Guest editor: Lotte Steuten | VP & Head of Consulting
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Whereas the COVID-19 pandemic took the world by surprise, there’s another one unfolding in plain sight: antimicrobial resistance (AMR). By using antibiotics too often and inappropriately, bacteria have evolved to become resistant to them, rendering antibiotic treatments ineffective.
The first comprehensive assessment of the global burden of AMR estimated that in
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2019, there were 4.95 million AMR-associated deaths, of which 1.27 million attributable to bacterial AMR. This makes AMR a leading cause of death globally. It comes at a hefty cost too. The World Bank’s most optimistic scenario has projected losses of world output to exceed $1 trillion annually after 2030 and reach $2 trillion annually by 2050.
In parallel, uptake of AMR diagnostics to support antibiotic stewardship is suboptimal, and global antibiotic development pipelines are weak. Because AMR stewardship will necessarily limit the use of a new antibiotic, traditional pricing arrangements where revenues depend on volumes sold are unlikely to be profitable. Moreover, value assessment methods recognising the broader value of antibiotics including their public health effects - such as preventing infection transmission and slowing down AMR development- are needed to help match the size of the required monetary incentives to the full value that antibiotics offer.
During its 60 years of existence, OHE has widely researched and published on the challenges associated with low economic returns from investment in antibiotics, proposing new policy options, HTA and payments mechanisms, and calls for multi-disciplinary actions. It is therefore very exciting to now see important progress on this front, with subscription-style payment models being explored in the US and the UK.
In the US, the PASTEUR Act, if passed, will allow the government to enter into contracts with manufacturers whose antibiotics will then be valued based on their public health importance and novelty, and rewarded agreed-upon amounts annually rather than by dose. In England, NHS and NICE are piloting a new HTA and payment model which intends to incentivise manufacturers to invest in antibiotic R&D by paying them upfront for their product, based on the value it provides to the NHS rather than on how much of it is used. This value is currently capped at £10 million per year over 10 years, which is said to reflect the ‘fair share’ of England’s contribution to a global pull incentive estimated at $4.2 billion over 10 years.
In addition to delinking revenue from the number of units sold, the model is novel in explicitly aiming to reward the broader public health value of antibiotics, sometimes referred to with the acronym “STEDI”: spectrum, transmission, enablement, diversity, and insurance value. To arrive at an appropriate value assessment, this is critical, as antibiotics, much like vaccines and AMR diagnostics, generate a relatively large part of their value from such positive externalities.
At the time of writing, NICE is expected to shortly publish its final guidance on the two selected antibiotics in their pilot. The extent to which these broader elements are considered in the value assessment is as yet not fully clear. After pioneering with a ground-breaking AMR pilot that attracts national and international attention, we hope that they will “STEDI-ly” lead the way towards broader value recognition.
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“Ignoring this “positive economic externality” is one market failure at the heart of mispricing innovative antimicrobial agents, and HTA needs methods to incorporate this additional value in their assessments"
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Despite the threat of antimicrobial resistance, antimicrobial agents valuable to society are unlikely to come to the market unless investors have a clear path to earn an adequate return on investment. HTA-agencies generally approach their assessment of
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antimicrobial agents from a perspective that does not recognize many elements of value provided by antimicrobial agents apart from immediate health gains. Health technology assessment agencies should broaden their methodological tool kit and philosophy to better support solutions addressing the long-term threat of antimicrobial resistance.
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Generic preference-based measures are often used for capturing patients’ health-related quality of life (QOL) to assess quality-adjusted life years (QALYs) in health technology assessment (HTA). Whilst this type of measure, which includes commonly used EQ-5D instruments, are useful for enabling comparability between assessments, they might not always capture all the dimensions of QOL that are important to patients.
Our interactive summary report provides three case studies exploring examples of health conditions where the EQ-5D has been shown to, or is likely to, perform sub-optimally in reflecting the dimensions of QOL that matter to patients with Multiple sclerosis, Alzheimer’s disease or Sickle cell disease.
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The NICE methods review consultation included a proposal to consider health inequalities (HI) more explicitly in their Health Technology Assessment (HTA) process. This proposal is part of a larger commitment to put an increased focus on tackling HI, as one of the key trends and developments in the NICE 2021 to 2026 strategy. NICE has just published the results of a public dialogue on health inequalities (‘NICE listens’), with the aim of identifying people’s views on health inequalities. The report is a good first step towards the identification of the most relevant dimensions that the concept of HI can encompass. But there is still a long way to go before NICE finds a way to tackle all the complexity of this concept. In our blog, we provide an overall view of the main challenges.
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The theme of World TB Day 2022 is “Invest to End TB. Save Lives.” Much progress has been made in reducing deaths from TB, but, as a 2020 paper from OHE and Center for Global Development (CGD) authors highlighted, the rate of decline is slow, and the 2035 Strategic Development Goal and Convergence targets may not be achieved until 2074, nearly 40 years later than anticipated. Therefor, CGD and OHE set out a blueprint for a novel financing mechanism to get a new universal regimen for TB, the “Market-Driven, Value-Based, Advance Commitment (MVAC)” that would create and guarantee a market for new TB drugs if and when innovators succeeded in developing and launching a breakthrough TB regimen. The MVAC would enable them to shape the innovation agenda, adding an HTA value-based purchase commitment to “push” based development funded in product development partnerships.
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The UK’s Spring Statement 2022 provided no extra funding for the health and social care sector. But given consumer price inflation is expected to reach 8% in 2022/23 this will have an impact on the health and care budget, alongside a cost-of-living crisis that has real implications for those working in the sector and those waiting for care. Analysis by the Health Foundation shows higher inflation means reduced spending power for health and social care budgets. The UK government would have to top up spending in cash terms by £2.4bn in 2024/25 in order to match the growth ambitions set out at the Spending Review.
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Health technology assessment (HTA) agencies are considering adopting a lifecycle approach to assessments to address uncertainties in the evidence base at launch and to revisit the clinical and economic value of therapies in a dynamic clinical landscape. For reassessments of therapies post launch, HTA agencies are looking to real-world evidence (RWE) to enhance the clinical and economic evidence base, though challenges and concerns in using RWE in decision-making exists. The Institute for Clinical and Economic Review (ICER) piloted a 24-month observational RWE reassessment. Key learnings from this pilot include identifying the benefits and challenges with using RWE in reassessments and considerations on prioritizing and selecting topics relevant for RWE updates.
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Prevention of violence against women and children should not be about economics, but for those who need it to be, a recent analysis reported trial-based cost-effectiveness estimates for interventions designed to prevent VAWG in Ghana, Kenya, Pakistan, Rwanda, South Africa, and Zambia. Considering all effects, interventions that improve participants’ livelihood skills, including their financial management skills, can be cost saving, while also reducing perpetration of violence from men, even if they do not reduce experience of violence among women and girls in the short term.
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26 MAY | There is a wealth of evidence showing societal support to prioritise interventions for severe illnesses. However, little practice has been observed in applying greater (and explicit) value to improving health of the sicker patients in value assessments.
This means that there are still treatments for life-threatening or
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long-lasting and debilitating conditions, which are not funded because they do not meet traditional value assessment paradigms.
Join us for the first OHE Masterclass of 2022 where thought leaders and international expert will discuss theory, practice and current policy debate around severity.
Book your ticket today for our Early Bird discount.
Book your ticket here.
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ON-DEMAND | We have launched a new suite of on-demand lectures, associated with our Masterclass Series, which are available on a mix-and-match basis for only £20 each.
To get you started on your learning journey, we are offering the first ‘What is Value?’ lecture for free.
View all available lectures here.
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