GIM 2007 -
POSTED ON: 01 Apr 2007
RESEARCHERS: Waleed Elgindy, Lindsey Hein, Matt Knapstein, and Koji Torihara
The number of people living with HIV/AIDS in the world today has risen to 33.2 million, with some 2.5 million people newly infected in 2007. The disease is one of the leading causes of death worldwide, particularly in developing countries. But Brazil is one developing country that has committed to fighting back. Through comprehensive and effective public policy, the Brazilian government has made significant strides in combating the epidemic and has earned a place at the forefront of HIV/AIDS prevention and treatment. Here, in coordination with the Global Health Initiatives program, Brazil’s health and business environment is examined for lessons on enhancing viral load technology and leveraging that success in other developing nations.
Because many people were expecting an AIDS epidemic in the early 1990s, the Brazilian government took dramatic steps to make treatment free. Specifically, the Brazilian Ministry of Health determined that effective HIV/AIDS treatment was not a privilege for the wealthy, but rather a necessity for the entire Brazilian population. Brazil invested the necessary resources to make treatment available at a relatively low cost, and the country’s successful system became a model for other developing nations such as Costa Rica, El Salvador, and Panama.
In 1996 the Brazilian government boldly affirmed that the cure would be less expensive than the disease and began offering universal antiretroviral treatment to all patients. Antiretroviral (ARV) drugs can potentially dramatically improve the health and extend the lives of those afflicted with HIV/AIDS, but their high costs and demanding clinical requirements keep them out of reach for most people, particularly in developing countries, where infection levels are often high and resources scarce. Although the government spent around $400 million on ARV drugs in 2005—approximately $2,500 per patient—it projected savings of at least $2 billion in total health care costs between 1996 and 2005 due to early treatment, reduced hospital admissions, and reduced treatment of opportunistic infections. Based on these results, Brazil will continue to invest in viral load technologies and is planning on expanding the number of testing sites.
Brazil had an estimated 620,000 HIV/AIDS cases in 2006, representing an adult prevalence of 0.5 percent of the population. This figure is relatively low, even compared to prevalence rates among developed nations—for example, North America had a prevalence of 0.6 percent. Of Brazilian cases, approximately 180,000 patients were on ARVs, representing an increase of 20,000 patients from 2005. Because the Brazilian government pays for ARVs, impoverished patients among these 180,000 patients represent almost half of the total number of worldwide poor with free access to these drugs. Also, due to the government’s commitment to AIDS treatment and diagnosis, Brazil’s health care professionals and clinicians are among the most well-trained and adept in diagnosing and treating HIV/AIDS. More than 60 percent of Brazil’s population cannot afford health care, and the government pays for all aspects of their HIV/AIDS treatment. For those who can afford insurance, the government still bears the full cost of the ARVs.
Brazil also offers a wide range of public infrastructure contexts in which patients can access HIV/AIDS care, from local clinics to state-based outpatient services in large hospitals. More than 1,200 public alternative care and HIV testing services have been established to support Brazil’s HIV/AIDS program. The infrastructure of these services fits local or regional capacities and needs; even in favelas (shanty towns) the quality of care is often relatively strong.
Brazil’s Ministry of Health (MOH) establishes the guidelines and norms for HIV/AIDS services and also provides ARVs and the equipment needed for viral load and CD4/CD8 testing. Seventy-two labs perform viral load testing, the diagnostic process of counting the number of HIV virus cells in a patient, which is often performed with CD4/CD8 testing to measure the level of immune system t-cells. These tests are critical tools for patient monitoring and management as HIV/AIDS progresses. The MOH determines what specific equipment will be used in the public facilities, as well as the guidelines and infrastructure for when and how tests should be performed. But much of the day-to-day management and organization of health services has been decentralized from the federal to the local level. Program funds are increasingly managed by states and municipalities. As a result, variability in the accountability, strategy, and practices of local facility managers has often led to considerable disparity in the quality of treatment from location to location.
Although the MOH is ultimately the “buyer,” there are others who play a crucial role in the identification, selection, administration, usage, and review of existing viral load testing throughout Brazil. In addition to the MOH, stakeholders in this process include HIV/AIDS patients, HIV/AIDS physicians, hospital viral load lab technicians, hospital administrators, and non-governmental organizations. Thus it is important to garner and incorporate feedback from all quarters as equipment is developed and marketed, especially because no one has a better understanding of the limitations of the equipment or a stronger interest in their improvement than those who work with the machines and their output on a daily basis. To gain insights from such stakeholders and others, on-site interviews were conducted with key medical experts, hospital administrators, lab technicians, and clinical lab researchers, and marketing surveys were designed for further research. Although the hospital administrators and non-governmental organizations do not use the equipment daily, they wield a great deal of influence and work to optimize funding for HIV treatment and prevention activities.
There is great evidence for collaboration between government health officials and the network of civil society non-governmental organizations (NGOs) in Brazil. NGOs in Brazil have been extremely influential, and much of Brazil’s success with AIDS has been a result of the government’s willingness to work closely with these organizations to improve treatment options. In this context, the study finds that the viral load test market is fairly competitive, with several global healthcare companies participating in the provision of test equipment and supplies across Brazil. In the last round of assigning government tenders for viral load testing equipment for all of Brazil’s 72 public facilities, the MOH selected Bayer’s device (Bayer System 340 bDNA Analyzer) largely because of how the device was priced. Negotiation of contracts and pricing between the MOH and global suppliers of diagnostic devices and supplies is critical to the affordability of the national HIV/AIDS program. Currently, the government’s contract is on a purely variable cost-basis ($10 per test with no associated fixed cost). Through keen management of the program, Brazil has seen a 67 percent decrease in the average cost of care per ARV patient per year. In 2007 alone the MOH saw the per-test cost for viral load testing decrease from $29 to $10 upon switching to the Bayer product. Further reducing this cost will be a key consideration in the selection of future viral load test products for the nationwide system.
But costs are not the only consideration in the selection of viral load test products. Sensitivity to the widest possible range of HIV strains is essential. Viral load testing results help doctors determine the right time to initiate or adjust treatment and measure success in reducing or maintaining HIV levels in patients. Without highly sensitive equipment that can keep up with HIV’s continuous mutations, the tests are useless.
In addition, current product offerings generally require cumbersome and labor-intensive infrastructure for collecting, transporting, storing, and interpreting blood samples. These factors become particularly challenging in rural areas where medical infrastructure is less developed. Firsthand observations revealed that in some of the poorer parts Brazil, testing equipment and computers were outdated and needed replacement. In some cases, newer equipment was being kept in storage for fear that it would be stolen. These factors contribute to poorer overall levels of HIV/AIDS treatment in lower-income regions of the country.
It is also suggested that technical specifications of successful testing devices focus on the following factors: right-sized batch sizes for clinic/facility volume demands, reduced amounts of capital to maintain a quality control infrastructure (e.g., transportation, air conditioning, refrigerators/freezers, dry ice, and computers), and reduced amounts of blood serum/plasma drawn from patients. In terms of functional specifications, the design of equipment should account for the potential of theft (a tremendous concern in developing countries) and the need for paper output. Since viral load testing is almost always performed with CD4/CD8 testing, manufacturers should consider developing devices that bundle these essential monitoring tools.
Ultimately, an enhanced understanding of Brazil’s approach to HIV/AIDS is useful in identifying opportunities for improvement of viral load technology and its increased adoption elsewhere. Though Brazil is clearly taking a highly thoughtful approach in the fight against AIDS, tactically there is more to be done to determine what elements could ultimately be transferred effectively to other countries.