Off-Patent Biological and Biosimilar Medicines in Belgium: A Market Landscape Analysis

Abstract

Background and objective: Best-value biological medicines may generate competition in the off-patent biologicals market, resulting in having more resources available to provide patients with access to necessary medicines while maintaining high-quality care. Belgium is a country known to have low biosimilar market shares, suggesting a malfunctioning market for off-patent biologicals. This study aims to gain an in-depth understanding of the Belgian off-patent biologicals market, by looking at the evolution in volumes and costs of the relevant products in the market.Methods: This study included a combination of quantitative and qualitative research methods. The quantitative part of this study consisted of the analysis of market data obtained by the National Institute for Health and Disability Insurance (NIHDI) for all relevant products in the Belgian off-patent biologicals market (i.e. TNF-inhibitors, insulins, granulocyte colony-stimulating factors, epoetins, rituximab, trastuzumab). In addition, for the qualitative part of this study, semi-structured interviews with Belgian stakeholders were conducted between December 2019 and March 2020.Results: Belgian market data and stakeholder perceptions suggest a suboptimal market environment for off-patent biological and biosimilar medicines. Shifts are observed after loss of exclusivities of originator biologicals toward second-generation products or new therapeutic class products, at a higher cost and often limited added value. Moreover, cost reductions for off-patent biologicals after biosimilar market entry are mainly determined by mandatory price reductions applicable to both originator and biosimilar products, and not by lower prices induced by competition. For products used in the retail setting, significant mandatory price reductions for both originator and reference products with low biosimilar volumes were pointed out as the main reasons for the lack of price competition. For products dispensed in hospitals, the hospital financing system is important. First, it does not always encourage the use of lower cost alternatives. Second, competition mainly takes place at the level of confidential discounts in tenders. Most interviewees acknowledged the lack of a competitive environment, which is not supportive of a sustainable Belgian off-patent biologicals market.Conclusion: Market data and stakeholder perceptions indicate that the sustainability of the Belgian market for off-patent biologicals is challenged. A sustainable market ensures access to biological therapies now and in the future.

Perceptions About Biosimilar Medicines Among Belgian Patients in the Ambulatory Care

“…Most patients in the study sample had not heard of biosimilar medicines before. This is not surprising in view of the limited biosimilar market shares in the retail setting and demonstrates the knowledge gap among Belgian patients (Moorkens et al, 2020c;Vandenplas et al, 2021b). When looking at those patients that are familiar with biosimilars, they were mainly informed by their physician, patient association, and the internet.…”

“…High biosimilar market shares are observed in the United Kingdom, Denmark, Norway, and the Netherlands. Typically slower adopters such as Belgium, Poland, or Romania experience difficulties capturing the full potential of a more competitive market, generated by the market entry of biosimilars ( Moorkens et al, 2020c ; Vandenplas et al, 2021b ). Expenditures on biologicals have been increasing year after year in Europe, with a growing proportion that has lost their market exclusivities and may therefore come under competition from biosimilars ( IQVIA, 2020 ).…”

Biosimilar Use and Switching in Belgium: Avenues for Integrated Policymaking

“…In 2016, a convention was agreed between the Ministry of Social Affairs and Health with industry and professional associations with the aim of fostering biosimilar uptake ( Beleidscel van de minister van Sociale Zaken en Volksgezondheid, 2016 ). Despite this, and a series of ad hoc measures over the past years, biosimilar adoption in Belgium remains challenged ( Moorkens et al, 2020a ; CM, 2021 ; Medaxes, 2021 ; Vandenplas et al, 2021 ). Notwithstanding the short-term savings that have been realized due to biosimilar market entry ( Medaxes, 2021 ), which can be mainly attributed to the mandatory price reductions that original biologicals undergo in Belgium at the time of biosimilar entry and further confidential discounting in tendering, it can be argued that the way the healthcare system is organized in Belgium may impede the establishment of a sustainable, off-patent biological and biosimilar market environment with continued competition over the longer term ( Van Wilder, 2021 ; Vandenplas et al, 2021 ).…”

Knowledge and perception of biosimilars in ambulatory care: a survey among Belgian community pharmacists and physicians

“…Policy actions include the establishment of a biosimilar usage target in hospitals, biosimilar use monitoring, and the stimulation of tender procedures. In 2018, a media campaign was launched to provide information on biosimilars to healthcare providers, patients and by extent the general public [ 12 , 21 – 23 ]. This joint initiative by the Belgian competent authority and the reimbursement agency included the launch of a website with biosimilar information, patient leaflets and radio spots [ 22 , 24 ].…”