1. 1
Competing in An Outcomes-Oriented
Healthcare World
Presented by Chris Bogan,
Chief Executive Officer

2. Page | 2
What We See Influences How We Act!
How Many Faces Do You See?
Source: Three Faces at http://www.mindfake.com/illusion_41.html

3. Page | 3
Which Figure Is Largest In This Optical Illusion?
Do We React To Healthcare Stakeholders In This Same Way?
Source: Three Faces at http://www.mindfake.com/illusion_41.html

4. “We always overestimate the
change that will occur in the next
two years and underestimate the
change that will occur in the next
ten. Don't let yourself be lulled into
inaction.”
– Bill Gates
We Overestimate The Pace Of Change And Underestimate The
Long-term Impact Of Change: Consider Health Outcomes
NATIONAL STRATEGY FOR QUALITY IMPROVEMENT IN HEALTH CARE.
‘‘(a) ESTABLISHMENT OF NATIONAL STRATEGY AND PRIORITIES.—
‘‘(1) NATIONAL STRATEGY.—The Secretary, through a transparent collaborative
process, shall establish a national strategy to improve the delivery of health care
services, patient health outcomes, and population health. . . .
- Excerpted from the Patient Protection and Affordable Care Act, 2010
Page | 4

5. Increasingly Doctors Consider Cost as Part of the Treatment
Algorithm – Affecting A Product’s Launch & Growth Potential
Cost & Insurance Plan Become A Critical
Consideration
Stent Patients Can Clot Post
Surgery
“Do you have good insurance?”
That’s critical to ask your patients. If
you have any concern, then you
wouldn’t want to put them (stent
patients) on prasugrel. The higher co-
pays could mean they don’t fill their
prescription or they miss starting or
taking their medicine. With stent
patients, you just don’t want to take
that risk.”
-- Cardiologist & Epidemiologist, Duke
University Medical Center
Post-Mortem Analysis of A Disappointing Launch for Effient
Page | 5Source: BP,LLC Field Research

6. Memorial Sloan Kettering Cancer Center Now Believes Cost Is A
Legitimate Criteria By Which To Assess Treatments
“AT Memorial Sloan-
Kettering Cancer Center, we
recently made a decision
that should have been a no-
brainer: we are not going to
give a phenomenally
expensive new cancer drug
to our patients. . . .”
NY Times OpEd Column
Page | 6

7. For 2400 Years, Physicians Have Tried To Heed The Words of
Hippocrates
“First do
no harm .
. . . .”
Hippocratic
Oath
Page | 7

8. Is A Physician “Doing Harm” If He / She Knowingly Prescribes
Treatments That Increase Patient Risk Of Personal Bankruptcy?
Number of Americans Struggling Under Medical Bills
35 Million
Pursued by Medical
Collections
1.7 Million
Bankrupt
by Medical
Bills
56 Million:
Trouble Paying
Med Bills
17 Million:
Credit ratings
hurt by Med
Bills
15 Million
Deplete savings
to pay Med Bills11 Million:
Run Up Credit
Card Debt to pay
Med Bills
10 Million:
Skimp on food, rent
& heat to pay Med
Bills
Medical Bills Are Greatest Single
Cause of Personal Bankruptcy in U.S.
Source: Stats from Nerdwallet Health - http://www.nerdwallet.com/blog/health/2014/03/26/medical-bankruptcy/
Page | 8

9. Our Field Research Picks Up Many Market Signals That Companies Are
Accelerating Their Investments Into Outcomes Research
Effective
Outcomes
Research is
Increasing in 7 of
10 companies in
next 24 months
N = 32
Page | 9Source: BP,LLC Field Research
“WHAT IS YOUR ORGANIZATION’S EXPECTED INVESTMENT FOR HEALTH OUTCOMES
RESEARCH DURING THE NEXT 24 MONTHS?”

