Dear All: We had hints back in January that this was coming (see this post), but now it is really happening! In brief, UK’s NHS will test the world’s first subscription-style payment model in which payments delinked from volume are used to incentivise pharmaceutical companies to develop new drugs for resistant infections. Below my signature, I’ve reproduced the entire text below for immediate reference. The details on precise timing and number of involved compounds remain scant but overall this is FANTASTIC NEWS! All best wishes, –jr
John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Expert-in-Residence, Wellcome Trust. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: http://amr.solutions/blog/
PS: If you are new to this area and need background on the reasons we need Pull incentives, start with these posts. In short, all approaches to solving this problem have trade-offs, but a substantial Market Entry Reward granted on approval of a high-value new antibiotic is the mechanism that has the best chance of working in the real world:
- http://amr.solutions/blog/summary-of-drive-ab-slides-from-at-the-asm-escmid-meeting (Sep 2017)
- http://amr.solutions/blog/incentives-for-antibiotics-recent-papers-with-an-emphasis-on-pull (Oct 2017)
- http://amr.solutions/blog/push-pull-push-pull-highlights-from-davos-2018 (Jan 2018)
- http://amr.solutions/blog/lets-make-a-pull-incentive-happen-in-the-us-during-the-116th-congress (Feb 2019)
- http://amr.solutions/blog/scary-scarier-scariest-part-2-what-can-you-do-about-it (May 2019)
Full text from https://www.gov.uk/government/news/development-of-new-antibiotics-encouraged-with-new-pharmaceutical-payment-system:
Development of New Antibiotics Encouraged With New Pharmaceutical Payment System
The new trial will be led by the National Institute for Health and Care Excellence (NICE) and NHS England and NHS Improvement.
It will test a ‘subscription’ style model that pays pharmaceutical companies upfront for access to drugs based on their usefulness to the NHS. (emphasis added)
This will make it more attractive for companies to invest the estimated £1 billion it costs to develop a new drug, as they can be reassured they will still be paid for the drug even though it may be stored for reserves.
Currently, drugs companies are paid by volume of antibiotics sold, while the NHS is trying to reduce their use to prevent antimicrobial resistance (AMR).
Low returns on investment in development mean industry is reluctant to invest in the research and clinical trials necessary to bring new antibiotics to market.
NICE and NHS England and NHS Improvement are calling for companies to identify products to be considered for the initial phase of the test.
The work will be evaluated from the start and findings will be shared with the rest of the world so that other healthcare systems can test similar models.
Antibiotics have started to fail, with resistant bacteria already causing more than 700,000 deaths globally every year, making it vital that antibiotics are used only when needed.
Today’s announcements follows the government’s 2040 AMR vision and 5-year national action plan, published in January, and the appointment of Professor Dame Sally Davies as the first UK Special Envoy on AMR.
The latest phase of the ‘Keep Antibiotics Working Campaign’ will launch at the beginning of coughs and colds season this October to help reduce inappropriate use of antibiotics.
Health and Social Care Secretary, Matt Hancock, said:
There is no greater threat to global health than drug-resistant infections, yet there have been no major new antibiotic drug classes discovered since the 1980s.
Imagine a world in which a papercut can lead to infection that can’t be controlled. We must stop that from happening. Tackling superbugs needs global leadership and peoples’ lives depend on us finding a new way forward.
Our NHS is in a unique position to take a global lead in testing new payment models. We will take the lead but this is a global problem and we cannot succeed alone.
I am proud the UK is taking the first steps towards a solution and I am urging the rest of the world to join us in the fight against superbugs.
Health Minister Nicola Blackwood said:
Having a full pipeline of antimicrobials is critical in our efforts to address AMR, but currently not enough pharmaceutical companies are investing in the development of new drugs.
This project is an important step but it will only address global market failure if other countries do the same, which is why we want to involve as many countries as we can and share our learning from this work.
Today we are sending a strong signal to the rest of the world that there are workable models to stimulate investment in these vital medicines and that together we can tackle AMR.
Upcoming meetings of interest to the AMR community:
- [NEW] 10-11 Jul 2019 (Tyson’s Corner, VA): US PACCARB meeting featuring a vote on an updated National Action Plan and discussions of antifungal resistance. Go here for detail.
- 10-11 Jul 2019 (Madison, WI): Tiny Earth Symposium, a teaching consortium that uses crowd-sourcing of antibiotic-producing microbes to improve undergraduate education. Details here.
- 11-12 Jul 2019 (Washington, DC): FDA-sponsored workshop entitled “Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes.” Go here for more details.
- 12 Jul 2019 (FDA, White Oak Campus): Public workshop to discuss the 2018 LPAD guidance. Register here.
- 15-19 Jul 2019 (Dallas, TX): Small World Initiative Instructor Training Workshop — training for undergraduate professors and high school teachers in wet lab techniques, parallel curricula, pedagogical instruction to engage students in the hunt for new antibiotics in soil. Go here to register.
- 18 Jul 2019 (webinar, 9:00-10:30 CEST): REVIVE webinar entitled “IEnabling academia to fill the discovery gap – Learnings from industry and funders.” Go here to register.
- [NEW] 31 Jul 2019 (Philadelphia, PA): Wistar Institute-sponsored “Symposium on Gram-Negative Bacteria Resistance – New Approaches in Pushing Back the Tide.” Go here for details.
- 20 Aug 2019 (webinar, 17:00-18:30 CEST): REVIVE webinar entitled “Models for antimicrobial R&D: Computational modelling for population PK and PKPD.” Go here to register.
- [Mark your calendar now!] 3-6 Sep 2019 (Boston). Annual ASM-ESCMID Conference on Antibiotic Development. The Bootcamp series will continue on 3 Sep with main meeting on 4-6 Sep. Mark your calendar now and check back here for details.
- 6 Sep 2019 (Cambridge): CeBIL Annual Symposium 2019: Legal Innovation to Support the Development of Anti-Microbial Drugs. For more details and to register, go here.
- 6-8 Sep 2019 (Bilbao, Spain): 5th ESCMID conference on Vaccines. Check back here for details.
- 2-6 Oct 2019 (Washington, DC): IDSA’s annual IDWeek meeting.
- 19-27 Oct 2019 (Annecy, France): International Course on Antibiotics and Resistance (ICARe) – A soup-to-nuts intensive residential training program on all things AMR, especially R&D for new antibiotics. See this link for details.
- 16-18 Dec 2019 (Bangkok, Thailand): 3rd International Symposium on Alternatives to Antibiotics in Animal Production. Go here for details: https://www.ars.usda.gov/alternativestoantibiotics/
- 1-6 Mar 2020 (Il Ciocco, Tuscany, Italy): GRC on Antibacterial Discovery and Development: “Now is the time to re-boot antibiotic R&D before it’s too little, too late.” Go here for details.
- 12-13 Mar 2020 (Berlin?): BEAM-, Novo REPAIR-, CARB-X-, DZIF-, ND4BB-, ENABLE-supported (among a long list!) Conference on Novel Antimicrobials and AMR Diagnostics. Final location is TBD, details will appear here, and you should mark your calendar now.
- 16-17 Mar 2020 (London): BSAC Spring Conference entitled: “Bridging the gap between science, policy and effective antimicrobial use.” Go here for details.
- 18-21 Apr 2020 (Paris): Annual ECCMID meeting (#30)
- 25-30 May 2020 (Rotterdam), Annual ESPID meeting (European Society for Pediatric ID, #38)
- 10-13 Apr 2021 (Vienna): Annual ECCMID meeting (#31)