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Navigating Antimicrobial Resistance: Challenges and Future Opportunities for the Antimicrobial Products Subscription Model
Bhagya Chengat, Senior Consultant, Real World Evidence, Real World Evidence and Commercial & Marketing Solutions, UK & I
Sarah Jenner, Principal, Payer, Provider and Government, Real World Evidence and Commercial & Marketing Solutions, UK & I
Daniel Mora-Brito, Engagement Manager, Global Public Health, Thought Leadership, EMEA
Rachel Freeman, Principal, Antimicrobial Resistance, Global Public Health
Nov 18, 2024

Antimicrobial resistance (AMR) arises when microorganisms such as bacteria, viruses, fungi, and parasites develop the ability to withstand the effects of antimicrobial agents, including antibiotics, antivirals, antifungals, and antiparasitics (1). The misuse and overuse of antimicrobials in human medicine, veterinary practices and agriculture are key drivers of AMR.

AMR compromises the efficacy of modern medical practices, rendering routine surgeries, cancer therapies, and other medical procedures more hazardous. With an estimated 4.71 million deaths associated with bacterial AMR occurring globally in 2021, including 1.14 million deaths directly attributable to the same phenomenon, this global health threat is not to be underestimated. Recent projections indicate that at the current rate, over 39 million deaths could be directly attributable to bacterial AMR between 2025 and 2050 (2). Recognising the urgency for concrete action, the United Nations General Assembly adopted a political declaration in September 2024, reaffirming AMR as a global health threat and suggesting immediate measures to improve the response (3).

cultured bacteria in petri dish

Effective treatment of bacterial infections requires innovation and investment in novel antibiotics, among other things. Despite this need, the approval rate of new antimicrobials by the United States Food and Drug Administration (U.S. FDA), for example, has significantly declined in recent years. Globally, since 2017, there have been 12 antibiotic launches, with an average revenue of US$ 5 million in the first year following the launch (4). Additionally, the number of major pharmaceutical companies actively developing new antimicrobials has drastically decreased. By December 2020,

only two of the top 50 pharmaceutical companies by sales were engaged in developing antimicrobials, a stark contrast to the 18 companies involved in 1990 (5). The lack of commercial success presents a significant challenge to encourage investment in antibiotic research and development (R&D), indicating that additional incentives are required to stimulate and sustain the antibiotic pipeline.

NHS innovates with a fixed fee model to stimulate research and development and ensure responsible use

To respond to this problem, the United Kingdom’s National Health Service (NHS) has proposed a new route, the Antimicrobial Products Subscription Model, as an innovative approach to incentivise the development of new antibiotics (6). Unlike traditional payment models, the subscription model provides companies with a fixed annual fee, ensuring sustainable investment in antibiotic R&D regardless of usage volume. This delinked payment structure aims to encourage the development of new antibiotics while preventing their overuse. The model is part of the UK's broader strategy to address AMR.

To qualify for the Antimicrobial Products Subscription Model, products must meet specific eligibility criteria, including targeting WHO priority pathogens and demonstrating significant clinical value to the NHS (6).

Figure 1: Summary of evidence requirements for the antimicrobial products subscription model

The evaluation process also considers the product's potential impact on public health and its ability to address unmet medical needs. The products submitted for evaluation will be scored based on the provided evidence, which will subsequently determine the compensation for the companies. This rigorous assessment ensures that only the most valuable and effective antimicrobials are included in the subscription model.

Figure 2: Strengths and challenges of the antimicrobial products subscription model

The role of RWE in the AMR response

Comprehensive data on the incidence, prevalence, and patterns of antimicrobial resistance and use are essential for understanding the scope of the problem in informing on the implementation of effective interventions. High-quality data are crucial to the decision-making process underpinning the Antimicrobial Products Subscription Model. In this regard, real-world data on AMR and antibiotic use are essential for the development of evidence-based policy guiding the R&D of new antibiotics and monitoring antibiotic use and outcomes in the real world.

