The use of cost-effectiveness analysis for health benefit package design - should countries follow a sectoral, incremental or hybrid approach?

BACKGROUND: Countries around the world are increasingly rethinking the design of their health benefit package to achieve universal health coverage. Countries can periodically revise their packages on the basis of sectoral cost-effectiveness analyses, i.e. by evaluating a broad set of services against a 'doing nothing' scenario using a budget constraint. Alternatively, they can use incremental cost-effectiveness analyses, i.e. to evaluate specific services against current practice using a threshold. In addition, countries may employ hybrid approaches which combines elements of sectoral and incremental cost-effectiveness analysis - a country may e.g. not evaluate the comprehensive set of all services but rather relatively small sets of services targeting a certain condition. However, there is little practical guidance for countries as to which kind of approach they should follow. METHODS: The present study was based on expert consultation. We refined the typology of approaches of cost-effectiveness analysis for benefit package design, identified factors that should be considered in the choice of approach, and developed recommendations. We reached consensus among experts over the course of several review rounds. RESULTS: Sectoral cost-effectiveness analysis is especially suited in contexts with large allocative inefficiencies in current service provision and can, in theory, realize large efficiency gains. However, it may be challenging to implement a comprehensive redesign of the package in practice. Incremental cost-effectiveness analysis is especially relevant in contexts where specific new services may impact the sustainability of the health system. It may potentially support efficiency improvement, but its focus has typically been on new services while existing inefficiencies remain unchallenged. The use of hybrid approach may be a way forward to address the strengths and weaknesses of sectoral and incremental analysis areas. Such analysis may be especially useful to target disease areas with suspected high inefficiencies in service provision, and would then make good use of the available research capacity and be politically rewarding. However, disease-specific analyses bear the risk of not addressing resource allocation inefficiencies across disease areas. CONCLUSIONS: Countries should carefully select their approach of cost-effectiveness analyses for benefit package design, based on their decision-making context.

We need to talk about values: a proposed framework for the articulation of normative reasoning in health technology assessment.

It is acknowledged that health technology assessment (HTA) is an inherently value-based activity that makes use of normative reasoning alongside empirical evidence. But the language used to conceptualise and articulate HTA's normative aspects is demonstrably unnuanced, imprecise, and inconsistently employed, undermining transparency and preventing proper scrutiny of the rationales on which decisions are based. This paper - developed through a cross-disciplinary collaboration of 24 researchers with expertise in healthcare priority-setting - seeks to address this problem by offering a clear definition of key terms and distinguishing between the types of normative commitment invoked during HTA, thus providing a novel conceptual framework for the articulation of reasoning. Through application to a hypothetical case, it is illustrated how this framework can operate as a practical tool through which HTA practitioners and policymakers can enhance the transparency and coherence of their decision-making, while enabling others to hold them more easily to account. The framework is offered as a starting point for further discussion amongst those with a desire to enhance the legitimacy and fairness of HTA by facilitating practical public reasoning, in which decisions are made on behalf of the public, in public view, through a chain of reasoning that withstands ethical scrutiny.

The Evolving Nature of Health Technology Assessment: A Critical Appraisal of NICE's New Methods Manual.

OBJECTIVES: The National Institute for Health and Care Excellence (NICE) recently completed a review of its methods for health technology assessment, involving a 2-stage public consultation. We appraise proposed methodological changes and analyze key decisions. METHODS: We categorize all changes proposed in the first consultation as "critical," "moderate" or "limited" updates, considering the importance of the topic and the degree of change or the level of reinforcement. Proposals were followed through the review process, for their inclusion, exclusion, or amendment in the second consultation and the new manual. RESULTS: The end-of-life value modifier was replaced with a new "disease severity" modifier and other potential modifiers were rejected. The usefulness of a comprehensive evidence base was emphasized, clarifying when nonrandomized studies can be used, with further guidance on "real-world" evidence developed separately. A greater degree of uncertainty was accepted in circumstances when evidence generation raised challenges, in particular for children, rare diseases, and innovative technologies. For some topics, such as health inequality, discounting, unrelated healthcare costs, and value of information, significant changes were possibly warranted, but NICE decided not to make any revisions at present. CONCLUSION: Most of the changes to NICE's health technology assessment methods are appropriate and modest in impact. Nevertheless, some decisions were not well justified and further research is needed on several topics, including investigation of societal preferences. Ultimately, NICE's role of protecting National Health Services resources for valuable interventions that can contribute toward improving overall population health must be safeguarded, without accepting weaker evidence.

