Informing vaccine decision-making: A strategic multi-attribute ranking tool for vaccines—SMART Vaccines 2.0

Informing vaccine decision-making: A strategic multi-attribute ranking tool for vaccines—SMART Vaccines 2.0

Vaccine xxx (2016) xxx–xxx Contents lists available at ScienceDirect Vaccine journal homepage: www.elsevier.com/locate/vaccine Commentary Informin...

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Vaccine xxx (2016) xxx–xxx

Contents lists available at ScienceDirect

Vaccine journal homepage: www.elsevier.com/locate/vaccine

Commentary

Informing vaccine decision-making: A strategic multi-attribute ranking tool for vaccines—SMART Vaccines 2.0 Stacey Knobler a,⇑, Karin Bok b, Bruce Gellin b a b

Fogarty International Center, National Institutes of Health, USA National Vaccine Program Office, US Department of Health and Human Services, USA

a r t i c l e

i n f o

Article history: Available online xxxx Keywords: Vaccine Vaccine decision making Public health Global health

a b s t r a c t SMART Vaccines 2.0 software is being developed to support decision-making among multiple stakeholders in the process of prioritizing investments to optimize the outcomes of vaccine development and deployment. Vaccines and associated vaccination programs are one of the most successful and effective public health interventions to prevent communicable diseases and vaccine researchers are continually working towards expanding targets for communicable and non-communicable diseases through preventive and therapeutic modes. A growing body of evidence on emerging vaccine technologies, trends in disease burden, costs associated with vaccine development and deployment, and benefits derived from disease prevention through vaccination and a range of other factors can inform decision-making and investment in new and improved vaccines and targeted utilization of already existing vaccines. Recognizing that an array of inputs influences these decisions, the strategic multi-attribute ranking method for vaccines (SMART Vaccines 2.0) is in development as a web-based tool—modified from a U. S. Institute of Medicine Committee effort (IOM, 2015)—to highlight data needs and create transparency to facilitate dialogue and information-sharing among decision-makers and to optimize the investment of resources leading to improved health outcomes. Current development efforts of the SMART Vaccines 2.0 framework seek to generate a weighted recommendation on vaccine development or vaccination priorities based on population, disease, economic, and vaccine-specific data in combination with individual preference and weights of user-selected attributes incorporating valuations of health, economics, demographics, public concern, scientific and business, programmatic, and political considerations. Further development of the design and utility of the tool is being carried out by the National Vaccine Program Office of the Department of Health and Human Services and the Fogarty International Center of the National Institutes of Health. We aim to demonstrate the utility of SMART Vaccines 2.0 through the engagement of a community of relevant stakeholders and to identify a limited number of pilot projects to determine explicitly defined attribute preferences and the related data and model requirements that are responsive to user needs and able to improve the use of evidence for vaccine-related decision-making and consequential priorities of vaccination options. Ó 2016 Elsevier Ltd. All rights reserved.

1. Introduction In development to support prioritization and decision-making related to vaccine research, development, and deployment, the SMART Vaccines 2.0 software tool may be able to play an important role in achieving the Global Health 2035 goals of a grand convergence in health [1,2]. It is expected that refining the process for ⇑ Corresponding author at: Division of International Epidemiology and Population Studies of Fogarty International Center, National Institutes of Health, 16 Center Drive, Building 16, Room 202, Bethesda, MD 20892, USA. E-mail address: [email protected] (S. Knobler).

prioritization of investments will optimize the health outcomes associated with vaccine development and delivery and contribute to a narrowing of the current gaps in infectious, child, and maternal mortality rates among low-, middle-, and high-income countries. As described in more detail elsewhere in this supplement [3], The National Vaccine Plan calls for ‘‘developing and implementing a process for prioritizing and evaluating new vaccine targets of domestic and global public health importance” [4]. It was following this directive that The US Department of Health and Human Services’s National Vaccine Program Office (NVPO) charged the U. S. Institute of Medicine (IOM) with developing a framework of decision support for prioritization of investments in new vaccine

http://dx.doi.org/10.1016/j.vaccine.2016.10.086 0264-410X/Ó 2016 Elsevier Ltd. All rights reserved.

