June 30, 2015
In May, Circ MedTech, the makers of the PrePex device for adult voluntary medical male circumcision (VMMC), announced it would sell its non-surgical device at US$12 per unit to the 14 WHO-designated priority VMMC countries. The World Health Organization (WHO) prequalified PrePex in 2013, rendering it the first alternative to surgery available for purchase by PEPFAR and other public health providers.
For advocates following VMMC device rollout, this may sound familiar. The US$12 price has been mentioned, without written commitment, since ICASA 2013. So what does this change? Well, it means that organizations in priority countries won’t be faced with the US$20 price tag that’s been attached to the device in some pilot programs and for private purchase.
A second device, the ShangRing, was prequalified by WHO this month for VMMC in healthy males aged 13 years and older. (In contrast, PrePex is currently only officially prequalified for males 18 and older, although efforts are already underway by WHO and the company to recommend PrePex for adolescents and update the official instructions for use. Circ MedTech is also in advanced stages of adapting PrePex technology for use in infants and children.)
A VMMC “device” is an alternative to the conventional surgical methods. PrePex and ShangRing are both ring-based designs worn for a week with the aim of cutting off the blood supply through pressure, resulting in the death of the foreskin tissue. These devices eliminate the need for sutures and take less time than surgery, but the device must remain in place for a week and wound healing takes slightly longer than with surgery. Devices may be desirable for some men, could potentially simplify the VMMC experience for some and reduce the burden of labor for healthcare workers in resource-limited settings.
These device developments, however, come as VMMC programs generally are facing unexpected challenges in terms of global rollout. As AVAC covered in Prevention on the Line, the pace of VMMC is expected to drop this year in part because of scaled-back resources available from the PEPFAR program, which to-date has funded the bulk of VMMC procedures worldwide. Even with the official price reduction for PrePex and the prequalification of ShangRing, a device is only one component of any VMMC program. Whether devices will roll out depends on available funding for the overall expenses for comprehensive VMMC programs, surgical and non-surgical alike.
In terms of what a full-scale device-oriented VMMC program might look like, Rwanda continues to lead in scale-up. The country aims to circumcise 800,000 men with the PrePex device by 2016. Rwanda began routine implementation of the device in 2014 and a study presented at CROI 2015 showed 63 percent of men selected PrePex over conventional surgery. If not for stock outs of the device, study presenter and implementer Eugene Rugwizangoga (Jhpiego) posited that this number would have been higher. Overall uptake of VMMC has increased in Rwanda, aided by efficiencies such as task-shifting and mobile teams. According to Rugwizangoga, introduction of PrePex has accelerated this trend.
Zimbabwe recently included the PrePex device as part of its Accelerated VMMC Operational Plan 2014-2018 with a target of circumcising 1.3 million men by 2018. It is critical that overall funding for VMMC programming in the final PEPFAR Country Operating Plan for Zimbabwe, Global Fund and in national government investments supports the ambitious country plan.
Other countries prioritizing VMMC scale-up are in varying stages of PrePex implementation and monitoring for the type and frequency of complications that could occur outside a controlled study setting. In the VMMC device context, these two stages are referred to as active and passive surveillance. Active surveillance involves performing 1,000 non-experimental, routine device procedures and providing active follow-up for clients who fail to return for device removal. Men are monitored through home visits, in-depth interviews and genital exams. Passive surveillance is the monitoring and reporting of adverse events seen in the clinic as part of ongoing, routine service delivery.
The ShangRing device is made by Wuhu Snnda Medical Treatment Appliance Technology Company, which has marketed the device in China since 2006. More recently it was assessed in Kenya, Uganda and Zambia. Similar to its guidance on PrePex, WHO recommends that training resources for health providers are made available and that men (and adolescents) and caregivers receive accurate information on its use. WHO also endorses a one- to two-year safety data follow-up on ShangRing use in non-research settings.
It has been suggested that the ShangRing device will sell for around US$8 per unit in priority VMMC countries as part of comprehensive HIV prevention programming. With this new device entering into programs, it will be important to watch both the donors and the manufacturers to understand how procurement volumes and pricing evolve for both devices, as well as other devices in development.
It also remains unclear what role devices will play in VMMC programs in general. Though the pace of VMMC scale-up has doubled each year since 2011, exceeding targets and reaching over 9 million circumcisions, funding commitments have begun to decline. VMMC in sub-Saharan Africa is experiencing a contraction. PEPFAR, the primary underwriter of VMMC, has not set new targets and its funding has shrunk. Furthermore, reports suggest that countries are not seeking funds through Global Fund grants to fill the gap left by PEPFAR. And UNAIDS prevention targets, including for VMMC, have yet to see the light of day.
The big lift now is to ensure political will to support the continuation and even expansion of VMMC programming in its entirety. If not, we could soon see clinics shuttered and newly invested infrastructure come undone. New cases of HIV that might have otherwise been prevented will occur. This makes little financial or public health sense. Countries should be resourced to perform at current or even expanded capacity – with strategic investments in devices as well as overall VMMC programs.