Supply-Side Cost-Effectiveness Thresholds: Questions for Evidence-Based Policy.

There is growing interest in cost-effectiveness thresholds as a tool to inform resource allocation decisions in health care. Studies from several countries have sought to estimate health system opportunity costs, which supply-side cost-effectiveness thresholds are intended to represent. In this paper, we consider the role of empirical estimates of supply-side thresholds in policy-making. Recent studies estimate the cost per unit of health based on average displacement or outcome elasticity. We distinguish the types of point estimates reported in empirical work, including marginal productivity, average displacement, and outcome elasticity. Using this classification, we summarise the limitations of current approaches to threshold estimation in terms of theory, methods, and data. We highlight the questions that arise from alternative interpretations of thresholds and provide recommendations to policymakers seeking to use a supply-side threshold where the evidence base is emerging or incomplete. We recommend that: (1) policymakers must clearly define the scope of the application of a threshold, and the theoretical basis for empirical estimates should be consistent with that scope; (2) a process for the assessment of new evidence and for determining changes in the threshold to be applied in policy-making should be created; (3) decision-making processes should retain flexibility in the application of a threshold; and (4) policymakers should provide support for decision-makers relating to the use of thresholds and the implementation of decisions stemming from their application.

What is the value of explicit priority setting for health interventions? A simulation study.

Many countries seek to secure efficiency in health spending through establishing explicit priority setting institutions (PSIs). Since such institutions divert resources from frontline services which benefit patients directly, it is legitimate and reasonable to ask whether they are worth the money. We address this question by comparing, through simulation, the health benefits and costs from implementing two alternative funding approaches - one scenario in which an active PSI enables cost-effectiveness-threshold based funding decisions, and a counterfactual scenario where there is no PSI. We present indicative results for one dataset from the United Kingdom (published in 2015) and one from Malawi (published in 2018), which show that the threshold rule reliably resulted in decreased health system costs, improved health benefits, or both. Our model is implemented in Microsoft Excel and designed to be user-friendly, and both the model and a user guide are made publicly available, in order to enable others to parameterise the model based on the local setting. Although inevitably stylised, we believe that our modelling and results offer a valid perspective on the added value of explicit PSIs.

Developing and piloting a context-specified ethics framework for health technology assessment: the South African Values and Ethics for Universal Health Coverage approach.

OBJECTIVES: While ethics has been identified as a core component of health technology assessment (HTA), there are few examples of practical, systematic inclusion of ethics analysis in HTA. Some attribute the scarcity of ethics analysis in HTA to debates about appropriate methodology and the need for ethics frameworks that are relevant to local social values. The "South African Values and Ethics for Universal Health Coverage" (SAVE-UHC) project models an approach that countries can use to develop HTA ethics frameworks that are specific to their national contexts. METHODS: The SAVE-UHC approach consisted of two phases. In Phase I, the research team convened and facilitated a national multistakeholder working group to develop a provisional ethics framework through a collaborative, engagement-driven process. In Phase II, the research team refined the model framework by piloting it through three simulated HTA appraisal committee meetings. Each simulated committee reviewed two case studies of sample health interventions: opioid substitution therapy and either a novel contraceptive implant or seasonal influenza immunization for children under five. RESULTS: The methodology was fit-for-purpose, resulting in a context-specified ethics framework and producing relevant findings to inform application of the framework for the given HTA context. CONCLUSIONS: The SAVE-UHC approach provides a model for developing, piloting, and refining an ethics framework for health priority-setting that is responsive to national social values. This approach also helps identify key facilitators and challenges for integrating ethics analysis into HTA processes.

The Use of Cost-Effectiveness Thresholds for Evaluating Health Interventions in Low- and Middle-Income Countries From 2015 to 2020: A Review.

