The financial impact of medicines without competition in Italy

Novel medicines have been reported in the recent literature as one of the major drivers of the spending growth in the last two decades. The aim of this paper was to analyse the financial impact of therapeutic entities without competition (non-competition medicines, NCMs) in Italy and to describe their dynamics in terms of sales and cost. NCMs were defined as medicines without multiple manufacturers, without expired patents, and with a marketing authorization period not exceeding 15 years. Among these, only medicines first marketed in 2014 were evaluated to assess median sales and mean cost trends since the first year of marketing over a 6-year period. Following the cohort identification, the NCMs spending was calculated and the proportion to overall INHS pharmaceutical spending was estimated on a yearly basis. NCMs spending amounted to 9.6 billion euro in 2023, with an increase of 86.5% in comparison to 2014 (CAGR of 6.4%), corresponding to a 38.6% share on the public pharmaceutical expenditure. In the third marketing year, sales were more than double compared to those in the first year and the cost was descending. The NCMs represented a critical and growing share of the public pharmaceutical spending. This suggests the need to develop suitable spending projections approaches and appropriate pricing policies for these medicines.