Reimbursing for innovative antibiotics / Encouraging updates from the AMR conference

Dear All (with thanks to Kevin as the lead author on this note and also with a wonkish note alert … refresh your coffee and settle in!),

Several years ago, DRIVE-AB planted some seeds across Europe on reforming how we pay for antibiotics. As a consequence, we are seeing some hopeful sprouts in several countries:

  • Previous newsletters have examined antibiotic reimbursement pilots in England and Sweden as well as legislation proposed in the US [link].
  • In the virtual AMR Conference this week, several speakers gave updates on progress on incentives (for a summary, go here for Kevin’s talk at the meeting).
  • And as the conference closed, Sweden announced the first 5 drugs in their access pilot: ceftolozane-tazobactam, imipenem-cilastatin-relebactam, cefiderocol, meropenem-vaborbactam, and fosfomycin.


And to top it off, there is a bit of especially instructive good news from Germany. 


As context, we have to start with some bad news. Recall that reimbursement systems in many countries create intense financial pressure to not prescribe new hospital antibiotics due to an 1980s-era reform known as the hospital-bundled payment or Diagnosis-Related Group (DRG) system. A DRG is the fixed amount the hospital receives for care of a patient with a given illness. If the hospital can deliver all elements of the needed care within the DRG payment amount, then a profit is made. If not, it leads to a loss.

The problem with DRGs arises when (as is common) the DRG cost bundle is mainly based on generic antibiotics. You’re admitted for pneumonia, you need antibiotics, but the DRG is only enough for a generic. It’s obvious that the hospital will inevitably lose money if a newer, more expensive antibiotic is used. This is the sort of thing that leads to continued use of colistin (cheap!) when better drugs (expensive!) are available (newsletter).

This problem has been recognized, and the proposed legislative solution in the US is the DISARM Act, by which antibiotics in the hospital are reimbursed outside of the DRG (to learn more read this background article by Kevin). 
 
Progressing further with the bad news, the DRG hurdle was made worse in Germany by a 2018 revamp of their Health Technology Assessment (HTA) processes for hospital products. In the revamped model, antibiotics automatically faced generic pricing unless they could prove “added benefit” compared to existing therapies in the HTA process. Essentially, new antibiotics needed to demonstrate superiority, which any careful observer knows is nearly impossible for new antibiotics. (For more on why superiority is nearly impossible to show and why that is a GOOD thing, see these newsletters [link] and [link], these papers [link] and [link], and this slide deck [link]). 

Net effect of all this? Germany unintentionally put a nail in the coffin for new hospital antibiotics.


But, the good news in Germany is that now “reserve” antibiotics are automatically assumed to have “added benefit” in the early health technology assessment (HTA) process (see below the signature block for the sources we used). This “added benefit” will put “reserve” antibiotics in a stronger position to negotiate prices higher than generic antibiotics with payors. The DRG hurdle remains in Germany, but at least this is a step towards pricing antibiotics closer to their full value.

At least two other countries have already taken steps to address their versions of the DRG problem. In the US, the Centers for Medicare and Medicaid Services agreed in 2019 that QIDP antibiotics (QIDP = Qualified Infectious Disease Product, an idea from the GAIN Act) were eligible for NTAP, the New Technology Add-on Payment that is a temporary way to reward new technologies outside of the DRG bundle. This was a good idea that sadly did not work out for wonkish reasons that lead to the need for the DISARM Act (go here for a detailed newsletter and see also the article by Kevin that was cited above). France has had a DRG carve-out system since 2004 for specified new medicines. Some costly antifungals and a few antibiotics are on this list. Encouragingly, the system in France has not negatively affected antimicrobial stewardship: a recent evaluation of the program by the French Sénat found several areas for improvement, but stewardship was not one of them (link).
 
What qualifies as a reserve antibiotic in Germany? That definition has been tasked to the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM). The definition will take account of things such as the WHO’s Priority Pathogen list, the classification of antibiotics by the WHO (see the AWaRe list, link), as well as the resistance data from the RKI and the Central Office for the Evaluation of Resistance Data for Systemically Active Antibiotics (Z.A.R.S.) at the BfArM. 
 
Why is this so exciting? On the one hand, it’s still only a partial fix … the DRG obstacle remains as does the overall need for Pull incentives (link). But, the positive side is from the lessons learned on the way to implementing this fix:

  • Unintended consequences have hurt antibiotic R&D. From introduction of DRGs, to HTA reforms, and even excellent stewardship efforts, good ideas sometimes have unintended implications for antibiotic innovation. We must remain attentive. 
  • Speaking up works! This German reform discussed above comes after feedback from stakeholders. Everyone is busy, but responding to these public consultations is important.
  • Strikingly similar barriers to antibiotic reimbursement emerge time after time in country after country.
  • Partial victories should be celebrated as they spread understanding of the issues to our non-technical colleagues.

 

So, good for Germany for stepping up and solving one part of this problem! And good for France for taking this on in 2004!

And on the theme of speaking up, please note the 4 Sep 2020 deadline for the comments on EMA’s Strategy to 2020 [link to newsletter]. The opportunity to influence the AMR agenda is real but nothing will happen unless you send in your thoughts!

All best wishes, Kevin and John

Reference materials: The commentary we could find is all in German:  (1) Nov 2019 news article on the proposed amendment; (2) Dec 2019 comments on proposed amendment from Federal Joint Committee overseeing physicians and insurance; and (3) Feb 2020 comments from German industry association (vfa) 


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  

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:

  • Novo REPAIR Impact Fund closed its most recent round on 31 Jul 2020. Go here for current details.
  • 2020 funding rounds for CARB-X have not been announced.
  • 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.


Upcoming meetings of interest to the AMR community:

  • [NEW] (it’s over now, but you can still watch it!) 24-28 Aug 2020 BEAM Alliance-sponsored AMR Conference. Go here to access the recorded sessions. This was a very, very good meeting!
  • September 2020. University of Sheffield (UK). Applications are being taken for a new 1-year (full-time) or 2-year (part-time) Masters of Science course in Antimicrobial Resistance. The program runs annually from September and covers microbiology, clinical practice and policy. The course webpage is here.
  • 9-10 Sep 2020 (Washington, DC): US PACCARB public meeting. Go here for details.
  • [NEW] 24 Sep 2020 (online, 15.30-17.30 CEST; 9.30-11.30a EST; 7-9p IST): Antibiotic Bootcamp Series webinar entitled “Moving from preclinical to clinical-stage: Challenges and opportunities.” Moderated by Erin Duffy (CARB-X), this webinar is jointly sponsored by GARDP, CARB-X, Novo REPAIR, JPIAMR, Wellcome Trust, ASM, and ESCMID. Since we can’t the ASM-ESCMID meeting, we’re still going to have the bootcamps! Go here to register.
  • [NEW] 2 Oct 2020 (online meeting): 7th annual Boston Area Antimicrobial Research Network (BAARN) meeting. Go here for details.
  • 21-25 Oct 2020 (online meeting), IDWeek 2020. Go here for details.
  • 26-29 Oct 2020 (online meeting), Annual ESPID meeting (European Society for Pediatric ID, #38)
  • 27 Oct 2020 (online meeting), BARDA Industry Day, a discussion of U.S. Government medical countermeasure priorities. Mark your calendar now and watch this website for details.
  • 9-12 Jul 2021 (Vienna): Annual ECCMID meeting (#31)
  • 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.
  • 20-24 June 2021 (Toronto): International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD-12). Go here for details.
  • 3-7 Jun 2021 (Anaheim), ASM Microbe 2021. Go here for details.
  • 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.
  • 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.
  • 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.

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