Epidémiologie, évaluation et politiques de santé, Université Paris Descartes, Sorbonne Paris Cité, France.
J Med Econ. 2013;16(1):96-107. doi: 10.3111/13696998.2012.729549. Epub 2012 Sep 26.
Two anti-cancer drugs are currently approved for the treatment of HER2-positive metastatic breast cancer (MBC): trastuzumab-based therapy (TBT) administered intravenously as first line therapy until disease progression and lapatinib, an oral self-administered dual therapy with capecitabine (L+C) as second intention for patients who continue to progress despite TBT. In current practice, TBT is still prescribed beyond disease progression. In addition to medical reasons, the difficulty to switch eligible patients to oral drugs may also be explained by economic reasons. Thus, we aimed at comparing the budgetary impact of TBT and L+C for progressing HER2+MBC after TBT from the French Health Insurance perspective.
A budget impact analysis was performed on a 3-year time horizon (2012-2014) to simulate a dynamic cohort of 4182 HER2-positive patients with a progressing MBC treated with TBT (73%) and L + C (27%). The model was adjusted on progression-free survival (PFS). Office visits, clinical evaluations, drug acquisition, administration costs, and transportation costs obtained from the literature and published databases were considered.
In the base case analysis (2012), the annual treatment cost per patient for TBT (€36,077) was 2-times higher than that of L + C (€17,165). Using L + C for all patients (n = 4182) would avoid €34.8 million of drug administration and transportation costs. Hospital costs represented 1% vs 88%, while community costs represented 99% vs 12% of L + C and TBT treatment costs, respectively. The lack of direct comparison PFS and treatment dosage modification data were the main limitations. However, no major changes from baseline results were observed from sensitivity analyses.
Despite a slightly higher acquisition cost, the treatment cost of L + C remains lower than that of TBT, and it is the only approved anti-HER2 treatment for HER2-positive patients with progressing MBC. Based on this, it seems important to consider the potential savings for Health Insurance with the use of oral drug due to the reduction of outpatient hospitalizations. Such reductions may result in a subsequent budget reduction for hospitals, but may also provide those facing acute medical activity with opportunities to better manage other diseases whose treatment cannot be externalized.
目前有两种抗癌药物被批准用于治疗人表皮生长因子受体 2（HER2）阳性转移性乳腺癌（MBC）：曲妥珠单抗为基础的治疗（TBT）作为一线治疗，直至疾病进展；而拉帕替尼是一种口服的双重药物，与卡培他滨（L+C）联合使用，作为 TBT 继续进展的二线治疗药物。在目前的实践中，TBT 在疾病进展后仍被开具处方。除了医疗原因外，难以将符合条件的患者转为口服药物治疗也可能是由于经济原因。因此，我们旨在从法国医保的角度比较 TBT 和 L+C 在 TBT 治疗进展后 HER2+MBC 的预算影响。
在三年内（2012-2014 年）进行预算影响分析，模拟一组 4182 名 HER2 阳性、MBC 进展的患者的动态队列，这些患者接受 TBT（73%）和 L+C（27%）治疗。该模型根据无进展生存期（PFS）进行调整。就诊、临床评估、药物获取、管理成本和交通成本均从文献和已发表的数据库中获得。
在基线分析（2012 年）中，TBT 每位患者的年治疗成本（€36077）是 L+C 的两倍（€17165）。如果所有患者（n=4182）均使用 L+C，则可避免€3480 万的药物管理和交通成本。医院成本占 1%，而社区成本分别占 L+C 和 TBT 治疗成本的 99%和 12%。缺乏直接比较 PFS 和治疗剂量调整数据是主要的局限性。然而，敏感性分析并未对基线结果产生重大影响。
尽管 L+C 的采购成本略高，但 L+C 的治疗成本仍低于 TBT，并且是唯一批准用于 HER2 阳性、MBC 进展患者的抗 HER2 治疗药物。因此，考虑到由于减少了门诊住院治疗，医保可能会节省相关费用。这种减少可能会导致医院的预算减少，但也可能为面临急性医疗活动的医院提供机会，以更好地管理无法进行外部化治疗的其他疾病。
