Policies for biosimilar uptake in Europe: An overview

Abstract

BackgroundAcross European countries, differences exist in biosimilar policies, leading to variations in uptake of biosimilars and divergences in savings all over Europe.ObjectivesThe aim of this article is to provide an overview of different initiatives and policies that may influence the uptake of biosimilars in different European countries. Recommendations will be formulated on how to create sustainable uptake.MethodsAn overview of policies on biosimilars was obtained via a questionnaire, supplemented with relevant articles. Topics were organized in five themes: availability, pricing, reimbursement, demand-side policies, and recommendations to enhance uptake.ResultsIn all countries studied, biological medicines are available. Restrictions are mainly dependent on local organization of the healthcare system. Countries are willing to include biosimilars for reimbursement, but for commercial reasons they are not always marketed. In two thirds of countries, originator and biosimilar products may be subjected to internal reference pricing systems. Few countries have implemented specific incentives targeting physicians. Several countries are implementing pharmacist substitution; however, the scope and rules governing such substitution tend to vary between these countries. Reported educational policies tend to target primarily physicians, whereas fewer initiatives were reported for patients. Recommendations as proposed by the different country experts ranged from the need for information and communication on biosimilars to competitive pricing, more support for switching and guidance on substitution.ConclusionsMost countries have put in place specific supply-side policies for promoting access to biosimilars. To supplement these measures, we propose that investments should be made to clearly communicate on biosimilars and educate stakeholders. Especially physicians need to be informed on the entry and use of biosimilars in order to create trust. When physicians are well-informed on the treatment options, further incentives should be offered to prescribe biosimilars. Gainsharing can be used as an incentive to prescribe, dispense or use biosimilars. This approach, in combination with binding quota, may support a sustainable biosimilar market.

Ongoing strategies to improve the management of upper respiratory tract infections and reduce inappropriate antibiotic use particularly among lower and middle-income countries: findings and implications for the future

“…A systematic review was not performed as there has already been an appreciable number of recent publications, including systematic reviews, discussing ongoing research in this area, which includes current self-purchasing rates as well as public awareness campaigns 29 Consequently, our findings and suggested activities for key stakeholder groups are based on relevant publications known to the authors, coupled with their considerable knowledge of ongoing activities in their own countries (and more broadly) to improve the prescribing and dispensing of antibiotics for patients with URTIs. This approach has been used successfully to stimulate debate in other priority healthcare areas to provide future guidance [161][162][163][164][165][166][167][168][169][170][171] .…”

Pharmacotherapeutic interventions for bipolar disorder type II: addressing multiple symptoms and approaches with a particular emphasis on strategies in lower and middle-income countries

“…We have used such approaches before to stimulate debate in priority disease areas to provide future guidance [128][129][130][131][132][133][134][135][136][137]. The 2018 World Bank classification has been used to categorize countries into LMICs or upper-income countries [138] wherever pertinent.…”

Identifying Key Benefits in European Off-Patent Biologics and Biosimilar Markets: It is Not Only About Price!

“…As a result, patients are less likely to have access to these expensive biologic treatments [43,44]. The purchasing price of offpatent originators and biosimilars, which is regulated by the national authority, can also vary in different European countries, and within the same country prices may also be different if dispensed via ambulatory care or a retailer [15]. Additionally, there could be other factors such as a negotiated price between the manufacturers and hospitals, local tenders, existing contractual arrangements, and the price sensitivity of payers for biosimilars.…”

“…The principle reason behind this favorable market environment is that countries wish to capture the savings arising from the lower price of biosimilars in an era of restricted healthcare budgets, an increase in the burden of life-threatening diseases, early detection of these diseases, and an increase in the ageing population. Biosimilars are at least 15-45% less expensive than the originator biologics [14], although prices of biosimilars vary across European countries [15]. However, price evolution of off-patent biologics and biosimilars is rapid across European countries and discounts on selected biosimilars can reach up to 80% [16].…”