Economic evaluation of short treatment for multidrug-resistant tuberculosis, Ethiopia and South Africa: the STREAM trial

Madan, Jason; Rosu, Laura; Tefera, Mamo Girma; Rensburg, Craig van; Evans, Denise; Langley, Ivor; Tomeny, Ewan; Nunn, Andrew; Phillips, Patrick; Rusen, I. D.; Squire, S. Bertel

doi:10.2471/blt.19.243584

Cited by 17 publications

(18 citation statements)

References 19 publications

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Section: Discussionmentioning

confidence: 98%

“…The costs of Models D, E and F are $4,334, $7,705 and $3,420 respectively, and these total costs are similar to those of shorter treatment regimen used in Ethiopia and South Africa [ 20 ]. It was however, difficult to compare cost drivers with Ethiopia and South Africa because different cost components were used to build the costs; while we built staff costs and the costs of consumables into in-patient and out-patient care; they were treated as separate cost components in the evaluation of the short treatment models in Ethiopia and south Africa [ 20 ]. As expected, Model E which differs from Model D only by the hospitalization of patients for 120 days, is almost twice the cost of Model D. Therefore, using a treatment model of nine month’s duration, with an injectable agent without hospitalization results in a cost savings of $3,371 per patient as compared to the same model with hospitalization for 120 days.…”

Section: Discussionmentioning

confidence: 98%

“…In 2016, the World Health Organization (WHO) recommended the utilization of Shorter Treatment Regimen [15] based on reported success rates of 85% and above [16][17][18][19]. These shorter treatment regimen models have been implemented in several countries at costs ranging between $4,552 and $6,618 [20]. WHO now recommends a further modification; the use of a shorter, all oral, bedaquiline-containing regimen for eligible patients: patients without previous exposure to second-line medicines for more than one month, without fluoroquinolone resistance and in the absence of extensive TB disease or severe extra-pulmonary TB [21].…”

Section: Introductionmentioning

confidence: 99%

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Cost comparison of nine-month treatment regimens with 20-month standardized care for the treatment of rifampicin-resistant/multi-drug resistant tuberculosis in Nigeria

et al. 2020

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Background Globally, drug resistant tuberculosis (DR-TB) continues to be a public health threat. Nigeria, which accounts for a significant proportion of the global burden of rifampicin/multi-drug resistant-TB (RR/MDR-TB) had a funding gap of $168 million dollars for TB treatment in 2018. Since 2010, Nigeria has utilized five different models of care for RR/MDR-TB (Models A-E); Models A, B and C based on a standardized WHO-approved treatment regimen of 20–24 months, were phased out between 2015 and 2019 and replaced by Models D and E. Model D is a fully ambulatory model of 9–12 months during which a shorter treatment regimen including a second-line injectable agent is utilized. Model E is identical to Model D but has patients hospitalized for the first four months of care while Model F which is to be introduced in 2020, is a fully ambulatory, oral bedaquiline-containing shorter treatment regimen of 9–12 months. Treatment models for RR/MDR-TB of 20–24 months duration have had treatment success rates of 52–66% while shorter treatment regimens have reported success rates of 85% and above. In addition, replacing the second-line injectable agent in a shorter treatment regimen with bedaquiline has been found to further improve treatment success in patients with fluoroquinolone-susceptible RR/MDR-TB. Reliable cost data for RR/MDR-TB care are limited, specifically costs of models that utilize shorter treatment regimens and which are vital to guide Nigeria through the provision of RR/MDR-TB care at scale. We therefore conducted a cost analysis of shorter treatment regimens in use and to be used in Nigeria (Models D, E and F) and compared them to three models of longer duration utilized previously in Nigeria (Models A, B and C) to identify any changes in cost from transitioning from Models A-C to Models D-F and opportunities for cost savings. Methods We obtained costs for TB diagnostic and monitoring tests, in-patient and out-patient care from a previous study, inflated these costs to 2019 NGN and then converted to 2020 USD. We obtained other costs from the average of six health facilities and drug costs from the global drug facility. We modeled treatment on strict adherence to two Nigerian National guidelines for programmatic and clinical management of drug-resistant tuberculosis. Results We estimated that the total costs of care from the health sector perspective for Models D, E and F were $4,334, $7,705 and $3,420 respectively. This is significantly lower than the costs of Models A, B and C which were $14,781, $12, 113, $7,572 respectively. Conclusion Replacing Models A–C with Models D and E reduced the costs of RR/MDR-TB care in Nigeria by approximately $5,470 (48%) per patient treated and transitioning from Models D and E to Model F would result in further cost savings of $914 to $4,285 (21 to 56%) for every patient placed on Model F. If the improved outcomes of patients managed using bedaquiline-containing shorter treatment regimens in other countries can be attained in Nigeria, Model F would be the recommended model for the scale up of RR/MDR-TB care in Nigeria.