OBJECTIVES: Evidence-informed priority setting, in particular cost-effectiveness analysis (CEA), can help target resources better to achieve universal health coverage. Central to the application of CEA is the use of a cost-effectiveness threshold. We add to the literature by looking at what thresholds have been used in published CEA and the proportion of interventions found to be cost-effective, by type of threshold. METHODS: We identified CEA studies in low- and middle-income countries from the Global Health Cost-Effectiveness Analysis Registry that were published between January 1, 2015, and January 6, 2020. We extracted data on the country of focus, type of interventions under consideration, funder, threshold used, and recommendations. RESULTS: A total of 230 studies with a total 713 interventions were included in this review; 1 to 3× gross domestic product (GDP) per capita was the most common type of threshold used in judging cost-effectiveness (84.3%). Approximately a third of studies (34.2%) using 1 to 3× GDP per capita applied a threshold at 3× GDP per capita. We have found that no study used locally developed thresholds. We found that 79.3% of interventions received a recommendation as "cost-effective" and that 85.9% of studies had at least 1 intervention that was considered cost-effective. The use of 1 to 3× GDP per capita led to a higher proportion of study interventions being judged as cost-effective compared with other types of thresholds. CONCLUSIONS: Despite the wide concerns about the use of 1 to 3× GDP per capita, this threshold is still widely used in the literature. Using this threshold leads to more interventions being recommended as "cost-effective." This study further explore alternatives to the 1 to 3× GDP as a decision rule.

Developing a How-to-Guide for Health Technology Reassessment: "The HTR Playbook".

BACKGROUND: To develop a knowledge translation (KT) tool that will provide guidance to stakeholders actively planning or considering implementation of a health technology reassessment (HTR) initiative. METHODS: The KT tool is an international and collaborative endeavour between HTR researchers in Canada, Australia, and the United Kingdom. Evidence from a meta-review of documented international HTR experiences and approaches provided the conceptual framing for the KT tool. The purpose, audience, format, and overall scope and content of the tool were established through iterative discussions and consensus. An initial version of the KT tool was beta-tested with an international community of relevant stakeholders (i.e., potential users) at the Health Technology Assessment International 2018 annual meeting. RESULTS: An open access workbook, referred to as the HTR playbook, was developed. As a KT tool, the HTR playbook is intended to simplify the complex HTR planning process by navigating users step-by-step through 6 strategic domains: characteristics of the candidate health technology (The Stats and Projections), stakeholders to engage (The Team), potential facilitators and/or barriers within the policy context (The Playing Field), strategic use of different levers and tools (The Offensive Plays), unintended consequences (The Defensive Plays), and metrics and methods for monitoring and evaluation (Winning the Game). CONCLUSION: The HTR playbook is intended to enhance a user's ability to successfully complete a HTR by helping them systematically consider the different elements and approaches to achieve the right care for the patient population in question.

Antimicrobial Resistance: Is Health Technology Assessment Part of the Solution or Part of the Problem?

Antimicrobial resistance is a serious challenge to the success and sustainability of our healthcare systems. There has been increasing policy attention given to antimicrobial resistance in the last few years, and increased amounts of funding have been channeled into funding for research and development of antimicrobial agents. Nevertheless, manufacturers doubt whether there will be a market for new antimicrobial technologies sufficient to enable them to recoup their investment. Health technology assessment (HTA) has a critical role in creating confidence that if valuable technologies can be developed they will be reimbursed at a level that captures their true value. We identify 3 deficiencies of current HTA processes for appraising antimicrobial agents: a methods-centric approach rather than problem-centric approach for dealing with new challenges, a lack of tools for thinking about changing patterns of infection, and the absence of an approach to epidemiological risks. We argue that, to play their role more effectively, HTA agencies need to broaden their methodological tool kit, design and communicate their analysis to a wider set of users, and incorporate long-term policy goals, such as containing resistance, as part of their evaluation criteria alongside immediate health gains.

An Introduction to the Main Types of Economic Evaluations Used for Informing Priority Setting and Resource Allocation in Healthcare: Key Features, Uses, and Limitations.

Economic evidence is increasingly being used for informing health policies. However, the underlining principles of health economic analyses are not always fully understood by non-health economists, and inappropriate types of analyses, as well as inconsistent methodologies, may be being used for informing health policy decisions. In addition, there is a lack of open access information and methodological guidance targeted to public health professionals, particularly those based in low- and middle-income country (LMIC) settings. The objective of this review is to provide a comprehensive and accessible introduction to economic evaluations for public health professionals with a focus on LMIC settings. We cover the main principles underlining the most common types of full economic evaluations used in healthcare decision making in the context of priority setting (namely cost-effectiveness/cost-utility analyses, cost-benefit analyses), and outline their key features, strengths and weaknesses. It is envisioned that this will help those conducting such analyses, as well as stakeholders that need to interpret their output, gain a greater understanding of these methods and help them select/distinguish between the different approaches. In particular, we highlight the need for greater awareness of the methods used to place a monetary value on the health benefits of interventions, and the potential for such estimates to be misinterpreted. Specifically, the economic benefits reported are typically an approximation, summarising the health benefits experienced by a population monetarily in terms of individual preferences or potential productivity gains, rather than actual realisable or fiscal monetary benefits to payers or society.

