Italian Medicines Agency Agenzia Italiana del Farmaco

AIFA Board of Directors approves the reclassification of gliflozines in class A of reimbursed products that can be purchased in pharmacies - AIFA Board of Directors approves the reclassification of gliflozines in class A of reimbursed products that can be purchased in pharmacies

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AIFA Board of Directors approves the reclassification of gliflozines in class A of reimbursed products that can be purchased in pharmacies

In compliance with the Budget Law 2024, the AIFA Board of Directors has approved the switch from direct distribution to distribution in pharmacies and the abolition of therapeutic plans for glyflozines, new-generation anti-diabetics also used to treat congestive heart failure and chronic renal failure. This is an important step towards simplification, greater adherence to therapies, and the reduction of waiting lists: patients will no longer have to undergo a specialist visit to renew their treatment plans, as had been expressly requested in the past by medical and patient associations, but a repeatable prescription will suffice to access the medicine.

Despite the fact that last year's Budget Law did not provide for any constraints on the invariance of costs relating to reclassifications, the Agency initiated and concluded renegotiations with the four glyfozine manufacturers, which led to a significant reduction in prices, with the signing of new contracts bound by the confidentiality pact, still in force in Italy as in other European countries. The discounts obtained, together with the saving of the not inconsiderable management costs of centralised purchasing and distribution of medicines by the Regions, suggest that savings can currently be expected on the basis of average national costs. Without prejudice to the fact that, as envisaged by the Budget Law 2024 itself, it will then be up to the Expenditure Monitoring table, set up at the Ministry of Health, to assess the actual trend during the course of the year.


Published on: 30 June 2025

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