Abstract
Since the first biosimilar medicine, Omnitrope® (active substance somatropin) was approved in 2006, 53 biosimilars have been authorized in Spain. We estimate the budget impact of biosimilars in Spain from the perspective of the National Health System (NHS) over the period between 2009 and 2019. Drug acquisition costs considering commercial discounts at public procurement procedures (hospital tenders) and uptake data for both originator and biosimilar as actual units consumed by the NHS were the two variables considered. Two scenarios were compared: a scenario where no biosimilars are available and the biosimilar scenario where biosimilars are effectively marketed. All molecules exposed to biosimilar competition during this period were included in the analysis. The robustness of the model was tested by conducting multiple sensitivity analyses. From the payer perspective, it is estimated that the savings produced by the adoption of biosimilars would reach EUR 2306 million over 11 years corresponding to the cumulative savings from all biosimilars. Three molecules (infliximab, somatropin and epoetin) account for 60% of the savings. This study provides the first estimation of the financial impact of biosimilars in Spain, considering both the effect of discounts that manufacturers give to hospitals and the growing market share of biosimilars. We estimate that in our last year of data, 2019, the savings derived from the use of biosimilars relative total pharmaceutical spending in Spain is 3.92%. Although more research is needed, our evidence supports the case that biosimilars represent a great opportunity to the sustainability of the NHS through rationalizing pharmaceutical spending and that the full potential of biosimilar-savings has not been achieved yet, as there is a high variability in biosimilar uptake across autonomous regions.
Highlights
Drug research and development has led to market access for many important therapeutic innovations, and undoubtedly is one of the multiple factors that influence population aging [1]
The budget impact derived from the introduction of biosimilar medicines in the Spanish National Health System (NHS) would reach more than EUR 2306.48 million of cumulative savings in the 11-year period from 2009 to 2019 (Table 1)
Somatropin (EUR 375 million), epoetin (EUR 589 million) and infliximab (EUR 450 million) biosimilars provide the greatest contribution to the aggregate savings up to 2019, which is attributable to their long presence on European pharmaceutical market (10, 10 and 5 years, respectively) and the combination of their uptake and price volumes
Summary
Drug research and development has led to market access for many important therapeutic innovations, and undoubtedly is one of the multiple factors that influence population aging [1]. Shows how those innovations have significantly improved the way health systems treat and care for the sick, increasing life expectancy and quality of life. Those advances have come with an increase in health spending. Newhouse et al [5] and Willeme and Dumont [6] have pointed to the advances in health technology and the therapeutic innovations developed as the most important determinants of such increases in health expenditures, and among those, pharmaceutical spending.
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