Tackling the world’s health challenges requires the appropriate tools and information. Alongside essential R&D for innovative technologies to prevent, diagnose and treat diseases, ensuring their access and delivery to people and communities that need them is also a crucial part of the process.
Introducing new health technologies into health systems requires a series of decisions as well as systems to be put into place. Typically, these include evidence-based decision-making for implementing new policies and modified regulations, safety monitoring to detect and address any adverse reactions that may occur, and efficient procurement and supply chains. For ensuring sustainability, modelling of anticipated health impacts and cost effectiveness are also important. These obviously all take time and careful coordination.
To help increase the efficiency of related country-level planning, the ADP has published an initial pipeline product analysis of new health technologies for malaria, tuberculosis (TB) and selected neglected tropical diseases (NTDs). The report is the outcome of an extensive literature review and key informant interviews, which sought to identify the products most likely to enter the market by 2020. This effort complements work done by the World Health Organization (WHO), UNITAID and others, with a special focus on malaria, TB and selected NTDs.
The report identifies over 20 malaria vaccines in development and clinical testing. A number of new chemical entities for treatment of malaria under clinical trial, and the target product profiles of diagnostics required for the WHO malaria elimination strategy, are also described. Also listed are two new regimens for the treatment of TB currently under clinical trials– the first TB medicines to be introduced in the market in over 50 years. In the case of NTDs, the report identifies new treatment regimens with oral medicines for selected NTDs, which promise easier administration by health workers, shorter treatment times, and promote better drug adherence by patients. The report also explores the therapeutic vaccine pipeline for leishmaniasis. Specific features of the diagnostic tests in the pipeline will help address logistical barriers, by making it easier to perform diagnostics tests in all settings. For example, rapid diagnostic tests (RDTs) that do not rely on a cold chain and performed without sophisticated equipment will significantly improve the identification and treatment of malaria, TB and selected NTDs in resource-poor settings.
The analysis also highlighted a number of future challenges. For instance, the potential market for a specific product type can significantly influence the incentives for their development. Hence, even though there may be strong potential and need for preventative and immunotherapeutic vaccines, a sufficiently attractive market is needed for developers to embark on such projects. Similarly, medicines for which there is a small market and weak demand within health systems may face supply and procurement challenges. Affordability is also a barrier: The ‘Minicolumn’ test, currently the best confirmatory test for human African trypanosomiasis, remains unaffordable, and therefore unavailable in many settings. Finally, the analysis identifies a lack of research agendas as a constraint to development of the most essential and useful products in some disease and product areas. For leishmaniasis and Chagas disease, this gap in research priority-setting and target product profiles is particularly noted.
In its summary of the new products hopefully coming to market in the next five years, the pipeline analysis assists countries prepare for their in-country access and delivery and identify possible barriers in advance. Currently, for example, regulatory frameworks in many low- and middle-income countries (LMICs) do not allow for compassionate use programmes incorporating new medicines approved on the basis of Phase IIb trial data, as is the case for the two new MDR-TB drugs. With the introduction of any new drug, the means to fully monitor safety must also be anticipated. And decisions on the use of new health technologies in LMICs are strongly influenced by their affordability and cost-effectiveness.
The Pipeline analysis of new products for malaria, tuberculosis and neglected diseases is published as a ‘working paper’, acknowledging the need for continual updates to provide an accurate picture of the changing landscape. It is hoped that it can serve as a valuable and continuous resource for policy-makers and other stakeholders involved in health programme planning.
Barbara Milani is a Consultant for the Access and Delivery Partership.
Cecilia Oh is Programme Advisor at UNDP Bangkok Regional Hub.