cbi building product value (june 24 2010)final

Quality and Value Through OutcomesQuality 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‐QPresident, EPI Q

CBI Managed Care Marketing StrategiesPhiladelphia PAPhiladelphia, PAJune 23‐24, 2010

Quality and Value Through Outcomes

Top Pressures on Life Sciences Companies

Demonstrating l id i ivalue amid pricing pressures

6/29/2010 2©2010 EPI-Q, Inc.


Presentation Objectives

• Defining value from perspective of Health Economics and Outcomes Research (HEOR)

• Building product value – to encompass key stakeholder perspectivesp p

• Developing and executing an HEOR strategy to build h l dthe value story: case study

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Building Product Value Where We’ve ComeBuilding Product Value…..Where We ve Come From and Where We’re Going

Current• HEOR/Epi built

• Through value add services

• Contracting • Pricing –clinical differentiation

into clinical development programI l d ti tstrategies

(e.g., rebates)• Performance based contracts; Slow traction ff

• Include patient perspective

• Healthcare reform?

Previously

• Different countries and messages

reform?

Emerging & Future

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Defining Healthcare (Product) Value


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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Components of the Definition ofComponents of the Definition of Healthcare Value

Amount of benefit or satisfaction a stakeholder receives from the outputs or outcomes of healthcare

HealthcareM ltidi i l th t

outputs or outcomes of healthcare

Healthcare Value

Multidimensional measure that assess benefit and is an objective aspect of output or outcomes

Amount of benefit or satisfaction a stakeholder receives from thestakeholder receives from the outputs of healthcare

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Determining Product Value From Stakeholders’ Perspectives


Stakeholder Perspectives in Determining Value

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Stakeholder Determination of Product Value

• What will new Rx add?

Strengths?Li it ti d ?Limitations and gaps?Chronic, supportive, acute therapy?

MANAGED MANAGED CARECARE

• Impact on acute and down stream cost; provider and

dpatient considerations

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Stakeholder Determination of Product Value

• Concordant with available evidence?

ProviderProvider• Expedite employee return to work?

• Burden of illness (productivity, accidents)?

PatientPatientEmployerEmployer • Impact on patient QOL and functional status

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Assessing Commonalities Across Stakeholder

d

Assessing Commonalities Across Stakeholder Perspectives

ManagedCare

Employer Provider Patient

Added clinicalb fi f X X Xbenefit of treatment X X X

Compliance and/or Persistence X X

Impact on productivity X X

Patient ReportedPatient Reported Outcomes X X

Decreased total cost X X

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Building the Value Story Through HEOR


20 000 F t Vi f V l B ildi P• Why is there an unmet

• What is value proposition?

• What is CE of product?

• Direct cost?

20,000 Foot View of Value Building Process

INNOVATIVE HEOR STRATEGIES ARE REQUIRED TO DEFINE DIFFERENTIATION

20,000 Foot View of Value Building Process

need?

• Which patient segments

p p

• Clinical, economic, PRO o tcomes?

p

• Predicted volume and growth

• Productivity impact?

• Cost to deliver benefits?Productive?

INNOVATIVE HEOR STRATEGIES ARE REQUIRED TO DEFINE DIFFERENTIATION

“So What?” Factorsegments outcomes? benefits?

Incrementalbenefit?New class?

Direct Cost?Indirect?

Productive?

F l

Factor

Urgent Need?Populations?

B d t

Socioeconomic Impact

Formulary Position & Access

Appropriate Pullthrough

Unmet Need

Added Medical Benefit

Budget Impact

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Unmet Need


Scalable Solutions Based on HEOR

Sample Tactics

Scalable Solutions Based on HEOR Requirements

iation

Clinical Outcomes

Prospective, Retrospective Study/Registry

Differen

ti

Productivity and QOL

Prospective Study, Registry,

REMS

g Va

lue &

Safety Profile

y g yPRO Survey

Database, Registry, REMS

ncreasing

Treatment & Monitoring

Cost

Database Studies

Registry, REMS

Burden of Proof

I

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L hR l tPh IIIbPhase IIIa

EPI‐Q Strategic HEOR Road Map Activities

•Disease •Value /

•Budget impact •HEOR message

Launch & Phase IV

Regulatory Approval

Phase IIIbDevelopment

Phase IIIaDevelopmentPhase I/II Planning

Disease mapping

messaging/Product positioning

Budget impact analyses

HEOR messagedissemination strategy

•TrialTrial design/endpointselection

•Burden of illness •Field support models

•Effectiveness/ outcomes studies

•Plan any PRO •AMCP formulary•Plan any PRO potential

•Pricing evaluation •AMCP formularysubmissions

•Utilization review

•Economic•Reimbursement & Market access

•Field force •Disease management

modelingMarket access planning

trainingmanagement programming

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A Case Study of Erythropoietin Stimulating Agents (ESA)


ll f l iOverall Process for Developing HEOR Strategy

Develop Value Proposition

Establish Current Practice and Define Gaps

Create HEOR Value Proposition Pyramid™

Identify HEOR Tactics and Prioritize

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Prioritize


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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Product “X” Value Messages

•Less need for dose titrationMessage 1

• Reduce direct costsMessage 2

• Less adverse eventsMessage 3

• Improved patient complianceMessage 4

• Reduce physician and staffReduce physician and staff management and monitoring timeMessage 5

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Prioritize


Current Evidence

Non‐Compliant Patients – Continuity of Care

• 35‐55% of PD patients reported ESA non‐compliance.