Please cite this article in press as: Knobler S et al. Informing vaccine decision-making: A strategic multi-attribute ranking tool for vaccines—SMART Vaccines 2.0. Vaccine (2016), http://dx.doi.org/10.1016/j.vaccine.2016.10.086

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S. Knobler et al. / Vaccine xxx (2016) xxx–xxx

candidates. The prototype SMART Vaccines software tool was created by IOM and delivered to NVPO for further development and testing. The SMART Vaccines tool has been designed to model the dynamic and complex nature of decision-making among multiple stakeholders within the vaccine decision-making space—comprising the different interests, roles, and priorities of individuals engaged in vaccine research, research funding, purchasing, immunization programs, and policy. The model is data- and evidencedriven and allows the incorporation of both quantitative data and qualitative attributes to be included in the generation of prioritized rankings to inform decision-making around the development and delivery of new vaccines in conjunction with existing immunization schedules [5]. To allow for the enhanced and sustained evaluation of vaccine candidates, the prototype SMART Vaccines tool currently utilizes a set of predetermined as well as user-defined attributes to make a weighted recommendation on vaccine development or vaccination priorities based on pre-populated or user-entered demographic, disease, vaccine-specific, and other data. These attributes incorporate evaluations of health, economics, public concern, scientific, programmatic, and political considerations. The SMART Vaccines tool generates a score for each selected vaccine or vaccination option. The score is based on individual preference and weights of selected attributes.

     

scientific feasibility operational (financial and implementation) feasibility regulatory feasibility vaccine safety risk of epidemic or pandemic potential lack of availability of alternative disease interventions

In addition, a method to more comprehensively represent the full valuation of vaccines within the SMART Vaccines tool model was suggested. As described by Bloom et al., the value of vaccines in contributing to improved cognitive development and educational achievement; reduced absence from the workplace and school; and reduced long-term disability is not often sufficiently represented in cost-effectiveness analyses. A more robust calculation of the return on investments in vaccines and incorporation of these data into this platform would better capture these additional benefits and expand the utility of the SMART Vaccines 2.0 tool [3,6,7]. As evidenced from these initial discussions, a key first step toward improving the tool will be the engagement of the prospective user-community to consider the application of the tool in their organization’s existing decision-making structures. This input is intended to identify the modifications and enhancements necessary for SMART Vaccines 2.0 to add value to existing processes. Important issues to be reviewed as part of each of the engagement strategy will include:

2. Engaging decisionmaking stakeholders As a prototype, the current tool requires improvement before it is expected to have wider utility within the broad vaccine decisionmaking community of academic and government researchers, the vaccine industry, health and finance ministries, national vaccine and immunization advisory groups, and non-government and donor organizations. These improvements must represent how the different actors within the decision-making system might utilize the tool and the specific outcomes they seek to achieve within the system. Working directly with vaccine decision stakeholders, the NVPO along with the Fogarty International Center (FIC) of the National Institutes of Health (NIH) are collaborating to develop SMART Vaccines 2.0, supporting the following main objectives: transformation of the prototype tool to a web-based platform; iterative adaptation of the tool that is responsive to dynamic and emerging information; expansion and updating of the modelsupporting data warehouse; dissemination and use of the tool through direct engagement and training of the public sector, academic, and private sector stakeholders and decision-makers associated with vaccine development, purchasing, and delivery; and, the establishment of a hosting environment for the tool that is sustainable and provides global access to the tool by embedding it in an infrastructure that utilizes existing resources for maintenance of standards and capabilities. The ‘‘Global Health 2035: Mission Grand Convergence, MultiCriteria Systems Analysis to enhance and align vaccine decisions” meeting provided an opportunity to review the current functionality of the prototype tool and to obtain feedback—most specifically on the current attributes in the tool—from thought leaders and decision makers influencing vaccine research and policy. Important issues emerging from these discussions focused on the need to define a core set of attributes within the tool to eliminate current redundancies and better represent common considerations across the different categories of decision-makers influencing the investment in and development and delivery of new and existing vaccines. Attributes identified during the meeting included:  disease severity  disease incidence

1. Review of the computational design of the current SMART model; how does it currently generate the SMART ‘‘score” and whether modifications are needed. 2. Identification of sector-specific questions the users would like to answer and outcomes members would like to see from the SMART Model (e.g., health ministries may want to consider the relative value of introducing a new vaccine into the existing immunization schedule or a vaccine researcher may want to compare the relative value of different candidate vaccines to develop an optimal target product profile). 3. Definition and prioritization of elements of the software interface to include preferences on acquisition, use, and how and in what format users would receive the results and other information from the tool. 4. Identification of a streamlined set of attributes that represent universal, core aspects of the different decision-making communities so that the outcomes from a refined tool can be uniformly appreciated and referenced among different decisionmaking sectors. 5. Consideration of additional methods by which the broader value of vaccines (in areas such as education, and economic and social development) could be measured in a new tool [6]. 6. Review of how the current SMART model responds to the initial outputs identified above in order to determine the gaps in the current model and how to prioritize revisions to the tool. 3. Data needs, data gaps Persistent gaps of data availability and variable data quality represent a substantial challenge for systematic and rational vaccine evaluation [8]. To address the dynamic nature of the data needed to support the benefits of the SMART Vaccines 2.0 tool, the methods by which data are acquired, maintained, and accepted by the user communities must continue to evolve. The sources and architecture for such a data repository will be considered by the stakeholder working groups along with efforts to identify an organization(s) to sustain continued enhancements to the tool’s data sources for long-term use in strategic planning and decisionmaking related to vaccines.

