We have today an excellent report from the Global AMR R&D Hub entitled “Estimating Global Patient Needs and Market Potential for Priority Health Technologies Addressing Antimicrobial Resistance.” Both the bottom line and the key message of the report are clearly stated in the Preface:
“… we hope that by showing the astonishing mismatch between global needs and commercial potential, this study will help mobilize the required action to both support innovation and ensure these necessary new products are accessible to those with the greatest need around the world.”
The report is the output from a 3-year project in which the AMR Hub’s Expert Advisory Group undertook exhaustive modeling of the therapeutic and diagnostic markets. Here are the links you need:
- The webpage for the report
- The report itself
- A 3-page policy brief focused on therapeutics
- A 3-page policy brief focused on diagnostics
Here are a few excerpts from the analysis of therapeutics. As expected, the problem for therapeutics that reimbursement based on usage does not cover the costs of developing and maintaining a new antibiotic:
- “… there were an estimated 3.7 million cases of MDR BSI (bloodstream infection) and 1.7 million cases of MDR pneumonia attributable to Gram-negative pathogens worldwide in 2020.
- “In the absence of any intervention, patient numbers are forecast to rise to 5.5 million cases of MDR BSI and 2.8 million cases of MDR pneumonia by 2040.
- “… therapeutics for the treatment of BSI and pneumonia were estimated to generate less than $200 million ($184 million for BSI and $127 million for pneumonia) in sales revenue at their market peak in 2036, following a first launch in the US in 2025.
- “These estimates are broadly in line with similar estimates previously carried out and confirm a now solid body of evidence –from studies and anecdotally – that antibiotic markets are unattractive investments for private companies and investors, both in absolute terms and relative to other therapeutic areas.
- “… at the apex of the public health need (the products modelled here), the market may be failing most acutely and therefore struggle to deliver these most needed products to society.”
The messages are equally dark for diagnostics, but here the problem is due to limited uptake because of the way that use of a diagnostic currently creates costs that may be higher (at least from the perspective of the patient and provider) than the cost of treating empirically:
- Two rapid, near-patient diagnostics were modeled: one that separates bacterial from non-bacterial causes and one that predicts the presence of (and species of) a highly resistant Gram-negative pathogen.
- Due to the way that the cost of using a diagnostic drives clinicians to treat empirically, especially in Low- and Middle-Income Countries, the diagnostic separating bacterial from non-bacterial was predicted to reach only 2% of its target patients or 17 million patient-diagnoses out of ~800m who could benefit.
- The diagnostic predicting species and resistance improves only slightly on this: it reaches about 10% of the 30m who could benefit and it does this mainly in Upper- and Middle-Income Countries.
Strong stuff! Here are the report’s top 3 recommendations:
- That widespread and immediate use of existing policy levers i.e., national-level reform of pricing and reimbursement (ideally backed by broader value-assessment frameworks) are required, as current sales revenues from AMR technologies are insufficient to support private investment. This intra-country action would leave individual health systems to discriminate and value individual AMR technologies according to their own needs, priorities and available policy-levers.
- That such national efforts should be supplemented with additional pull support measures in order to reach the scale of return on investment to be attractive to private developers and investors and ensure critically important new products are both sustainably developed and also licensed in a broad number of countries with accompanying stewardship measures to ensure their longevity.
- To substantially progress the dialogue on possible global access, distribution, and supply chain efficiency mechanisms due to the growing reliance on smaller developers and the geographic location of the projected future AMR burden – outside HICs.
I know that I sound like a broken record, but it really, really, really is time for concerted global action on the AMR problem.
- For therapeutics, we need Pull incentives of a sufficient size to create and maintain an adequate antibiotic ecosystem.
- As the Hub states in its summary: “The specific features of these markets (the stewardship imperative, slow uptake, low and fragmented global volumes and cheap and plentiful older antibiotics) suggest that additional support and/or implementation of new models will be required in addition to the use of traditional policy levers.”
- The UK (NHS England) subscription pilot and the PASTEUR Act in the US are both good starts, but the rest of the G20 needs to get into the game: a new report of this type is great to have as confirmation, but the outcomes from YAS or YAM (yet-another-study, yet-another-model) would really be a foregone conclusion.
- As DRIVE-AB showed so very clearly, volume-delinked rewards are the tool that will break the logjam for therapeutics.
- The best solutions for diagnostics are still evolving (we eagerly await outputs from the IMI-sponsored VALUE-DX project), but the Hub’s policy report (and common sense) would suggest that the key is policy and reimbursement adjustments such that use of good diagnostics is not seen as a cost/obstacle at the local level.
- As the Hub’s summary states: “Broader value-frameworks – such as those being explored within ValueDx – that capture and incorporate longer-term health and economic impacts on the whole health system would improve the flow and rate of innovation.”
Let’s make it happen! All best wishes, –jr
John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Operating Partner, Advent Life Sciences. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://amr.solutions/blog/. All opinions are my own.
