Assessing antibiotic value: Two papers on antibiotic-specific gaps in traditional Health Technology Assessments

Dear All:

Among various paradoxes that surround antibiotic development, the challenge for health technology assessment (HTA) is often implied but to my knowledge has as yet only infrequently been formally discussed.

As one step towards filling this gap, the London-based Office of Health Economics (OHE) released a paper a few days ago that provides a detailed look at this problem (the link to the paper and a key quote are below my signature). The value of this paper lies in their systematic survey of how the elements typically considered by HTA overlook the many values that an antibiotic has to society as a whole:
​​

Benefits typically included in traditional HTABenefits not typically included in traditional HTA
Health gainTransmission value
Unmet NeedInsurance value
Cost offsetsDiversity value
Productivity benefitsNovel action value
Enablement value
Spectrum value

From the OHE paper.

A further contribution to this area is coming from a team led by Ramanan Laxminaryan (DRIVE-AB and CDDEP). As yet out only in abstract form (see below), the work by Leporowski et al. analyzes gaps in HTA approaches based on case studies. As noted in their analysis of the HTA process for 5 recent antibiotics, “The health technology assessments are based on clinical trial data and simple economic models that focus primarily on the direct treatment benefit of the drugs to patients.”

The challenge highlighted by both of these papers, can be summarized by noting that antibiotics are like fire extinguishers in that their best use is often in their non-use. Based on my understanding of economics, the problem is technically one of failure to recognize the positive externalities of antibiotics – as with fire extinguishers, the very existence of antibiotics has value for you, even if you don’t ever personally need them.

I don’t yet know how we as a community are going to solve this problem, but simply being able to talk about it is a good step!

All best wishes,

–jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Chief Strategy Officer, CARB-X | Expert-in-Residence, Wellcome Trust
Follow me on Twitter: @JohnRex_NewAbx

Online OHE paper:

2016 abstract by Leporowski et al.: 16th Biennial European Conference, Society for Medical Decision-Making, June 12 – 14, 2016, London, UK

Link: https://smdm.confex.com/smdm/16BEC/webprogram/Paper9957.html

1C-5 REVIEW OF THE HEALTH TECHNOLOGY ASSESSMENT PROCESS FOR ANTIBIOTICS IN SELECT EUROPEAN COUNTRIES
Monday, June 13, 2016: 12:15

Axel Leporowski1, Abigail Colson2, Alec Morton2 and Ramanan Laxminarayan3, (1)University of Heidelberg, Department of Economics, Heidelberg, Germany, (2)University of Strathclyde, Department of Management Science, Glasgow, United Kingdom, (3)Center for Disease Dynamics, Economics & Policy, Washington, DC

Purpose: It has been claimed that health technology assessment agencies do not take into account the full range of values associated with antibiotics when making reimbursement and pricing recommendations. In this paper we seek to document the types of evidence and value considered by European health technology assessment agencies when making recommendations about antibiotics.

Method(s): We studied five antibiotics that have gone through a health technology assessment process in at least two European countries since 2010: fidaxomicin, aztreonam, ceftaroline fosamil, tigecycline, and colistimethate sodium. We selected the drugs to include a mix of new technologies and reformulations of older products. For each antibiotic, we identified every report from a health technology assessment body publicly available in English, Spanish, German, or Dutch. We systematically reviewed the reports to identify the evidence, sources of value, and other factors the agency considered in the health technology assessment. We supplemented this review by interviewing the pharmaceutical companies that developed the products to collect additional information about the health technology assessment process and its data and modelling requirements.

Result(s): We found health technology assessments from at least two agencies for each product. Fidaxomicin was the most widely studied product with reports. The health technology assessments are based on clinical trial data and simple economic models that focus primarily on the direct treatment benefit of the drugs to patients. The threat of antibiotic resistance was mentioned irregularly. The assessments did not consider the value of antibiotics in enabling surgeries and other procedures, the insurance value of having an approved antibiotic ready when a new resistant outbreak emerges, or the diversity value of having multiple drugs with different modes of action available for a given infection.

Conclusion(s): Current health technology assessment practices do not encapsulate the full value of antibiotics. Ignoring the types of value unique to antibiotics may result in their being undervalued, which could make it less attractive for pharmaceutical companies to invest in research and development of new antibiotic. There is a need for simple modelling frameworks that can better capture the true economic value of antibiotics

Dear All,
 
The IDWeek 2024 program committee is again seeking programs on novel antimicrobial agents and novel diagnostics for presentation in pipeline sessions! Here’s what is sought:

  • “Industry partners are invited to submit antimicrobials that are in preclinical stages of development (Phase II and III preferred) or recently approved after January 2024.
  • “The pipeline sessions will include antibacterials, antifungals, and antivirals (excluding COVID-19 and HIV).
  • “The committee also invites companies developing novel diagnostic technologies with a minimum of some preliminary proof of concept data to submit.” 