Avoiding health technology assessment: a global survey of reasons for not using health technology assessment in decision making.

INTRODUCTION: Despite the documented benefits of using health technology assessments (HTA) to inform resource allocation in health care systems, HTA remains underused, especially in low- and middle-income countries. A survey of global health practitioners was conducted to reveal the top reasons ("excuses") that they had heard from colleagues, policymakers or other stakeholders for not using HTA in their settings. METHODS: There were 193 respondents to the survey. Most responses were from individuals in research organisations (37%), ministries of health (27%) and other government agencies (14%). Participants came from Southeast Asia (40%), the Western Pacific (30%), Africa (15%), Europe (7%), the Americas (7%) and the Eastern Mediterranean region (2%). RESULTS: The top five reasons encountered by respondents related to lack of data, lack of technical skills for HTA, the technocratic nature of the work, the lack of explicit decision rules and the perception that HTA puts a "price on life". CONCLUSIONS: This study aimed to understand and address the top reasons for not using HTA. They fall into three categories: (1) misconceptions about HTA; (2) feasibility issues; and (3) values, attitudes and politics. Previous literature has shown that these reasons can be addressed when identified, and even imperfect HTA analyses can provide useful information to a decision-maker.

The journey to UHC: how well are vertical programmes integrated in the health benefits package? A scoping review.

BACKGROUND: Countries are recommended to progressively work towards universal health coverage (UHC), and to make explicit choices regarding the expansion of priority services. However, there is little guidance on how to manage the inclusion of vertical programmes, funded by external partners, in health benefits packages (HBP) in low and middle-income countries (LMICs). OBJECTIVE: We conducted a scoping review to map the inclusion of six vertical programmes (HIV, tuberculosis, malaria, maternal and child health, contraceptives, immunisation) in 26 LMICs. METHODS: We identified 26 LMICs with an HBP that was not aspirational (eg, with evidence of implementation or funding). For each HBP, we collected information on the corresponding UHC scheme, health financing at the time of establishment, revisions since inception and entitlements. For each vertical programme, we developed a list of tracer interventions based on the Disease Control Priorities 3 and the 100 Core Health Indicators List. We then used this list of tracer interventions to map the coverage of the six vertical programmes. RESULTS: The review shows that there is no common starting point for countries embarking into UHC. Some HBPs were almost three decades old. Whole package revisions are rare. The inclusion of vertical programme does not follow a given pattern based on health financing indicators or country's income group. Maternal child health services are the most often included and family planning the least. Six countries in our sample covered all vertical programmes, while one covered only one of six. CONCLUSIONS: This review has shown that there has been a long history of countries facing this question and we have provided the first mapping of inclusion of vertical programmes in UHC. The results of the mapping can inform decisions in countries embarking in UHC.

Health technology assessment in sub-Saharan Africa: a descriptive analysis and narrative synthesis.

BACKGROUND: Countries in Sub-Saharan Africa (SSA) are moving towards universal health coverage. The process of Health Technology Assessment (HTA) can support decisions relating to benefit package design and service coverage. HTA involves institutional cooperation with agreed methods and procedural standards. We systematically reviewed the literature on policies and capacity building to support HTA institutionalisation in SSA. METHODS: We systematically reviewed the literature by searching major databases (PubMed, Embase, etc.) until June 2019 using terms considering three aspects: HTA; health policy, decision making; and SSA. We quantitatively extracted and descriptively analysed content and conducted a narrative synthesis eliciting themes from the selected literature, which varied in study type and apporach. RESULTS: Half of the 49 papers identified were primary research studies and mostly qualitative. Five countries were represented in six of ten studies; South Africa, Ghana, Uganda, Cameroon, and Ethiopia. Half of first authors were from SSA. Most informants were policy makers. Five themes emerged: (1) use of HTA; (2) decision-making in HTA; (3) values and criteria for setting priority areas in HTA; (4) involving stakeholders in HTA; and (5) specific examples of progress in HTA in SSA. The first one was the main theme where there was little use of evidence and research in making policy. The awareness of HTA and economic evaluation was low, with inadequate expertise and a lack of local data and tools. CONCLUSIONS: Despite growing interest in HTA in SSA countries, awareness remains low and HTA-related activities are uncoordinated and often disconnected from policy. Further training and skills development are needed, firmly linked to a strategy focusing on strengthening within-country partnerships, particularly among researchers and policy makers. The international community has an important role here by supporting policy- relevant technical assistance, highlighting that sustainable financing demands evidence-based processes for effective resource allocation, and catalysing knowledge-sharing opportunities among countries facing similar challenges.

