Health Economics Unit, Faculty of Health Sciences, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.
Clinical HIV Research Unit, Department of Internal Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Appl Health Econ Health Policy. 2018 Feb;16(1):43-54. doi: 10.1007/s40258-017-0352-8.
Nearly 20,000 people were diagnosed with multi-drug and rifampicin-resistant tuberculosis (MDR/RR-TB) in South Africa in 2015, yet only one-half of the patients who start treatment are expected to have a successful outcome. There is increasing evidence of the effectiveness and safety of new drug regimens containing bedaquiline for MDR/RR-TB; however, whether they are affordable for high-burden, limited-resource settings is uncertain.
Our objective was to determine the incremental cost effectiveness of a bedaquiline-based regimen for MDR/RR-TB treatment in South Africa compared with the standard kanamycin-based regimen.
We established a Markov model for ambulatory treatment of MDR/RR-TB in a high-HIV prevalence setting, parameterized using clinical outcomes from the South African National TB Programme (SA NTP) before (2012-2014) and after (2015-2016) bedaquiline roll-out. The effectiveness of treatment was evaluated in disability-adjusted life-years (DALYs). Ingredient costs from the provider's perspective were collected in 2016 South African Rand and converted to $US, including bedaquiline at $US675.23 per 6-month treatment course. Culture conversion rates were derived from the phase IIb trial of bedaquiline, and disability adjustments were adapted from published literature. Costs and effectiveness were discounted at 3%.
For non-bedaquiline regimens, the total expected cost over the 10-year time horizon for a patient with MDR/RR-TB was $US4439 with disability-adjusted survival of 5.1 years. Replacing capreomycin with bedaquiline in patients who failed MDR/RR-TB treatment and required treatment for extensively drug-resistant (XDR-TB) resulted in cost savings ($US4356; 1.8% less) and similar effectiveness (0.02 DALYs averted). As a result, the standard regimen (no bedaquiline) was dominated. Replacing kanamycin with bedaquiline to provide all patients with MDR/RR-TB access to bedaquiline cost $US4647 (4.3% more) and averted 0.17 DALYs compared with the no bedaquiline regimen. The incremental cost-effectiveness ratio was $US1242/DALY averted.
Markov modelling indicates providing bedaquiline for all patients with MDR/RR-TB could increase the 24-month treatment success rate in South Africa from 56.3% using the current regimen to 60.6%, at a cost $US2.6 million over a 10-year horizon, less than 1% of the estimated $US425 million SA NTP annual budget.
2015 年南非有近 2 万人被诊断患有耐多药和利福平耐药结核病（MDR/RR-TB），然而，预计开始治疗的患者中只有一半会有良好的治疗效果。含有贝达喹啉的新药方案在治疗耐多药/利福平耐药结核病方面的有效性和安全性证据越来越多；然而，对于高负担、资源有限的环境来说，它们是否负担得起还不确定。
我们的目的是确定在南非，与标准的卡那霉素方案相比，贝达喹啉方案治疗耐多药/利福平耐药结核病的增量成本效益。
我们在高艾滋病毒流行地区建立了一个贝达喹啉方案治疗耐多药/利福平耐药结核病的马尔可夫模型，该模型使用南非国家结核病规划（SA NTP）在贝达喹啉推出之前（2012-2014 年）和之后（2015-2016 年）的临床结果进行参数化。从残疾调整生命年（DALYs）的角度评估了治疗效果。从提供者的角度收集了 2016 年南非兰特的成分成本，并转换为美元，包括每 6 个月疗程 675.23 美元的贝达喹啉。培养转化率来自贝达喹啉的 IIb 期试验，残疾调整来自已发表的文献。成本和效果以 3%的贴现率贴现。
对于非贝达喹啉方案，耐多药/利福平耐药结核病患者在 10 年时间内的总预期成本为 4439 美元，残疾调整后的生存时间为 5.1 年。在耐多药/利福平耐药结核病治疗失败并需要广泛耐药结核病（XDR-TB）治疗的患者中，用贝达喹啉替代卷曲霉素可节省成本（4356 美元；节省 1.8%），并具有相似的效果（避免 0.02 个残疾调整生命年）。因此，标准方案（不使用贝达喹啉）被取代。为所有耐多药/利福平耐药结核病患者提供贝达喹啉，使他们都能获得贝达喹啉，这将使南非目前的方案在 24 个月的治疗成功率从 56.3%提高到 60.6%，在 10 年的时间里，这将增加 260 万美元的成本，低于南非国家结核病规划估计的 4.25 亿美元年度预算的 1%。
马尔可夫模型表明，为所有耐多药/利福平耐药结核病患者提供贝达喹啉，可使南非目前的方案在 24 个月时的治疗成功率从 56.3%提高到 60.6%，在 10 年的时间里，成本为 260 万美元，占南非国家结核病规划估计的 4.25 亿美元年度预算的不到 1%。
