Health Economics and Outcomes Research, CRHF, Medtronic plc, Mounds View, MN, USA.
Health Economics and Outcomes Research, Diabetes, Medtronic plc, Northridge, CA, USA.
J Med Econ. 2021 Jan-Dec;24(1):173-180. doi: 10.1080/13696998.2021.1877451.
The mortality benefit of implantable cardioverter defibrillators (ICDs) for primary prevention (PP) of sudden cardiac arrest (SCA) has been well-established, but ICD therapy remains globally underutilized. The results of the Improve SCA study showed a 49% relative risk reduction in all-cause mortality among ICD patients with 1.5 primary prevention (1.5PP) characteristics (patients with one or more risk factors, < 0.0001). We evaluated the cost-effectiveness of ICD compared to no ICD therapy among patients with 1.5PP characteristics in three Latin American countries and analyzed the factors involved in cost-effectiveness.
We used a published Markov model that compares costs and outcomes of ICD to no ICD therapy from local payers' perspective and included country-specific and disease-specific inputs from the Improve SCA study and current literature. We used WHO-recommended willingness-to-pay (WTP) thresholds to assess cost-effectiveness and compared model outcomes between countries.
Incremental costs per QALY (quality-adjusted life year) saved by ICD compared to no ICD therapy are Colombian Pesos COP$46,729,026 in Colombia, Mexican Pesos MXN$246,016 in Mexico, and Uruguayan Pesos UYU$1,213,614 in Uruguay in the base case scenario; all three figures are between 1-3-times GDP per capita for each country. One-way and probabilistic sensitivity analyses confirm the base case scenario results. Non-cardiac accumulated deaths are lower in Mexico, resulting in a comparatively increased cost-effective ICD therapy.
The Improve SCA study was not randomized, so clinical results could be biased; however, measures were taken to reduce this bias. Costs and benefits were modelled beyond the timeline of direct observation in the Improve SCA study.
ICD therapy is cost-effective in Mexico and Uruguay and potentially cost-effective in Colombia for a 1.5PP population. Variability in ICER estimates by country can be explained by differences in non-cardiac deaths and cost inputs.
植入式心脏复律除颤器（ICD）用于预防心搏骤停（SCA）的一级预防（PP）的死亡率获益已得到充分证实，但 ICD 治疗在全球范围内仍未得到充分利用。Improve SCA 研究的结果显示，具有 1.5 个一级预防（1.5PP）特征的 ICD 患者的全因死亡率相对风险降低了 49%（具有一个或多个危险因素的患者，<0.0001）。我们评估了在具有 1.5PP 特征的患者中，与不使用 ICD 治疗相比，ICD 在三个拉丁美洲国家的成本效益，并分析了成本效益相关的因素。
我们使用了一种已发表的马尔可夫模型，该模型从当地支付者的角度比较了 ICD 与不使用 ICD 治疗的成本和结果，并纳入了来自 Improve SCA 研究和当前文献的特定国家和特定疾病的输入。我们使用世界卫生组织推荐的意愿支付（WTP）阈值来评估成本效益，并比较了国家之间的模型结果。
与不使用 ICD 治疗相比，ICD 每节省一个质量调整生命年（QALY）的增量成本分别为哥伦比亚比索 COP$46,729,026、墨西哥比索 MXN$246,016 和乌拉圭比索 UYU$1,213,614，在基础方案中，这三个数字均为每个国家人均国内生产总值（GDP）的 1-3 倍。单向和概率敏感性分析证实了基础方案的结果。墨西哥的非心脏性累积死亡人数较低，导致比较而言 ICD 治疗更具成本效益。
Improve SCA 研究不是随机的，因此临床结果可能存在偏差；但是，已经采取了措施来减少这种偏差。成本和效益是在 Improve SCA 研究的直接观察时间之外建模的。
在 1.5PP 人群中，ICD 治疗在墨西哥和乌拉圭具有成本效益，在哥伦比亚可能具有成本效益。国家间 ICER 估计值的差异可以用非心脏性死亡和成本投入的差异来解释。