10. Michael Porter Has Conceptualized The “Hierarchy Of Outcomes”
-- But They Reflect Only Clinical Outcomes
Sustainability of health or recovery and nature of
recurrences
Tier 1
Health Status
Achieved or
Retained
Tier 3
Sustainability
of Health
Tier 2
Process of
Recovery
Survival
Degree of health or recovery
Time to recovery and time to return to normal activity
Disutility of care or treatment process (e.g. , diagnostic
errors, ineffective care, treatment-related discomfort,
complications, adverse effects)
Long-term consequences of therapy (e.g., care-induced
illness)
Recurrences
Care-induced
illnesses
Source: Michael E. Porter, What Is Value In Health Care?, N Engl J Med 2010; 363:2477-2481December 23, 2010DOI: 10.1056/NEJMp101102
Page | 10

11. Outcomes Innovation Is Another Strong Signal As New
Technologies Transform Many Conditions & Therapeutic Areas
Innovative
Outcomes
Research is
Increasing in
nearly 6 of 10
companies next
24 months
N = 32
Page | 11
“WHAT IS YOUR ORGANIZATION’S EXPECTED INVESTMENT FOR HEALTH OUTCOMES
RESEARCH DURING THE NEXT 24 MONTHS?”
Source: Best Practices ,LLC Field Research & Analysis

12. New Genomics Technologies Help Align Treatments With Specific
Sub-populations To Improve Health Outcomes
"By combining our expertise
in molecular diagnostics and
cancer research, we have
developed the first genetic
test to help doctors prescribe
the appropriate treatment for
kidney cancer patients based
on their tumor profile.“
--Executive Director Professor Jackie
Y. Ying, Exec. Director,
Institute of Bioengineering and
Nanotechnology (IBN), Singapore
General Hospital (SGH) and National
Cancer Centre Singapore (NCCS)
Coloured urogram (X-ray) of the left kidney of a patient with renal
clear cell carcinoma (blue).
Credit: Sovereign, ISM/Science Photo Library
“FIRST EVER KIDNEY CANCER MOLECULAR TEST PREDICTS
PATIENT’S SURVIVAL AND DRUG RESPONSE”
Page | 12

13. Patient-reported Outcomes Research Is A Critical Priority – Revealing
Patients Often View Successful Treatment Differently Than Clinicians
Patient-reported
Outcomes
Research is
Increasing in 5 of
10 companies
next 24 months
Page | 13
N = 32
“WHAT IS YOUR ORGANIZATION’S EXPECTED INVESTMENT FOR HEALTH OUTCOMES
RESEARCH DURING THE NEXT 24 MONTHS?”
Source: Best Practices ,LLC Field Research & Analysis

14. When One Examines Investment Along the Patient Journey, You
See Many Missed Opportunities
14
21%
10%
20%
17%
15%
Average % of Patient Initiatives Budget Invested at Each Stage of Patient Journey
Stage II:
Diagnosis of Condition
Stage III:
Consideration of
Therapeutic Options
Stage V:
Disease Management
Stage IV:
Treatment
Stage VI:
Patient Empowerment
Phase I:
Awareness & Screening
(n=18)
17%
Page | 14Source: Best Practices ,LLC Field Research & Analysis

15. New Treatment Models Focus on Patient-centered Outcomes –
Often By Including Quality of Life and Functional Perspectives
Duke Model:
Integrating Palliative Care Into Chronic Cancer Care
Source: Dr. Arif Kamal, MD, Director of Quality & Outcomes, Duke Cancer Institute, “Ensuring High-Quality
Palliative Care in Oncology Practice”
Page | 15

16. PatientsLikeMe.com Has Created An Open Research Exchange for
Patient Reported Outcomes
PLM lets patients drive better reporting, tracking and metrics
for improved care, discovery and outcomes.
Page | 16Source: www.patientslikeme.com

17. Patients & Clinicians See the World Through Different Lenses
Clinical Voice:
“Gait Disturbance”
=
Medical term for
reduced walking or
Disturbance in how
one walks
Patient Voice:
“Bump into things,”
“Limping,”
“Walk like a drunk,”
“Foot dragging,”
“Problems with stairs,”
“Stumbling walk”
Page | 17Source: Best Practices ,LLC Field Research & Analysis

