Value assessment of antimicrobials using the STEDI framework - How steady is the outcome?

Antimicrobial resistance (AMR) is one of the major threats to global population health, and the antimicrobial market requires substantial reimbursement reform and/or significant financial incentives to function properly. To address these challenges, England piloted a new health technology evaluation process in conjunction with a new payment model in 2019. The value assessment was performed using a dedicated broader value framework for antibiotics for the first time. This so-called STEDI framework is an acronym based on the five value elements it covers (Spectrum, Transmission, Enablement, Diversity, and Insurance value). Learnings from the pilot show that there are important considerations when implementing this value framework: The STEDI value profile of an antibiotic strongly depends on the local context and is impacted by trade-offs between individual value elements. Decision makers should therefore act carefully when applying STEDI to avoid distorting the overall evaluation result. Considering the STEDI value profile of an antibiotic is an important part of its value assessment as it allows for distinguishing between higher- and lower-value products. However, given the complexities surrounding its value assessment, further research must be undertaken to improve the overall STEDI evaluation process.

Recognizing the Broader Value of Meningococcal Vaccination: A Matter of Evidence, Ability, or Willingness?

OBJECTIVES: It is widely argued that the value of meningococcal vaccination extends beyond the narrow value elements traditionally considered in health technology assessment. Nevertheless, measuring broader value presents challenges, whereas assessment methods and outcomes vary widely. This article investigates the extent to which the broader value of meningococcal vaccination is recognized, considering the available evidence and decision maker's methodological ability and willingness. METHODS: A targeted literature review informed the classification of broader value elements according to their relevance to meningococcal vaccination and the quality of existing evidence. Focusing on relevant value elements with good evidentiary standards, decision makers' perspectives and methodological ability to consider them were assessed through case studies of health technology assessment of meningococcal B vaccination in England and The Netherlands. RESULTS: Value elements of high relevance to meningococcal vaccination with good quality evidence include caregivers' health gains, patients' lifetime productivity gains, and disease severity. The willingness and methodological ability to incorporate them into value assessments have been mixed. This is attributable to the scope of the value assessment perspective and the use of evaluation methods that do not fully capture broader value. For other broader value elements, evidence gaps are another potential barrier to value demonstration and recognition. CONCLUSIONS: The current evidence base confirms that the value of meningococcal vaccination spans beyond healthcare sector effects to health-related externalities, allocative value, and societal economic benefits. To ensure that the most efficient resource allocation outcomes are achieved, countries should consider how to improve their perspective and methodological ability to assess broader value elements accurately.

Vaccine-Preventable Hospitalisations from Seasonal Respiratory Diseases: What Is Their True Value?

Hospitals in England experience extremely high levels of bed occupancy in the winter. In these circumstances, vaccine-preventable hospitalisations due to seasonal respiratory infections have a high cost because of the missed opportunity to treat other patients on the waiting list. This paper estimates the number of hospitalisations that current vaccines against influenza, pneumococcal disease (PD), COVID-19, and a hypothetical Respiratory Syncytial Virus (RSV) vaccine, could prevent in the winter among older adults in England. Their costs were quantified using a conventional reference costing method and a novel opportunity costing approach considering the net monetary benefit (NMB) obtained from alternative uses of the hospital beds freed-up by vaccines. The influenza, PD and RSV vaccines could collectively prevent 72,813 bed days and save over £45 million in hospitalisation costs. The COVID-19 vaccine could prevent over 2 million bed days and save £1.3 billion. However, the value of hospital beds freed up by vaccination is likely to be 1.1-2 times larger (£48-93 million for flu, PD and RSV; £1.4-2.8 billion for COVID-19) when quantified in opportunity cost terms. Considering opportunity costs is key to ensuring maximum value is obtained from preventative budgets, as reference costing may significantly underestimate the true value of vaccines.

The Value of Vaccines in Maintaining Health System Capacity in England.