Assessing the performance of health technology assessment (HTA) agencies: developing a multi-country, multi-stakeholder, and multi-dimensional framework to explore mechanisms of impact.

BACKGROUND: Health technology assessment (HTA) agencies have an important role to play in managing the rising demands on health systems. However, creating and running such agencies potentially diverts resources from frontline services. A large number of studies address the question of 'what is the impact of HTA?'. Several points of heterogeneity in this literature include: purpose of the study, definition of HTA, definition of impact, and scope and rigour of evaluations. Our study seeks to address several limitations in this literature. This study aims to explore the mechanisms of impact of an HTA agency. In doing so, we consider HTA as an institution rather than a knowledge product to build an impact evaluation framework from an international, multi-stakeholder and multi-dimensional perspective. METHODS: We conducted 9 key informant interviews with experts from the international HTA community. We addressed several questions, informed by existing frameworks of impact within the literature, to understand their perspectives on the mechanisms of impact of an HTA agency. We analyse data using logic modelling and impact mapping, as tools to understand and visualise mechanisms of change. FINDINGS: Our impact mapping highlights several distinct, but not necessarily mutually exclusive, mechanisms through which the overall impact of an HTA agency is achieved. These are: the effective conduct of HTA studies; effective use of HTA in agenda-setting and policy formulation processes; effective engagement and external communications; good institutional reputation and fit within the healthcare and policy-making system; effective use of HTA as a tool for the negotiation of health technology prices; and the effective implementation of policy change regarding health technologies. We also identify indicators of these effects. CONCLUSIONS: Our findings and resulting evaluation framework complement and add to existing literature by offering a new perspective on the mechanisms by which HTA agencies generate impact. This new perspective considers HTA as an institution rather than a knowledge product, is international, multi-dimensional, and includes multi-stakeholder views. We hope the analysis will be useful to countries interested in managing HTA performance.

Ending AIDS as a public health threat by 2030: Time to reset targets for 2025.

Paul De Lay and co-authors introduce a Collection on the design of targets for ending the AIDS epidemic.

Evaluations of public health interventions produced by health technology assessment agencies: A mapping review and analysis by type and evidence content.

OBJECTIVES: Health technology assessments (HTAs) have been suggested as a strategy to bridge the evidence-to-policy gap in public health. It is unclear to what extent HTAs have been prepared to assist decisions to implement public health interventions (PHIs). We aimed to describe the experience of HTA agencies by mapping, classifying, and analyzing the evidence content of HTAs of PHIs. METHODS: We systematically searched databases of 35 HTA agencies from 18 countries for evaluations of PHIs between 2008-2018. Interventions were classified using the International Classification of Health Interventions and the evidence content analysed with the INAHTA Product-Type-mark checklist. RESULTS: Only 1010 (9%) of HTAs were on PHIs. 500 (50%) publications targeted Body Systems and Functions, 302 (30%) Health-related Behaviours, 137 (14%) the Environment and 44 (4%) Activities and Participation Domains. Out of 734 publications perused, few met the criteria of full-HTAs (71;10%) or mini-HTAs (110;15%). Most were rapid reviews (420;57%). 72% of all reports came from only 6 countries. CONCLUSION: HTAs on PHIs were uncommon relative to clinical interventions. HTAs on population-based PHIs were less comprehensive in quality and rigor of the evidence. Countries with more resources and mature HTA-systems had done the most evaluations. Exploring the experiences of forerunners could help overcome barriers to evaluations of PHIs and exploit the full potential of HTAs to promote evidence-based public health.

