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Abstract
Biological therapies are an effective treatment for a range of immune-mediated inflammatory diseases (IMIDs), including rheumatoid arthritis, psoriasis, and inflammatory bowel diseases. However, due to their high costs, considerable differences in their utilization exist across the world, even among the various European countries, with many countries restricting access despite professional society guideline recommendations. Adoption of biologics by healthcare providers has been particularly poor in many Central and Eastern European countries. Differences in utilization have also been observed across medical specialties, healthcare providers, and at a regional and national level. The objective of this paper is to provide an overview of the different market access policies for biologics in Europe and to investigate reasons for such differences. One of the potential solutions for providing broader access to IMID patients, where cost is the major barrier, is to encourage the use of biosimilars in place of their reference products. Biosimilars are generally less expensive alternatives to already licensed biological therapies and are approved on the basis that they are similar to the reference product in terms of quality, safety, and efficacy. Budget impact models predict considerable cost savings following the introduction of biosimilars in the next few years. These savings could be used to increase access to biologics and other innovative therapies.
Highlights
Biological therapies such as anti-tumor necrosis factor (TNF) and anti-interleukin antibodies are widely used for a range of immune-mediated inflammatory diseases (IMIDs), including rheumatoid arthritis (RA) (Smolen et al, 2016), psoriasis (PsO), and psoriatic arthritis (Boehncke and Schon, 2015), Crohn’s disease (CD) (Baumgart and Sandborn, 2012) and ulcerative colitis (UC) (Ordás et al, 2012; Fiorino et al, 2014)
Factors which contribute to these differences are complex and can be country-specific; macroeconomic conditions, including drug cost per person as a percentage of gross domestic product (GDP), have frequently been shown to be a key driver of disparities in the usage of biologics
There is a general lack of long-term data for all countries and the extent to which the introduction of biosimilars will increase uptake of biologics, including at an earlier disease stage, remains to be fully determined
Summary
Biological therapies such as anti-tumor necrosis factor (TNF) and anti-interleukin antibodies are widely used for a range of immune-mediated inflammatory diseases (IMIDs), including rheumatoid arthritis (RA) (Smolen et al, 2016), psoriasis (PsO), and psoriatic arthritis (Boehncke and Schon, 2015), Crohn’s disease (CD) (Baumgart and Sandborn, 2012) and ulcerative colitis (UC) (Ordás et al, 2012; Fiorino et al, 2014). The prevalence of psychiatric comorbidities such as depression and anxiety can be high in chronic inflammatory diseases (Enns et al, 2018) The burden these conditions pose to patients and their families cannot be understated; there is a substantial cost to society in terms of long-term treatment costs and decreased work-related productivity (Jacobs et al, 2011; Baumgart and le Claire, 2016; D’Angiolella et al, 2018). The impact of these conditions is further exacerbated by the fact that they disproportionately affect working-age people, with peak onset occurring at 40–50 years of age for RA, 20–40 years of age for UC and CD, and under 40 years of age for PsO ( Chorus et al, 2003; Duricova et al, 2014; Queiro et al, 2014). In addition to the costs to the healthcare system, in some European countries patients must make high co-payments to access biologics, which may lead to further inequities in their use (Kawalec et al, 2017)
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