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奥拉帕利作为 BRCA 突变型晚期卵巢癌的一线治疗:在西班牙是否具有成本效益?

Olaparib as first line in BRCA-mutated advanced ovarian carcinoma: Is it cost-effective in Spain?

机构信息

AstraZeneca Farmacéutica Spain S.A., Parque Norte. C/ Serrano Galvache, 56, 28033 Madrid, Spain.

Weber, Calle Moreto, 17, 28014 Madrid, Spain.

出版信息

Gynecol Oncol. 2022 Feb;164(2):406-414. doi: 10.1016/j.ygyno.2021.11.011. Epub 2021 Nov 26.

DOI:10.1016/j.ygyno.2021.11.011
PMID:34844775
Abstract

OBJECTIVE

To estimate the cost-effectiveness of olaparib after being funded by the Spanish National Health Service (SNHS) as first-line monotherapy maintenance treatment in patients with advanced high-grade serous ovarian carcinoma (HGSOC) and BRCA mutations in Spain.

METHODS

A semi-Markov model with one-month cycles was adapted to the Spanish healthcare setting, using the perspective of the SNHS, and a time horizon of 50 years. Two scenarios were compared: receiving olaparib vs. no maintenance treatment. The model comprised four health states and included the clinical results of the SOLO1 study, along with the direct healthcare costs associated with the use of first-line and subsequent treatment resources (2020 €). A discount rate of 3% was applied for future cost and quality-of-life outcomes. A probabilistic sensitivity analysis (PSA) was also carried out and a cost-effectiveness threshold of €25,000 per quality adjusted life year (QALY) was considered.

RESULTS

The introduction of olaparib as a first-line maintenance treatment for advanced HGSOC patients with BRCA mutations implied a cost of €131,614.98 compared to €102,369.54 without olaparib (difference: €29,245.44), with an improvement of 2.00 QALYs (5.56 and 3.57, respectively). Therefore, olaparib is cost-effective for advanced HGSOC patients with BRCA mutations, with an incremental cost-effectiveness ratio of €14,653.2/QALY. The results from the PSA showed that 92.1% of the simulations fell below the €25,000/QALY threshold. The model showed that olaparib could improve the overall survival by 2 years, vs. no maintenance treatment.

CONCLUSIONS

Olaparib as first-line maintenance treatment is cost-effective in advanced HGSOC patients with BRCA mutations in Spain.

摘要

目的

在西班牙国家卫生服务体系(SNHS)为 BRCA 突变的晚期高级别浆液性卵巢癌(HGSOC)患者提供资金后,评估奥拉帕利作为一线单药维持治疗的成本效益。

方法

采用具有一个月周期的半马尔可夫模型,适用于西班牙医疗保健环境,从 SNHS 的角度出发,时间范围为 50 年。比较了两种方案:接受奥拉帕利治疗与不进行维持治疗。该模型包括四个健康状态,并包含 SOLO1 研究的临床结果,以及与一线和后续治疗资源使用相关的直接医疗保健成本(2020 年€)。对未来成本和生活质量结果应用 3%的折扣率。还进行了概率敏感性分析(PSA),并考虑了每质量调整生命年(QALY)25,000 欧元的成本效益阈值。

结果

将奥拉帕利作为一线维持治疗引入 BRCA 突变的晚期 HGSOC 患者,与不使用奥拉帕利相比,成本为 131,614.98 欧元,而不使用奥拉帕利的成本为 102,369.54 欧元(差异:29,245.44 欧元),奥拉帕利改善了 2.00 个 QALYs(分别为 5.56 和 3.57)。因此,奥拉帕利对 BRCA 突变的晚期 HGSOC 患者具有成本效益,增量成本效益比为每 QALY 14,653.2 欧元。PSA 的结果表明,92.1%的模拟结果低于 25,000 欧元/QALY 的阈值。模型表明,与不进行维持治疗相比,奥拉帕利可将总生存时间延长 2 年。

结论

在西班牙,奥拉帕利作为一线维持治疗在 BRCA 突变的晚期 HGSOC 患者中具有成本效益。

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