OBJECTIVES: In situations of excess demand for healthcare, treating one patient means losing the opportunity to treat another. Therefore, each decision bears an opportunity cost. Nevertheless, when assessing the value of health technologies, these opportunity costs are not always fully considered. We present a pragmatic approach for conceptualizing vaccines' health system capacity value when considering opportunity costs. METHODS: Our approach proxies opportunity costs through the net monetary benefit forgone as scarce healthcare resources are used to treat a vaccine-preventable disease instead of a patient from the waiting list. We apply this approach to cost the resource "hospital beds" for 3 different scenarios of excess demand. Empirically, we estimate the opportunity costs saved for 4 selected vaccination programs from the national schedule in England during a hypothetical scenario of long-lasting excess demand induced by the pandemic. RESULTS: The opportunity cost avoided through vaccination rises with excess demand for treatment. When treating an acute vaccine-preventable outcome is a suboptimal choice compared with treating elective patients, preventing a vaccine-preventable disease from blocking a hospital bed generates opportunity cost savings of approximately twice the direct costs saved by avoiding vaccine-preventable hospitalizations. CONCLUSIONS: Policy makers should be aware that, in addition to preventing the outcome of interest, vaccines and other preventative health technologies deliver value in maintaining regular healthcare services and clearing the pent-up demand from the pandemic. Therefore, health system capacity value should be a key-value element in health technology assessment. Existing and potential future vaccination programs deliver more value than hitherto quantified.

Estimates of the Global Burden of COVID-19 and the Value of Broad and Equitable Access to COVID-19 Vaccines.

The objectives of this research were to produce a macro-level overview of the global COVID-19 burden and estimate the value of access to COVID-19 vaccines. A targeted literature review collated evidence of the burden. Linear modelling and data analysis estimated the health and economic effects of COVID-19 vaccines delivered in 2021, and whether additional value could have been achieved with broader and more equitable access. By 1 December 2020, there had been an estimated 17 million excess deaths due to COVID-19. Low-income countries allocated more than 30% of their healthcare budgets to COVID-19, compared to 8% in high-income countries. All country income groups experienced gross domestic product (GDP) growth lower than predicted in 2020. If all 92 countries eligible for COVAX Advance Market Committee (AMC), access had reached 40% vaccination coverage in 2021, 120% more excess deaths would have been averted, equivalent to USD 5 billion (109) in savings to healthcare systems. Every USD spent by advanced economies on vaccinations for less advanced economies averted USD 28 of economic losses in advanced economies and USD 29 in less advanced economies. The cost to high-income countries when not all countries are vaccinated far outweighs the cost of manufacturing and distributing vaccines globally.

Realising the broader value of vaccines in the UK.

Many health technology assessment (HTA) agencies limit their assessments of vaccines to the health benefits for the vaccinated individual, the costs associated with vaccine administration and the disease avoided. However, because the value of vaccines tends to accrue to a large extent beyond the vaccinated individual, they are systematically undervalued in many current HTA processes. This is also the case in the UK, where the Joint Committee on Vaccination and Immunisation (JCVI) is in charge of assessing preventative vaccines, while therapeutic vaccines fall in the realm of the National Institute for Clinical Excellence (NICE). To contribute to a forward-looking perspective, we designed a framework to capture the broader value of vaccination. We reviewed the current state of the global vaccines pipeline and selected seven preventative and three therapeutic vaccines that are likely to enter the UK market within five years. We assessed on which value elements the selected vaccines would potentially generate value, and compared those against the novel broader value framework. A review of the current value elements considered by the JCVI and NICE allowed identifying the critical gaps between potential value generation and value recognition. To our knowledge, this is the first time that the broader value of vaccination has been pro-actively assessed for pipeline vaccinations. Our findings show that the existing narrow evaluation frameworks are likely to systematically undervalue the value of potential future vaccines coming to the UK market. This is particularly relevant, where their impact on AMR and other health interventions, and on the productivity of the workforce is of concern. Recommendations to overcome this include an explicit and more consistent inclusion of, and data collection on, the impact of vaccines on AMR and other health interventions by JCVI and NICE; the consideration of a societal perspective and the fiscal impact of vaccines to societies.