Pradelli Lorenzo, Pinciroli Matteo, Houshmand Hirad, Grassi Beatrice, Bonelli Fabrizio, Calleri Mariella, Ruscio Maurizio
AdRes Health Economics and Outcomes Research, Torino, Italy.
DiaSorin SpA, via Crescentino, Saluggia, 13040, Italy.
Clinicoecon Outcomes Res. 2021 May 26;13:437-451. doi: 10.2147/CEOR.S306391. eCollection 2021.
This Lyme disease early detection economic model, for patients with suspected Lyme disease without (EM), compares outcomes of standard two-tier testing (sTTT), modified two-tier testing (mTTT) and the DiaSorin Lyme Detection Algorithm (LDA), a combination of both serology tests and Interferon-ɤ Release Assay.
A patient-level simulation model was built to incorporate effectiveness estimation from a structured focused literature review, and health-care cost inputs for the United States, Germany, and Italy. Simulated clinical outcomes were 1) percent of patients with timely and correct diagnosis, 2) patients appropriately treated and exposed to antibiotics therapy, and 3) patients with late Lyme disease manifestations. Expected health outcomes were expressed in terms of differences in quality-adjusted life years (QALYs) due to disseminated Lyme disease and persisting symptoms, and economic outcomes were analyzed from a third-party payer perspective.
The DiaSorin LDA resulted in a better sensitivity compared to sTTT and mTTT, 84% vs 49% and 45%, respectively, in the base case (13% of infected patients in the tested population). Due to the improved diagnostic performance, the LDA-based strategy is expected to be more effective, providing mean incremental 0.024 QALYs per tested patient, or 0.19 per infected patient. Furthermore, from a third-party payer perspective, the adoption of the LDA-based strategy would reduce the expected health-care cost for suspected and confirmed Lyme disease by roughly 40%, ie about $410, €130, and €170 per tested patient in the United States, Germany, and Italy, respectively, compared to sTTT. The results are most sensitive to the infection rate in the tested population, with LDA maintaining a cost advantage for Lyme disease active infection rates ≥0.8-2.5%.
LDA early diagnostic testing and subsequent treatment of subjects with early Lyme disease without EM are expected to outperform traditional management strategies both clinically and economically in the US, Germany, and Italy.
本莱姆病早期检测经济模型（EM）针对疑似莱姆病但无（具体情况未提及，推测为某种特定情况）的患者，比较了标准两层检测（sTTT）、改良两层检测（mTTT）以及DiaSorin莱姆病检测算法（LDA，一种血清学检测和干扰素-γ释放试验的组合）的结果。
构建了一个患者层面的模拟模型，纳入了结构化重点文献综述中的有效性估计，以及美国、德国和意大利的医疗保健成本投入。模拟的临床结果包括：1）及时且正确诊断的患者百分比；2）接受适当治疗并暴露于抗生素治疗的患者；3）出现莱姆病晚期表现的患者。预期健康结果以因播散性莱姆病和持续症状导致的质量调整生命年（QALY）差异来表示，经济结果则从第三方支付者的角度进行分析。
在基础病例中（测试人群中13%的感染患者），与sTTT和mTTT相比，DiaSorin LDA的敏感性更高，分别为84%、49%和45%。由于诊断性能的提高，基于LDA的策略预计更有效，每位测试患者平均增加0.024个QALY，每位感染患者增加0.19个QALY。此外，从第三方支付者的角度来看，与sTTT相比，采用基于LDA的策略将使疑似和确诊莱姆病的预期医疗保健成本分别降低约40%，即在美国、德国和意大利，每位测试患者分别约降低410美元、130欧元和170欧元。结果对测试人群中的感染率最为敏感，当莱姆病活跃感染率≥0.8 - 2.5%时，LDA保持成本优势。
在美国、德国和意大利，对无（具体情况未提及，推测为某种特定情况）的早期莱姆病患者进行LDA早期诊断检测及后续治疗，预计在临床和经济方面均优于传统管理策略。
