Hamburg Center for Health Economics, University of Hamburg, Hamburg, Germany.
Eur J Health Econ. 2023 Apr;24(3):437-451. doi: 10.1007/s10198-022-01484-4. Epub 2022 Jun 16.
In response to rapidly rising pharmaceutical costs, many countries have introduced health technology assessment (HTA) as a 'fourth hurdle'. We evaluated the causal effect of HTA based regulation on access to pharmaceuticals by using the introduction of Germany's HTA system (AMNOG) in 2011. We obtained launch data on pharmaceuticals for 30 European countries from the IQVIA (formerly IMS) database. Using difference-in-difference models, we estimated the effect of AMNOG on launch delay, the ranking order of launch delays, and the availability of pharmaceuticals. We then compared the results for Germany to Austria, Czechia, Italy, Portugal, and the UK. Across all six countries, launch delays decreased from the pre-AMNOG period (25.01 months) to the post-AMNOG period (14.34 months). However, the introduction of AMNOG consistently reduced the magnitude of the decrease in launch delay in Germany compared to the comparator countries (staggered DiD: + 4.31 months, p = 0.05). Our logit results indicate that the availability of pharmaceuticals in Germany increased as a result of AMNOG (staggered logit: + 5.78%, p = 0.009). We provide evidence on the trade-off between regulation and access. This can help policymakers make better-informed decisions to strike the right balance between cost savings achieved through HTA based regulation and access to pharmaceuticals.
针对不断上涨的药品成本，许多国家引入了卫生技术评估（HTA）作为“第四道关卡”。我们利用德国 2011 年引入的 HTA 系统（AMNOG）评估了 HTA 监管对药品可及性的因果效应。我们从 IQVIA（前身为 IMS）数据库中获取了 30 个欧洲国家的药品上市数据。我们使用差分模型，估计了 AMNOG 对上市延迟、上市延迟排名和药品可及性的影响。然后，我们将德国的结果与奥地利、捷克、意大利、葡萄牙和英国进行了比较。在这六个国家中，上市延迟从 AMNOG 前时期（25.01 个月）减少到 AMNOG 后时期（14.34 个月）。然而，与对照组国家相比，AMNOG 的引入始终降低了德国上市延迟减少的幅度（交错 DID：+4.31 个月，p=0.05）。我们的逻辑回归结果表明，由于 AMNOG，德国的药品供应增加（交错逻辑回归：+5.78%，p=0.009）。我们提供了有关监管和可及性之间权衡取舍的证据。这可以帮助政策制定者在通过 HTA 监管实现成本节约和药品可及性之间做出更好的决策，以达到适当的平衡。
