New paper on this topic
Diagnostic Market Stimulus pots to support a viable market for what is a classic ‘public good’
The use of diagnostics represents a classic example of a ‘public good’: the benefits are better antibiotic conservation and slower development of resistance and accrue to society at large over time, while the near-term costs are incurred by individual doctors or patients. It is simply more expensive and more time‑consuming for a doctor or a patient to use a diagnostic than simply to use a drug ‘just in case’ it is needed, even if a test could help save costs and reduce waste at a health system-wide level, and help preserve the usefulness of antibiotics for all, over the longer term. Many drug companies, meanwhile, including those producing affordable generic antibiotics, have no commercial interest in the advent of rapid diagnostics, which would act to limit the number of antibiotics prescribed. So it is not hard to see why diagnostic innovation has been so slow, with limited financial incentives to sell or buy these innovative products. Prize initiatives in the UK, the US and the EU have been important catalysts in raising attention for the need for rapid point-of-care diagnostics. But to sustain innovation in the medium and long term, and to encourage uptake of the resultant technology, further and more sustained intervention is needed. To overcome this mismatch between the costs and benefits of diagnostics, we propose a bold, globally-coordinated Diagnostic Market Stimulus pots (DMS), which would ensure a market based revenue stream for developers of products that match a recognised area of need. DMS would not pre-judge which diagnostics are best, rather they would follow the success of actual products bought by healthcare providers, by topping up the payments to developers to make sure the commercial benefits and the needs of society are better aligned. We envisage this support would come from the same global payer we proposed in our last paper on incentivising new antibiotics, but that the funding needed would be on a scale far less than what is necessary to stimulate the antibiotic market. As such, it could be incorporated within the same 16 – 37 billion USD market intervention that we recommended in May. We envisage that as well as incentivising future innovation, this would also encourage the uptake of relevant products that are already being developed or that are available today. Based on these initial proposals, we will continue to work on how to structure an effective DMS.
Funding from a Global Innovation Fund for AMR to jump-start early innovation in the field of rapid diagnostics
There needs to be greater funding available to product developers to support early-stage R&D activities. Many developers are small or medium-sized companies, which may face difficulties in securing private investment given an uncertain market backdrop. We believe the Global Innovation Fund for AMR, of 2 billion USD over 5 years – described in our February 2015 paper – has a key role to play in supporting the early-stage development of rapid diagnostics. This support should not be limited, though, to developers of what we classically think of as a diagnostic test to improve antibiotic use. Rather, it should also seek to support other complementary innovative technologies that may guide prescription or improve use – such as advanced computer learning or artificial intelligence-based systems for use by clinicians during diagnosis, guiding them towards optimal treatments.
Help build the long term economic case for rapid diagnostics as a public good in the fight against drug-resistant infections
For health systems to adopt a new technology, its clinical and cost-effectiveness must both be demonstrated using large, objective studies. The cost of doing this is usually borne by the company developing the technology. This can rise to tens of millions of USD, over and above the R&D costs, to build evidence from large randomised control trials. Given that rapid diagnostic tests for infectious diseases are a public good, with the benefits to society usually larger than the benefits to the individual patient or healthcare provider, there is a particular case for policy makers to support these trial processes. Health systems can play a crucial role in the evidence-building process, and in supporting the health economics studies that are together needed to demonstrate clinical and cost-effectiveness to regulators, purchasers and end users. If the world is serious about tackling the threat of drug-resistant infections, we need to fully embrace the step-change in technology that rapid point-of-care diagnostics represent. Only by doing this can we fundamentally and sustainably reduce our misuse and overuse of antibiotics. Incremental behaviour change alone will not have a big enough impact, and regulation can only go so far. Through targeted, measured interventions, on a global scale, we can ensure the use of rapid diagnostic tests that allow for a true “right patient, right antibiotic, right time” approach.
