WHO pre-qualifies MMC device
MEDIA RELEASE: The announcement last week that the World Health Organization (WHO) prequalified the PrePex device for non-surgical voluntary medical male circumcision (VMMC) offers another important option for expansion of VMMC programs in countries hard hit by the HIV epidemic. VMMC, as part of comprehensive HIV prevention programs, is starting to make an impact on the HIV epidemic in many communities and countries.
The impact of PrePex, and other non-surgical devices that could also be prequalified, will depend on several factors including the cost of the devices, the quality and scope of data available to guide decisions about product introduction, and sustained investment in product introduction including pilot projects and social marketing.
“PrePex and other devices could help expand VMMC programs to meet the HIV prevention needs of more men in Africa. But without strong programs, even the best products have little or no impact,” said Mitchell Warren, AVAC executive director. “Importantly, WHO’s prequalification paves the way for countries and international donors to procure the device and expand HIV prevention options. Evidence has shown that expanded VMMC programs can have a profound impact on rates of new HIV infections in men and women for years to come.”
“Now, national policy makers, civil society, traditional practitioners, and health providers need to understand the different roles for both surgical and non-surgical procedures and make decisions about whether it makes sense to use PrePex in local programs. If the decision is, ‘yes,’ the product needs to be strategically introduced in programs that have clear messages, committed financing and integration with surgery-based programs. We need action now to ensure these conditions are met,” Warren added.
“For PrePex to make a difference in VMMC scale-up, it has to be affordable,” Warren said. “AVAC and other advocates look forward to working with governments, donors and the manufacturer to help ensure that cost is not a barrier to the use of PrePex where it can make a difference.”
The cost of the device, at least at first, is reported to be around $20, which may be a barrier for widespread use. Bulk purchasing, the prequalification and introduction of additional devices, or a decision by the manufacturer could lead to a lower price. AVAC welcomes today’s statement from UNITAID, which finances the WHO prequalification program, stating that PrePex must be affordably priced.
Landmark clinical trials in three African countries showed that voluntary medical male circumcision (a term used to indicate the specific procedures used in the context of HIV prevention, versus traditional practices in initiation rites) reduced HIV-negative men’s risk of HIV infection by at least 60 percent and long-term follow-up has shown that VMMC is a highly effective and inexpensive intervention.
WHO based its prequalification of PrePex on a range of clinical data, including from trials of the device in Rwanda, Uganda and Zimbabwe, and evaluation of the manufacturing facilities and processes for the device. It stated that PrePex is safe and effective and can be used by both trained physicians and mid-level providers, such as nurses. In several countries, trained nurses already perform surgical VMMC. The specification that, with training, nurses, clinical officers and other mid-level providers can provide the PrePex device further expands the role of this cadre in providing VMMC and could allow for faster scale-up.
“International donors have indicated a willingness to fund pilot studies and introduction of PrePex for VMMC programs, but African governments, health care providers and local communities will need to decide how PrePex might best be used to expand VMMC programs. Governments must move swiftly to evaluate whether PrePex is a good additional option and develop policies and budgets to match. Most importantly, governments should continue allocating resources for this HIV prevention strategy overall,” said Angelo Kaggwa, program coordinator at AVAC and a co-coordinator of the Africans Telling the Truth about VMMC campaign.
“This initial prequalification of PrePex is only for men 18 and older. One of the key next steps for PrePex must be to gather data on safety and effectiveness among younger men and adolescents,” Kaggwa added. “Many men seeking surgical procedures are under 18, and we need to provide them with the range of options.”
“WHO prequalification of the PrePex device is most exciting and very welcome. Policy makers, health care providers, donors and civil society must now work together to find the best ways to add non-surgical devices to broader circumcision programs so that we can reach more men with VMMC – with a method that is relatively simple and convenient. I know, because I myself have been circumcised with the PrePex device. So when I add my voice to the PrePex conversations, it is from the perspective of the personal experience of a satisfied client,” said Dr. Mannasseh Phiri, a leading VMMC and HIV/AIDS activist in Zambian. “Circumcision, like HIV, is often difficult for us to discuss openly. And in many of our communities, medical circumcision of adult men is a relatively new concept that now exists alongside traditional circumcisions of young boys. We must continue to speak out about the great benefits of medical male circumcision for men and for women in our communities. We must encourage more and more men of all ages to come forward and get circumcised.”
Current modeling data project that, if 80 percent of adult men in 14 priority African countries (with high HIV incidence and low rates of VMMC) were to undergo the procedure by 2015, 20 percent of all new infections in men and women would be averted by 2025 in those countries. Non-surgical circumcision devices, like PrePex, provide more options to achieve these targets.
WHO prequalification is a process to ensure that medicines, diagnostics and medical devices meet international standards of quality, safety and efficacy. Prequalification helps donors and countries that do not have adequate regulatory capacity to review all products make informed decisions about purchasing medicines and devices. PrePex is the first male circumcision device prequalified by WHO. Other devices are also under development. Manufacturers apply for prequalification and must provide extensive information about the product’s quality, safety and efficacy, which is evaluated by staff from WHO and experts from national regulatory authorities worldwide. More information on devices and the prequalification process is available atwww.who.int/diagnostics_laboratory/evaluations/prequalification_status/en/index.html.