Introduction

It is estimated that 25,000 children less than 15 years of age develop Drug-Resistant tuberculosis (DR-TB) every year and unfortunately, less than 10% of them are diagnosed and treated. This represents a huge gap to meeting the United Nations High Level Meeting target of treating 115,000 children with DR-TB by 2022. 

Children less than 5 years of age in particular face numerous challenges to effective diagnosis and treatment. These include a lack of data on DR-TB in the youngest children, difficulty in using and interpreting results from current diagnostic tools, and until recently, a lack of child-friendly medicines for treatment. However, there has been significant progress made in the past few years to address some of these barriers. The World Health Organization (WHO) is now reporting on DR-TB treatment in children, with 8000 children less than 15 years of age having been reported as being treated in 2019. Numerous child-friendly formulations have become available and have been introduced into programmes (more information below). 

The Stop TB Partnership Global Drug Facility

The Global Drug Facility (GDF) is the world’s largest procurer of quality-assured TB medicines and diagnostics to the public sector. The goal of the GDF is to facilitate worldwide, equitable access to TB medicines and diagnostics across both public and private sectors. This goal is achieved through management and coordination of market activities for the full portfolio of TB medicines and diagnostics, strategic procurement and innovative logistics solutions, technical assistance and capacity building for TB programmes in better pharmaceutical management practices, and accelerated uptake of new TB medicines, regimens, and diagnostics.

Since its creation in 2001, GDF has facilitated access to TB medicines and diagnostics in more than 140 countries, making quality-assured treatments available to over 32 million people with TB. In 2020 alone, GDF delivered more than USD300 million worth of TB medicines and diagnostics to 124 countries. GDF has led the introduction of advanced diagnostics and supplies, longer and shorter all-oral regimens for drug-resistant TB, and child-friendly medicines for both drug-sensitive and drug-resistant TB. Since 2012, GDF has secured price reductions of over 50 percent for most second-line TB medicines, primarily by reducing risk to suppliers and minimizing their transaction costs. In 2020, GDF saved National TB Programs approximately USD36 million: USD28 million in medicine price reductions from competitive tenders and supplier negotiations; USD1.5 million by readjusting inaccurate quantification/order numbers; and USD6.5 million by allowing flexibility to cancel and postpone previously paid orders. GDF’s approach to bundle procurement with technical assistance on quantification and supply planning allows GDF to monitor for risks of future stockouts via national early warning systems and take necessary action to avoid stockouts.

United Nations Office for Project Services

The United Nations Office for Project Services (UNOPS) is an operational arm of the United Nations, supporting the successful implementation of its partners' peacebuilding, humanitarian, and development projects around the world. UNOPS provides project management and other services to governments, donors, and UN organizations. UNOPS has been the hosting entity for the Stop TB Partnership Secretariat since 1 January 2015, providing a range of financial and administrative support services to various units of the organization.

Background

GDF launched its Paediatric DR-TB Initiative in 2019 to support the introduction and scale-up of child-friendly formulations and all-oral regimens to treat DR-TB in children (more information available here: http://www.stoptb.org/gdf/pedsDRTBinitiative.asp). This initiative has led to the introduction of quality-assured, child-friendly, dispersible formulations of levofloxacin, moxifloxacin, clofazimine, cycloserine, ethambutol, pyrazinamide, ethionamide, isoniazid and most recently, bedaquiline (http://stoptb.org/news/stories/2020/ns20_021.html) in more than 50 countries . The initiative is a partnership model, with GDF providing procurement and supply chain technical assistance and catalytic procurement funding for new child-friendly formulations, implementing partners and programmes supporting introduction at the country level and expert clinicians providing clinical support to healthcare providers and developing tools and materials to support appropriate use and monitoring of the new formulations. Funding support for this initiative is provided by two bilateral donors.

GDF would like to continue this partnership approach to support the upcoming changes to the treatment landscape of DR-TB in children. It is expected that child-friendly formulations of delamanid and linezolid will become quality-assured and eligible for procurement in 2021. The WHO recently released updated guidance on the use of all-oral, bedaquiline-based, shorter treatment regimens for the treatment of DR-TB in children 6 years of age and older. Additional changes to the WHO recommendations on treatment of TB in children are expected later in 2021. 

The objective of this CFP is to identify an organization or organizations with a proven track record working in paediatric TB, particularly DR-TB, which can provide – as needed - clinical expertise to country programmes to support the introduction and appropriate use of the new formulations and regimens for paediatric TB as the formulations become quality-assured and WHO-recommended.