Please cite this article in press as: Knobler S et al. Informing vaccine decision-making: A strategic multi-attribute ranking tool for vaccines—SMART Vaccines 2.0. Vaccine (2016), http://dx.doi.org/10.1016/j.vaccine.2016.10.086

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Input from relevant stakeholders from multiple sectors and different governance and decision levels will enhance this effort by refining attribute preferences and identifying the related data and model enhancements necessary to generate improved and standardized evidence for vaccine-related decision-making and consequential priorities of vaccination options. 4. SMART Vaccines 2.0 and beyond An improved SMART Vaccines 2.0 tool is anticipated to facilitate transparency and consensus-building in decision making to generate the successful private-public partnerships required for optimal development and delivery of vaccines globally. For decisionmakers in high-income countries, it is envisioned that an enhanced SMART Vaccines tool can support the development of priority vaccine targets. Investments in vaccine research and development often represent contributions from multiple sectors within governments, industry, and other academic or non-governmental organizations. These same entities are influenced by different priorities that represent the interests of their individual constituencies and organizational objectives and mission. Despite their differing priorities, their decisionmaking is often comprised of similar factors that represent a frequently changing landscape of scientific innovation, disease emergence, financial profitability and affordability, production capabilities, and disease burden. In capturing and standardizing measures of these components of the decision-making process, the SMART Vaccines 2.0 tool will seek to better support the establishment of clear roadmaps for vaccine research and development that can be broadly supported—increasing the likelihood of their success. In low- and middle-income countries, where a growing number of national immunization technical advisory groups (NITAGs) are being established, the SMART Vaccines 2.0 tool can be used to produce not only scored priorities, but a clear demonstration of how these scoring results have been achieved: what data inputs were used; how the different inputs were prioritized or weighted; and, how the use and weighting of the data affect the results. This is essential in the efforts to increase the transparency of national decision-making processes (particularly in support of increased credibility of recommendations generated), and in the develop-

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ment of recommendations by NITAGs [9]. In addition, the opportunities for information-sharing through the documented use of the tool and its common ‘‘language” (about what and how specific evidence has informed decision-making) would help to increase knowledge-sharing among different sectors and clearly distinguish the important local context of decision-making among countries with highly variable budgets, disease epidemiology, and health priorities. The SMART Vaccines 2.0 tool can be used by different stakeholders with wide-ranging or even competing priorities around a single decision-making process where the differing inputs, priorities, and results can be compared in real-time and help to facilitate consensus-building around final decisions or recommendations. The SMART Vaccines tool may be uniquely valuable in helping these groups to more clearly and openly define their decisionmaking processes, the factors most important to their objectives and mandates, and the information or data sources they have used or require to make robust, evidence-informed decisions. Conflict of interest None. References [1] Jamison DT et al. Global health 2035: a world converging within a generation. Lancet 2013;382(9908):1898–955. [2] Mahmoud A. SMART Vaccines supplement; 2016. http://dx.doi.org/10.1016/ j.vaccine.2016.10.085. [3] Madhavan G, Gellin B. SMART Vaccines supplement; 2016. http://dx.doi.org/10. 1016/j.vaccine.2016.09.072. [4] U.S. National Vaccine Plan. 2010 05/12/2016]; Available from: . [5] Madhavan G, et al. (editors). In ranking vaccines: applications of a prioritization software tool: Phase III: use case studies and data framework. Washington (DC); 2015. [6] Bloom DE. SMART Vaccines supplement. Vaccine; 2016 [in press, this issue]. [7] Bloom DE, Madhavan G. Vaccines: from valuation to resource allocation. Vaccine 2015;33(Suppl. 2):B52–4. [8] Madhavan G et al. Bridging the gap: need for a data repository to support vaccine prioritization efforts. Vaccine 2015;33(Suppl. 2):B34–9. [9] Bryson M et al. A global look at national immunization technical advisory groups. Vaccine 2010;28(Suppl. 1):A13–7.

Please cite this article in press as: Knobler S et al. Informing vaccine decision-making: A strategic multi-attribute ranking tool for vaccines—SMART Vaccines 2.0. Vaccine (2016), http://dx.doi.org/10.1016/j.vaccine.2016.10.086