• HD patients on EPO have lower mean Hb when HD sessionsRate of non‐compliance

• HD patients on EPO have lower mean Hb when HD sessions are missed

• Greater number of hospitalizations, higher subsequent outpatient dose

Inpatient Inpatient ESA Use

• LOS <7 days receives appropriate dose whereas those in longer receive suboptimal dose resulting in lower mean Hblevels

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Non‐Compliant Patients – Continuity of Care

DATA GAPS

• The impact of extended dosing on resource utilization cost and outcomes in compliant and

Highutilization, cost, and outcomes in compliant and non‐compliant patients

• Outcomes data related to breaches in ESA continuity of care (e.g. missed scheduled

Moderatecontinuity of care (e.g. missed scheduled doses/hospitalizations)

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SafetyMortality

Value Proposition Pyramid

Mortality

Treatment ofHyporesponse

Incidence of Hyporesponse

Dose Response - HbVaribility

N li t P ti tNon-compliant Patients (persistence patterns)

T t t d M it i C tTreatment and Monitoring Costs

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Value and Diff ti ti

Database St d

Chart Ab t ti

Health E i (CEA

Prospective(R i t h t

Sample Scalable Solutions to Build Value Story

Differentiation Levels

Study Abstraction Economics (CEA, CMA, Modeling)

(Registry, cohort, Patient Reported Outcomes)

Tx and MonitoringTx and Monitoring Costs

XCompliance and/or Persistence X

Dose Response X XIncidence of hyporesponsehyporesponse

X XTreatment/ outcome of hyporesponse

Xhyporesponse

Safety, mortality X X X6/29/2010 ©2010 EPI-Q, Inc. 27


Primary Describe annual use and cost of therapies, lab tests,

Sample HEOR Planning Template

Primary Objective

Describe annual use and cost of therapies, lab tests, transfusions, and diagnostics

Secondary Describe differences in resource use, controlling forSecondary Objectives

Describe differences in resource use, controlling for comorbidities, hospitalization incidence, and dialysis vintage

Population Adult hemodialysis and peritoneal dialysis patientsPopulation Adult hemodialysis and peritoneal dialysis patients

Study DesignRetrospective, database study supplemented with SDO chart/database review.

Sample Endpoints

Fe, lab, costs/patientMean dose

Av # transfusionsIncidence Fe utilization

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Endpoints Mean dose Incidence Fe utilization


STABLE and AIS

Innovative HEOR Tactics Toward Building Value

STABLE and AIS Projects –

Outside the Box

$$$

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American Insomnia Study (AIS):American Insomnia Study (AIS):Outcomes and Key Value Points

P d di t t l t id tif i• Proved disease state was more prevalent….identifying a potentially larger market

D t t d th t 30% f d ti it l t b• Demonstrated that 30% of productivity lost by 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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Case Studies Across Brand Life CycleCase Studies Across Brand Life CycleProject Phase Challenge HEOR Tactic

AmericanInsomnia

III •Elevate importance of insomnia among payers

•Prospective epidemiological xInsomnia

Study (AIS)insomnia among payers because of perceived low burden of illness

•Inadequate screener for

epidemiological x‐sectional study of PRO and resource utilization (11,000 plan members)

•Inadequate screener for insomnia

•Incomplete understanding of prevalence (wide variability a

•Conducted in largest commercial plan

•International thoughtprevalence (wide variability a function of existing diagnostic criteria)

•International thought leaders led initiative: credibility and subsequent platform for messages

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ST dA d f Bi L E ll (STABLE) P j tSTandArds for BipoLar Excellence (STABLE) Project: Outcomes and Key Value Points

• Potentially increased number of patients diagnosed with bipolar disorder through performance measures potentially improving market sharemeasures…. potentially improving market share

• Engaged patient advocacy groups …..creating significant goodwill among major stakeholderssignificant goodwill among major stakeholders

• Obtained agreement of VA and major plans to test measures for full implementation potentiallymeasures for full implementation…..potentially improving market share and access

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Case Studies Across Brand Life CycleCase Studies Across Brand Life CyclePhase Challenge Solution

Standards for IV •National emphasis to •Canvass literature, sample Bipolar Excellence (STABLE P j t)

pscreen for and treat major depressive disorder

, pinterviews of health plans, primary care physicians (KABP)

•Measurement based QI program Project) •In our research, only

38% PCPs screened for bipolar disorder before treating for depression

(performance measures) complimenting current initiatives for major depressive disorder

•Engage KOL’s and patienttreating for depression.

•Only 40% of PCPsscreened for risk of suicide in patients with

•Engage KOL’s and patient advocacy

•Obtained endorsement of National Quality Forum (NQF)

bipolar disorderNational Quality Forum (NQF)

•Hold consensus conference to intro measures

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CHICAGO

Contact Information

CHICAGO1315 West 22nd StreetSuite 410Oak Brook Illinois 60523

Mark A. Jewell, PhDPresidentEmail mark.jewell@epi‐q.comT l 1 630 570 5505 22Oak Brook, Illinois 60523

USA

Laura Romeu

Tel +1 630 570 5505 ext 22Mobile +1 630 605 2391

Laura RomeuExecutive Vice PresidentEmail laura.romeu@epi‐q.comTel +1 630 570 5505 ext 26Mobile +1 630 805 2328

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cbi building product value (june 24 2010)final

Documents

epi q president

outcomes scalable solutions

b ildi p

dincludepatientti t

rems registry

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anunmet p pproposition

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