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Challenges in evaluating the cost-effectiveness of new diagnostic tests for HIV-associated tuberculosis.

ABSTRACT: With an emerging array of rapid diagnostic tests for tuberculosis, cost-effectiveness analyses are needed to inform scale-up in various populations and settings. Human immunodeficiency virus (HIV)-associated tuberculosis poses unique challenges in estimating and interpreting the cost-effectiveness of novel diagnostic tools. First, gains in sensitivity and specificity do not directly correlate with impact on clinical outcomes. Second, the cost-effectiveness of implementing tuberculosis diagnostics in HIV-infected populations is heavily influenced by downstream costs of HIV care. As a result, tuberculosis diagnostics may appear less cost-effective in this population than among HIV-uninfected individuals, raising important ethical and policy questions about the design and interpretation of cost-effectiveness analyses in this setting. Third, conventional cost-effectiveness benchmarks may be inadequate for making decisions about whether to adopt new diagnostics. If we are to appropriately deploy novel diagnostics for tuberculosis to people living with HIV in resource-constrained settings, these challenges in measuring cost-effectiveness must be more widely recognized and addressed.

SUBMITTER: Andrews JR

PROVIDER: S-EPMC3765010 | biostudies-other | 2013 Oct

REPOSITORIES: biostudies-other

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Challenges in evaluating the cost-effectiveness of new diagnostic tests for HIV-associated tuberculosis.

Andrews Jason R JR Lawn Stephen D SD Dowdy David W DW Walensky Rochelle P RP

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20130620 7

With an emerging array of rapid diagnostic tests for tuberculosis, cost-effectiveness analyses are needed to inform scale-up in various populations and settings. Human immunodeficiency virus (HIV)-associated tuberculosis poses unique challenges in estimating and interpreting the cost-effectiveness of novel diagnostic tools. First, gains in sensitivity and specificity do not directly correlate with impact on clinical outcomes. Second, the cost-effectiveness of implementing tuberculosis diagnostic ...[more]

PMID: 23788239

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Project description:BackgroundThis paper forms part of an update of the World Health Organization Choosing Interventions that are Cost-Effective (WHO-CHOICE) programmes. It provides an assessment of global health system performance during the first decade of the 21st century (2000-2010) with respect to allocative efficiency in HIV, tuberculosis (TB) and malaria control, thereby shining a spotlight on programme development and scale up in these Millennium Development Goal (MDG) priority areas; and examining the cost-effectiveness of selected best-practice interventions and intervention packages commonly in use during that period.MethodsGeneralized cost-effectiveness analysis (GCEA) was used to determine the cost-effectiveness of the selected interventions. Impact modelling was performed using the OpenMalaria platform for malaria and using the Goals and TIME (TB Impact Model and Estimates) models in Spectrum for HIV and TB. All health system costs, regardless of payer, were included and reported in international dollars. Health outcomes are estimated and reported as the gain in healthy life years (HLYs) due to the specific intervention or combination. Analysis was restricted to eastern sub-Saharan Africa and Southeast Asia.ResultsAt the reference year of 2010, commonly used interventions for HIV, TB and malaria were cost-effective, with cost-effectiveness ratios less than I$ 100/HLY saved for virtually all interventions included. HIV, TB and malaria prevention and treatment interventions are highly cost-effective and can be implemented through a phased approach to full coverage to achieve maximum health benefits and contribute to the progressive elimination of these diseases.ConclusionDuring the first decade of the 21st century (2000-2010), the global community has done well overall for HIV, TB, and malaria programmes as regards both economic efficiency and programmatic selection criteria. The role of international assistance, financial and technical, arguably was critical to these successes. As the global community now tackles the challenge of universal health coverage, this analysis can reinforce commitment to Sustainable Development Goal targets but also the importance of continued focus on these critical programme areas.

Project description:BACKGROUND:Tuberculosis (TB) is the leading cause of death among HIV-positive patients. We assessed the cost-effectiveness of including lateral-flow urine lipoarabinomannan (LF-LAM) in TB diagnostic algorithms for severely ill or immunosuppressed HIV-positive patients with symptoms of TB in Kenya. METHODS:From a decision-analysis tree, ten diagnostic algorithms were elaborated and compared. All algorithms included clinical exam. The costs of each algorithm were calculated using a 'micro-costing' method. The efficacy was estimated through a prospective study that included severely ill or immunosuppressed (CD4<200cells/μL) HIV-positive adults with symptoms of TB. The cost-effectiveness analysis was performed using the disability-adjusted life year (DALY) averted as effectiveness outcome. A 4% discount rate was applied. RESULTS:The algorithm that added LF-LAM alone to the clinical exam lead to the least average cost per TB case detected (€47) and was the most cost-effective with a cost/DALY averted of €4.6. The algorithms including LF-LAM, microscopy and X-ray, and LF-LAM and Xpert in sputum, detected a high number of TB cases with a cost/DALY averted of €6.1 for each of them. In the comparisons of the algorithms two by two, using LF-LAM instead of microscopy (clinic&LAM vs clinic&microscopy) and using LF-LAM along with GeneXpert in sputum instead of GeneXpert in urine along with GeneXpert in sputum, (clinic&LAM&Xpert_sputum vs clinic&Xpert_sputum&Xpert_urine) led to the highest increase in the cost-effectiveness ratios (ICERs): €-7.2 and €-12.6 respectively. In these two comparisons, using LF-LAM increased the number of TB patients detected while reducing costs. Adding LF-LAM to smear microscopy alone or to smear microscopy and Xray led to the highest increase in the additional number of TB cases detected (31 and 25 respectively) with an incremental efficiency estimated at 134 and 344 DALYs respectively. The ICERs were €22.0 and €8.6 respectively. CONCLUSION:Including LF-LAM in TB diagnostic algorithms is cost-effective for severely ill or immunosuppressed HIV-positive patients.