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Section: Discussionmentioning

confidence: 98%

Section: Discussionmentioning

confidence: 98%

Section: Introductionmentioning

confidence: 99%

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Cost comparison of nine-month treatment regimens with 20-month standardized care for the treatment of rifampicin-resistant/multi-drug resistant tuberculosis in Nigeria

et al. 2020

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“…Data regarding staff time and staff activities involved in the management of MDR-TB treatment for each regimen will be collected by the focal health economists in each country using a standardised questionnaire developed by the health economic team, pilot tested in all HE sites and used in the first phase of the trial. 6 …”

Section: Methods and Analysismentioning

confidence: 99%

Economic evaluation protocol of a short, all-oral bedaquiline-containing regimen for the treatment of rifampicin-resistant tuberculosis from the STREAM trial

et al. 2020

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IntroductionA December 2019 WHO rapid communication recommended the use of 9-month all-oral regimens for treating multidrug-resistant tuberculosis (MDR-TB). Besides the clinical benefits, they are thought to be less costly than the injectable-containing regimens, for both the patient and the health system. STREAM is the first randomised controlled trial with an economical evaluation to compare all-oral and injectable-containing 9–11-month MDR-TB treatment regimens.Methods and analysisHealth system costs of delivering a 9-month injectable-containing regimen and a 9-month all-oral bedaquiline-containing regimen will be collected in Ethiopia, India, Moldova and Uganda, using ‘bottom-up’ and ‘top-down’ costing approaches. Patient costs will be collected using questionnaires that have been developed based on the STOP-TB questionnaire. The primary objective of the study is to estimate the cost utility of the two regimens, from a health system perspective. Secondary objectives include estimating the cost utility from a societal perspective as well as evaluating the cost-effectiveness of the regimens, using both health system and societal perspectives. The effect measure for the cost–utility analysis will be the quality-adjusted life years (QALY), while the effect measure for the cost-effectiveness analysis will be the efficacy outcome from the clinical trial.Ethics and disseminationThe study has been evaluated and approved by the Ethics Advisory Group of theInternational Union Against Tuberculosis and Lung Diseaseand also approved by ethics committees in all participating countries. All participants have provided written informed consent. The results of the economic evaluation will be published in a peer-reviewed journal.Trial registration numberNCT18148631.

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“…Conceived by the Union and global partners with initial funding from USAID, the trial has recruited over 1000 patients to two distinct stages. Results from STREAM Stage 1 were published in 2019 and 2020 [4,5], and recruitment was recently completed for the second stage in January, 2020. As of March 31, 2020, 126 participants remain on MDR-TB treatment with 21 of those in the intensive phase of treatment and 312 participants remain in active follow-up.…”

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confidence: 99%

Challenges in Tuberculosis Clinical Trials in the Face of the COVID-19 Pandemic: A Sponsor’s Perspective

Rusen

2020

TropicalMed

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The COVID-19 pandemic has caused unforeseen and extreme changes in societal and health system functioning not previously experienced in most countries in a lifetime. The impact of the pandemic on clinical trials can be especially profound given their complexities and operational requirements. The STREAM Clinical Trial is the largest trial for MDR-TB ever conducted. Currently operating in seven countries, the trial had 126 participants on treatment and 312 additional participants in active follow up as of March 31, 2020. Areas of particular concern during this global emergency include treatment continuity, supply chain management and participant safety monitoring. This commentary highlights some of the challenges faced due to the pandemic and the steps taken to protect the safety of trial participants and the integrity of the trial.

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Economic evaluation of short treatment for multidrug-resistant tuberculosis, Ethiopia and South Africa: the STREAM trial

Cited by 17 publications

References 19 publications

Cost comparison of nine-month treatment regimens with 20-month standardized care for the treatment of rifampicin-resistant/multi-drug resistant tuberculosis in Nigeria

Cost comparison of nine-month treatment regimens with 20-month standardized care for the treatment of rifampicin-resistant/multi-drug resistant tuberculosis in Nigeria

Economic evaluation protocol of a short, all-oral bedaquiline-containing regimen for the treatment of rifampicin-resistant tuberculosis from the STREAM trial

Challenges in Tuberculosis Clinical Trials in the Face of the COVID-19 Pandemic: A Sponsor’s Perspective

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