■为了研究生物仿制药静脉注射曲妥珠单抗-dkst与参考静脉注射(曲妥珠单抗-IV)和皮下曲妥珠单抗(曲妥珠单抗-SC)(有/没有帕妥珠单抗)在转移性乳腺癌(MBC)中的成本效率和预算中立的扩展途径。
■在1,000名MBC患者的小组中进行经济模拟建模,以估计:1)通过在10-100%的转化率下从曲妥珠单抗IV或曲妥珠单抗-SC转换为曲妥珠单抗-dkst的成本节省3个体重组:第一四分位数(Q1:62.2kg),中位数(73.1公斤),第三四分位数(Q3:88.6公斤),和2)预算中立,从成本节约中扩大对曲妥珠单抗-dkst的访问。
■在单药治疗中,曲妥珠单抗-IV的转化(%)可节省1年成本,从2,272,189美元(Q1;10%)降至31,506,804美元(Q3;100%),曲妥珠单抗-SC单药治疗可节省2,071,277美元(Q3;10%)至35,775美元(Q1;100%).与帕妥珠单抗联合使用,曲妥珠单抗-dkst在所有患者体重方面具有成本效益,与曲妥珠单抗-IV相比,一年节省高达32,662,714美元(Q3;100%),与曲妥珠单抗-SC相比,一年节省高达35,322,461美元(Q1;100%)。来自曲妥珠单抗-IV单一疗法的转化的节省可以提供3,087(Q1;10%)和30,911(Q3;100%)之间的额外曲妥珠单抗-dkst剂量-足以治疗58至583名患者一年。曲妥珠单抗-SC单一疗法的转化可以提供1,559(Q3;10%)和48,598(Q1;100%)之间的额外曲妥珠单抗-dkst剂量或38至918额外的曲妥珠单抗-dkst一年治疗。与帕妥珠单抗联合使用,曲妥珠单抗-IV的转化可提供311次(Q1;10%)至3,939次(Q3;100%)维持剂量(帕妥珠单抗+曲妥珠单抗-dkst)或17次至210次额外的1年方案(所有药物).从曲妥珠单抗-SC转换的节省可以扩大到226(Q3;10%)至4,782(Q1;100%)的额外维持剂量或12至254个为期一年的方案。
■这项对生物仿制药治疗癌症药物的首次成本效益和扩展访问研究表明,在单药治疗以及与帕妥珠单抗和紫杉醇联合治疗的所有患者体重中,曲妥珠单抗-dkst比曲妥珠单抗-IV和曲妥珠单抗-SC更具成本效益。这些成本节约可以在预算中立的基础上为更多患者提供曲妥珠单抗-dkst治疗。
UNASSIGNED: To investigate the cost-efficiency and budget-neutral expanded access of biosimilar intravenous trastuzumab-dkst versus reference intravenous (trastuzumab-IV) and subcutaneous trastuzumab (trastuzumab-SC) (with/without pertuzumab) in metastatic breast cancer (MBC).
UNASSIGNED: Economic simulation modeling in
a panel of 1,000 MBC patients to estimate: 1) cost-savings by conversion from trastuzumab-IV or trastuzumab-SC to trastuzumab-dkst at 10-100% conversion rates in 3 weight groups: first quartile (Q1:62.2 kg), median (73.1 kg), third quartile (Q3:88.6 kg), and 2) budget-neutral expanded access to trastuzumab-dkst from cost-savings.
UNASSIGNED: In monotherapy, conversion (%) from trastuzumab-IV generates one-year cost-savings from $2,272,189 (Q1;10%) to $31,506,804 (Q3;100%) and from trastuzumab-SC monotherapy savings range from $2,071,277 (Q3;10%) to $35,775,475 (Q1;100%). In combination with pertuzumab, trastuzumab-dkst is cost-efficient in all patient weights with one-year savings over trastuzumab-IV up to $32,662,714 (Q3;100%) and over trastuzumab-SC up to $35,322,461 (Q1;100%). Savings from conversion from trastuzumab-IV monotherapy could provide between 3,087 (Q1;10%) and 30,911 (Q3;100%) additional trastuzumab-dkst doses-enough to treat 58 to 583 patients for one year. Conversion from trastuzumab-SC monotherapy could provide between 1,559 (Q3;10%) and 48,598 (Q1;100%) additional trastuzumab-dkst doses or 38 to 918 additional one-year treatments with trastuzumab-dkst. In combination with pertuzumab, conversion from trastuzumab-IV could provide from 311 (Q1;10%) to 3,939 (Q3;100%) maintenance doses (pertuzumab + trastuzumab-dkst) or 17 to 210 additional one-year regimens (all agents). Savings from conversion from trastuzumab-SC could expand access to 226 (Q3;10%) to 4,782 (Q1;100%) additional maintenance doses or 12 to 254 one-year regimens.
UNASSIGNED: This first cost-efficiency and expanded access study of biosimilar therapeutic cancer agents shows that trastuzumab-dkst is cost-efficient over trastuzumab-IV and trastuzumab-SC across all patient weights in both monotherapy and combination with pertuzumab and paclitaxel. These cost savings could provide more patients with trastuzumab-dkst treatment on
a budget-neutral basis.