The Impact of Biosimilar Launch on Molecule Price and Pharmaceutical Expense: The Case of the Insulin Glargine in Italy

Abstract

Italian Medicines Agency (AIFA) sets the ex-factory price of hospital drug and negotiates discounts for the purchases to public institutions. Hospital and local health authority (ASL) are allowed to purchase drugs with a discount on the official selling price. Lower prices can be obtained through tenders, which are organized by groups of hospitals or at regional level. This research aims to analyze the impact on tender discounts and on the pharmaceutical expense of the therapeutic area following the biosimilar launch. An overview analysis of the insulin market was conducted, to individuate the market share (in terms of volume) covered by the originator insulin glargine from Jan 2016 to Mar 2017. An analysis of the monthly real purchase discount in tender was conducted to calculate the actual hospital expenditure and the changes in tender discount after the biosimilar introduction. The real tender price was statistically calculated starting from a QuintilesIMS database, which gathers sales data of hospital and local healthcare unit distribution. Since February 2016, the biosimilar introduction involved an increase of the originator tender discount from 11% to 20% compared to the ex-factory price. The biosimilar presented a price around 13% lower than the originator, remaining almost stable during the period of analysis. At regional level different prices were applied, resulting in a high variability of biosimilar adoption. Finally, tender price decreased among other long-acting basal insulins. The biosimilars launch increases the level of competition of the market, pushing the originators to reduce their prices through tender discounts. This effect seems to involve not only the originator but also the other molecules within the therapeutic area, showing a common trend of price reduction. This entails an opportunity of saving for the healthcare system, especially for chronic and high spending therapeutic areas.