This is a great opportunity to tell the story of your development project! The deadline to submit is Wednesday, June 26 via the application portal. Any questions should be directed to program@idsociety.org. Please share this email with anyone you think might be interested in applying!
 
In addition, I’ll also note that those with a more general story to tell should look at the BugHub Stage (and the Global BugHub stage). Both BugHub variants seek “presentations that touch on your experience of working in infectious diseases and presentations that ultimately lead to a greater understanding of our diverse field” via a TED Talk-esque speech about your work. The deadline for applications is 26 June, the same as for the pipeline sessions.

I look forward to seeing you there! 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.

John’s Top Recurring Meetings

Virtual meetings are easy to attend, but regular attendance at annual in-person events is the key to building your network and gaining deeper insight. My personal favorites for such in-person meetings are below. Of particular value for developers are the AMR Conference and the ASM-ESCMID conference. Hope to see you there!

  • 27-30 April 2024 (Barcelona, Spain): 34th ECCMID, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. Go here for details. 
  • 17-20 Sep 2024 (Porto, Portugal): ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. Go here for the meeting’s general website. You can’t register (yet) for the 2024 event, but save the date!
  • 16-20 Oct 2024 (Los Angeles, USA): IDWeek 2024, the annual meeting of the Infectious Diseases Society of America. Save the date! More details to come!
  • 25-26 February 2025 (Basel, Switzerland): The 9th AMR Conference 2025. Go here to register

Upcoming meetings of interest to the AMR community:

  • [NEW]  9 Apr 2024 (virtual, 830a-10a ET): GARDP’s next REVIVE webinar entitled “Progressing a discovery project – Criteria and challenges.” Register here.
  • [NEW] 9 Apr 2024 (virtual, 10a-1130a ET): CDC webinar “Impacts of Antimicrobial Resistance on Cancer Care.” Click here for details and to register.
  • 10-11 Apr 2024 (virtual): Sepsis Alliance AMR Conference, a 2-day conference focused on “Practical technologies to manage sepsis and counteract the expanding challenge of antimicrobial resistance.” Go here for details and to register.
  • 26 Apr 2024 (Barcelona, Spain): ESCMID workshop entitled “Using Data Science and Machine Learning for Infection Science: A Hands-on Introduction.” Click here to register or here for more details. 
  • 27-30 April 2024 (Barcelona, Spain): 34th ECCMID, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. See Recurring Meetings list, above.
  • 26-31 May 2024 (Montreal, Canada): EDAR7, the McGill AMR Centre’s 7th edition of their Environmental Dimension of Antimicrobial Resistance conference. Go here for details; final abstract deadline is 21 Dec 2023.
  • 28-29 May 2024 (in person, Uppsala, Sweden): Uppsala Antibiotic Days, a broad-ranging 2-day program hosted by the Uppsala Antibiotic Center. Go here for details and to register.
  • [NEW] 30-31 May 2024 (face-to-face in Rockville, Maryland as well as online, 8.30-5.30p ET on 30 May, 9-2.40p on 31 May): NIAID-sponsored workshop entitled “Towards realizing the promise of adjunctive immune therapy for invasive fungal infections”. The agenda covers host immunity to invasive fungal infections, immune modulators in the context of fungal infections; and strategies for testing immune modulators as adjunctive therapy. Go here for more details and to register.
  • 9-13 June 2024 (in person, Ascona, Switzerland): “New Approaches to Combat Antibiotic-Resistant Bacteria, 2nd Edition” is a Sunday-Thursday residential workshop focused on the deep biology of AMR. Sponsored by NCCR AntiResist (a Swiss National Science Foundation consortium), the scientific program has the feel of a Gordon Conference. Space is limited, so you are encouraged to apply promptly — go here for details.
  • 13-17 June 2024 (Atlanta, Georgia): ASM Microbe, the annual meeting of the American Society for Microbiology. You can’t register yet, but you can go here for general details.
  • 17-20 Sep 2024 (Porto, Portugal): ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. See Recurring Meetings list, above.
  • 16-20 Oct 2024 (Los Angeles, USA): IDWeek 2024, the annual meeting of the Infectious Diseases Society of America. See Recurring Meetings list, above. 
  • 19-27 Oct 2024 (Annecy, France, residential in-person program): ICARe (Interdisciplinary Course on Antibiotics and Resistance). Now in its 8th year, Patrice Courvalin directs the program with the support of an all-star scientific committee and faculty. The resulting soup-to-nuts training covers all aspects of antimicrobials, is very intense, and routinely gets rave reviews! Seating is limited, so mark your calendars now if you are interested. Applications open in March 2024 — go here for more details.
  • 4-5 Dec 2024 (in person, Washington, DC): “Fungal Dx 2024: Fungal Diagnostics in Clinical Practice” is a 2-day in-person workshop organized by ISHAM‘s Fungal Diagnostics Working Group. The program and registration links are available at https://fungaldx.com/; the agenda is comprehensive and features an all-star global list of speakers.

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