arises in particular from the fact that there is currently restrictive legislation for the regions in the recovery plan that currently makes it difficult to provide drugs not included in the Lea through an autonomous decision by these regions.