Aifa: when drugs are 'innovative', priority for antibiotics and those doing research in Italy

A fast track for those doing research on the precious antibiotics that are essential for fighting the new super-bacteria, but also priority for those who decide to do clinical and pre-clinical research on a new drug in our country. Aifa, the Italian Medicines Agency, has just redefined the criteria that pharmaceutical companies must comply with in order to gain the 'patent' for drug innovation, which allows immediate recognition of reimbursability with automatic inclusion in regional reference books, but also access to funding through the 1.3 billion Innovative Medicines Fund (100 million of which are earmarked precisely for so-called 'reserve' antibiotics).

Rewriting the requirements for the recognition of therapeutic innovativeness - i.e. drugs for pathologies without real treatment alternatives or with added therapeutic value compared to those already on the market - is the Determination published in the Official Gazette of 12 July, the result of extensive consultation with patient associations and stakeholders, which as mentioned for the first time automatically includes antibiotics for the fight against antimicrobial resistance in the Innovative Medicines Fund, while also rewarding national research in the pharmaceutical field. When assessing innovativeness, it may in fact be considered an added value if the pre-clinical and clinical development of the drug has been developed and conducted predominantly in Italy. "The aim is to obtain innovative drugs in therapeutic areas where there is a real need, to the benefit of citizens and the SSN itself. It is essential to establish which drugs have such a therapeutic advantage as to merit economic incentives that, in order to ensure the sustainability of the system, cannot be extended to everything that is simply new,' says Aifa president, Robert Nisticò - 'At the same time, we are strengthening our commitment to promote pharmaceutical research and development in our country and the fight against antibiotic resistance'.

The innovativeness of a drug," explains the annex to Aifa's determination, "is assessed on the basis of the production technology of its active ingredient, its mechanism of action, the way it is administered to the patient, its clinical efficacy and safety, its effects on the quality of life, and its implications for the organisation of healthcare. Innovative drug status, which is necessary for access to the Fund's resources and benefits, is assessed and awarded by Aifa, based on the newly introduced criteria: the presence of a therapeutic need, an added therapeutic benefit, and at least 'moderate' quality of evidence. There are in fact two measurement scales with five levels for therapeutic advantage (highest, important, moderate, minor and absent), and four levels for quality of evidence (high, moderate, low and very low). In the case of medicines for rare and ultra-rare diseases 'therapeutic innovativeness may be assessed even if the quality of evidence is low'. Access to the Innovative Medicines Fund will have a maximum duration of 36 months and can only be granted to drugs for the treatment of 'serious diseases or pathological conditions with medium to low epidemiological impact'.