In 2012, bedaquiline was conditionally approved by the U.S. Food and Drug Administration for the treatment of drug-resistant tuberculosis (TB), making it the first new TB drug to enter the market in more than 40 years. With the rise of multidrug-resistant and extensively drug-resistant TB leaving patients with fewer treatment options, the approval of bedaquiline gave new hope to health professionals and TB sufferers around the world.
However, uptake of bedaquiline has been slow for many reasons. Chief among these is the high cost of bedaquiline and accompanying medicines. A full treatment course of bedaquiline is estimated to be $900 in low-income countries—well beyond the reach of much of the population in these countries.
In March 2015, USAID partnered with Johnson & Johnson affiliate Janssen to increase access to bedaquiline for people in low-income countries. By establishing a global bedaquiline donation program, the organizations are aiming to provide treatment to 30,000 MDR- and XDR-TB patients over four years.
Releasing new medicines, however, requires a strong health system to ensure proper medicine use, monitor adverse medicine reactions, and optimize patient safety. To establish local capacity in the management of bedaquiline, the USAID-funded Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program is providing technical assistance to countries involved in the donation program.
Swaziland: Steps Toward Stronger Systems
Swaziland is one of the countries benefiting from the bedaquiline donation program. With a high TB/HIV co-infection rate, increasing numbers of confirmed XDR-TB patients, and some patients experiencing severe adverse reactions to existing TB medicines, Swaziland demonstrated a clear need for bedaquiline. SIAPS Program worked extensively with Swaziland to ensure the country’s health and pharmaceutical systems were prepared to accept the first shipment of donated bedaquiline, which arrived in December 2015.
As a first step, USAID and SIAPS worked with the Swaziland National Tuberculosis Control Programme (NTP) to identify areas within the health system that needed capacity building or support. The identified areas for technical assistance were broadly classified under pharmacovigilance, clinical capacity building, and monitoring and evaluation, which aligned with WHO recommendations for bedaquiline use.
The NTP then established a technical working group, which developed and approved a national implementation plan for bedaquiline. This made it possible for the NTP to define a centralized distribution pathway, develop a pharmacovigilance process for new TB medicines, and establish other interventions that would effectively address gaps within the pharmaceutical system.
Noting that pharmacy and clinical staff in Swaziland had limited experience working with bedaquiline, SIAPS led a clinical training workshop on bedaquiline use in September 2015. The workshop was attended by more than 70 health care workers, implementing partners, and Ministry of Health and NTP staff. These staff members are now able to provide ongoing trainings on bedaquiline use at their respective facilities, aided by clinical guidelines for bedaquiline use, job aids on adverse event management, and standard operating procedures developed by SIAPS Program and the NTP.
SIAPS staff learned some important lessons during the process of preparing Swaziland’s health system for bedaquiline implementation:
- Stakeholder coordination is incredibly important: With multiple stakeholders (NGOs, Ministry of Health, NTP, donors, etc.) involved in providing health care to TB patients, SIAPS staff had to contend with many different approaches and funding sources to improve TB care and services in country. As such, the implementation of new TB medicines was a challenge for Swaziland, as stakeholders were working to obtain and use bedaquiline in different ways. This resulted in parallel systems and a duplication of efforts, despite having similar objectives and a shared pool of patients. SIAPS staff found that this could be prevented by working with the NTP to coordinate activities and responsibilities of in-country stakeholders to keep everyone on track to reaching common goals.
- Build upon existing systems rather than establishing new ones: Before adopting bedaquiline, Swaziland had an established active surveillance system for antiretroviral and anti-TB medicines. SIAPS Program worked with the National Pharmacovigilance Unit to modify the system to address the additional reporting needs for bedaquiline including a process for reporting the occurrence of serious adverse events (SAEs) within 24 hours amongst others. Additionally, the NTP selected the most experienced TB treatment sites to serve as focal points and referral centers for bedaquiline treatment. The NTP increased laboratory capacity and prioritized the training of health care workers from those sites, sending them to the initial clinical training workshop with the aim of enabling them to act as trainers for workers in surrounding facilities.
SIAPS Program’s experience in Swaziland brought to light many key factors to bear in mind while implementing bedaquiline and other new TB medicines in low-resource settings. It is important to manage the process carefully, working with key stakeholders to review the country’s health system for gaps and leverage existing strengths. By employing an approach that works to strengthen health and pharmaceutical systems as a whole, SIAPS is laying the foundation for a future free from TB.
Authors: Kelly Sawyer, Technical Associate-TB, SIAPS Program; Dumebi Mordi, Senior Technical Advisor, SIAPS Program