Leopold C, Vogler S, Habl C, Mantel-Teeuwisse A K, Espin J
Health Policy. 2013 Dec;113(3):313-22. doi: 10.1016/j.healthpol.2013.09.018.
To survey possible funding models and pricing practices as well as prices for the treatment package of trastuzumab and its accompanying diagnostic test in European countries, as an example of personalised medicines.
Qualitative descriptive data on national pharmaceutical pricing and funding policies applied to trastuzumab and its accompanying diagnostic test were obtained from a survey among competent authorities from 27 European countries as of August 2011. Further, price data (for the years 2005-2013) of trastuzumab in the respective European countries were surveyed and analysed.
In 2011, testing and treatment mainly took place in hospitals or in specific day-care ambulatory clinics. In the European countries either both trastuzumab and the accompanying diagnostic test were funded from hospital budgets (n = 13) or only medicines were funded from the third party payers such social insurances and the test from hospital budgets (n = 14). Neither combined funding of both medicine and diagnostic test by third party payers was identified in the surveyed countries nor did the respondents from the competent authorities identify any managed entry agreements. National pricing procedures are different for trastuzumab versus its diagnostic test, as most countries apply price control policies for trastuzumab but have free pricing for the diagnostic test. The ex-factory price is, on average, €609 per 150 mg vial with powder in 2013; in nine countries the price of trastuzumab went down from 2005 till 2013.
The example of trastuzumab and its accompanying diagnostic test highlights some problems of the interface between different funding streams (out-patient and hospital) but also with regard to the interface between the medicine applied in combination with a medical device. The findings suggest a need for further developing and refining policy options to address the identified interface issues.
以个性化药物曲妥珠单抗及其配套诊断检测为例，调查欧洲各国可能的资助模式、定价做法以及该治疗方案的价格。
截至2011年8月，通过对27个欧洲国家主管当局进行调查，获取了适用于曲妥珠单抗及其配套诊断检测的国家药品定价和资助政策的定性描述性数据。此外，还对各欧洲国家曲妥珠单抗的价格数据（2005 - 2013年）进行了调查和分析。
2011年，检测和治疗主要在医院或特定的日间门诊诊所进行。在欧洲国家，要么曲妥珠单抗及其配套诊断检测均由医院预算资助（n = 13），要么只有药物由第三方支付者如社会保险资助，检测由医院预算资助（n = 14）。在所调查的国家中，未发现第三方支付者对药物和诊断检测进行联合资助的情况，主管当局的受访者也未提及任何有管理的进入协议。曲妥珠单抗与其诊断检测的国家定价程序不同，因为大多数国家对曲妥珠单抗实施价格控制政策，但对诊断检测实行自由定价。2013年，每瓶150毫克粉末状曲妥珠单抗的出厂价平均为609欧元；在九个国家，曲妥珠单抗的价格从2005年到2013年有所下降。
曲妥珠单抗及其配套诊断检测的例子凸显了不同资助渠道（门诊和医院）之间接口的一些问题，以及药物与医疗器械联合应用时接口方面的问题。研究结果表明，需要进一步制定和完善政策选项，以解决所发现的接口问题。
