Health Economics Unit, School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town.
Clinical HIV Research Unit, Department of Internal Medicine, Faculty of Health Sciences, University of the Witwatersrand Johannesburg, South Africa;, Department of Medicine, University of Colorado, Aurora, Colorado, USA.
Int J Tuberc Lung Dis. 2018 Aug 1;22(8):918-925. doi: 10.5588/ijtld.17.0869.
Adverse drug reactions (ADRs) are common during standard, long-course treatment for multidrug-resistant and rifampicin-resistant tuberculosis (MDR-/RR-TB). In particular, second-line injectables (SLIs) are associated with permanent hearing loss, acute renal injury and electrolyte imbalance. We adapted an established Markov model for ambulatory treatment to estimate the impact of the toxicity profile on the incremental cost-effectiveness ratio (ICER) for a proposed MDR-/RR-TB regimen replacing the SLI with bedaquiline (BDQ).
Treatment effectiveness was evaluated in disability-adjusted life-years (DALYs). Clinical outcomes and ingredient costs from a provider perspective were derived from the South African public-sector treatment program or extracted from the literature. Costs and effectiveness were discounted at 3% per year over 10 years.
A BDQ-based MDR-/RR-TB regimen compared with the SLI regimen had a mean ICER of US$516 per DALY averted using the standard Markov model. Costs for both regimens increased and effectiveness decreased for the SLI regimen once adjusted for toxicity. The resulting ICER for the BDQ-based regimen was cost saving (US$96/patient) and more effective (0.96 DALYs averted) after adjusting for ADRs.
Decision-analysis models of treatment for MDR-/RR-TB, including new drug regimens, should consider the costs of managing ADRs and their sequelae.
在多药耐药和利福平耐药结核病（MDR-/RR-TB）的标准长程治疗中，不良反应（ADRs）很常见。特别是，二线注射剂（SLIs）与永久性听力损失、急性肾损伤和电解质失衡有关。我们改编了一个现有的门诊治疗马尔可夫模型，以估计毒性特征对提议的 MDR-/RR-TB 方案的增量成本效益比（ICER）的影响，该方案用贝达喹啉（BDQ）替代 SLI。
从残疾调整生命年（DALYs）的角度评估治疗效果。从南非公共部门治疗计划中得出或从文献中提取临床结果和成分成本。成本和效果在 10 年内每年贴现 3%。
BDQ 为基础的 MDR-/RR-TB 方案与 SLI 方案相比，使用标准马尔可夫模型，每避免一个 DALY 的平均 ICER 为 516 美元。一旦调整了毒性，两种方案的成本都增加了，而 SLI 方案的效果降低了。在调整 ADR 后，BDQ 方案的 ICER 为节省成本（每位患者 96 美元），更有效（避免 0.96 DALY）。
MDR-/RR-TB 治疗的决策分析模型，包括新的药物方案，应考虑管理 ADRs 及其后果的成本。