18. Patients – Through PRO Social Media -- Have Helped Reshape Diagnostics
for Conditions Like Fibromyalgia & Chronic Fatigue Syndrome
Old Diagnostic Sample:
“What’s Your Degree of Pep?”
New Diagnostic Uses Patient Perspectives To Reinvent
Diagnostic:
Source: “Pharmacotherapy for fibromyalgia”, published in Frontiers in Pharmacology, 30 March 2011 | doi: 10.3389/fphar.2011.00017, Howard S. Smith1*, Donna Bracken2 and Joshua M. Smith.
http://journal.frontiersin.org/Journal/10.3389/fphar.2011.00017/full
Page | 18

19. Patient-Reported-Outcomes Via Social Media May Become A
“Disruptive Technology” in Healthcare
Founded 2006
Conditions:
fibromyalgia,
multiple
sclerosis, ALS +
2000 others
Concluded ALS
Drug Did Not
Work 18 Months
Before Clinical
Trial Concluded,
2010
Among Top 50
Most Disruptive
Companies –
MIT Technology
Review, 2012
online
network of
+ 250,000
patients by
2014
April 2014:
Genentech
Enters 5-year
Subscription to
PatientsLikeMe
Database
Page | 19Source: Patientslikeme.com & Best Practices Analysis

20. “. . . Curing somebody for Hepatitis C has benefits
that go beyond the liver. It's recognized now that
hepatitis C is a chronic inflammatory condition that
over time leads to more diabetes, more heart disease,
more CNS disease and you could certainly
reasonably argue curing somebody of their hepatitis C
infection has collateral benefits that go beyond the
liver. And we've actually shown that in our own Phase
3 studies. It's a result that's somewhat
underappreciated. We have looked at PRO, patient
reported outcomes, and we have shown in a blind
fashion that the people in the studies that achieve an
SVR, they had much better outcomes than those that
didn't. And the better outcomes were they felt
better, they had less bodily pain and they had
even better mental health status.”
-- Norbert Bischofberger - Executive Vice President, R&D
and Chief Scientific Officer, Gilead Sciences
Q1-2014 analysts meeting transcript
Patient-Reported Outcomes Spotlight New “Off Balance Sheet”
Benefits Of Effective Treatment
Photo Source: Vertex Pharmaceuticals 2012 Annual Report;
http://investors.vrtx.com/2010ar/ Page | 20

21. The Payer Hierarchy of Outcomes Again Looks Very Different
From A Clinician’s View
Total Cost of
Care
Reduction
Cost
Avoidance
Reduced
Hospital Stay
Lower
Hospital Re-
admission
Price
Differentiation
/ Comparative
Effectiveness
Non-
responders
Quality of Life
/ AdherenceTreatment
Duration
Hospital Re-
admission
Rate
Price
Page | 21Source: Best Practices ,LLC Field Research & Analysis

22. 48%
The Rise of HEOR (Health Economics Outcomes Research) Groups
Signals New Emphasis on Outcomes Research for ACOs & IDNs
% Companies Rating Research
Partnerships With ACOs and IDNS
Highly & Somewhat Effective
• HEOR Leadership Is Ascending
• VP-level execs now often lead
HEOR
• HEOR specific roles emerging for
global & national units
Page | 22Source: Best Practices ,LLC Field Research & Analysis

23. Bio-Pharma Field Staff Acknowledge Their Companies At Times
Send Mixed & Confusing Signals To Thought Leaders
“Multiple people
(within our
company) are
engaging KOLs on
outcomes”
“Different team members offer / quote
different fee rates for KOL activities in
this area, confusing the KOLs
and making them distrustful”
“Lack of
communication on
learning”
“Lack of
communication
regarding
strategy”
“Poor coordination
across teams”
“Not clear why you are
engaging, what is the
business need. It can’t
simply be: ‘We’re
launching a product’. ” FIELD INTERVIEWS WITH BIO-
PHARMA STAFF CALLING ON KOLS
RE: OUTCOMES
Page | 23Source: Best Practices ,LLC Field Research & Analysis

