Inotai András, Ágh Tamás, Karpenko Alexei Willem, Zemplényi Antal, Kaló Zoltán
a Syreon Research Institute , Budapest , Hungary.
b Department of Health Policy and Health Economics , Eötvös Loránd University (ELTE) , Budapest , Hungary.
Expert Rev Pharmacoecon Outcomes Res. 2019 Apr;19(2):105-113. doi: 10.1080/14737167.2019.1554437. Epub 2018 Dec 7.
Trastuzumab, the standard treatment for HER-2 positive breast cancer, may be associated with access restrictions in countries with severe economic constraints. This study aimed to compare intravenous (IVT) and subcutaneous trastuzumab (SCT) forms and to explore the transferability of value propositions to Central and Eastern European (CEE) countries. Areas covered: After screening 376 abstracts, 42 articles were included in the final review. Statistical test results were rarely reported; therefore, the similarity of adverse event profiles of SCT and IVT could not be validated. Potential time savings for patients due to subcutaneous administration was not validated in CEE settings, where patient's waiting time for treatment administration is fairly long. Standard patient reported outcome instruments were rarely used to confirm the preference of patients/health care professionals to SCT over IVT. Moreover, feasibility of self/home administration of SCT, especially in case of concomitant intravenous chemotherapies, was not considered. Cost comparisons considered neither the patent expiry of IVT nor the incremental cost of potential differences in adverse events. Expert commentary: Potential benefits of SCT were not tested by any studies in CEE countries. The main policy objective should be to facilitate the uptake of multisource biologicals in lower income countries with access barriers.
曲妥珠单抗是HER-2阳性乳腺癌的标准治疗药物,但在经济严重受限的国家可能存在获取限制。本研究旨在比较静脉注射(IVT)和皮下注射曲妥珠单抗(SCT)两种剂型,并探讨价值主张向中东欧(CEE)国家转移的可行性。涵盖领域:在筛选了376篇摘要后,最终纳入综述的文章有42篇。统计检验结果很少被报告;因此,SCT和IVT不良事件谱的相似性无法得到验证。在中东欧地区,由于患者等待治疗给药的时间相当长,皮下给药可能为患者节省的时间未得到验证。很少使用标准的患者报告结局工具来证实患者/医疗保健专业人员对SCT优于IVT的偏好。此外,未考虑SCT自我/家庭给药的可行性,尤其是在同时进行静脉化疗的情况下。成本比较既未考虑IVT的专利到期情况,也未考虑不良事件潜在差异的增量成本。专家评论:中东欧国家的任何研究都未测试SCT的潜在益处。主要政策目标应是促进在存在获取障碍的低收入国家采用多源生物制品。