Dear All (and with thanks to Kevin Outterson for co-authoring),
We’ve written and talked before from various perspectives about the groundbreaking UK NHS England-, NHS Improvement-, and NICE-sponsored antibiotic subscription pilot project:
- 10 Feb 2021: Fabulous 5-minute video explainer on the economics of antibiotics by Andrew Jack of Financial Times
- Superb discussions of Push/Pull, the role of the Netflix model, and more!
- Cameos by Kevin (Outterson), Christine (Ardal), and Manica (Balasegaram)! Don’t miss it!
- 29 Mar 2020 newsletter: “UK Antibiotic Subscription Pilot Implies Pull Incentive Of Up To $4b Across The G20”
- 3 Apr 2020 newsletter: “UK Antibiotic Subscription Pilot: Post-Webinar FAQ Document”
- 18 Dec 2020 newsletter: “UK Pilot Antibiotic Subscription Model: Two Candidate Antibiotics Chosen!”
- 22 Jan 2021 YouTube video (11 minutes): “The STEDI values of antibiotics and how this connects to the UK pilot”
- For more on STEDI, see the references in Section 1 of the 14 Apr 2020 newsletter entitled “Pull Incentives For Antibiotics: How Much And Why? — A Literature Survey”
- For global breadth…
- See the 9 Dec 2020 newsletter entitled “Global Survey Of Novel Antibiotic Reimbursement Models / PASTEUR Act Introduced To US House.” This newsletter covers the US (PASTEUR) and the rest of the world (including the UK pilot)
- The excellent paper by Gotham et al. on global reimbursement models is well worth a read
- Similarly, an excellent global survey with a Canadian perspective was authored by Dutescu and Hillier
- And finally, there was a call in the Swiss Parliament by Fiala Doris for “incentives … in which remuneration is independent of the amount purchased”!
- For a really deep dive, the 19 Sep 2020 newsletter entitled “In Praise Of Non-Inferiority” and its associated YouTube video take you through the background on why typical HTA metrics based on superiority outcomes in clinical trials are not a good idea for novel antibiotics!
- And finally (shameless plug): I’ve just posted a 4-minute YouTube video on how Jane Austen’s Sense and Sensibility gives you insight into the almost magical effect of a good antibiotic on serious bacterial infections: embedded in this classic novel is a a great medical story that really highlights the importance of avoiding superiority designs when developing new antimicrobials!
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Today’s news is that the project team gave a superb webinar update on 25 Jan 2021. The slides from the webinar are available on the project team’s home webpage; a video of the meeting is to follow. The key features of the program remain as previously discussed and can be briefly summarized as:
- The goal of the project is to test ways to reimburse for the full value of a new antibiotic
- To that end, two antibiotics will undergo a value assessment during 2021 by NICE based on both direct values (to the patient) and indirect values (to the system)
- The inclusion of indirect values is the big step here based on the STEDI values discussed above
- An example would be a Transmission value: treating patient #1 means that patient #2 never gets the infection: the Transmission value reimburses for the prevented infection.
- Contracts should be signed and delinked payments flowing by April 2022
- As demonstrated by this webinar, the project continues to share its insights globally
- The hope is that we’ll see other countries create subscription programs that fit their unique health systems!
Some additional slide-by-slide notes are found just below our signature. We once again thank the UK team for their vision … it is fantastic to see this project coming to life! All best wishes, John & Kevin
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.
Kevin Outterson, JD, Professor of Law, Boston University & Executive Director, CARB-X (these views are personal and do not necessarily reflect the views of CARB-X or any of its funders) @koutterson
- Slide 6: The pilot seeks to reimburse for both direct value (to a treated patient) and indirect value (to the system)
- “The principle of the model is that companies are paid for antimicrobials based on the estimated value
of benefits to patients and the NHS which is consistent with good stewardship rather than payments
based on volumes used. - “The value of the antimicrobials will be estimated by NICE through an adapted Health Technology Assessment with information from health economic modelling and expert opinion.
- “The model will capture value not just from the direct health gain to patients treated, but also additional
elements e.g. insurance value, diversity value, transmission value and enablement value. - “Value assessment will be used to inform commercial discussions, leading to payments to companies
of an annual fixed fee in instalments.”
- “The principle of the model is that companies are paid for antimicrobials based on the estimated value
- Slide 7: The pilot is designed to exercise the model: What data are needed to value a new antibiotic?
- “The model is being tested through application to two antimicrobial products selected via competitive
procurement exercise:- One existing antibiotic (has received marketing authorisation in past 2-3 years)
- One antibiotic that is new to market (with expectation of a marketing authorisation by end 2020 and with plans to
launch in UK)
- “Future policy for the evaluation and purchasing of antimicrobials will be informed by the outcomes
from this project.”
- “The model is being tested through application to two antimicrobial products selected via competitive
- Slide 3 and Slide 12: Two products have been selected based on Spectrum (and how this addresses UK need), Novelty, Supply, etc.
