A tectonic shift is well underway for Pharma: the transformation to a Value-based Healthcare Ecosystem. Companies that rapidly adopt Value to Patients will reap sustainable competitive differentiation...Those who cling to today's broken system will become extinct...$2.7 Trillion is at stake!

1. Adverse Event
Patient Outcome Analyses
Untapped Potential for
Enhanced Patient Safety &
Sustainable Competitive
Differentiation
Philippe Barzin
Strategic Business Planning & Execution
PJB Management Consulting
www.philippebarzin.com

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A Tectonic Shift is Underway
U.S. Ranks Last on
Health System
Performance Based
on Measures of
Quality, Efficiency,
Access, Equity, and
Healthy Lives
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The Transformation to a Value-based Healthcare
Ecosystem is Well Under Way
From a fragmented supply-driven Health Care system to a patient-centered system
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Pharma is Jointly Accountable and
Not Ready Yet to be Part of the Solution
 Pharma still has a "one size fits all mentality“
 Pharma's narrow goals include improving
access, containing costs or boosting profits
 Payers and Patients are demanding
performance
 In the near future, we will be paid for value to
patients, not for products. To be ready and
rapidly improve the situation... Senior Leaders
need to commit to:
- Rigorously MEASURE VALUE FOR EACH
PATIENT- as close as possible to real time -
the accurate costs for the full care cycle,
outcomes that matter , how long the process
takes and how sustainable outcomes are.
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MDs Continuously Monitor Indicators,
Patients Care About Outcomes
PROSTATE CANCER
typical indicator: PSA
 Survive
 Become incontinent
 Experience ED
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DIABETES
typical indicator: HbA1c
 Lose vision
 Need dialysis
 Undergo amputation
Proactively focus on meaningful outcomes to patients
before someone else does

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An Elegant Example for Baby Step?
• Founded in 2010
• Mission: reduce systemic healthcare
costs by improving patient safety
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RxFilter™ – making drug safety information
accessible through a proprietary 17-step
algorithmic process that refines the FDA
Adverse Events Reporting System (FAERS)
RxScore™ - making drug safety
information actionable through a predictive
algorithmic scoring model that provides a
drug safety ranking system based
predominately on post-marketing safety
signals
Interestingly, AdverseEvents also developed "RxOutcomes" which incorporates average cost of AEs with the average cost of the drug and "RxSignal" which
predicts FDA Alerts up to 3.5 years in advance, according to the company.
Disclaimer: I have no financial ties with AdverseEvents. I thank Jim Davis [EVP] for helping me prepare this part of my presentation

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Example of Comparative Outcomes: Diabetes
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PRR & ROR for “Death” Outcome: Diabetes

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Example of Comparative Outcomes:
Metastatic Prostate Cancer

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Zometa Outcomes – Illustrative Only
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Even With Clinical Trials, it is Impossible to Fully Understand the Impact
of any Particular Medical Drug or Device Until it is Widely Used
• Internal pharmacovigilance
• FDA’s AERS database
• WHO’s VigiBase™
Coming soon:
• Safety observations in ACO
& IDN Electronic Health
Records (EHR)
• Safety observations in
social media
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PhRMA, FDA and NIH Partner to Study
More Holistic Observational Data (Claims & EHR)
OBSERVATIONAL MEDICAL OUTCOMES PARTNERSHIP
(OMOP)
•Since 2008, supports the management and analysis of data
accumulated from 100 + million patients
using Amazon’s Elastic Cloud Computing (EC2) technology
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Comprehensive and Standardized Outcome
Measurement on a Global Basis is Accelerating
Another
example:
ICHOM:
International
Consortium for
Health Outcomes
Measurement
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Major Barriers BUT This is Our New Normal:
$ 2.7 Trillion* is at Stake…
• Size and Complexity
• Lots of internal inertia
• “Technical barriers”
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*Estimated US Health Care Budget – Source: McKinsey

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Companies that Rapidly Adopt Value to Patients Will
Reap Sustainable Competitive Differentiation...Those
Who Cling to Today's Broken System Will Become
Extinct...
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16. Contact me:
Philippe.J.Barzin@gmail.com

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Key References
• Lee, Thomas H. "October 2013." The Strategy That Will Fix Health Care. Harvard Business
Review, n.d. Web.
• Mahon, Mary. "U.S. Ranks Last Among Seven Countries." - The Commonwealth Fund. The
Commonwealth Fund, 23 June 2010. Web.
• Porter, Michael E., and Elizabeth Olmsted. Teisberg. Redefining Health Care: Creating Value-
based Competition on Results. Boston, MA: Harvard Business School, 2006. Print.
• Goodman, John C. "Cost of Adverse Events" | NCPA. National Center for Policy Analysis
(NCPA), 7 Apr. 2011. Web. 17 Oct. 2013.
• Health Care Transparency 101. Castlight Health - Christine H. Evans, 1 Apr. 2013. Web.
• Latkovic, Tom. "Insights & Publications." Claiming the $1 Trillion Prize in US Health Care.
McKinsey, 1 Sept. 2013. Web.
• http://www.qualityforum.org/Setting_Priorities/Improving_Healthcare_Quality.aspx
• http://www.ncqa.org/Directories/HealthPlans/StateofHealthCareQuality.aspx
• http://www.adverahealth.com
• http://omop.org/
• http://ichom.org/#&panel1-2
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