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 HTA | Benefits not typically included in traditional HTA |
|---|---|
| Health gain | Transmission value |
| Unmet Need | Insurance value |
| Cost offsets | Diversity value |
| Productivity benefits | Novel 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:
- Link: https://www.ohe.org/news/assessing-value-new-antibiotics-additional-elements-value-health-technology-assessment
- Key quote: “Paradoxically, the possibility exists that while a new antibiotic may be licensed earlier in response to public health imperatives to expand patient access to effective antibiotics, it may take longer for it to be reimbursed by payers at the national level if the evidence base is limited, and indeed it may never be reimbursed, because of lack of HTA-relevant evidence.”
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