Economic impact of avoidable cancer deaths caused by diagnostic delay during the COVID-19 pandemic: A national population-based modelling study in England, UK.

INTRODUCTION: Delays in cancer diagnosis arose from the commencement of non-pharmaceutical interventions (NPI) introduced in the UK in March 2020 in response to the COVID-19 pandemic. Our earlier work predicted this will lead to approximately 3620 avoidable deaths for four major tumour types (breast, bowel, lung, and oesophageal cancer) in the next 5 years. Here, using national population-based modelling, we estimate the health and economic losses resulting from these avoidable cancer deaths. We also compare these with the impact of an equivalent number of COVID-19 deaths to understand the welfare consequences of the different health conditions. METHODS: We estimate health losses using quality-adjusted life years (QALYs) and lost economic productivity using the human capital (HC) approach. The analysis uses linked English National Health Service (NHS) cancer registration and hospital administrative datasets for patients aged 15-84 years, diagnosed with breast, colorectal, and oesophageal cancer between 1st Jan to 31st Dec 2010, with follow-up data until 31st Dec 2014, and diagnosed with lung cancer between 1st Jan to 31st Dec 31 2012, with follow-up data until 31st Dec 2015. Productivity losses are based on the estimation of excess additional deaths due to cancer at 1, 3 and 5 years for the four cancer types, which were derived from a previous analysis using this dataset. A total of 500 random samples drawn from the total number of COVID-19 deaths reported by the Office for National Statistics, stratified by gender, were used to estimate productivity losses for an equivalent number of deaths (n = 3620) due to SARS-CoV-2 infection. RESULTS: We collected data for 32,583 patients with breast cancer, 24,975 with colorectal cancer, 6744 with oesophageal cancer, and 29,305 with lung cancer. We estimate that across the four site-specific cancers combined in England alone, additional excess cancer deaths would amount to a loss of 32,700 QALYs (95% CI 31,300-34,100) and productivity losses of £103.8million GBP (73.2-132.2) in the next five years. For breast cancer, we estimate a loss of 4100 QALYS (3900-4400) and productivity losses of £23.2 m (18.2-28.6); for colorectal cancer, 15,000 QALYS (14,100-16,000) lost and productivity losses of £35.7 m (22.4-48.7); for lung cancer 10,900 QALYS (9,900-11,700) lost and productivity losses of £38.3 m (14.0-59.9) for lung cancer; and for oesophageal cancer, 2700 QALYS (2300-3,100) lost and productivity losses of £6.6 m (-6 to -17.6). In comparison, the equivalent number of COVID-19 deaths caused approximately 21,450 QALYs lost, as well as productivity losses amounting to £76.4 m (73.5-79.2). CONCLUSION: Premature cancer deaths resulting from diagnostic delays during the first wave of the COVID-19 pandemic in the UK will result in significant economic losses. On a per-capita basis, this impact is, in fact, greater than that of deaths directly attributable to COVID-19. These results emphasise the importance of robust evaluation of the trade-offs of the wider health, welfare and economic effects of NPI to support both resource allocation and the prioritisation of time-critical health services directly impacted in a pandemic, such as cancer care.

How Should the World Pay for a Coronavirus Disease (COVID-19) Vaccine?

The potential health and economic value of a vaccine for coronavirus disease (COVID-19) is self-evident given nearly 2 million deaths, "collateral" loss of life as other conditions go untreated, and massive economic damage. Results from the first licensed products are very encouraging; however, there are important reasons why we will likely need second and third generation vaccines. Dedicated incentives and funding focused explicitly on nurturing and advancing competing second and third generation vaccines are essential. This article proposes a collaborative, market-based financing mechanism for the world to incentivize and pay for the development of, and provide equitable access to, second and third generation COVID-19 vaccines. Specifically, we propose consideration of a Benefit-Based Advance Market Commitment (BBAMC). The BBAMC uses health technology assessment to determine value-based prices to guarantee overall market revenues, not revenue for any specific product or company. The poorest countries would not pay a value-based price but a discounted "tail-price." Innovators must agree to supply them at this tail price or to facilitate technology transfer to local licensees at low or zero cost to enable them to supply at this price. We expect these purchases to be paid for in full or large part by global donors. The BBAMC therefore sets prices in relation to value, protects intellectual property rights, encourages competition, and ensures all populations get access to vaccines, subject to agreed priority allocation rules.