Yellow Window Management Consultants, Antwerp, Belgium.
J Med Econ. 2010;13(2):295-301. doi: 10.3111/13696998.2010.491427.
This article aims to calculate the impact of orphan drugs on the Belgian drug budget in 2008 and to forecast its impact over the following 5 years.
The 2008 budget impact was calculated by triangulating information derived from multiple Belgian data sources. The 2008-2013 budget impact analysis was based on three scenarios reflecting different levels of growth in the number of registered orphan drugs in the European Union, the number of drugs reimbursed in Belgium, and the average annual cost per patient per drug in Belgium.
The orphan drug budget impact amounted to €66.2 million (or 5% of the Belgian hospital drug budget) in 2008. The impact would increase to €130-204 million in 2013, depending on the scenario.
This static analysis measured orphan drug costs only, assuming that other components of health expenditure do not change over time. The analysis showed that the budget impact of orphan drugs in Belgium is substantial and rising, thereby putting pressure on total drug expenditure. Policy options to address the rising budget impact include pricing linked to return on investment, risk-sharing arrangements and re-appraisal of orphan drug status if additional indications are approved.
本文旨在计算 2008 年孤儿药对比利时药品预算的影响，并预测未来 5 年的影响。
通过对来自多个比利时数据来源的信息进行三角测量，计算了 2008 年的预算影响。2008-2013 年的预算影响分析基于三种情景，反映了欧盟注册孤儿药数量、比利时报销药品数量以及比利时每名患者每种药品平均年度费用的不同增长水平。
2008 年孤儿药预算影响为 6620 万欧元（占比利时医院药品预算的 5%）。根据不同的情景，2013 年的影响将增加到 1.30 亿至 2.04 亿欧元。
这项静态分析仅衡量了孤儿药的成本，假设其他卫生支出部分不会随时间变化。分析表明，比利时孤儿药的预算影响是巨大的，而且还在不断上升，从而给总药品支出带来压力。解决预算影响不断上升的政策选择包括与投资回报挂钩的定价、风险分担安排以及在批准额外适应症时重新评估孤儿药地位。
