Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine, Nanjing, China.
Nanjing University of Chinese Medicine, Nanjing, China.
Medicine (Baltimore). 2023 Dec 15;102(50):e36387. doi: 10.1097/MD.0000000000036387.
BACKGROUND: The cost-effectiveness of sotorasib and its reasonable price in the United States (US) and China remain unknown. Our objective was to estimate the price at which sotorasib could be economical as second-line treatment for advanced non-small-cell lung cancer patients with Kirsten rat sarcoma viral oncogene homolog p.G12C-mutation in 2 countries. METHODS: We conducted an economic evaluation from the perspective of US and Chinese payers. To analyze US patients, we built a partitioned survival model. However, since we lacked Asian-specific overall survival data, we created a state transition model for the Chinese patients. We obtained patients' baseline characteristics and clinical data from CodeBreaK200, while utilities and costs were gathered from public databases and published literature. We calculated costs (US dollar), life years, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios. We conducted price simulation to guide pricing strategies. Additionally, we assessed the reliability of our results through sensitivity analyses, scenario analyses, and subgroup analyses. RESULTS: The incremental cost-effectiveness ratios of sotorasib compared to docetaxel were $1501,852 per quality-adjusted life-years (QALY) in the US and $469,106/QALY in China, respectively, which meant sotorasib was unlikely to be economical at the currently available price of $20,878 (240 × 120 mg) in both countries. Price simulation results revealed that sotorasib would be preferred at a price lower than $1400 at the willingness-to-pay threshold of $37,376 in China and a price lower than $2220 at the willingness-to-pay threshold of $150,000 in the US. Sensitivity, scenario, and subgroup analyses showed that these conclusions were generally robust, the model was most sensitive to the utilities of progression-free survival and post-progression survival. CONCLUSIONS: Sotorasib could potentially be a cost-effective therapy in the US and China following price reductions. Our evidence-based pricing strategy can assist decision-makers and clinicians in making optimal decisions. However, further analysis of budget impact and affordability is needed.
背景：在美国（US）和中国，索托拉西布的成本效益及其合理价格尚不清楚。我们的目标是评估索托拉西布作为二线治疗用于美国和中国具有 Kirsten 大鼠肉瘤病毒致癌基因同源物 p.G12C 突变的晚期非小细胞肺癌患者的经济性。
方法：我们从美国和中国支付者的角度进行了经济评估。为了分析美国患者，我们构建了一个分区生存模型。但是，由于我们缺乏亚洲特有的总生存数据，我们为中国患者创建了一个状态转换模型。我们从 CodeBreaK200 获得患者的基线特征和临床数据，而效用和成本则来自公共数据库和已发表的文献。我们计算了成本（美元）、生命年、质量调整生命年（QALY）和增量成本效益比。我们进行了价格模拟，以指导定价策略。此外，我们通过敏感性分析、情景分析和亚组分析来评估结果的可靠性。
结果：与多西他赛相比，索托拉西布在美国的增量成本效益比为每质量调整生命年（QALY）1501852 美元，在中国为 469106/QALY，这意味着在两国，以目前 20878 美元（240×120 毫克）的价格，索托拉西布不太可能具有经济性。价格模拟结果表明，在中国，当支付意愿阈值为 37376 美元时，索托拉西布的价格低于 1400 美元，在美国，当支付意愿阈值为 150000 美元时，索托拉西布的价格低于 2220 美元，索托拉西布更受欢迎。敏感性、情景和亚组分析表明，这些结论总体上是稳健的，模型对无进展生存期和进展后生存期的效用最为敏感。
结论：在价格降低后，索托拉西布在美国和中国可能具有成本效益。我们的循证定价策略可以帮助决策者和临床医生做出最佳决策。但是，需要进一步分析预算影响和负担能力。
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