PHP85 - Role Of Budget Impact Analysis In Market Access Of Biosimilars

Abstract

Biologics have made substantial contribution in a number of diseases, but the high cost of therapy in the arena of cost containment impacting their accessibility and sustainability. Biosimilars are a viable alternative after patent expiry of many first generation originator biologics. Expecting a 20-30% difference in price from a branded product, budget impact is being considered an important area driving the market access of these products. Hence, we reviewed the published budget impact analysis (BIA) of the biosimilars conducted in different countries’. We searched the PubMed, ISPOR, google scholar database etc. for English language articles with search terms “budget impact” OR “budget analysis” AND “biosimilar” OR “subsequent entry biological” OR “follow-on biological”. The methodology of analysis and the major outcomes such as cost saving and additional patients treated were reviewed from the included studies. Articles reporting the BIA of biosimilars were identified. The studies with BIA were segregated based on the countries. The source of funding, model used, and description provided around the model for the BIA was identified. The budget savings projected over 2015-2019 ranged from 95.8mn to 433mn at 10% and 30% discount, respectively, for UK, Italy, France, and Germany. The net benefit of 29.8mn over 3 years period resulted in treatment of 1025 to 1615 more patients yearly. ISPOR BIA good practice II task force guidance was used to assess the analytical framework, data sources, and reporting format. The use of biosimilars seems to economically attractive, probably due to cost-savings and additional patients’ treatment. However, there is low availability of BIAs for biosimilars, where they were introduced long back and/or no availability in countries where just entered the market. This potential raises the need for highly robust BIAs, thus, aid in decision-making for judicious allocation of the budget.