Assessing Social Justice in Economic Evaluation to Scale up Novel MDR-TB Regimens

Johns Hopkins University, Baltimore MD

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Abstract

? DESCRIPTION (provided by applicant): The goal of the proposed 4-year multi-disciplinary project is to develop an innovative methodology to enhance traditional economic evaluation, using novel regimens for Multi-Drug-Resistant Tuberculosis (MDR-TB) as a paradigm case. Over 400,000 people living with HIV die of TB every year, accounting for 25% of the world's HIV-related deaths, and the HIV epidemic may drive growing MDR-TB prevalence. MDR-TB is caused by bacterial strains that don't respond to standard 1st-line drugs. It typically requires a burdensome 24- month treatment regimen with 2nd-line drugs so toxic that completion of the originally intended regimen is the exception rather than the rule. Two new drugs are in Phase IIb and Phase III trials for the treatment of MDR- TB. The emergence of novel MDR-TB regimens may improve cure rates and/or shorten treatment duration, but may also increase treatment costs, thus presenting decision makers with choices of far-reaching consequence about whether, how, and where to scale up novel regimens to the population level. Economic evaluation to assess `value for money' is a critical component of this decision-making process. The most familiar form of economic evaluation is cost-effectiveness analysis (CEA). Traditional CEA compares the costs of interventions against measures of effectiveness such as disability-adjusted life years (DALYs) averted. While value for money no doubt matters, decision-making processes that focus narrowly on it will fail to track people's experience of treatment-induced social disadvantages like stigma, shame, or family strain. This social justice gap in traditional CEA is a longstanding general problem in the ethics of health policy, because it sometimes leads to policy choices that harm the most disadvantaged groups as an unintended consequence. Failure to fill the social justice gap may undercut disease control for MDR-TB, HIV, and MDR-TB/HIV co-infection, because these illnesses tend to afflict groups who already bear the heaviest burdens of social and health disadvantage. Our proposed methodology, justice-enhanced CEA, is designed to fill the social justice gap by enabling decision makers to assess impacts on social justice side-by-side with cost-effectiveness. We will develop this methodology by achieving 3 specific aims: (1) using in-depth interviews with MDR-TB patients, healthcare providers, and community members in 3 HIV-endemic, high MDR-TB-burden settings, we will describe patients' experiences of MDR-TB treatment, focusing on what is most relevant to social justice; (2) using our previously developed core framework of social justice, we will construct social justice assessments for major treatment outcomes under standard and novel MDR-TB regimens across a range of settings; and (3) using decision analysis modeling, we will produce and disseminate a prototype decision tool for justice- enhanced CEA. The tool will enable users to assess at the same time the changes in cost-effectiveness and social justice expected from introducing novel MDR-TB regimens. Our overarching goal is to support scale-up decisions that are more ethically responsible overall than they would be if they used traditional CEA alone.