Sweeney Sedona, Gomez Gabriela, Kitson Nichola, Sinha Animesh, Yatskevich Natalia, Staples Suzanne, Moodliar Ronelle, Motlhako Sharon, Maloma Matshepo, Rassool Mohammed, Ngubane Nosipho, Ndlovu Ella, Nyang'wa Bern-Thomas
Global Health and Development, London School of Hygiene and Tropical Medicine, London, UK
Vaccine Epidemiology and Modelling, Sanofi Pasteur SA, Lyon, France.
BMJ Open. 2020 Oct 10;10(10):e036599. doi: 10.1136/bmjopen-2019-036599.
Current treatment regimens for multidrug-resistant tuberculosis (MDR-TB) are long, poorly tolerated and have poor outcomes. Furthermore, the costs of treating MDR-TB are much greater than those for treating drug-susceptible TB, both for health service and patient-incurred costs. Urgent action is needed to identify short, effective, tolerable and cheaper treatments for people with both quinolone-susceptible and quinolone-resistant MDR-TB. We present the protocol for an economic evaluation (PRACTECAL-EE substudy) alongside an ongoing clinical trial (TB-PRACTECAL) aiming to assess the costs to patients and providers of new regimens, as well as their cost-effectiveness and impact on participant poverty levels. This substudy is based on data from the three countries participating in the main trial.
Primary cost data will be collected from the provider and patient perspectives, following economic best practice. We will estimate the probability that new MDR-TB regimens containing bedaquiline, pretomanid and linezolid are cost-effective from a societal perspective as compared with the standard of care for MDR-TB patients in Uzbekistan, South Africa and Belarus. Analysis uses a Markov model populated with primary cost and outcome data collected at each study site. We will also estimate the impact of new regimens on prevalence of catastrophic patient costs due to TB.
Ethical approval has been obtained from the London School of Hygiene & Tropical Medicine and Médecins Sans Frontières. Local ethical approval will be sought in each study site. The results of the economic evaluation will be shared with the country health authorities and published in a peer-reviewed journal.
ClinicalTrials.gov Registry (NCT04207112); Pre-results.
目前针对耐多药结核病（MDR-TB）的治疗方案疗程长、耐受性差且疗效不佳。此外，无论是卫生服务成本还是患者自付费用，耐多药结核病的治疗费用都远高于药物敏感结核病。迫切需要采取行动，为喹诺酮敏感和耐药的耐多药结核病患者确定短程、有效、耐受性好且成本更低的治疗方法。我们展示了一项经济评估方案（PRACTECAL-EE子研究）以及一项正在进行的临床试验（TB-PRACTECAL），旨在评估新方案对患者和提供者的成本，以及它们的成本效益和对参与者贫困水平的影响。这项子研究基于参与主要试验的三个国家的数据。
将按照经济最佳实践，从提供者和患者的角度收集主要成本数据。我们将估计，从社会角度来看，与乌兹别克斯坦、南非和白俄罗斯耐多药结核病患者的标准治疗相比，含贝达喹啉、普瑞玛尼和利奈唑胺的新耐多药结核病方案具有成本效益的概率。分析使用一个马尔可夫模型，该模型填充了在每个研究地点收集的主要成本和结果数据。我们还将估计新方案对因结核病导致的灾难性患者成本患病率的影响。
已获得伦敦卫生与热带医学院和无国界医生组织的伦理批准。将在每个研究地点寻求当地伦理批准。经济评估的结果将与国家卫生当局分享，并发表在同行评审期刊上。
ClinicalTrials.gov注册库（NCT04207112）；预结果。