24. Payers, Patients & Physicians All Seek More Comparative
Effectiveness Research (CER) Against Multiple Reference Points
CER vs.
Market Leader
“WHAT IS YOUR ORGANIZATION’S EXPECTED INVESTMENT FOR COMPARATIVE
EFFECTIVENESS RESEARCH DURING THE NEXT 24 MONTHS?”
Crowded
Market CER
N = 32
CER vs.
Generics
CER vs. Fixed
Dose Combos
Page | 24Source: Best Practices ,LLC Field Research & Analysis

25. National & Private Payers Are Examining CER to Assess Product
Differentiation and Reimbursement Merits
“. . . In an early benefit assessment pursuant to
the Act on the Reform of the Market for
Medicinal Products (AMNOG), the German
Institute for Quality and Efficiency in Health
Care (IQWiG) has examined whether this new
drug for MS offers an added benefit over the
appropriate comparator therapy specified by the
Federal Joint Committee (G-BA). However, no
added benefit can be determined, as no suitable
data are available, neither for the direct nor for
the indirect comparison.”
-- The German Institute for Quality and
Efficiency in Health Care (IQWiG)
August 1, 2014
Source: https://www.iqwig.de/en/press/press_releases/press_releases/dimethyl_fumarate_for_ms_added_benefit_is_not_proven.6230.html
Page | 25

26. Measuring Outcomes Quality Requires Multiple Metrics Reaching
Across Patients, Payers & Providers
26
The Holy Grail: Integrated Outcomes Reflecting All Three Perspectives
Family /
Caregiver
Satisfaction
Patient
Outcomes
Patient
Satisfaction
Physician
Satisfaction
Cost
Containment
Speed of
Action &
AEs
Payer
Recognition
Cost
Avoidance
Page | 26
Survival,
Safety,
Efficacy &
Quality of
Life
Source: Best Practices ,LLC Field Research & Analysis

27. (Efficacy + QOL –
Safety Risk Factors
– Rehospitalizatiza-
tion – Total Cost)
Page | 27
(Efficacy + QOL
Benefits – Safety,
Side Effects & Risk
Factors)
(Efficacy +Daily
Function + QOL
Benefits –
Safety Factors)
(Efficacy –
Price/Cost – CER v.
Generic -
Rehospitalization +
QOL Benefits)
Looking Forward, The First Bio-pharma Companies That Produce
Integrated Outcomes Research Will Have A Decided Advantage
3 Questions To Compete in An
Outcomes Oriented-World
1. Are you conducting research trials
focusing on clinical outcomes,
payer outcomes and patient-
reported outcomes?
2. Do you have a well conceived
strategic plan for your scientific
publications that includes all four
outcomes perspectives?
3. Do your scientific publications
report outcomes research findings
for Patient, Payer, Physician &
ACO/IDN perspectives?
Scientific Publication Audit Factors By
Stakeholder

28. Key Insights To Propel Your Organization Forward
1. Health outcomes is a cresting tsunami.
2. Investment levels are rising for all
outcomes types.
3. Patients, payers, physicians & ACOs/IDNs
use different metrics.
4. Patient social media platforms & ACO / IDN
networks are changing the healthcare
business model.
5. Integrated scorecards will include all
customer perspectives
6. Many companies seem slow in getting
ready to compete in an outcomes oriented
world!
Page | 28
Best Practices, LLC
Source: BP,LLC Field Research & Analysis

29. Page | 29
About The Speaker
Chris Bogan is founder & CEO of Best Practices, LLC, a global thought leader in the field
of best practice performance improvement for companies in the bio-pharmaceutical.
medical device and healthcare sector.
#1 On Amazon.Com
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Customer Satisfaction
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CEUTICALS
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CRO’s
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SOLVING
Client Sectors
E-mail: cbogan@best-in-class.com
(Phone) 919-767-9228

30. Page | 3030
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