This document discusses assessing the value of new antibiotics through health technology assessment (HTA). It identifies four benefits typically included in HTA evaluations and six additional benefits not traditionally considered but relevant for antibiotics. These additional benefits include insurance value, diversity value, diagnostic value, uniqueness, enablement value, and spectrum value. The document notes that HTA methods may not fully capture the value of antibiotics in addressing antimicrobial resistance and that new payment mechanisms are needed given antibiotics must have limited use to delay resistance development.

1. Professor Adrian Towse
Director of the Office of Health Economics
Issues Panel
ISPOR 20th Annual European Congress, Glasgow 2017
How can we assess the value of
new antibiotics?

2. Taken from OHE-AIM publication, May 2017
• This Briefing, from OHE and the
Academy of Infection Management,
discusses 10 elements of value which
can be split into two groups: four
relevant benefits typically included in
HTA, and six other types of benefits
not traditionally included. These were
discussed at a multi-country, multi-
disciplinary, multi-stakeholder Value
Forum.
• Free download from
https://www.ohe.org/publications/additional-elements-
value-health-technology-assessment-decisions
• Or from https://www.aiminfection.org/article/bad-bugs-
undervalued-drugs-time-to-change-the-way-we-value-
antibiotics

3. HTA challenges for antibiotics
• Concerns that current HTA/payer methods
may not capture the full range of benefits of
antibiotics, including value of tackling AMR
• Two key challenges:
1. Clinical trials typically designed to demonstrate
non-inferiority, whereas HTA bodies generally
require demonstration of clinical superiority
2. HTA bodies/payers generally do not have a
mechanism to assess the broader public health
benefits of antibiotics, including tackling rise in
AMR

4. Additional Elements of Value Relevant to
Antibiotics
Relevant benefits included
in traditional HTA
Other types of benefit of
possible relevance to
antibiotics
Health gain Insurance value
Unmet need Diversity value
Cost offsets Diagnostic value
Productivity benefits Uniqueness or innovation value
Enablement value
Spectrum value
• Need also to focus on the evidence requirements for
new elements of value

5. Relevant benefits included in traditional HTA
Health gain
• Includes both life
extension and quality of
life gains
• Generally accepted as
key criterion for positive
HTA recommendation
• Evidence typically
required by HTA bodies
often unachievable for
antibiotics (superiority
trials)
Unmet need
• Includes both severity of
disease and current
availability of alternative
treatments
• Could include use of
priority pathogen lists

6. Relevant benefits included in traditional HTA
Cost offsets
• Reduction in costs in
other areas that come
from use of new medicine
• Use of modelling studies
and/or evidence from
clinical trials
Productivity benefits
• Gains or losses related to
value of patient’s time,
receiving medical care or
out of work
• Use of modelling studies
and/or evidence from
clinical trials /
observational studies

7. Other types of benefit of possible relevance
to antibiotics
Insurance value
• Value of having treatment
available in case of
catastrophic health event,
e.g. outbreak of MDR
infections which cannot be
contained by existing ‘last-
line’ antibiotics
• Analogous to availability of a
fire engine (Rex and
Outterson, 2016)
• Also need to add in the
“precautionary principle” –
maybe we have two fire
engines
• Use of modelling studies
Diversity value
• Selection pressure:
Antibiotic able to eradicate
susceptible species of
bacteria but not other
resistant pathogen so
resistant pathogens survive
and multiply and the
antibiotic becomes
ineffective
• Evidence that reducing
selection pressure by
withdrawing antibiotic for
period of time may lead to
restoration of
susceptibilities
• Use of modelling studies

8. Other types of benefit of possible relevance
to antibiotics
Diagnostic value
• If infection is accurately
and speedily diagnosed
then appropriate
antibiotic therapy can be
started earlier
• Need evidence of test
accuracy
Uniqueness or
innovation value
• Potential value associated
with new or unique
mechanism of action (MOA)
• antibiotics with novel MOA
may avoid problems of
cross-resistance seen
amongst existing classes
• Discovery of new MOA
antibiotic makes it easier
for “follow on” products to
enter market
• Evidence of new or unique
mechanism of action

9. Other types of benefit of possible relevance
to antibiotics
Enablement value
• Availability of effective
antibiotics underpins
many surgical procedures
and treatments for people
with compromised
immune systems
• Use of modelling studies
Spectrum value
• Narrow spectrum antibiotics
may be more valuable than
broad spectrum antibiotics
as could reduce spread of
AMR by preventing
‘collateral damage’ to the
microbiome
• Depends on the antibiotic

10. Innovation in Payment Mechanisms
• Good stewardship requires the use of new
antibiotics to be limited to delay the build up of
resistance.
• Volumes will be too low to give a return on
investment – even at prices that recognise all
of the value.
• Partial delinkage is needed between drug
volumes / use and revenue with some revenues
coming via a separate payment mechanism.
• Could be an insurance policy, or a per-member-
per-month fee.

11. Insights gained from the Value Forum
• Some of the additional elements of value not typically considered in
traditional HTA are not unique to antibiotics
• Transmission value is important in assessing the value of a vaccine
• Surrogate end-points are used in a number of disease areas
• Measurement of some elements likely to require modelling studies,
evidence on decision-makers and/or the public’s attitudes towards risk
• New elements of value should be seen as additional elements within
current HTA frameworks rather than requiring a completely new
assessment framework for antibiotics.
• Need for collaboration and/or engagement with international and global
organisations such the OECD and EUnetHTA.
• Need for different contractual arrangements to complement the value
assessment – cannot be delivered through a “high” price.

12. Adrian Towse
The Office of Health Economics
The Office of Health Economics is a charity (registration number 1170829) and
a company limited by guarantee (registered number 09848965)
Southside, 7th Floor, 105 Victoria Street, London SW1E 6QT
Website: www.ohe.org Blog: http://news.ohe.org
Email: atowse@ohe.org
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