Current funding opportunities (most current list is here):
- CARB-X recently announced that their existing resources will be reserved to fund their existing portfolio (more than 80 total awards, and counting, as they include contracting from prior rounds). New rounds from CARB-X will occur only after new funding is obtained in 2021.
- It’s not a funder, but AiCuris’ AiCubator offers incubator support to very early stage projects. Read more about it here.
- The Global AMR R&D Hub’s dynamic dashboard (link) summarizes the global clinical development pipeline, incentives for AMR R&D, and investors/investments in AMR R&D.
- In addition to the lists provided by the Global AMR R&D Hub, you might also be interested in my most current lists of R&D incentives (link) and priority pathogens (link).
Upcoming meetings of interest to the AMR community (most current list is here):
- 24-26 Aug 2021 (virtual, EU-centered timings): The 5th edition of the annual AMR conference sponsored by the BEAM Alliance, CARB-X, the Novo REPAIR Impact Fund, the IMI Accelerator, and the European Biotechnology Network. The in-person version of this meeting is consistently excellent; the video-based version will have to do for 2021. Go here for details.
- 30 Aug – 1 Sep 2021 (virtual, East Coast US timings): FDA (CBER)-NIAID-sponsored workshop entitled “Science and Regulation of Bacteriophage Therapy.” Go here for details and to register.
- 1-2 Sep 2021 (virtual, 10a-3p EST on both days): FDA -sponsored workshop entitled “Advancing the Development of Pediatric Therapeutics (ADEPT 7) Complex Innovative Trial Design.”
- In brief, “The Complex Innovative Trial Design Pilot Meeting Program (CID Program) facilitates and advances the use of complex and innovative trial designs that have the potential to optimize drug development in small populations.
- “Innovations that have been proposed include Bayesian and other methods of utilizing external historical information from previous pediatric trials or other populations (such as adults), adaptive designs, bridging biomarkers, etc.”
- “The workshop will specifically focus on two topics of interest: bridging biomarkers in pediatric extrapolation and Bayesian techniques in pediatric studies. In addition, the workshop will allow for an open dialogue around the use of these approaches among regulators, industry, academia, and patient organizations.”
- Looks fascinating. Go here for the detailed Federal Register notice and here to register.
- 30 Sep 2021 (virtual, 9a-noon EST, 2-5p BST): Featuring Dame Sally Davies and Marc Mendelson, this is a Vivli-sponsored workshop entitled “A Foundation Briefing on Industry AMR Surveillance: Data for Action” that will discuss Vivli’s new surveillance sharing platform. Go here to register.
- 8 Oct 2021 (Boston, in person, 9a-6.30p, COVID vaccination required): 8th annual BAARN (Boston Area Antimicrobial Research Network) meeting. Go here for details; registration link is pending.
- 8-11 Oct 2021 (Aberdeen, Scotland): 10th Trends in Medical Mycology. Go here for details.
- 11-15 Oct 2021 (physical, somewhere in the UK): UK-focused Innovation Mission sponsored by Innovate UK in collaboration with AMR Insights and Oxford innovation. This free event seeks to connect AMR-focused start-ups, SMEs and Multinationals, Academia, Research Institutes, Regional Development Companies and other interested stakeholders in the UK, Europe and other parts of the world. Go here for more details.
- 16-24 Oct 2021 (Annecy, France): Interdisciplinary Course on Antibiotics and Resistance (ICARe). This is a soup-to-nuts residential course on antibiotics, antibiotic resistance, and antibiotic R&D. The course is very intense, very detailed, and gets rave reviews. Registration is here and is limited to 40 students. Bonus feature: For obvious reasons, the course didn’t happen in 2020! But as a celebration of the course’s 5th year, a webinar version was held on 29 Oct 2020: go here to stream it.
- [NEW] 22 Oct 2021 (virtual, 3:30 PM CET/9:30 AM ET): CARB-X webinar entitled “European Celebration of 5 Years of Progress with CARB-X: A virtual discussion of progress and plans to accelerate innovation globally.” Don’t be thrown by the word ‘European’ in the title — the early agenda does have a European flavor but the implications are global. Go here to register.
- 5-8 Nov 2021 (Albuquerque, New Mexico): Biannual meeting of the MSGERC (Mycoses Study Group Education and Research Consortium). Save-the-date announcement is here, details to follow.
- 6-11 Mar 2022 (Il Ciocco, Tuscany): Gordon Research Conference entitled “New Antibacterial Discovery and Development”. Go here for details, go here for the linked 5-6 Mar Gordon Research Seminar that precedes it.
- 9-13 May 2022 (Athens and online): 40th Annual Meeting of the European Society for Paediatric Infectious Diseases, Go here for details.
- 20-24 Sep 2022 (New Delhi): 21st Congress of the International Society for Human and Animal Mycology (ISHAM). Go here for details.
- 25-28 Oct 2022 (Stellenbosch, South Africa): The University of Cape Town’s H3D Research Centre will celebrate its 10th anniversary with a symposium covering the Centre’s research on Malaria, TB, Neglected Tropical Diseases, and AMR. Go here to register.