Policy Changes Required to Increase Uptake of Biosimilars

The impact of past policy measures to increase the uptake of biosimilars in Belgium have been varied and limited, according to a study published in Health Research Policy and Systems.¹ Investigators believe a holistic policy framework is necessary to create a competitive and sustainable off-patent biologicals market, using a proactive and complementary set of measures individualized to the Belgian healthcare system.

Yannick Vandenplas, PhD

Credit: HICT.com

“Given the increasing expenses on pharmaceuticals in the past couple of years in a system that is mainly publicly funded, Belgium faces several challenges to maintain the financial sustainability of its high-quality healthcare system in the coming decades,” wrote Yannick Vandenplas, PhD, doctoral researcher, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Belgium, and colleagues. “The Belgian government has taken several measures to increase the uptake of biosimilars in past years. However, no formal evaluation of the impact of these measures has been made yet.”

Biosimilar market shares in Belgium have been low and comparatively slow to increase compared with other Western European countries, despite the need for biosimilars to obtain a competitive and sustainable market. Previous research has emphasized challenges, including the lack of trust and knowledge about biosimilars among patients and providers alike, the absence of incentives for use, a faulty tendering system, and shifts in medication prescription.²

Investigators conducted a retrospective interrupted time series analysis to determine the impact of policy measures to increase the uptake of biosimilars using an autoregressive integrated moving average (ARIMA) model coupled with the Box-Jenkins method. Two distinct packages of measures were defined: the first wave introduced in January 2016 and the second wave implemented between December 2018 and January 2019. Each wave focused on different products or healthcare settings, such as hospital or ambulatory care.

Defined daily doses (DDD) per month and quarter were collected via the Belgian National Institute for Health and Disability Insurance (NIHDI). In total, 3 molecules were included in the analysis: etanercept (ambulatory care), filgrastim (hospital care), and epoetin (hospital care). These were chosen because they were introduced to the Belgian market early enough to determine the impact of previous policy measures.

In the ambulatory care setting, investigators evaluated the effect of a financial prescriber incentive in 2019. Post-intervention, 44.504 (95% confidence interval [CI] −61.61 to −14.812; P < .001) fewer etanercept biosimilar DDD were dispensed monthly than expected without intervention.

Of the interventions modelled for biosimilars in the hospital setting, the first included prescription targets for biosimilars and the monitoring of hospitals on adequate tendering in 2016. A small decrease (449.820 DDD) in quarterly epoetin biosimilar uptake was reported (95% CI −880.113 to −19.527; P = .05). Regarding filgrastim, 1809.833 DDD (95% CI 1354.797 to 2264.869; P < .001) more biosimilars were dispensed directly after the first intervention and 151.639 DDD (95% CI −203.128 to −100.150; P < 0.001) fewer biosimilars each quarter after the first intervention.

The second intervention was an information campaign on biosimilars. This led to an increase of 2733.692 DDD of quarterly epoetin biosimilar uptake (95% CI 1648.648 to 3818.736; P < .001). An immediate and continued increase of 700.932 DDD in quarterly biosimilar volume was reported after the second intervention (95% CI 180.536 to 1221.328; P = .016).

“Notwithstanding the confounding effect of shifts to other molecules that must be considered, the observation remains that only minor increases in biosimilar volumes have been observed for the 3 molecules studied,” investigators noted. “This underlines the unsustainable situation of the Belgian off-patent biologicals market. Moreover, this analysis illustrates that the measures taken to increase biosimilar use have been insufficient to date. More is needed to make the Belgian market more competitive and sustainable.”

References

1. ^{Vandenplas Y, Simoens S, Van Wilder P, Vulto AG, Huys I. The impact of policy interventions to promote the uptake of biosimilar medicines in Belgium: a nationwide interrupted time series analysis. Health Res Policy Syst. 2023;21(1):68. Published 2023 Jul 6. doi:10.1186/s12961-023-01015-4}
2. ^{Moorkens E, Vulto AG, Huys I, Vulto AG. Biosimilars in Belgium: a proposal for a more competitive market. Acta Clin Belg. 2020;12:1–12.}