17 Jun 2021
He is responsible for overseeing the NHS E&I’s national work to reduce antimicrobial resistance. Jeff will be speaking at BSAC’s Infection Clinical Dilemmas webinar – Diagnostic driven strategies for antimicrobial resistance in the UK on 20 July 2021, 4.30-6pm BST, hosted in collaboration with the Longitude Prize.
1. We know that new treatments and diagnostics for AMR continue to be a priority for the UK’s NHS. Where are you seeing the most clinical need/demand today?
In a nutshell, the need continues to be in the development of point-of-care tests (POCT) and rapid diagnostics which can support the timely identification of appropriate treatment. Gram-negative infections, especially urinary-tract infections (UTIs), are a current priority focus area. In these cases, the lack of timely, accurate diagnostics can typically lead to the prescription of antibiotics in advance of a confirmed diagnosis or without confirmation of which bacteria is causing the infection. As the development of Integrated Care Systems comes into place, with integrated care pathways being the norm, there is an opportunity to embed appropriate approaches to UTI management across local pathways. Diagnostics are essential to this being a success.
2. Where are you seeing the most innovation taking place?
This is an area we are currently working on. The biggest issue is not the lack of opportunity for innovation but that it is well-evidenced as cost effective, from the viewpoint of patient and health outcomes, and that the payment mechanisms incentivise such innovation. The revised payment model for new antibiotic treatments which NHS E&I and NICE are currently piloting is an example of how alternative arrangements could operate, with lessons for the future.
We are also working with the Accelerated Access Collaborative (AAC) and Academic Health Science Networks (AHSNs) to develop greater strategic alignment with wider AMR priorities. Professor Dame Sue Hill Chief Scientist for NHS England and Improvement recently joined the AAC Board and work has begun to identify barriers to access and adoption of AMR diagnostics by the NHS. This will inform wider work to better support and funding focused on embedding diagnostic innovation.
3. What are the priorities and/or focus areas for the NHS AMR team in the next one to five years?
Our intention is to build upon the current individual workstream-based approach (e.g. separate prescribing, diagnostics, infection prevention & control etc. workstreams) to develop pathway-based workstreams. These would bring different teams together to focus upon improvement across a pathway for a given aspect of AMR.
A priority is integrating timely diagnostics into an integrated care pathway. The pathways of current focus are UTI (chronic, recurrent and acute), sepsis and, possibly, fungal infections.
The priorities are built around the National AMR Plan ambitions of:
It may be ambitious but it is imperative.
4. In the UK, cases of drug resistant E. coli continue to deteriorate year on year, with the most obvious manifestation appearing in urinary tract infection (UTI) numbers. In your opinion, what’s needed to better balance the risk of prescribing an inappropriate antibiotic versus the risk of patients deteriorating and developing sepsis?
To better balance the risk and curb the rise of drug-resistant bacteria like E. coli, two important changes are from a diagnostics standpoint. First, we need clinical/diagnostic guidelines that have a default of no antibiotic and, second, we need a simple diagnostic that safely replaces – and supersedes – current tests, like the standard dipstick.
Additionally, other social and behavioural analysis measures must be put in place around these changes in tools and technologies. It is clear from data that there are significantly different E.coli/UTI infection rates and also differences in prescribing patterns between localities which cannot readily be explained by differences in populations or comorbidities.
NHS E&I is working with NHSX and NHS Digital to develop an integrated AMR dashboard, with data capable of being cut at multiple levels, to help identify where the key causes of variation may lie. In addition, a key aim of the Gram-negative/UTI pathway work is for this to reach back into social care and public awareness in order to support understanding of what symptoms may or may not indicate a UTI, and also to support identification at an individual level of the reasons why recurrent UTIs may be occurring and the role which local practice may be playing in this.
5. The Longitude Prize supports medical device innovators and product developers. How can we further strengthen the connections or catalyse greater collaboration between new diagnostic innovators and clinicians within the NHS?
Apart from the work that Tony Young (National Clinical Lead for Innovation NHS E&I) and others are doing, what is missing is the capability to develop an IVD from a product development viewpoint. Depending on industry, it can be too expensive to produce and most academic innovators lack experience in the IVD development pathway. This would not be for the likes of a Longitude Prize to fund but there is an opportunity to work with the likes of the NHS and BEIS on nurturing and developing these innovative capabilities.
