The document discusses the importance of health economics and outcomes research (HEOR) in demonstrating the value of healthcare products to various stakeholders, including payers and patients. It outlines strategies to build product value by understanding stakeholder perspectives, assessing quality of life, and implementing effective HEOR tactics through case studies. The document emphasizes the need for innovative approaches to address pricing pressures and improve treatment outcomes in a changing healthcare environment.

1. Quality and Value Through Outcomes
Defining , Demonstrating, and
Measuring Value Through Health
Economics and Outcomes Research in
a New Payer Environment
EPI-Q, Inc.
Presented by:
Mark Jewell, Ph.D.
President, EPI Q
President, EPI‐Q
CBI Managed Care Marketing Strategies
Philadelphia, PA
Philadelphia PA
June 23‐24, 2010

2. Quality and Value Through Outcomes
Top Pressures on Life Sciences Companies
Demonstrating
value amid pricing
l id i i
pressures
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3. Quality and Value Through Outcomes
Presentation Objectives
• Defining value from perspective of Health Economics
and Outcomes Research (HEOR)
• Building product value – to encompass key stakeholder
p p
perspectives
• Developing and executing an HEOR strategy to build
the value story: case study
h l d
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4. Quality and Value Through Outcomes
Building Product Value…..Where We ve Come
Building Product Value Where We’ve Come
From and Where We’re Going
Current
• HEOR/Epi built
• Through value into clinical
add services • Pricing –clinical development
• Contracting differentiation program
strategies • Performance based • I l d
Include patient
ti t
(e.g., rebates) contracts; Slow perspective
traction • Healthcare
• Different countries
ff reform?
and messages Emerging &
Previously
Future
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5. Quality and Value Through Outcomes
Defining Healthcare (Product) Value

6. Quality and Value Through Outcomes
Definition of Healthcare Value
A measure of a stakeholder’s utility for a particular
combination of quality and output.
(AMA Physician Consortium for Performance Improvement, Aug 2008)
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7. Quality and Value Through Outcomes
Components of the Definition of
Components of the Definition of
Healthcare Value
Amount of benefit or satisfaction a
stakeholder receives from the
outputs or outcomes of healthcare
outputs or outcomes of healthcare
Multidimensional measure that
M ltidi i l th t Healthcare
Healthcare
assess benefit and is an objective
aspect of output or outcomes Value
Amount of benefit or satisfaction a
stakeholder receives from the
stakeholder receives from the
outputs of healthcare
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8. Quality and Value Through Outcomes
Determining Product Value From Stakeholders’
Perspectives

9. Quality and Value Through Outcomes
Stakeholder Perspectives in Determining Value
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10. Quality and Value Through Outcomes
Stakeholder Determination of Product Value
• What will new Rx add?
Strengths?
Limitations and gaps?
Li it ti d ?
Chronic, supportive,
acute therapy?
MANAGED • Impact on acute and down
CARE stream cost; provider and
patient considerations
d
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11. Quality and Value Through Outcomes
Stakeholder Determination of Product Value
• Concordant with available
evidence?
• Expedite employee return
Provider to work?
• Burden of illness
(productivity, accidents)?
Employer Patient • Impact on patient QOL and
functional status
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12. Quality and Value Through Outcomes
Assessing Commonalities Across Stakeholder
Assessing Commonalities Across Stakeholder
Perspectives
Managed
d
Employer Provider Patient
Care
Added clinical
benefit of treatment
b fi f X X X
Compliance and/or
Persistence X X
Impact on
productivity X X
Patient Reported
Reported
Outcomes X X
Decreased total cost X X
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13. Quality and Value Through Outcomes
Building the Value Story Through HEOR