There are already existing robust data sources that provide some part of the picture. The IQVIA Medical Research Data (IMRD), for example, has been used in studies to assess occurrence of urine sampling practice and same-day antibiotic prescribing for patients with a suspected lower urinary tract infection (7).

cultured bacteria in petri dish

There are already existing robust data sources that provide some part of the picture. The IQVIA Medical Research Data (IMRD), for example, has been used in studies to assess occurrence of urine sampling practice and same-day antibiotic prescribing for patients with a suspected lower urinary tract infection (7).

Further, the IQVIA Antimicrobial Dashboards, which are currently under development, can provide insights into

patterns of antibiotic use in secondary care. Important metrics displayed in these tools include prescribing WHO AWaRe (Access, Watch and Reserve) category and proportion of broad-spectrum antibiotic prescribing. Additionally, product-specific insights can also be generated to understand current patterns of use and support monitoring efforts post-launch.

While selected data sources can address some research objectives related to treatment patterns, healthcare resource utilisation, and patient outcomes, a significant challenge for companies aiming to submit to the subscription model is the lack of linked data – including antimicrobial susceptibility test result data – that could serve as a reliable data asset in support of real-world evidence (RWE) generation. It is essential for companies to have granular real-world data (RWD) on prescribing, resistance, healthcare interactions, and outcomes to support the value of their antibacterial agents to the NHS. This will not only help pharmaceutical companies meet the RWE criteria in the Antimicrobial Products Subscription Model but also support a data-driven approach to combating AMR.

Figure 3. IQVIA Antimicrobial Dashboards showing organisational performance compared to the regional average over time. For example, the host organisation shows a lower percentage of use of the Access category antibiotics than the regional average


Opportunities ahead

Through cross-sector collaboration, there is an opportunity to embed high-quality RWD and evidence into multiple levels of decision-making associated with the Antimicrobial Products Subscription Model. This can heavily support life sciences players in demonstrating the value of their products against concrete health system interventions, creating a virtuous circle of data-driven assessments that can, in turn, give way to greater innovation and better patient outcomes.

IQVIA is keen to work with all stakeholders to deliver a data-driven response to AMR. As a subset of this response, IQVIA can assist clients with their submission for the Antimicrobial Products Subscription Model and provide a structured and thorough service to help them successfully navigate the submission process.

Figure 4: Illustration of IQVIA’s strategy for assisting companies with the antimicrobial products subscription model submissions

As the international community searches for alternative and highly effective avenues to tackle AMR, IQVIA provides capabilities that service different needs: from offering an overview of global antibiotic use to streamlining the engagement of life sciences actors in initiatives such as the model described in this article. In conclusion, as a common threat to these actions, integrating data insights into the AMR response can significantly improve the capacity of critical health system actors to make the right decisions, optimizing the use of scarce resources and ensuring that current and future responses are efficient, aligned and coordinated.

References

  1. Antimicrobial resistance - World Health Organisation (WHO). https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance .
  2. Naghavi, M., Vollset, S. E., Ikuta, K. S., Swetschinski, L. R., Gray, A. P., Wool, E. E., ... & Dekker, D. M. (2024). Global burden of bacterial antimicrobial resistance 1990–2021: a systematic analysis with forecasts to 2050. The Lancet, 404(10459), 1199-1226.
  3. https://press.un.org/en/2024/ga12642.doc.htm#:~:text=The%20General%20Assembly%20today%20adopted,the%20Goals%20of%20the%202030
  4. https://www.iqvia.com/locations/emea/blogs/2024/10/antimicrobial-resistance-understanding-the-threat-and-shaping-the-response
  5. McEnany, M., & Outterson, K. (2024). Changes in revenues associated with antimicrobial reimbursement reforms in Germany. Humanities and Social Sciences Communications, 11(1), 1-12.
  6. NHS England - Antimicrobial products subscription model: guidance on commercial arrangements https://www.england.nhs.uk/long-read/antimicrobial-products-subscription-model-guidance-on-commercial-arrangements/.
  7. Ciaccio L, Fountain H, Beech E, et al Trends in urine sampling rates of general practice patients with suspected lower urinary tract infections in England, 2015–2022: a population-based study. BMJ Open 2024;14:e084485. doi: 10.1136/bmjopen-2024-084485

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