Ludwig Saskia, Dintsios Charalabos-Markos
Cologne Institute for Health Economics and Clinical Epidemiology, University of Cologne, Germany.
Institute of Health Services Research and Health Economics, Medical Faculty Heinrich-Heine University Düsseldorf, Düsseldorf, Germany.
Value Health. 2016 Dec;19(8):1016-1025. doi: 10.1016/j.jval.2016.05.016. Epub 2016 Jul 15.
In Germany, an arbitration board is setting reimbursement amounts for drug innovations when price negations between payers and manufacturers fail.
To empirically analyze all arbitrations since the reform of Germany's Act to Reorganize the Pharmaceuticals' Market in the Statutory Health Insurance System came into effect.
All available relevant documents up to January 2016 were screened and the identified contentious issues between the negotiation parties extracted. Reimbursement requests of both the negotiating parties and the arbitrations were transformed into a comparable format on the basis of defined daily doses and then contrasted among each other.
In the given period, 16 arbitrations took place. The arbitration board is implementing the same criteria used in the negotiations between manufacturers and payers. Almost all arbitrations dealt with generic appropriate comparative therapies. Reimbursement amounts set by arbitration were on average 38.4% less than the mean of negotiation parties' requests (69.2% less than the manufacturers' requests). The corresponding prescription volumes were arranged rather centrally. All but one arbitration refer to a 1-year contract period. The arbitration board rarely decided on further technical contentious points. Hence, no heuristics referring to them were derivable.
There is some evidence for a quasi-algorithmic approach of the arbitration board, even though it is legally determined that it has to decide while taking the peculiar conditions of each case into due consideration, including the characteristics of the respective therapeutic area. The balance of interests proved to be within a very narrow space albeit it concerns in principle discretionary decisions. Thus, the purpose of arbitration seems not to be achieved sufficiently.
在德国，当支付方与制造商之间的价格谈判失败时，仲裁委员会会确定药物创新的报销金额。
对德国《法定医疗保险体系中药品市场重组法案》改革生效以来的所有仲裁进行实证分析。
筛选截至2016年1月所有可得的相关文件，并提取谈判双方之间已确定的争议问题。基于规定日剂量，将谈判双方的报销申请和仲裁结果转换为可比形式，然后相互对比。
在给定期间内，共进行了16次仲裁。仲裁委员会采用了制造商与支付方谈判中使用的相同标准。几乎所有仲裁都涉及通用的适当对比疗法。仲裁确定的报销金额平均比谈判双方申请的均值低38.4%（比制造商的申请低69.2%）。相应的处方量分布较为集中。除一次仲裁外，所有仲裁的合同期均为1年。仲裁委员会很少就进一步的技术争议点做出决定。因此，无法从中得出相关启发法。
有证据表明仲裁委员会采用了一种准算法方法，尽管法律规定其必须在充分考虑每个案件的特殊情况（包括各自治疗领域的特点）的情况下做出决定。尽管这原则上涉及自由裁量决定，但利益平衡的空间非常狭窄。因此，仲裁的目的似乎没有得到充分实现。