14. Quality and Value Through Outcomes
20,000 Foot View of Value Building Process
20 000 F t Vi f V l B ildi P
20,000 Foot View of Value Building Process
• Why is there • What is value • What is CE of • Direct cost?
an unmet p p
proposition? product?
p
INNOVATIVE HEOR STRATEGIES ARE REQUIRED TO DEFINE DIFFERENTIATION
need? • Productivity
• Clinical, • Predicted impact?
“So
• Which economic, volume and
patient PRO growth What?”
• Cost to deliver
segments outcomes?
o tcomes? Productive? benefits?
Factor
Incremental Direct Cost?
benefit? Indirect?
New class?
Formulary
F l
Urgent Need? Appropriate Position &
Populations? Socioeconomic Pullthrough Access
Impact
Budget
B d t
Impact
Added Medical
Benefit
Unmet Need
Unmet Need
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15. Quality and Value Through Outcomes
Scalable Solutions Based on HEOR
Scalable Solutions Based on HEOR
Requirements
Sample Tactics
Clinical Prospective,
Outcomes Retrospective
iation
Study/Registry
g Value & Differenti
REMS
Productivity Prospective
and QOL y g y
Study, Registry,
PRO Survey
Safety Profile Database,
Registry, REMS
Registry, REMS
Increasing
Treatment & Database Studies
Monitoring
Cost
Burden of Proof
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16. Quality and Value Through Outcomes
EPI‐Q Strategic HEOR Road Map Activities
Phase IIIa
Phase IIIa Phase IIIb
Ph IIIb Regulatory
R l t Launch
L h
Phase I/II Planning Development Development Approval & Phase IV
•Value
Disease
•Disease Budget impact
•Budget impact HEOR message
•HEOR message
messaging/Product
/
mapping analyses dissemination
positioning
strategy
Trial
•Trial
•Field support •Effectiveness/
design/endpoint •Burden of illness
models outcomes studies
selection
•Plan any PRO
•Plan any PRO •AMCP formulary
•AMCP formulary
•Pricing evaluation •Utilization review
potential submissions
•Reimbursement & •Disease
•Economic •Field force
Market access
Market access management
management
modeling training
planning programming
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17. Quality and Value Through Outcomes
A Case Study of Erythropoietin
Stimulating Agents (ESA)

18. Quality and Value Through Outcomes
Overall Process for Developing HEOR Strategy
ll f l i
Develop Value Proposition
Establish Current Practice
and Define Gaps
Create HEOR Value
Proposition Pyramid™
Identify HEOR Tactics and
Prioritize
Prioritize
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19. Quality and Value Through Outcomes
Determining the Initial Value Proposition
• Review clinical trial data (Phase II)
• Interview key opinion leaders and/or prescribers
• Interview select sponsor representatives
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20. Quality and Value Through Outcomes
Product “X” Value Messages
Message 1 •Less need for dose titration
Message 2 • Reduce direct costs
Message 3 • Less adverse events
Message 4 • Improved patient compliance
• Reduce physician and staff
Reduce physician and staff
Message 5
management and monitoring time
20
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21. Quality and Value Through Outcomes
Overall Process for Developing HEOR Strategy
ll f l i
Develop Value Proposition
Establish Current Practice
and Define Gaps
Create HEOR Value
Proposition Pyramid™
Identify HEOR Tactics and
Prioritize
Prioritize
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22. Quality and Value Through Outcomes
Non‐Compliant Patients – Continuity of Care
Current Evidence
• 35‐55% of PD patients reported ESA non‐compliance.
• HD patients on EPO have lower mean Hb when HD sessions
HD patients on EPO have lower mean Hb when HD sessions
Rate of non‐ are missed
compliance
• Greater number of hospitalizations, higher subsequent
outpatient dose
• LOS <7 days receives appropriate dose whereas those in
Inpatient longer receive suboptimal dose resulting in lower mean Hb
ESA Use levels
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23. Quality and Value Through Outcomes
Non‐Compliant Patients – Continuity of Care
DATA GAPS
• The impact of extended dosing on resource
utilization, cost, and outcomes in compliant and
utilization cost and outcomes in compliant and
High non‐compliant patients
• Outcomes data related to breaches in ESA
continuity of care (e.g. missed scheduled
continuity of care (e.g. missed scheduled
Moderate doses/hospitalizations)
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24. Quality and Value Through Outcomes
Overall Process for Developing HEOR Strategy
ll f l i
Develop Value Proposition
Establish Current Practice
and Define Gaps
Create HEOR Value
Proposition Pyramid™
Identify HEOR Tactics and
Prioritize
Prioritize
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25. Quality and Value Through Outcomes
Value Proposition Pyramid
Safety
Mortality
Treatment of
Hyporesponse
Incidence of
Hyporesponse
Dose Response - Hb
Varibility
Non-compliant P ti t
N li t Patients
(persistence patterns)
Treatment and Monitoring Costs
T t t d M it i C t
25
6/29/2010 ©2010 EPI-Q, Inc.

