Country planning for health interventions under development: lessons from the malaria vaccine decision-making framework and implications for other new interventions

Abstract

Traditionally it has taken years or decades for new public health interventions targeting diseases found in developing countries to be accessible to those most in need. One reason for the delay has been insufficient anticipation of the eventual processes and evidence required for decision making by countries. This paper describes research into the anticipated processes and data needed to inform decision making on malaria vaccines, the most advanced of which is still in phase 3 trials. From 2006 to 2008, a series of country consultations in Africa led to the development of a guide to assist countries in preparing their malaria vaccine decision-making frameworks. The guide builds upon the World Health Organization’s Vaccine Introduction Guidelines. It identifies the processes and data for decisions, when they would be needed relative to the development timelines of the intervention, and where they will come from. Policy development will be supported by data (e.g. malaria disease burden; roles of other malaria interventions; malaria vaccine impact; economic and financial issues; malaria vaccine efficacy, quality and safety) as will implementation decisions (e.g. programmatic issues and socio-cultural environment). This generic guide can now be applied to any future malaria vaccine. The paper discusses the opportunities and challenges to early planning for country decision-making—from the potential for timely, evidence-informed decisions to the risks of over-promising around an intervention still under development. Careful and well-structured planning by countries is an important way to ensure that new interventions do not remain unused for years or decades after they become available.

Conceptual frameworks and key dimensions to support coverage decisions for vaccines

“…Eighty-six publications were excluded because they: lacked a decisional framework for community vaccine adoption (n = 53) or an appropriate study design (e.g., narrative reviews) (n = 13); provided a narrow focus on a single dimension (e.g., economic analysis of vaccines) (n = 10); focused on nonhuman vaccinations (n = 1), or addressed a framework already described in an included review(n = 9)(see additional file 1). We identified three additional systematic reviews [13,15,16] as well as nine primary studies [17][18][19][20][21][22][23][24][25] that were not included in the systematic reviews. We selected an additional two reviews through hand searches [26,27], leading to a total of 14 included publications.…”

“…Of these, seven targeted different geographic and cultural contexts: two publications focused on a middle-income country (South Africa) [18,21], one on low to middle-income countries [24], two on the national immunisation policy of developed and high-income countries (United States, South Korea) [17,25], while two was applied to malaria-endemic countries [19,22]. The remaining two studies focused on accelerating the adoption of new vaccines in Global Alliance for Vaccines and Immunization (GAVI) eligible countries [23] as well as a proposal for embracing the GRADE approach in the development of immunisation related WHO recommendations [20].…”

“…Eight of the frameworks analysed in Table 1 [16][17][18][19][20][21][22][23][25][26][27] reported that they considered guidance and recommendations from WHO guidelines [5].…”

“…-International guidelines and advice of the South African National Advisory Group on Immunisation (NAGI) and other local and international experts. -Political process: besides the technical aspects, the budget process also involves communication between the Ministers of Health and Finance and approval by a wider committee of Ministers, the national Cabinet and Parliament.Brooks and Ba Nguz, 2012[19] Milstien et al, 2010[22] …”

Policy analysis for deciding on a malaria vaccine RTS,S in Tanzania

“…When a decision is made to adopt and implement a new health intervention in low and middle income countries (LMICs), it often takes years or decades before the benefits of the new interventions are realized [ 1 – 5 ]. Thus, as new interventions become available, there is a need to improve understanding of the policy making process, as it applies to technology adoption and implementation [ 5 – 13 ]. The evidence-based information is needed in order to plan appropriately, set priority and choose from amongst the available alternatives [ 14 , 15 ].…”