OBJECTIVES: Analyse the time-to-reimbursement of European Medicines Agency (EMA)-approved new active principles in Italy, through tracking the Italian Medicines Agency (AIFA) Price and Reimbursement (P&R) process, from Technical Scientific Committee (CTS) opening to Official Journal (OJ) publication.

METHODS: Data analysed were taken from published official documents: each step of the Italian P&R process (CTS opening, scientific assessment by CTS, price negotiation with Price and Reimbursement Committee [CPR] and OJ publication) were tracked monthly from January 2016 to December 2019, through the update of an internal excel database.

RESULTS: In the analysed period, 133 new drugs were reimbursed in class A or H and categorized in: oncological (40), innovative (31), innovative oncological (19), rare disease (54 of which 36 orphan drugs) and other approved drugs. During the four-year period (2016-2019), 33 drugs were reimbursed yearly on average, with a peak of 49 in 2017 and a minimum of 24 in 2016. The average time-to-reimbursement between CTS opening and OJ publication has increased over this period, from 228 (sd±86) days in 2016 to 363 (sd±199) days in 2019 (average annual rate +16.8%). This increase is almost exclusively determined by the CTS-CPR active assessment, and more specifically by the CPR step. In fact, the CPR assessment timeframe has increased from 88 (sd±46) days in 2016 to 233 (sd±147) days in 2019 (average annual rate +38.3%). The CTS assessment timeframe, except for a peak in 2017, has not changed significantly during the observation period.

CONCLUSIONS: Our results can help pharma companies in setting their expectations for launches in Italy. The longer time-to-reimbursement, mostly linked to the CPR assessment, reveals an increasing complexity in achieving a win-win agreement on the price and/or economic conditions, able to meet both AIFA needs of cost-containment and pharmaceutical budget management, and Pharma Companies’ access expectations.