Background

Currently, there are no solutions to prevent congenital transmission of Chagas disease during pregnancy, which affects 1–40% of pregnant women in Latin America and is associated with a 5% transmission risk. With therapeutic vaccines under development, now is the right time to determine the economic value of such a vaccine to prevent congenital transmission.

Methods

We developed a computational decision model that represented the clinical outcomes and diagnostic testing strategies for an infant born to a Chagas-positive woman in Mexico and evaluated the impact of vaccination.

Results

Compared to no vaccination, a 25% efficacious vaccine averted 125 [95% uncertainty interval (UI): 122–128] congenital cases, 1.9 (95% UI: 1.6–2.2) infant deaths, and 78 (95% UI: 66–91) DALYs per 10,000 infected pregnant women; a 50% efficacious vaccine averted 251 (95% UI: 248–254) cases, 3.8 (95% UI: 3.6–4.2) deaths, and 160 (95% UI: 148–171) DALYs; and a 75% efficacious vaccine averted 376 (95% UI: 374–378) cases, 5.8 (95% UI: 5.5–6.1) deaths, and 238 (95% UI: 227–249) DALYs. A 25% efficacious vaccine was cost-effective (incremental cost-effectiveness ratio <3× Mexico’s gross domestic product per capita, <$29,698/DALY averted) when the vaccine cost ≤$240 and ≤$310 and cost-saving when ≤$10 and ≤$80 from the third-party payer and societal perspectives, respectively. A 50% efficacious vaccine was cost-effective when costing ≤$490 and ≤$615 and cost-saving when ≤$25 and ≤$160, from the third-party payer and societal perspectives, respectively. A 75% efficacious vaccine was cost-effective when ≤$720 and ≤$930 and cost-saving when ≤$40 and ≤$250 from the third-party payer and societal perspectives, respectively. Additionally, 13–42 fewer infants progressed to chronic disease, saving $0.41-$1.21 million to society.

Conclusion

We delineated the thresholds at which therapeutic vaccination of Chagas-positive pregnant women would be cost-effective and cost-saving, providing economic guidance for decision-makers to consider when developing and bringing such a vaccine to market.

中文翻译：

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用于孕妇预防先天性传播的治疗性南美锥虫病疫苗的潜在经济价值。

背景

目前，尚无预防妊娠期南美锥虫病先天性传播的解决方案，该病影响拉丁美洲 1-40% 的孕妇，并与 5% 的传播风险相关。随着治疗性疫苗的开发，现在是确定这种疫苗预防先天性传播的经济价值的合适时机。

方法

我们开发了一个计算决策模型，该模型代表墨西哥一名南美锥虫阳性妇女所生婴儿的临床结果和诊断测试策略，并评估了疫苗接种的影响。

结果

与未接种疫苗相比，25% 有效的疫苗避免了 125 [95% 不确定区间 (UI): 122–128] 先天性病例、1.9 (95% UI: 1.6–2.2) 婴儿死亡和 78 (95% UI: 66– 91) 每 10,000 名受感染孕妇的 DALY；一种 50% 有效的疫苗避免了 251 例（95% UI：248-254）例、3.8 例（95% UI：3.6-4.2）死亡和 160 例（95% UI：148-171）DALY；75% 有效的疫苗避免了 376 例（95% UI：374-378）例、5.8 例（95% UI：5.5-6.1）死亡和 238 例（95% UI：227-249）DALY。当疫苗成本≤240 美元和≤310 美元时，25% 有效的疫苗具有成本效益（增量成本效益比 <3× 墨西哥人均国内生产总值，<29,698 美元/避免的 DALY），当疫苗成本≤10 美元和≤80 美元时可节省成本分别从第三方支付者和社会的角度来看。从第三方支付者和社会的角度来看，当成本≤490 美元和≤615 美元时，一种有效率为 50% 的疫苗具有成本效益，而当≤25 美元和≤160 美元时，则可以节省成本。从第三方支付者和社会的角度来看，当≤720 美元和≤930 美元时，有效率为 75% 的疫苗具有成本效益，而当≤40 美元和≤250 美元时，则可以节省成本。此外，进展为慢性病的婴儿减少了 13-42 名，为社会节省了 0.41-121 万美元。

结论

我们描述了南美锥虫阳性孕妇的治疗性疫苗接种具有成本效益和成本效益的阈值，为决策者在开发和将这种疫苗推向市场时考虑提供经济指导。