National Health Care Institute (Zorginstituut Nederland, ZIN), Diemen, The Netherlands.
Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands.
Int J Technol Assess Health Care. 2023 Jun 15;39(1):e44. doi: 10.1017/S0266462323000338.
This study aimed to compare assessments between Beneluxa Initiative member countries' assessments and identify alignments and divergences.
A retrospective comparative analysis was performed that investigated (i) number and type of assessed indications (for Austria (AT), Belgium (BE), Ireland (IE), and the Netherlands (NL)); (ii) added benefit conclusions (for BE, IE, and NL); and (iii) the main arguments underlying differences in conclusions (for BE, IE, and NL). Data were retrieved directly from agency representatives and from public HTA reports. European Medicines Agency approved indications were included for drugs assessed between 2016 and 2020, excluding veterinary drugs, generics, and biosimilars.
Only 44 (10 percent) of the 444 included indications were assessed by all four member countries. Between any pair of two countries, the overlap was higher, from 63 (AT-NL) to 188 (BE-IE). Added benefit conclusions matched exactly in 62-74 percent of the indications, depending on the countries compared. In the remaining cases, most often a difference of one added benefit level was observed (e.g., higher vs. equal relative effect). Contradictory outcomes were very rare: only three cases were observed (lower vs. higher effect). When assessing the underlying arguments for seven cases with different outcomes, differences were attributable to slight differences in weighing of evidence and uncertainties rather than disagreement on aspects within the assessment itself.
Despite high variability in European HTA procedures, collaboration on HTA between the Beneluxa Initiative member countries is very feasible and would likely not result in added benefit conclusions that would be very different from added benefit conclusions in national procedures.
本研究旨在比较比荷卢经济联盟成员国的评估,并确定趋同和分歧。
采用回顾性比较分析,调查(i)评估的适应症数量和类型(针对奥地利(AT)、比利时(BE)、爱尔兰(IE)和荷兰(NL));(ii)附加获益结论(针对 BE、IE 和 NL);以及(iii)结论差异的主要论据(针对 BE、IE 和 NL)。数据直接从机构代表和公开的 HTA 报告中检索。纳入了在 2016 年至 2020 年期间评估的药物的欧洲药品管理局批准的适应症,不包括兽药、仿制药和生物类似药。
只有 44 个(10%)纳入的 444 个适应症由四个成员国全部评估。在任意两个国家之间,重叠度更高,从 63 个(AT-NL)到 188 个(BE-IE)。附加获益结论在 62-74%的适应症中完全一致,具体取决于比较的国家。在其余情况下,最常见的是观察到一个附加获益水平的差异(例如,更高与相等的相对效果)。相反的结果非常罕见:仅观察到三个案例(较低与较高的效果)。在评估七个结果不同的案例的潜在论据时,差异归因于证据和不确定性的权重略有差异,而不是评估本身内部的分歧。
尽管欧洲 HTA 程序存在高度的可变性,但比荷卢经济联盟成员国之间的 HTA 合作是非常可行的,不太可能导致附加获益结论与国家程序中的附加获益结论有很大不同。