Cbi Building Product Value (June 24 2010)Final
- 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 6/29/2010 ©2010 EPI-Q, Inc. 2
- 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 6/29/2010 ©2010 EPI-Q, Inc. 3
- 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 6/29/2010 ©2010 EPI-Q, Inc. 4
- 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) 6/29/2010 ©2010 EPI-Q, Inc. 6
- 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 6/29/2010 ©2010 EPI-Q, Inc. 7
- 8. Quality and Value Through Outcomes Determining Product Value From Stakeholders’ Perspectives
- 9. Quality and Value Through Outcomes Stakeholder Perspectives in Determining Value 6/29/2010 ©2010 EPI-Q, Inc. 9
- 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 6/29/2010 ©2010 EPI-Q, Inc. 10
- 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 6/29/2010 ©2010 EPI-Q, Inc. 11
- 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 6/29/2010 ©2010 EPI-Q, Inc. 12
- 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 6/29/2010 ©2010 EPI-Q, Inc. 14
- 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 6/29/2010 ©2010 EPI-Q, Inc. 15
- 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 6/29/2010 ©2010 EPI-Q, Inc. 16
- 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 6/29/2010 ©2010 EPI-Q, Inc. 18
- 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 6/29/2010 ©2010 EPI-Q, Inc. 19
- 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 6/29/2010 ©2010 EPI-Q, Inc.
- 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 6/29/2010 ©2010 EPI-Q, Inc. 21
- 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 6/29/2010 ©2010 EPI-Q, Inc. 22
- 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) 6/29/2010 ©2010 EPI-Q, Inc. 23
- 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 6/29/2010 ©2010 EPI-Q, Inc. 24
- 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 6/29/2010 ©2010 EPI-Q, Inc. 27
- 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 6/29/2010 ©2010 EPI-Q, Inc. 28
- 29. Quality and Value Through Outcomes Innovative HEOR Tactics Toward Building Value STABLE and AIS STABLE and AIS Projects – Outside the Box $$$ 6/29/2010 ©2010 EPI-Q, Inc. 29
- 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 6/29/2010 ©2010 EPI-Q, Inc. 30
- 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 6/29/2010 ©2010 EPI-Q, Inc. 31
- 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 6/29/2010 ©2010 EPI-Q, Inc. 32
- 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 6/29/2010 ©2010 EPI-Q, Inc. 33
- 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 6/29/2010 ©2010 EPI-Q, Inc. 34