26. Quality and Value Through Outcomes
Overall Process for Developing HEOR Strategy
ll f l i
Develop Value Proposition
Establish Current Practice
and Define Gaps
Create HEOR Value
Proposition Pyramid™
Identify HEOR Tactics and
Prioritize
Prioritize
6/29/2010 ©2010 EPI-Q, Inc. 26

27. Quality and Value Through Outcomes
Sample Scalable Solutions to Build Value Story
Value and Database Chart Health Prospective
Differentiation
Diff ti ti Study
St d Abstraction E
Ab t ti Economics (CEA, (R i t
i (CEA (Registry, cohort,
h t
Levels CMA, Modeling) Patient Reported
Outcomes)
Tx and Monitoring
and Monitoring
Costs
X
Compliance and/or
Persistence X
Dose Response X X
Incidence of
hyporesponse
Treatment/ X X
outcome of X
hyporesponse
Safety, mortality X X X
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28. Quality and Value Through Outcomes
Sample HEOR Planning Template
Primary
Primary Describe annual use and cost of therapies, lab tests,
Describe annual use and cost of therapies, lab tests,
Objective transfusions, and diagnostics
Secondary
Secondary Describe differences in resource use, controlling for
Describe differences in resource use, controlling for
Objectives comorbidities, hospitalization incidence, and dialysis vintage
Population Adult hemodialysis and peritoneal dialysis patients
Adult hemodialysis and peritoneal dialysis patients
Retrospective, database study supplemented with SDO
Study Design
chart/database review.
Sample Fe, lab, costs/patient Av # transfusions
Endpoints Mean dose
Mean dose Incidence Fe
Incidence Fe utilization
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29. Quality and Value Through Outcomes
Innovative HEOR Tactics Toward Building Value
STABLE and AIS
STABLE and AIS
Projects –
Outside the Box
$$$
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30. Quality and Value Through Outcomes
American Insomnia Study (AIS):
American Insomnia Study (AIS):
Outcomes and Key Value Points
•P
Proved disease state was more prevalent….identifying
d di t t l t id tif i
a potentially larger market
•D
Demonstrated that 30% of productivity lost by
t t d th t 30% f d ti it l t b
employers and 10% of all accidents is due to poor
sleep….potential for new prescriptions by expanding
the market and increasing access
• Influenced policy to increase number of patients
receiving a diagnosis….and eligible for treatment
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31. Quality and Value Through Outcomes
Case Studies Across Brand Life Cycle
Case Studies Across Brand Life Cycle
Project Phase Challenge HEOR Tactic
American III •Elevate importance of •Prospective
Insomnia
Insomnia insomnia among payers
insomnia among payers epidemiological xx‐
Study (AIS) because of perceived low sectional study of PRO
burden of illness and resource utilization
(11,000 plan members)
•Inadequate screener for
•Inadequate screener for
insomnia •Conducted in largest
commercial plan
•Incomplete understanding of
prevalence (wide variability a
prevalence (wide variability a •International thought
•International thought
function of existing diagnostic leaders led initiative:
criteria) credibility and
subsequent platform
for messages
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32. Quality and Value Through Outcomes
STandArds for BipoLar Excellence (STABLE) P j t
ST dA d f Bi L E ll (STABLE) Project:
Outcomes and Key Value Points
• Potentially increased number of patients diagnosed
with bipolar disorder through performance
measures…. potentially improving market share
measures potentially improving market share
• Engaged patient advocacy groups …..creating
significant goodwill among major stakeholders
significant goodwill among major stakeholders
• Obtained agreement of VA and major plans to test
measures for full implementation…..potentially
measures for full implementation potentially
improving market share and access
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33. Quality and Value Through Outcomes
Case Studies Across Brand Life Cycle
Case Studies Across Brand Life Cycle
Phase Challenge Solution
Standards for IV p
•National emphasis to , p
•Canvass literature, sample
Bipolar screen for and treat interviews of health plans,
Excellence major depressive primary care physicians (KABP)
(STABLE disorder •Measurement based QI program
Project)
P j t) •In our research, only (performance measures)
38% PCPs screened for complimenting current initiatives
bipolar disorder before for major depressive disorder
treating for depression. •Engage KOL’s and patient
treating for depression •Engage KOL’s and patient
•Only 40% of PCPs advocacy
screened for risk of •Obtained endorsement of
suicide in patients with National Quality Forum (NQF)
National Quality Forum (NQF)
bipolar disorder
•Hold consensus conference to
intro measures
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34. Quality and Value Through Outcomes
Contact Information
CHICAGO Mark A. Jewell, PhD
1315 West 22nd Street President
Suite 410 Email mark.jewell@epi‐q.com
Oak Brook, Illinois 60523
Oak Brook Illinois 60523 Tel +1 630 570 5505 ext 22
T l 1 630 570 5505 22
USA Mobile +1 630 605 2391
Laura Romeu
Laura Romeu
Executive Vice President
Email laura.romeu@epi‐q.com
Tel +1 630 570 5505 ext 26
Mobile +1 630 805 2328
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