DIAGNOSTICS:
LIFE PRESERVERS FOR PEOPLE AND ANTIBIOTICS
Barry Eisenstein, MD
Senior Vice President, Scientific Affairs
Cubist Pharmaceuticals
FIRST: IS THIS A BACTERIAL INFECTION?
Will this diagnostic innovation curb overuse and
eliminate/reduce misuse of antibiotics?
One of many examples …
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THIS IS HOW THE LONGITUDE PRIZE IS LOOKING AT IT
Criteria for entry evaluation
Entrants choose scope: (type of diagnostic and what infection)
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Differentiate between bacterial vs. viral infections
Distinguish between bacterial classes: G+ vs GIdentify specific bacterial strain and genus
Specifies resistance profile and AB susceptibility
Must be point-of-care
• level of resource required to use the diagnostic
• level of expertise required to administer it and
• time taken to provide result (the shorter, the better)
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TIMING IS EVERYTHING WITH ABX INTERVENTION
With compliments to John Rex’s “The Golden Hour”
• Gaieski DF, Crit Care Med 38: 1045-53, 2010
• When analyzed for time from triage to appropriate antibiotics, there
was a significant association at the <1 hour time cutoff
• Mortality 19.5 v. 33.2%; odds ratio, 0.30 [95% confidence interval,
0.11-0.83]; p = .02
• Kumar, ICAAC 2012
• “We see step-wise increases in mortality at 15-minute intervals”
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Rex JH - 2014-09-23 FDA-NIH Overview of diagnostics & development
… IN CLINICAL AND CLINICAL TRIAL SETTINGS
Prescribing antibiotics is a puzzle with extreme time
limitations for the sickest. Rapid diagnostics could result in:
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Targeted patient use
Better outcomes
Being better armed for the likely potential of bacterial outbreaks
More appropriate use, less resistance
Antibiotics trials cost more and take longer than they should.
Rapid diagnostics could result in:
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Targeted patient enrollment (right pathogen)
Faster enrollment + reduced contamination with prior use
Optimized spending that can be re-invested in discovery
Maybe superiority trials could be possible someday
DIAGNOSTICS CAN MAKE A DIFFERENCE … BUT:
We could have the greatest, most informative diagnostic test
available tomorrow, but if the results can’t be acted on at the
point of and time of care, the key issue of mortality will not
be addressed
• Access to a rapid result is critical
• Reimbursement continues to be an issue for the therapeutic, but
even more so for the diagnostic
Unlike oncology, we are not talking about “companion
diagnostics” where reimbursement and use of diagnostics
and therapeutics are coupled
• Until we have true rapid diagnostic tools, we MUST use empiric
therapy - remember the clock is ticking
• Traditional culture and susceptibility testing will ALWAYS have a role
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MORE ABOUT THE ECONOMICS (AND THE ECOLOGY)
• Pressing need to unite economic interests of various stakeholders to realize
system-level benefits to hospitals and payers
• Quick and appropriate antibiotic use leads to lower mortality rates, shorter
hospital stays and decreased costs
• Conversely, appropriate antibiotic restriction has profound environmental
benefits and reduces emergence of resistance. Good comes in both
directions when you use the right drug at the right time for the right
duration – the true meaning of “antibiotic stewardship”
• Appropriate antibiotics and related ID diagnostics should be considered for
reimbursement based on value each offers the system
• On September 19th Cubist submitted its position on reimbursement
enhancements to the U.S. House of Representatives Committee on Energy
and Commerce. You can read the full document in the News section of
cubist.com
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30-YEARS OF DATA. WHERE HAS INNOVATION THRIVED?
Diseases
Cost of Therapy
$50K
Measured By
$100K
+$200,000
Orphan disorders
$100,000
Select new cancer
Annual costs
Course of therapy
$50,000
Annual costs
$100,000+
Course of therapy
Multiple sclerosis
Hepatitis C
$200K
Lupus
$35,000
Annual costs
Antibacterial
Infections
$3,000
Course of therapy
For illustrative purposes only.
Investors have rewarded companies working in markets with high &
predictable prices – while antibiotics have not kept pace … Yet infections,
because of resistance, drive a need for never-ending innovation
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THIS MATTERS: FOR REAL PEOPLE IN THE REAL WORLD
With compliments to Charlene Reed
Societal awareness is improving, but remains low. We are talking about a
global pandemic … why isn’t anyone addressing this?
• Anyone
• Anywhere
• Anytime
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• Not a chronic condition
• Not specific to a body area