Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
Ecole de Santé Publique, Université Libre de Bruxelles (ULB), Brussels, Belgium.
Health Res Policy Syst. 2023 Jul 6;21(1):68. doi: 10.1186/s12961-023-01015-4.
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. This study aimed to investigate the impact of the implemented measures on biosimilar uptake.
An interrupted time series analysis was performed using an autoregressive integrated moving average (ARIMA) model with the Box-Jenkins method. All data were expressed as defined daily doses (DDD) per month/quarter and obtained from the Belgian National Institute for Health and Disability Insurance (NIHDI). Three molecules were included in the analysis: etanercept (ambulatory), filgrastim (hospital), and epoetin (hospital). A significance level of 5% was used for all analyses.
In the ambulatory care, the effect of a financial prescriber incentive of 2019 was investigated. After this intervention, 44.504 (95% CI -61.61 to -14.812; P < 0.001) fewer etanercept biosimilar DDDs were dispensed monthly than expected in the absence of the intervention. Two interventions were modelled for biosimilars in the hospital setting. The first intervention of 2016 includes prescription targets for biosimilars and monitoring of hospitals on adequate tendering. The second intervention involves an information campaign on biosimilars. After the first intervention, a small decrease in quarterly epoetin biosimilar uptake of 449.820 DDD (95% CI -880.113 to -19.527; P = 0.05) was observed. The second intervention led to a larger increase in quarterly epoetin biosimilar uptake of 2733.692 DDD (95% CI 1648.648-3818.736; P < 0.001). For filgrastim, 1809.833 DDD (95% CI 1354.797-2264.869; P < 0.001) more biosimilars were dispensed immediately 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. An immediate and sustained increase of 700.932 DDD (95% CI 180.536-1221.328; P = 0.016) in quarterly biosimilar volume was observed after the second intervention. All other parameter estimates were not statistically significant.
The results of this study suggest that the impact of past policy interventions to increase the uptake of biosimilars has been variable and limited. A holistic policy framework is required to develop a competitive and sustainable off-patent biologicals market in Belgium.
近年来，比利时政府采取了多项措施来提高生物类似药的采用率。然而，尚未对这些措施的影响进行正式评估。本研究旨在调查已实施措施对生物类似药采用率的影响。
使用自回归综合移动平均 (ARIMA) 模型和 Box-Jenkins 方法进行了中断时间序列分析。所有数据均以每月/每季度的定义日剂量 (DDD) 表示，并从比利时国家健康和残疾保险研究所 (NIHDI) 获得。该分析纳入了三种分子：依那西普（门诊）、非格司亭（住院）和促红细胞生成素（住院）。所有分析均采用 5%的显著性水平。
在门诊护理中，研究了 2019 年的财务处方激励措施的效果。在干预后，与没有干预时相比，每月依那西普生物类似药 DDD 的配药量减少了 44.504（95%CI-61.61 至-14.812；P<0.001）。在医院环境中对生物类似药进行了两次建模干预。2016 年的第一次干预包括生物类似药的处方目标和对医院进行适当招标的监测。第二次干预涉及生物类似物的宣传活动。第一次干预后，观察到每季度促红细胞生成素生物类似药采用量减少 449.820 DDD（95%CI-880.113 至-19.527；P=0.05）。第二次干预导致每季度促红细胞生成素生物类似药采用量增加 2733.692 DDD（95%CI1648.648-3818.736；P<0.001）。对于非格司亭，第一次干预后立即配给了 1809.833 DDD（95%CI1354.797-2264.869；P<0.001）的生物类似药，并且在第一次干预后每季度配给的生物类似药减少了 151.639 DDD（95%CI-203.128 至-100.150；P<0.001）。第二次干预后，每季度生物类似药的数量立即且持续增加了 700.932 DDD（95%CI180.536-1221.328；P=0.016）。其他所有参数估计均无统计学意义。
本研究结果表明，过去为提高生物类似药采用率而采取的政策干预措施的影响是多样且有限的。需要制定一个整体的政策框架，以在比利时发展具有竞争力和可持续性的非专利生物制品市场。
