Cost-effectiveness of early versus standard antiretroviral therapy in HIV-Infected adults in Haiti
Koenig SP, Bang H, Severe P, Jean Juste MA, Ambroise A, Edwards A, Hippolyte J, Fitzgerald DW, McGreevy J, Riviere C, Marcelin S, Secours R, Johnson WD, Pape JW, Schackman BR, PLoS Med. 2011 Sep;8(9):e1001095. Epub 2011 Sep 20
In a randomized clinical trial of early versus standard antiretroviral therapy (ART) in HIV-infected adults with a CD4 cell count between 200 and 350 cells/mm(3) in Haiti, early ART decreased mortality by 75%. Koenig and colleagues assessed the cost-effectiveness of early versus standard ART in this trial. Trial data included use of ART and other medications, laboratory tests, outpatient visits, radiographic studies, procedures, and hospital services. Medication, laboratory, radiograph, labour, and overhead costs were from the study clinic, and hospital and procedure costs were from local providers. The authors evaluated cost per year of life saved, including patient and caregiver costs, with a median of 21 months and maximum of 36 months of follow-up, and with costs and life expectancy discounted at 3% per annum. Between 2005 and 2008, 816 participants were enrolled and followed for a median of 21 months. Mean total costs per patient during the trial were US$1,381 for early ART and US$1,033 for standard ART. After excluding research-related laboratory tests without clinical benefit, costs were US$1,158 (early ART) and US$979 (standard ART). Early ART patients had higher mean costs for ART (US$398 versus US$81) but lower costs for non-ART medications, CD4 cell counts, clinically indicated tests, and radiographs (US$275 versus US$384). The cost-effectiveness ratio after a maximum of 3 years for early versus standard ART was US$3,975/YLS (95% CI US$2,129/YLS-US$9,979/year of life saved) including research-related tests, and US$2,050/YLS excluding research-related tests (95% CI US$722/year of life saved-US$5,537/year of life saved). Initiating ART in HIV-infected adults with a CD4 cell count between 200 and 350 cells/mm(3) in Haiti, consistent with World Health Organization advice, was cost-effective (US$/YLS <3 times gross domestic product per capita) after a maximum of 3 years, after excluding research-related laboratory tests.
For abstract access click here.
Editor’s note: The World Health Organization changed it treatment guidelines in 2010 in part because of the findings of the CIPRA HT-001 trial in Haiti. The trial’s data safety and monitoring board (DSMB) had recommended stopping the trial early due to the substantial difference in mortality seen in those starting antiretroviral therapy when their CD4 count dropped to 350/μl compared to those who started at a CD4 count of 200/μl or less, the old WHO-recommended level. This study is the first to estimate cost-effectiveness of the new approach using trial data as opposed to simulation models. To do this fairly, all research-related costs had to be removed. The time horizon was short, limited by the 3–year length of the trial, which means that it is not possible to know whether the early group would continue to have a survival benefit over the long term once the later group starts on treatment or whether there will be differences in the need for more costly second line therapy. WHO designates health interventions as cost-effective if the cost per disability-adjusted life year (DALY) is less that 3 times a country’s gross domestic product (GDP) - Haiti’s is 785 US$ - or under a threshold per life year saved – Haiti’s in 2009 was 2355 US$. This study shows that early initiation of antiretroviral therapy is cost-effective for Haiti. Decision-makers in other countries facing budget constraints should consider economic analyses as a helpful element in setting priorities. Access to treatment and support for retention in care should ensured first for the sickest patients but expansion of treatment eligibility to get more people on treatment earlier in their HIV disease course should be the next step.