DIAGNOSTICS:LIFE PRESERVERS FOR PEOPLE AND ANTIBIOTICS

Barry Eisenstein, MD

Senior Vice President, Scientific Affairs

Cubist Pharmaceuticals

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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 ITCriteria for entry evaluation

Entrants choose scope: (type of diagnostic and what infection)

• Differentiate between bacterial vs. viral infections• Distinguish between bacterial classes: G+ vs G-• Identify 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

Rex JH - 2014-09-23 FDA-NIH Overview of diagnostics & development

• 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”

With compliments to John Rex’s “The Golden Hour”

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… IN CLINICAL AND CLINICAL TRIAL SETTINGS

Antibiotics trials cost more and take longer than they should. Rapid diagnostics could result in:

• 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

Prescribing antibiotics is a puzzle with extreme time limitations for the sickest. Rapid diagnostics could result in:

• Targeted patient use• Better outcomes• Being better armed for the likely potential of bacterial outbreaks• More appropriate use, less resistance

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DIAGNOSTICS CAN MAKE A DIFFERENCE … BUT:

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

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

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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

Diseases Cost of Therapy Measured By

Orphan disorders Annual costs

Select new cancer Course of therapy

Multiple sclerosis Annual costs

Hepatitis C Course of therapy

Lupus Annual costs

Antibacterial Infections Course of therapy

$50K $100K $200K

+$200,000

$100,000

$50,000

$100,000+

$35,000

$3,000

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 innovation8

30-YEARS OF DATA. WHERE HAS INNOVATION THRIVED?

For illustrative purposes only.

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THIS MATTERS: FOR REAL PEOPLE IN THE REAL WORLDWith compliments to Charlene Reed

• Anyone • Anywhere• Anytime

• Not a chronic condition• Not specific to a body area

Societal awareness is improving, but remains low. We are talking about a global pandemic … why isn’t anyone addressing this?