- Very recently licensed: Cefiderocol (Fetroja, Shionogi)
- Already licensed: Ceftazidime with avibactam (Zavicefta, Pfizer)
- Selection balanced the WHO priority list as well as unmet need in the UK
- Slides 17-19: NICE will work during 2021 to model the value of these compounds
- An enhanced version of the standard NICE technology appraisal will be used
- Elements to be considered include Direct health effects to patients + indirect elements of value (e.g., Spectrum, Transmission, Enablement, Diversity and Insurance value; STEDI)
- Modeling will be focused on high-value clinical scenarios
- Specific examples were not given, but you could imagine the project examining values such as preventing ICU closure by stopping spread
- The key metric is QALYs at a population level
- The goal is for contracts to be signed and payments flowing by April 2022
- There is an active outreach to share the project internationally
- UK is the G7 President in 2021 — a great opportunity
- The goal is to encourage development of shared principles such as
- Quantitative and/or qualitative assessment of the value of new antimicrobials coming
to market - Delinking reimbursement to companies from volume of sales
- Robust stewardship of new and existing antimicrobials
- Incentivising good manufacturing practice and robust supply
- Quantitative and/or qualitative assessment of the value of new antimicrobials coming
Current funding opportunities (most current list is here):
- The US Department of Defense is funding pre-clinical research on small molecules vs. P. aeruginosa. See this newsletter for details. The deadline is 18 Feb 2021.
- FDA have announced two fellowship opportunities (one for research on ordinal endpoints, one for research on endpoints in cUTI), both with a 26 Feb 2021 deadline. See this newsletter for more details.
- CDC has released an RFP entitled “Safe Healthcare, Epidemiology, and Prevention Research Development (SHEPheRD)” that seeks support for a broad range of healthcare epidemiology projects. See this newsletter for details. The deadline is 3 Mar 2021.
- The Stockholm-based PAR Foundation seeks applications for projects with the potential to prevent infections and antimicrobial resistance in the elderly. Grants can be for up to 1M SEK (~$120,000) for projects running up to 3 years. The deadline for applications is 10 Mar 2021; go here for further details.
- JPIAMR has an open research call entitled “One Health interventions to prevent or reduce the development and transmission of AMR.” More details on the call are here; the deadline for pre-proposals is 16 Mar 2021.
- The National Institute of Allergy and Infectious Diseases (NIAID) Applicant Assistance Program (AAP) provides no cost support for companies planning to apply for a Phase II, Fast Track, or Direct-to-Phase II SBIR or STTR Award. Go here for details.
- Novo REPAIR Impact Fund closed its most recent round on 31 Jul 2020. Go here for current details.
- 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.
- The Global AMR R&D Hub’s dynamic dashboard (link) summarizes funders and projects by geography, stage, and more.
- It’s not a funder, but AiCuris’ AiCubator offers incubator support to very early stage projects. Read more about it here.
- Finally, you might also be interested in the 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):
- 10-11 Feb 2021 (online, 10a-4p EST): Virtual public meeting of PACCARB (US Presidential Advisory Council on Combatting Antimicrobial Resistant Bacteria). Go here for details.
- 25 Feb 2021 (online, 5-6.30p CET): GARDP-sponsored webinar entitled “From discovery to the pre-clinical antimicrobial candidate,” moderated by Michael Mourez. Go here to register.
- 10-12 Mar 2021 (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; abstract deadline is 15 Nov 2020.
- 12 Mar 2021 (virtual, 11a-1p EST): BARDA-sponsored workshop entitled “Vaccines Against Antimicrobial Resistant Threats.” BARDA wants to support development of vaccines vs. E. coli, K. pneumoniae, P. aeruginosa, and S. aureus! Sign-up for here to learn more.
- 15-18 Mar 2021 (virtual, EU afternoon timing): The Uppsala Health Summit is focusing this year on “Managing Antimicrobial Resistance through Behaviour Change.” This is a multi-disciplinary and multi-stakeholder (policy, industry, academia, civil society) program that focuses on a different topic each year. Go here to for more details.
- 9-12 Jul 2021 (Vienna): Annual ECCMID meeting (#31)
- 10-12 May 2021 (virtual): UK-focused Virtual AMR Innovation Mission sponsored by Innovate UK in collaboration with AMR Insights and Oxford innovation. This free 3-day virtual 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. It will be followed (COVID-willing!) by a face-to-face mission scheduled for 11-15 Oct 2021. Go here for more details.
- 18-21 May 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.
- 24-29 May 2021 (online and in Geneva): ESPID 2021, the 39th Annual Meeting of the European Society for Paediatric Infectious Diseases. Save-the-date announcement is here, details to follow.
- 3-7 Jun 2021 (Anaheim), ASM Microbe 2021. Go here for details.
- 20-24 June 2021 (Toronto): International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD-12). Go here for details.
- 20-24 Jun 2021 (virtual, various times): World Microbe Forum sponsored by the American Society for Microbiology (ASM) and the Federation of European Microbiological Societies (FEMS). Go here for more details and to register.
- 27 Jun-2 Jul 2021 (Ventura, CA): Gordon Research Conference entitled “Antimicrobial Peptides”. Go here for details, go here for the linked 26-27 Jun Gordon Research Seminar that precedes it.
- 5-21 Aug 2021 (Marine Biology Laboratory, Woods Hole, MA): Residential course entitled “Molecular Mycology: Current Approaches to Fungal Pathogenesis.” This 2-week intensive training program has run annually for many years and gets outstanding reviews. Go here for details.
- 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.
- 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.