Equally, another area that needs to be strengthened is ensuring there’s a clear pathway from product design to “the bedside”. Often, medtech innovation can lose sight of the real world context and clinical need of the people on the ground who will, ultimately, use these devices in their day-to-day work.
6. How can we better strengthen the relationship between clinicians and developers so that the latter truly understand frontline needs? What role does behaviour change have in this?
It is more than just bringing the clinicians and developers together. We need to bring funders, industry influencers, policymakers, health economists, patients; the whole ecosystem of players together. Clinicians, however, do have a key role to play. They need to be champions of what’s needed, leading the dissemination of information and helping to facilitate the creation of pilot schemes where innovation can be tested in practice. Behaviour change – essential to the cultivation of stewardship best practice – of course applies to all parties.
7. When it comes to the adoption of diagnostic tests within the NHS, what are the core pathways to commissioning that developers need to know about?
Given the expectation of NHS commissioners to follow NICE guidance in determining their priorities, NICE’s Diagnostics Assessment Programme is central to securing commissioner support for embedding the use of new diagnostics tests. However, given that there are no separate payment mechanisms currently in place for diagnostics within this framework, there is no direct financial lever to incentivise much-needed adoption.
It is for that reason we are prioritising both the pathway-based work and engaging with the development of Integrated Care Systems. The latter will support identification and embed the key “levers of change” to maximise the likelihood of adoption of pathways.
In October 2016, the AAC was established following the Accelerated Access Review. The AAC is chaired by Lord Ara Darzi and has members representing each of the collaborative’s key partner organisations. The AAC exists to get more proven innovations into the hands of clinicians and patients, faster, and to make the NHS a great place to innovate so that the development of valuable innovations can be accelerated.
The AAC and AHSNs are the key players in this field currently.
8. Today, end-to-end clinical studies following patients from diagnosis through care to outcomes is rarely available for developers. What do you think the impact is of this disconnect and what could be done to change or improve this situation?
NHS E&I is working with NHSX and NHS Digital to develop a Trusted Research Environment for AMR data. This will facilitate both the linking of data across AMR pathways and the ability for authorised researchers to drill down and identify patterns across pathways for cohorts of patients.
The introduction of Integrated Care Systems will further facilitate at a local level the implementation of pathway-based approaches. This is a positive direction of travel but I would argue that even then there needs to be more of a patient-focused and patient-led approach as the transition from home to primary care to secondary care is not as seamless as it ought to be. The NHS AMR team is developing a patient-centred pathway for chronic and recurrent UTIs which could be a model for others to follow.
9. What are the common pitfalls that you see product developers and manufacturers falling into when it comes to commercialisation of products/approaching public health bodies like the NHS?
Generally, smaller companies don’t know who to approach within public health systems. From an AMR diagnostics perspective, there is just one team within the NHS that can help direct and inform them of public health priorities and opportunities. Then there is also the issue of procurement and adoption which are the responsibility of separate entities within the NHS.
10. More generally, how do you think Covid-19 has changed our understanding and awareness of the need for rapid diagnostics in public health?
Covid-19 has accelerated public awareness of the role of point-of-care testing in the management of a health crisis. Most importantly it has also shown that industry and the NHS can work together efficiently and rapidly to provide both tests and vaccines. The key is to have the shared vision of patient benefit, cost effectiveness and market value.
11. How do you think this will impact or shape the AMR agenda?
As for Covid-19, there is no reason that if we can have a Target Product Profile (TPP), details on the minimum and optimal performance and operational characteristics of priority diagnostic tests, that meets all three criteria (patient benefit, cost effectiveness and market value) then there can be more rapid adoption of technologies. The approaches which have been taken to facilitate integration of data, and the creation of multi-organisational groups to rapidly authorise change, whilst still operating within a structured approach to decision-making, demonstrates that models can be built upon to facilitate wider developments.
12. What are the key emerging issues or trends in global public health AND/OR the biotech industry that developers should keep a close eye on?
The big ticket item is the convergence of technologies. Data will be a key part of this evolution but, right now, I believe that new engineering technologies from outside the Life Sciences could improve theranostics (a combination of therapy and diagnostics) and be applied from one area to another, such as CRISPR (a technology that can be used to edit genes).
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Congratulations to the winners of the Longitude Prize on AMR, Sysmex Astrego!