Outpatient Oncology Unit, Kyoto University Hospital, Kyoto, Japan.
Clin Ther. 2010 Feb;32(2):311-26. doi: 10.1016/j.clinthera.2010.01.029.
This study assessed the cost-effectiveness and budget impact of third-generation chemotherapy regimens with prophylactic granulocyte colony-stimulating factor (G-CSF) relative to second-generation regimens without prophylactic G-CSF for patients with high-risk early breast cancer in Japan.
We conducted a cost-effectiveness analysis with Markov modeling and calculated incremental cost-effectiveness ratios (ICERs) for the comparison between second-generation regimens without prophylactic G-CSF and third-generation regimens with prophylactic G-CSF. The comparisons consisted of fluorouracil, doxorubicin, and cyclophosphamide, a second-generation regimen, versus docetaxel, doxorubicin, and cyclophosphamide (TAC) with G-CSF, a third-generation regimen; and doxorubicin, cyclophosphamide, and paclitaxel (AC-T) q3wk, a second-generation regimen, versus dose-dense (DD) AC-T q2wk with G-CSF, a third-generation regimen. Patients were stratified by the age at which chemotherapy was started into cohorts aged 35, 45, and 55 years. Outcomes were estimated in terms of life-years (LYs) and quality-adjusted LYs (QALYs). ICER calculations were done from a societal perspective. We also estimated the budget impact, which included the additional public medical expenditures that would cover all subsequent changes after the additional cost of choosing third-generation regimens if G-CSF were approved for use in third-generation regimens for breast cancer. Costs were calculated using prescription drug prices as of 2006.
Estimated ICER values for TAC with prophylactic G-CSF were yen956,471/LY and yen919,443/ QALY for age 35 years, yen1,125,540/LY and yen1,078,967/QALY for age 45 years, and yen1,302,746/LY and yen1,224,896/QALY for age 55 years. Values for DD AC-T q2wk with prophylactic G-CSF were yen291,931/LY and yen311,232/QALY for age 35 years, yen357,354/LY and yen380,148/QALY for age 45 years, and yen377,011/LY and yen399,761/QALY for age 55 years. TAC or DD AC-T q2wk with prophylactic G-CSF would yield cost savings compared with the respective second-generation regimens if the per-dose cost of G-CSF decreased from yen31,355 to yen15,700 (TAC) or to yen24,300 (DD AC-T). The estimated budget impact is yen9.5 to yen11.0 billion per year for the next 5 years.
According to a Markov model for patients with high-risk early breast cancer in Japan, third-generation regimens with prophylactic G-CSF will yield improved outcomes at a greater cost, but estimated ICER values are still less than the suggested cost-effectiveness threshold value of yen6 million (US $60,000, assuming US $1 = yen100) for a gain of 1 QALY.
本研究旨在评估对于日本高危早期乳腺癌患者，与无预防性粒细胞集落刺激因子（G-CSF）的第二代方案相比，具有预防性 G-CSF 的第三代化疗方案的成本效果和预算影响。
我们采用 Markov 模型进行成本效果分析，并计算了第二代方案无预防性 G-CSF 与第三代方案有预防性 G-CSF 之间的增量成本效果比（ICER）。比较包括第二代方案氟尿嘧啶、多柔比星和环磷酰胺（FAC）与第三代方案多西他赛、多柔比星和环磷酰胺（TAC）联合 G-CSF；第二代方案阿霉素、环磷酰胺和紫杉醇（AC-T）每 3 周一次与第三代方案密集型 AC-T（每 2 周一次）联合 G-CSF。根据化疗开始时的年龄，患者被分为 35 岁、45 岁和 55 岁三个年龄组。结果以生命年（LY）和质量调整生命年（QALY）来衡量。ICER 计算从社会角度出发。我们还估计了预算影响，包括如果批准 G-CSF 用于第三代乳腺癌治疗方案，选择第三代方案后所有后续变化所涉及的额外公共医疗支出。成本使用 2006 年的处方药价格计算。
对于年龄 35 岁的患者，TAC 联合预防性 G-CSF 的估计 ICER 值为 956471 日元/LY 和 919443 日元/QALY；对于年龄 45 岁的患者，TAC 联合预防性 G-CSF 的估计 ICER 值为 1125540 日元/LY 和 1078967 日元/QALY；对于年龄 55 岁的患者，TAC 联合预防性 G-CSF 的估计 ICER 值为 1302746 日元/LY 和 1224896 日元/QALY。对于年龄 35 岁的患者，DD AC-T 联合预防性 G-CSF 的估计 ICER 值为 291931 日元/LY 和 311232 日元/QALY；对于年龄 45 岁的患者，DD AC-T 联合预防性 G-CSF 的估计 ICER 值为 357354 日元/LY 和 380148 日元/QALY；对于年龄 55 岁的患者，DD AC-T 联合预防性 G-CSF 的估计 ICER 值为 377011 日元/LY 和 399761 日元/QALY。如果 G-CSF 的每剂量成本从 31355 日元降至 15700 日元（TAC）或降至 24300 日元（DD AC-T），与相应的第二代方案相比，TAC 或 DD AC-T 联合预防性 G-CSF 可能会节省成本。未来 5 年的预算影响估计为每年 95 亿至 110 亿日元。
根据日本高危早期乳腺癌患者的 Markov 模型，具有预防性 G-CSF 的第三代方案在增加成本的情况下可改善结果，但估计的 ICER 值仍低于日元 600 万（60000 美元，假设 1 美元=100 日元）的建议成本效果阈值，即每增加 1 个 QALY 的成本。
