Competing in Outcomes World - Chris Bogan Keynote - Final

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Competing in An Outcomes-Oriented Healthcare World

Presented by Chris Bogan, Chief Executive Officer

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What We See Influences How We Act! How Many Faces Do You See?

Source: Three Faces at http://www.mindfake.com/illusion_41.html

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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

“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

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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

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

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For 2400 Years, Physicians Have Tried To Heed The Words of Hippocrates

“First do

no harm .

. . . .”Hippocratic

Oath

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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 MillionPursued by Medical

Collections1.7 MillionBankrupt

by Medical Bills

56 Million: Trouble Paying

Med Bills

17 Million: Credit ratings hurt by Med

Bills

15 MillionDeplete 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/

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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 OUTCOMESRESEARCH DURING THE NEXT 24 MONTHS?”

Michael Porter Has Conceptualized The “Hierarchy Of Outcomes” -- But They Reflect Only Clinical Outcomes

Sustainability of health or recovery and nature of recurrences

Tier 1Health Status Achieved or

Retained

Tier 3 Sustainability

of Health

Tier 2Process 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-inducedillnesses

Source: Michael E. Porter, What Is Value In Health Care?, N Engl J Med 2010; 363:2477-2481December 23, 2010DOI: 10.1056/NEJMp101102

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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

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Source: Best Practices ,LLC Field Research & Analysis

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”

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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

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N = 32



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

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”

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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

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”


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

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Patient-Reported-Outcomes Via Social Media May Become A “Disruptive Technology” in Healthcare

Founded 2006 Conditions: fibromyalgia,

multiple sclerosis, ALS +

2000 othersConcluded 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

“. . . 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 SciencesQ1-2014 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

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


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


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 KOLsand 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 KOLSRE: OUTCOMES


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 COMPARATIVEEFFECTIVENESS RESEARCH DURING THE NEXT 24 MONTHS?”

Crowded Market CER

N = 32

CER vs. Generics

CER vs. Fixed Dose Combos


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.htmlPage | 25

Measuring Outcomes Quality Requires Multiple Metrics Reaching Across Patients, Payers & Providers

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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

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Survival, Safety,

Efficacy & Quality of

Life


(Efficacy + QOL –Safety Risk Factors – Rehospitalizatiza-

tion – Total Cost)

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(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

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!

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Best Practices, LLC

Source: BP,LLC Field Research & Analysis

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About The SpeakerChris 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 Reader Ratings –

Customer Satisfaction

PHARMA-CEUTICALS

BIOTECH

CRO’s

COMMER-CIAL / R&D

HOSPITALS

MEDICALDEVICE

GROUPPROBLEMSOLVING

Client Sectors

E-mail: [email protected] (Phone) 919-767-9228

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Learn More About Our Company

Our company is an internationally recognized thought leader in the field of best practice benchmarking®. Weprovide research, consulting, benchmark database, publishing and advisory services to thebiopharmaceutical and medical device sectors. We work closely with business intelligence groups. Our workis based on the simple yet profound principle that organizations can chart a course to superior economicperformance by leveraging the best business practices, operating tactics and winning strategies of world-class companies.

Best Practices, LLC6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517

www.best-in-class.comPhone: (919) 403-0251

Competing in Outcomes World - Chris Bogan Keynote - Final

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