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Rosu, Laura, Madan, Jason J, Tomeny, Ewan 
ORCID: https://orcid.org/0000-0003-4547-2389, Muniyandi, Malaisamy, Nidoi, Jasper, Girma, Mamo, Vilc, Valentina, Bindroo, Priyaka, Dhandhukiya, Rajdeep, Bayissa, Adamu K, Kokebu, Daniel M., Gopalan, Narendran, Solanki, Rajesh, Bhatnagar, Anuj K, Tudor, Elena, Kirenga, Bruce, Meredith, Sarah K, Nunn, Andrew, Bronson, Gay, Rusen, I.D., Squire, Bertie ORCID: https://orcid.org/0000-0001-7173-9038 and Worrall, Eve ORCID: https://orcid.org/0000-0001-9147-3388
(2023)
'Economic evaluation of shortened, bedaquiline-containing treatment regimens for rifampicin-resistant tuberculosis (STREAM stage 2): a within-trial analysis of a randomised controlled trial'. Lancet Global Health, Vol 11, Issue 2, e265-e277.
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Abstract
Background
The STREAM stage 2 trial assessed two bedaquiline-containing regimens for rifampicin-resistant tuberculosis: a 9-month all-oral regimen and a 6-month regimen containing an injectable drug for the first 2 months. We did a within-trial economic evaluation of these regimens.
Methods
STREAM stage 2 was an international, phase 3, non-inferiority randomised trial in which participants with rifampicin-resistant tuberculosis were randomly assigned (1:2:2:2) to the 2011 WHO regimen (terminated early), a 9-month injectable-containing regimen (control regimen), a 9-month all-oral regimen with bedaquiline (oral regimen), or a 6-month regimen with bedaquiline and an injectable for the first 2 months (6-month regimen). We prospectively collected direct and indirect costs and health-related quality of life data from trial participants until week 76 of follow-up. Cost-effectiveness of the oral and 6-month regimens versus control was estimated in four countries (oral regimen) and two countries (6-month regimen), using health-related quality of life for cost-utility analysis and trial efficacy for cost-effectiveness analysis. This trial is registered with ISRCTN, ISRCTN18148631.
Findings
300 participants were included in the economic analyses (Ethiopia, 61; India, 142; Moldova, 51; Uganda, 46). In the cost-utility analysis, the oral regimen was not cost-effective in Ethiopia, India, Moldova, and Uganda from either a provider or societal perspective. In Moldova, the oral regimen was dominant from a societal perspective. In the cost-effectiveness analysis, the oral regimen was likely to be cost-effective from a provider perspective at willingness-to-pay thresholds per additional favourable outcome of more than US$4500 in Ethiopia, $1900 in India, $3950 in Moldova, and $7900 in Uganda, and from a societal perspective at thresholds of more than $15 900 in Ethiopia, $3150 in India, and $4350 in Uganda, while in Moldova the oral regimen was dominant. In Ethiopia and India, the 6-month regimen would cost tuberculosis programmes and participants less than the control regimen and was highly likely to be cost-effective in both cost-utility analysis and cost-effectiveness analysis. Reducing the bedaquiline price from $1·81 to $1·00 per tablet made the oral regimen cost-effective in the provider-perspective cost-utility analysis in India and Moldova and dominate over the control regimen in the provider-perspective cost-effectiveness analysis in India.
Interpretation
At current costs, the oral bedaquiline-containing regimen for rifampicin-resistant tuberculosis is unlikely to be cost-effective in many low-income and middle-income countries. The 6-month regimen represents a cost-effective alternative if injectable use for 2 months is acceptable.
| Item Type: | Article |
|---|---|
| Subjects: | QV Pharmacology > Anti-Inflammatory Agents. Anti-Infective Agents. Antineoplastic Agents > QV 268 Antitubercular agents. Antitubercular antibiotics QW Microbiology and Immunology > QW 45 Microbial drug resistance. General or not elsewhere classified. WF Respiratory System > Tuberculosis > WF 200 Tuberculosis (General) |
| Faculty: Department: | Biological Sciences > Vector Biology Department Clinical Sciences & International Health > Clinical Sciences Department Clinical Sciences & International Health > International Public Health Department |
| Digital Object Identifer (DOI): | https://doi.org/10.1016/S2214-109X(22)00498-3 |
| Depositing User: | Rachel Dominguez |
| Date Deposited: | 12 Jan 2023 14:21 |
| Last Modified: | 14 Jun 2023 11:14 |
| URI: | https://archive.lstmed.ac.uk/id/eprint/21532 |
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