Hum Vaccin Immunother. 2012 Sep;8(9):1326-34. doi: 10.4161/hv.20550. Epub 2012 Aug 16.
Today the task of cancer vaccine developers is not only to excel in cancer immunology and art of conducting immunotherapy trials but also in the analysis and forecasting the cost-effectiveness of the final product. This article reviews methodology used by EU health-technology bodies in the appraisal of new therapies based on economic and clinical values and different budgetary uncertainties. Increasingly, new oncology treatments were able to access EU market only under provision of risk-sharing agreements with payers and examples of such agreements are given here. Cancer vaccine developers should consider early collection of patient reported outcomes in order to project additional clinical and economic value with immunotherapy. Furthermore, early interaction with different stakeholders including patient organizations, physicians and payer bodies can facilitate market access.
如今，癌症疫苗研发人员的任务不仅是在癌症免疫学和免疫疗法试验方面出类拔萃，还要在分析和预测最终产品的成本效益方面表现出色。本文回顾了欧盟卫生技术评估机构在基于经济和临床价值以及不同预算不确定性的情况下评估新疗法的方法。越来越多的新型肿瘤学治疗方法只有在与支付方达成风险共担协议的情况下才能进入欧盟市场，本文给出了这些协议的例子。癌症疫苗研发人员应该考虑早期收集患者报告的结果，以便为免疫疗法带来额外的临床和经济价值。此外，早期与包括患者组织、医生和支付方在内的不同利益相关者进行互动可以促进市场准入。
