Press release no 683 - Type 2 diabetes mellitus is a chronic disease with a growing prevalence in the Italian population of 6-7% (over 3.5 million patients), and a significant impact in terms of morbidity and mortality. About one third of patients are looked after exclusively by General Practitioners (GPs), who so far were not authorised to prescribe 3 categories of medicines that have become of great importance for the treatment of diabetes and its complications: SGLT2 inhibitors, GLP1 receptor agonists and DPP4 inhibitors.

With the introduction of Note 100, a large number of medicinal products, including combinations, can now be prescribed directly by GPs, in addition to all specialists of the National Health Service (NHS). This is a long-awaited measure, required by both patient associations and doctors. It will allow GPs to play a major role in the integrated management of diabetes.

The correct implementation of AIFA Note will require a training effort by the NHS through all the envisaged channels, as well as a dialogue with regional and national stakeholders, with whom AIFA is ready to cooperate straightaway.

This AIFA Note will help provide the best possible treatment to all patients with type 2 diabetes, by no longer relying solely on the correction of blood sugar, but also on the prevention of cardiovascular and kidney complications that represent important criticalities of this disease. Recent studies have shown that some of these medicines (SGLT2i and GLP1-RA) can reduce cardiovascular risk (particularly heart failure, myocardial infarction, stroke, etc.) and slow the progression of nephropathy.

Like other Notes recently published by AIFA, Note 100 aims not only to define the reimbursement of medicines, but has also been conceived as a guidance document that makes it possible to identify the most appropriate therapeutic option for the individual patient in relation to his characteristics, the general clinical framework and the risk factors.

The work carried out by AIFA’s Technical-Scientific Commission (CTS) required more than a year of in-depth analysis, and the Note was shared with scientific societies in the sector (SID, Italian Society of Diabetology; AMD, Italian Association of Diabetologists; SIMG, Italian Society of General Medicine). The contents of the Note are in line with the most recent national and international guidelines.

The Note on antidiabetics is also an excellent example of the application of the 2022 Budget Law, whereby AIFA is asked to update the list of medicines reimbursed by the NHS on an annual basis. With the Note, the review of medicines dispensed by the NHS does not only include a price alignment, but combines sustainability with interventions aimed at promoting prescriptive appropriateness, the central role of GPs as well as patient care.