College of Pharmacy, Chung-Ang University, Seoul, South Korea.
Mailman School of Public Health, Columbia University, New York, NY, USA.
BioDrugs. 2019 Aug;33(4):423-436. doi: 10.1007/s40259-019-00359-0.
As the economic burden of treating cancer patients has been soaring in European countries, performing a budget impact analysis is becoming one of the requirements for payers' application dossiers.
The objective of this study was to estimate the budgetary impact of introducing the biosimilar trastuzumab (CT-P6) from the payer's perspective and to determine the number of additional patients who could be treated with resulting savings in 28 European countries.
A budget impact model was developed to analyze the financial impact of switching from originator trastuzumab to biosimilar CT-P6 in the treatment of early and metastatic breast cancer and metastatic gastric cancer with a time horizon of 1-5 years. Budgetary savings and the number of patients potentially affected were measured based on epidemiological and sales volume data. The base-case analysis assumed that the price of CT-P6 is 70% of the originator price, the switching rate of originator to CT-P6 in the first year is 20%, and the annual growth in the switching rate for each subsequent year is 5%.
For analyses using the base-case scenario following CT-P6 introduction, the total estimated budgetary savings over a 5-year period (depending on the scenario) ranged from €1.13 billion to €2.27 billion based on epidemiological data, or from €0.91 billion to €1.82 billion based on sales volume data. In the first year only, the projected budgetary savings ranged from €58 million to €136 million, and the number of additional patients who could be treated using the savings ranged from 3503 to 7078 by sensitivity analysis.
The conducted budget impact analysis assessing a switch from originator trastuzumab to biosimilar CT-P6 in 28 European countries indicates that budget savings could be between €0.91 billion and €2.27 billion over the next 5 years. These savings could be used to help improve patient access to local biologics in their respective countries while simultaneously strengthening the overall public health landscape across the European Union.
随着欧洲国家治疗癌症患者的经济负担不断飙升，进行预算影响分析已成为支付方申请文件的要求之一。
本研究旨在从支付方的角度评估引入生物类似药曲妥珠单抗（CT-P6）的预算影响，并确定在 28 个欧洲国家可通过节省费用而增加治疗的患者数量。
开发了一种预算影响模型，以分析在 1-5 年内将曲妥珠单抗生物类似药 CT-P6 用于早期和转移性乳腺癌和转移性胃癌的治疗，从支付方角度分析其对财务的影响。根据流行病学和销售数据来衡量预算节省和潜在受影响患者的数量。基础分析假设 CT-P6 的价格为原研药的 70%，第一年的原研药向 CT-P6 的转换率为 20%，随后每年的转换率增长率为 5%。
根据 CT-P6 引入后的基础情况分析，基于流行病学数据，5 年内（具体取决于方案）总预算节省估计范围为 11.3 亿欧元至 22.7 亿欧元，基于销售数据则为 9.10 亿欧元至 18.20 亿欧元。仅在第一年，预计预算节省范围为 5800 万欧元至 1.36 亿欧元，通过敏感性分析，使用节省费用可增加治疗的患者数量范围为 3503 例至 7078 例。
对 28 个欧洲国家从原研曲妥珠单抗转换为生物类似药 CT-P6 的预算影响分析表明，未来 5 年内预算可节省 9.10 亿欧元至 22.70 亿欧元。这些节省可用于帮助改善各国当地生物制剂的患者可及性，同时加强欧盟整体公共卫生状况。