Project description:BackgroundPrevious studies have showed that the early diagnosis of threatened preterm labor decreases neonatal morbidity and mortality, avoids maternal morbidity induced by antepartum bed rest and unnecessary treatment, and reduces costs. Although there are many diagnostic tests, none is clearly recommended by international guidelines. The aim of our study was to compare seven diagnostic methods in terms of effectiveness and cost using a decision analysis model in singleton pregnancy presenting threatened preterm labor, between 24 and 34 weeks of gestation.MethodsSeven diagnostic strategies based on individual or combined use of the following tests: cervical length, cervical fibronectin test, cervical interleukin test and protein in maternal serum, were compared using a decision analysis model. Effectiveness was expressed in terms of serious adverse neonatal events avoided (neonatal morbidity and mortality) at the hospital discharge. The economic analysis was performed from the health care system perspective. Deterministic and probabilistic analyses were performed to test the robustness of the model.ResultsAt 24-34 weeks of gestation, the association of cervical length and qualitative fibronectin was the most efficient strategy dominating all alternatives, reducing the perinatal death or severe neonatal morbidity rate up to 15% and the costs up to 31% according to the gestational age. This result was confirmed by the deterministic sensitivity analyses. The probabilistic analysis showed that the association of cervical length and qualitative fibronectin dominated cervical length?<?15 mm in more than 90% of the simulations. The comparison with the other tests revealed more uncertainty.ConclusionsA test using cervical length and qualitative fetal fibronectin appears to be the best diagnostic strategy. Decisions regarding its generalization and funding in France in this population of women should take into account the high, lifetime costs induced by prematurity.

Project description:BACKGROUND AND OBJECTIVES:Cutaneous leishmaniasis is responsible for chronic and disfiguring skin lesions resulting in morbidity and social stigma. The gold standard to diagnose cutaneous leishmaniasis is microscopy but has a variable sensitivity and requires trained personnel. Using four scenarios, the objective of this study is to compare the cost effectiveness of microscopy with two new tools: Loopamp™ Leishmania Detection Kit (LAMP) and CL Detect™ Rapid Test (RDT). METHODS:Data related to the cost and accuracy of these tools were collected at the clinic of the National Malaria and Leishmaniasis Control Program in Kabul, Afghanistan. The effectiveness estimates were measured based on the tools' performance but also indirectly, using the disability-adjusted life years. A decision tree was designed in TreeAge Healthcare Pro 2016, combined with a Markov model representing the natural history of cutaneous leishmaniasis. In addition to a deterministic analysis, univariate sensitivity and probabilistic analyses were performed to test the robustness of the results. RESULTS:If the tools are compared at the National Malaria and Leishmaniasis Control Program level in a period of low incidence, microscopy remains the preferred option. LAMP becomes more appropriate during cutaneous leishmaniasis seasons or outbreaks when its capacity to process several tests (e.g. up to 48) at a time can be maximised. RDT has a cost similar to microscopy when used at the reference clinic but as it is relatively easy to use, it could be implemented at the peripheral level, which would become cheaper than employing microscopy at the reference clinic. Moreover, combining RDT with microscopy or LAMP at the reference clinic for the negative suspects is economically more interesting than directly performing LAMP or microscopy respectively on all cutaneous leishmaniasis suspects at the reference clinic. CONCLUSIONS:When taking advantage of their respective strengths, LAMP and RDT can prove to be cost-effective alternatives to using microscopy alone at the reference clinic.

Project description:Indian guidelines recommend routine referral for HIV testing of all tuberculosis (TB) patients in the nine states with the highest HIV prevalence, and selective referral for testing elsewhere. We assessed the clinical impact and cost-effectiveness of alternative HIV testing referral strategies among TB patients in India.We utilized a computer model of HIV and TB disease to project outcomes for patients with active TB in India. We compared life expectancy, cost, and cost-effectiveness for three HIV testing referral strategies: 1) selective referral for HIV testing of those with increased HIV risk, 2) routine referral of patients in the nine highest HIV prevalence states with selective referral elsewhere (current standard), and 3) routine referral of all patients for HIV testing. TB-related data were from the World Health Organization. HIV prevalence among TB patients was 9.0% in the highest prevalence states, 2.9% in the other states, and 4.9% overall. The selective referral strategy, beginning from age 33.50 years, had a projected discounted life expectancy of 16.88 years and a mean lifetime HIV/TB treatment cost of US$100. The current standard increased mean life expectancy to 16.90 years with additional per-person cost of US$10; the incremental cost-effectiveness ratio was US$650/year of life saved (YLS) compared to selective referral. Routine referral of all patients for HIV testing increased life expectancy to 16.91 years, with an incremental cost-effectiveness ratio of US$730/YLS compared to the current standard. For HIV-infected patients cured of TB, receiving antiretroviral therapy increased survival from 4.71 to 13.87 years. Results were most sensitive to the HIV prevalence and the cost of second-line antiretroviral therapy.Referral of all patients with active TB in India for HIV testing will be both effective and cost-effective. While effective implementation of this strategy would require investment, routine, voluntary HIV testing of TB patients in India should be recommended.

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Challenges in evaluating the cost-effectiveness of new diagnostic tests for HIV-associated tuberculosis.

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Challenges in evaluating the cost-effectiveness of new diagnostic tests for HIV-associated tuberculosis.

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