Dranitsaris George, Ortega Ana, Lubbe Martie S, Truter Ilse
Department of Pharmacy, Nelson Mandela Metropolitan University, Port Elizabeth, South Africa.
J Oncol Pharm Pract. 2012 Mar;18(1):57-67. doi: 10.1177/1078155210390724. Epub 2011 Mar 7.
Several European governments have recently mandated price cuts in drugs to reduce health care spending. However, such measures without supportive evidence may compromise patient care because manufacturers may withdraw current products or not launch new agents. A value-based pricing scheme may be a better approach for determining a fair drug price and may be a medium for negotiations between the key stakeholders. To demonstrate this approach, pharmacoeconomic (PE) modeling was used from the Spanish health care system perspective to estimate a value-based price for bevacizumab, a drug that provides a 1.4-month survival benefit to patients with metastatic colorectal cancer (mCRC). The threshold used for economic value was three times the Spanish per capita GDP, as recommended by the World Health Organization (WHO).
A PE model was developed to simulate outcomes in mCRC patients receiving chemotherapy ± bevacizumab. Clinical data were obtained from randomized trials and costs from a Spanish hospital. Utility estimates were determined by interviewing 24 Spanish oncology nurses and pharmacists. A price per dose of bevacizumab was then estimated using a target threshold of € 78,300 per quality-adjusted life year gained, which is three times the Spanish per capita GDP.
For a 1.4-month survival benefit, a price of € 342 per dose would be considered cost effective from the Spanish public health care perspective. The price may be increased to € 733 or € 843 per dose if the drug were able to improve patient quality of life or enhance survival from 1.4 to 3 months.
This study demonstrated that a value-based pricing approach using PE modeling and the WHO criteria for economic value is feasible and perhaps a better alternative to government mandated price cuts. The former approach would be a good starting point for opening dialog between European government payers and the pharmaceutical industry.
最近，一些欧洲国家政府强制要求降低药品价格以减少医疗保健支出。然而，此类缺乏支持证据的措施可能会危及患者护理，因为制药商可能会撤回现有产品或不推出新药物。基于价值的定价方案可能是确定公平药品价格的更好方法，并且可能是关键利益相关者之间进行谈判的媒介。为了证明这种方法，从西班牙医疗保健系统的角度使用药物经济学（PE）模型来估计贝伐单抗的基于价值的价格，贝伐单抗可为转移性结直肠癌（mCRC）患者提供1.4个月的生存获益。按照世界卫生组织（WHO）的建议，用于经济价值的阈值为西班牙人均国内生产总值的三倍。
开发了一个PE模型来模拟接受化疗±贝伐单抗的mCRC患者的治疗结果。临床数据来自随机试验，成本数据来自一家西班牙医院。通过采访24名西班牙肿瘤学护士和药剂师来确定效用估计值。然后使用每获得一个质量调整生命年78,300欧元的目标阈值来估计贝伐单抗的每剂价格，这是西班牙人均国内生产总值的三倍。
从西班牙公共医疗保健的角度来看，对于1.4个月的生存获益，每剂342欧元的价格将被认为具有成本效益。如果该药物能够改善患者的生活质量或将生存期从1.4个月延长至3个月，则每剂价格可提高到733欧元或843欧元。
本研究表明，使用PE模型和WHO经济价值标准的基于价值的定价方法是可行的，并且可能是政府强制降价的更好替代方案。前一种方法将是欧洲政府付款方与制药行业展开对话的良好起点。
