Like generic drugs for small molecules, biosimilars offer the hope for reducing drug prices after biologic therapies lose their patent protections. But how big an impact do biosimilars have and how comfortable are physicians with using these substitute products?
A paper by Robinson and Jarrion (2021) use data from France as a case study to answer this question.
France first relies on its single-payer health insurance system to control drug prices. The Comité Economique des Produits de Santé (CEPS) negotiates with manufacturers a national tariff for each new drug and biologic. This price depends on (i) the price of comparable products, (ii) the treatment’s clinical value compared to standard of care, (iii) it’s cost-effectiveness, (iv) the prices charged in other European countries, and (v) the volume of prescriptions expected to be written. These negotiations are then supplemented with negotiations between each hospital or hospital purchasing group and the drug manufacturer. While French hospitals receive a flat DRG-based reimbursement per admissions, there are carve-outs (i.e., technology add-ons) for expensive drugs and devices.
But how big are the biosimilar discounts resulting from all these negotiations? To answer this question, the authors use 2004-2020 data on three tumor necrosis factor inhibitor (TNFi) immunology biologics: Remicade, Enbrel, and Humira. The authors price data come from the Base des Médicaments et Informations Tarifaires (Drug and Tariff Information Base). The authors also used hospital data to get sales volumes at hospital ambulatory clinics.
Using these data, the authors find that for Remicade:
The first biosimilar to be launched, Inflectra, gained and retained the highest market share and had achieved 41 percent of the national market by January 2020. Each of the two subsequent biosimilar entrants gained approximately 18 percent of the market, whereas the fourth biosimilar had failed to gain any traction (0 percent market share) as of January 2020. The reference biologic Remicade itself suffered a dramatic fall in use and retained only one-quarter of the market by 2020.
…sales revenues for Remicade decreased from 276.4 million euros in 2015 to 33.8 million euros in 2019 under competitive pressure from the five biosimilars.26 In contrast, the combined sales of the Remicade biosimilars increased from 6.7 million euros in 2015 to 59.5 million euros in 2019.
The findings were similar for Humira and Enbrel.
Hospital ambulatory sales for Enbrel declined from 251.4 million euros in 2015 to 49.8 million euros in 2019, whereas those for Humira declined from 4.0 million euros to 730,580 euros between 2015 and 2019. Sales of their biosimilars rose from zero in 2015 to 36.8 million euros and 50.7 million euros, respectively, in 2019.
Note that while Remiciade can only be administered at hospital clinics in France, Enbrel and Humira can be administered at either hospital ambulatory clinics or physician outpatient setting.
This study shows that significant uptake of biosimilars is occurring in France in recent years.