Budget Impact Analysis of Biosimilar Products in Spain in the Period 2009–2019

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.

Budget impact analysis and treatment availability with biosimilar TNF inhibitors in rheumatic diseases in Poland: real-world evidence using a nationwide database

“…Prior projections are based on fixed degrees of market penetration and expected price reductions estimated at a time point when biosimilars were being introduced to the market, often covered only a single drug or clinical indication 15 26–29. We identified only one study that included a savings analysis based on real drug prices over the long term 30. Although conducted on a national level, the study (corresponding to our estimated savings model) has several limitations, including no reporting of patients treated or drug unit utilisation and no calculation of real-life savings, which precludes a direct comparison.…”

Biosimilars in rare diseases: a focus on paroxysmal nocturnal hemoglobinuria

“… 68 Similarly, a Spanish budget impact analysis estimated that figures for the period 20092019 show biosimilar competition to have resulted in cost savings of €2.3 billion, about half the savings being due to a reduction in list prices, and the other half originating from hospital tender discounts. 69 Although the discount on biosimilars may vary from country to country, by 2020, annual savings could be seen to have increased up to €10 billion if they achieve at least a 50% share. 70 Biosimilar versions of biologics approved for rare diseases, such as eculizumab RP, could, therefore, offer an important means of generating cost savings and improving access.…”

Evaluating the benefits of TNF-alfa inhibitor biosimilar competition on off-patent and on-patent drug markets: A Southern European analysis

“…For instance, competitive purchasing procedures that incorporate TNF-alfa inhibitor biosimilars and allow the selection of 'best-value' products have generated notable savings within the immunomodulators and immunosuppressants drug class. Garcia-Goñi et al recently estimated that the market entry of TNF-alfa inhibitor biosimilars in the period 2009-2019 led to EUR 1,265M savings for the Spanish National Health Service (SNS: Servicio Nacional de Salud), and that infliximab biosimilars were the primary contributors to savings generation (García-Goñi et al, 2021). Published Portuguese SNS reports do not yet indicate the contribution of all marketed TNF-alfa inhibitor biosimilars to savings generation.…”