Medicines Without Competition Now Eat Up Nearly 40% of Italy’s Public Drug Budget

A handful of medicines that face no market competition are quietly reshaping the finances of Italy’s National Health Service. A new analysis by researchers at the Italian Medicines Agency, published in BMC Health Services Research, finds that spending on what the authors call non-competition medicines reached 9.6 billion euros in 2023, an increase of 86.5 percent compared with 2014. That figure corresponds to a compound annual growth rate of 6.4 percent and represents 38.6 percent of the entire public pharmaceutical expenditure in Italy. In other words, nearly four out of every ten euros the Italian health service spends on medicines now goes to products that no generic or biosimilar manufacturer can challenge.

The study was motivated by a growing body of literature identifying novel medicines as one of the major drivers of pharmaceutical spending growth over the last two decades. As expensive new therapies for cancer, rare diseases and immune disorders reach the market, health systems across Europe have struggled to predict and contain the budgetary consequences. The Italian team set out to quantify precisely how much of the national drug bill is attributable to therapeutic entities that operate outside the normal dynamics of market competition, and to describe how their sales and unit costs evolve over time.

Defining which medicines count as non-competition products required a careful methodological framework. The researchers classified a medicine as a non-competition medicine if three conditions were met simultaneously: the product was not marketed by multiple manufacturers, its patents had not expired, and its marketing authorization period did not exceed fifteen years. This triple filter excludes older molecules that have lost patent protection and face generic competition, as well as products that, despite their novelty, are already sold by several companies. The definition captures the window in which a manufacturer holds exclusive control over pricing and volume, before the competitive pressures that typically drive prices downward can take hold.

To understand the financial trajectory of these products, the team focused on a specific cohort: non-competition medicines first marketed in 2014. For this group, they tracked median sales and mean cost trends from the first year of marketing over a six-year period. This longitudinal design allowed the researchers to observe a characteristic lifecycle pattern that has important implications for budget planning. Once the cohort was identified, the researchers calculated total non-competition medicine spending and estimated its proportion of overall Italian National Health Service pharmaceutical spending on a yearly basis.

The headline numbers are striking. Non-competition medicine spending amounted to 9.6 billion euros in 2023, up 86.5 percent from 2014, with a compound annual growth rate of 6.4 percent. That growth rate substantially outpaces general pharmaceutical inflation and reflects both the entry of new high-priced therapies and the expanding use of existing ones. By 2023, these products accounted for 38.6 percent of public pharmaceutical expenditure, meaning that a market segment defined by the absence of competition has become the single largest structural component of the Italian drug budget.

Perhaps the most revealing finding concerns the dynamics of individual products after launch. In the third marketing year, sales of the 2014 cohort were more than double those recorded in the first year, while the mean cost was descending. This combination, rapidly rising volumes alongside gradually falling unit prices, is a signature of successful uptake: as physicians gain experience with a new therapy and eligibility criteria broaden, more patients are treated, and the total expenditure climbs even as the price per unit eases slightly. For budget holders, this means the heaviest financial burden of a new medicine arrives not at launch but in the years that follow.

This lifecycle pattern has direct consequences for how health systems forecast spending. Traditional projection models often assume that a new medicine’s budget impact in its first year is a reasonable predictor of subsequent years. The Italian data suggest that assumption is badly flawed for non-competition medicines, whose sales can more than double within two years of introduction. A health service that budgets for a product’s launch-year costs may find itself facing an unbudgeted shortfall within a single planning cycle. The authors argue that their findings point to the need for suitable spending projection approaches tailored specifically to these products.

The findings also carry weight for pricing policy. Because non-competition medicines face no generic or biosimilar pressure during their exclusive period, their prices are shaped by negotiation, managed entry agreements and value-based pricing frameworks rather than by market forces. The Italian Medicines Agency, which employs the study’s authors, sits at the center of this system, negotiating reimbursement conditions and monitoring expenditure. The study’s conclusion that these medicines represent a critical and growing share of public pharmaceutical spending suggests that pricing policies designed for a competitive market may need rethinking when applied to products that will face no competition for a decade or more.

The Italian experience resonates far beyond its borders. Health systems across Europe and North America are grappling with the same structural shift: an increasing share of drug spending concentrated in patented, single-source therapies, particularly advanced therapy medicinal products and other high-cost innovations. Italy’s National Health Service, with its centralized purchasing and national negotiation of drug prices, offers an unusually transparent window into these dynamics, because expenditure data can be tracked at the level of individual therapeutic entities over time. The 38.6 percent share documented here provides a benchmark that other countries can use to assess whether their own exposure to non-competition medicines is comparable.

The study, which received no external funding and declared no conflicts of interest, stops short of prescribing specific remedies, but its message is clear. Non-competition medicines are no longer a marginal category; they are the engine of pharmaceutical spending growth in Italy, and their financial trajectory follows a predictable pattern of steep volume expansion in the first years after launch. Health systems that fail to anticipate this pattern risk repeated budget crises, while those that build the observed lifecycle dynamics into their projections and negotiate pricing accordingly may be better positioned to afford innovation without crowding out other forms of care. As the pipeline of expensive new therapies continues to grow, the arithmetic documented in this study will only become more consequential.

Subject of Research: Pharmaceutical spending on non-competition medicines in the Italian National Health Service

Article Title: The financial impact of medicines without competition in Italy

Article References: The financial impact of medicines without competition in Italy. (n.d.). https://doi.org/10.1186/s12913-026-14421-5

Image Credits: AI Generated

DOI: 10.1186/s12913-026-14421-5

Keywords: pharmaceutical expenditure, Italy, non-competition medicines, health economics, drug pricing, Italian National Health Service, pharmacoeconomics, spending projections, value-based pricing, health technology assessment, drug regulation, public finance