Press release no. 673 - With a note addressed to the Regional Health Departments, AIFA has communicated the reopening of the 5% Fund and the definition of access criteria. The new methods to access the Fund aim to protect the sustainability of a tool that lawmakers devised to allow access to medicines not yet marketed in Italy, which represent a hope of cure for patients suffering from rare and serious diseases, i.e. the treatment of single cases with an important or maximum therapeutic need.
Should the requests be consecutively reiterated, AIFA will take the appropriate steps - depending on the condition and stage of development of the medicine - to evaluate alternative access strategies, such as making the medicine available pursuant to Law 648/96, or starting a clinical study, or launching a therapeutic use program in agreement with the manufacturer.