OBJECTIVES: Under Article 48 of Law 326/2003, AIFA has established an innovative funding scheme (Fondo AIFA 5%). Italian pharmaceutical companies are required to donate 5% of their promotional expenditure to an independent research fund. Half of this allowance is used for the reimbursement of orphan and life saving drugs awaiting market entry. This study is aimed to assess how many applications have been submitted to the Technical Committee of AIFA (CTS) and how they have been evaluated. METHODS: The reports of CTS meetings from January 2013 to May 2015 were reviewed, checking number and characteristics of drugs under evaluation, and analysing each single decision taken by CTS. RESULTS: Over the period under analysis, CTS evaluated 15 drugs, for the treatment of 61 patients. The therapeutic areas mainly represented were the respiratory system (cystic fibrosis), the onco-haematology (multiple myeloma and MCL) and other rare diseases (Duchenne muscular dystrophy, short-bowel syndrome, cystic fibrosis, inborn errors of primary bile acid synthesis). Out of 61 patient applications, 16 were approved, 26 rejected as the product obtained a full registration and reimbursement in the meantime, 8 rejected (expanded access program or drug already included in 648 List), 6 rejected due to the lack of data or waiting CHMP’s decision, and 5 rejected due to technical reasons. CONCLUSIONS: AIFA has a very high engagement to assure patient access to orphan and life saving drugs. The 2014 fund amounted to 15,6 million Euro, half of it to be used for the reimbursement of orphan and life saving drugs awaiting market entry, whilst the other half aimed to support independent research, drug information programs and pharmacovigilance costs. However, having said this, the expenditure for the sole orphan and life saving drugs from the Fondo AIFA in 2014 amounted only to 239.895 Euro.