How can we evaluate the potential of innovative vaccine products and technologies in resource constrained settings? A total systems effectiveness (TSE) approach to decision-making
Siobhan Botwright,
Anna-Lea Kahn,
Raymond Hutubessy,
Patrick Lydon,
Joseph Biey,
Abdoul Karim Sidibe,
Ibrahima Diarra,
Mardiati Nadjib,
Auliya A. Suwantika,
Ery Setiawan,
Rachel Archer,
Debra Kristensen,
Marion Menozzi-Arnaud,
Ado Mpia Bwaka,
Jason M. Mwenda,
Birgitte K. Giersing
Affiliations
Siobhan Botwright
Department of Immunization, Vaccines & Biologicals, World Health Organization Headquarters, 20 Avenue Appia, 1211-CH 27 Geneva, Switzerland
Anna-Lea Kahn
Department of Immunization, Vaccines & Biologicals, World Health Organization Headquarters, 20 Avenue Appia, 1211-CH 27 Geneva, Switzerland
Raymond Hutubessy
Department of Immunization, Vaccines & Biologicals, World Health Organization Headquarters, 20 Avenue Appia, 1211-CH 27 Geneva, Switzerland
Patrick Lydon
Department of Immunization, Vaccines & Biologicals, World Health Organization Headquarters, 20 Avenue Appia, 1211-CH 27 Geneva, Switzerland
Joseph Biey
Inter-Country Support Team, Regional Office for Africa, World Health Organization, Ouagadougou, Burkina Faso
Abdoul Karim Sidibe
WHO Country Office for Mali (OMS/MALI), Quartier Ntomiboro-Bougou, B.P. 99, Bamako, Mali
Ibrahima Diarra
Direction Générale de la Santé et de l’Hygiène Publique, Cité Administrative Bamako, Bamako BP 232, Mali
Mardiati Nadjib
Department of Health Policy and Administration, Faculty of Public Health Universitas, Indonesia
Auliya A. Suwantika
Department of Pharmacology and Clinical Pharmacy, Universitas Padjadjaran, Indonesia Jl. Raya Bandung-Sumedang Km. 21 Jatinangor, Sumedang, West Java 45363, Indonesia; Center of Excellence in Higher Education for Pharmaceutical Care Innovation, Universitas Padjadjaran, Indonesia Jl. Raya Bandung-Sumedang Km. 21 Jatinangor, Sumedang, West Java 45363, Indonesia
Ery Setiawan
Department of Health Policy and Administration, Faculty of Public Health Universitas, Indonesia
Rachel Archer
Health Intervention and Technology Assessment Program (HITAP), Ministry of Public Health, 6th Floor, 6th Building, Department of Health, Ministry of Public Health, Tiwanon Road, Muang, Nonthaburi 11000, Thailand
Debra Kristensen
PATH, Rue de Varembé 7, 1202 Geneva, Switzerland
Marion Menozzi-Arnaud
Gavi, the Vaccine Alliance, Global Health Campus, Chemin du Pommier 40, 1218 Grand, Saconnex, Geneva, Switzerland
Ado Mpia Bwaka
Inter-Country Support Team, Regional Office for Africa, World Health Organization, Ouagadougou, Burkina Faso
Jason M. Mwenda
Regional Office for Africa, World Health Organization, Brazzaville, Congo
Birgitte K. Giersing
Department of Immunization, Vaccines & Biologicals, World Health Organization Headquarters, 20 Avenue Appia, 1211-CH 27 Geneva, Switzerland; Corresponding author.
Innovations in vaccine product attributes could play an important role in addressing coverage and equity (C&E) gaps, but there is currently a poor understanding of the full system impact and trade-offs associated with investing in such technologies, both from the perspective of national immunisation programmes (NIPs) and vaccine developers. Total Systems Effectiveness (TSE) was developed as an approach to evaluate vaccines with different product attributes from a systems perspective, in order to analyse and compare the value of innovative vaccine products in different settings.The TSE approach has been advanced over the years by various stakeholders including the Bill and Melinda Gates Foundation (BMGF), Gavi, PATH, UNICEF and WHO. WHO further developed the TSE approach to incorporate the country perspective into immunisation decision-making, in order for countries to evaluate innovative products for introduction and product switch decisions, and for vaccine development stakeholders to conduct their assessments of product value in line with country preferences. This paper describes the original TSE approach, development of the tool and processes for NIPs to apply the WHO TSE approach, and results from piloting in 12 countries across Africa, Asia and the Americas. The WHO TSE framework emerged from this piloting effort.The WHO TSE approach has been welcomed by NIP and vaccine development stakeholders as a useful tool to evaluate trade-offs between different products. It was emphasised that the concept of “total systems effectiveness” is likely to be context-specific and that TSE is valuable in facilitating a deliberative process to articulate NIP priorities, for decisions around product choice, and for prioritising the development of future vaccine innovations.
