disseminate clinical data early to support payer coverage decisions
TRANSCRIPT
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Early Dissemination of Clinical Data to Support Payer Coverage Decisions
Todd Berner MDHealth Outcomes and PharmacoeconomicsResearch & Development Endo PharmaceuticalsDecember 7, 2011
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©2010 Endo Pharmaceuticals Inc.
COMPARATIVE EFFECTIVENESS RESEARCH AND HEALTH TECHNOLOGY ASSESSMENT What are the Evidentiary Standards for CER? What is the role of Cost in CER? What is the relevant Comparator? Should CER be limited to just drugs? What should Decision Makers do when CER yields
ambiguous results?
Nellesen D, et al Pharmacoeconomics 2010
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©2010 Endo Pharmaceuticals Inc.
PATIENT HETEROGENEITY AND DRUG DEVELOPMENT
Investigating different patient populations early in the Drug Development path
Hypothesis development aroundSubgroup responseBiomarkersGenetic markersPROs
Incorporate into Phase III development plan
Nellesen D, et al Pharmacoeconomics 2010
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©2010 Endo Pharmaceuticals Inc.
TAILORED THERAPEUTICS
Creating Value By defining
who not to treat as much (as not more as) who to treat
Subgroups at higher risk for adverse events Risks
May require bigger and even more expensive Clinical Trials in order to power subgroup analyses
Nellesen D, et al Pharmacoeconomics 2010
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©2010 Endo Pharmaceuticals Inc.
CONFLICT BETWEEN CER AND REGULATORY DECISION MAKING BODIES
Research needs to be extremely responsive to the policy decision makers who shall implement it
Yet the whole research enterprise is really set up to not accomplish that
Nellesen D, et al Pharmacoeconomics 2010
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THE BENEFITS OF ESTABLISHING OPEN DIALOGUE WITH PAYERS THROUGHOUT THE DEVELOPMENT
PROCESS
Successful products must provide meaningful value
that payers appreciate
FDA approval is not enough, products have to fulfill unmet medical and
economic needs
Relationship with payers can help tailor a clinical
development strategy that demonstrates both clinical
and economic value
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DESIGN A CLINICAL PROGRAM TO DEMONSTRATE VALUE
Phase I Indication Selection Unmet Need
Phase II Meaningful Endpoints
PROEconomics
Phase III
Trial Design Comparators
Phase IV
Real World Risk Sharing
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WHAT KIND OF FOOTPRINT IN THE FIELD DOES IT TAKE?
Clinical Experience Existing Managed Care Pharmacy Network Clinical Development Background REMS Implementation Experience Analytic Capabilities
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REGIONAL AND NATIONAL (CORPORATE) ALIGNMENT OVERLAY
CorpCorp
CorpCorp
Corp
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HOPE FIELD TEAM
HOPE Field Team
Disseminate outcomes and
pharmaco-economic
data
Expand visibility in managed markets
Assess customer needs and
develop product- specific
analytics
Respond to payor
requests for scientific data
Conduct research that support Endo
products
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HOPE FIELD TEAM-- EXECUTION
OBJECTIVE: Account Plans for top accounts
Identify each customer’s business strategy, strengths, and challenges
Inform customers of the clinical, social, and economic benefits of Endo‘s existing and pipeline products
Collaborate with Managed Markets and Sales/Marketing to manage the business by setting shared objectives
Create influence maps for each customer SMART Results, as of a date certain
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U n d e rs ta n d th e C h a n n e l D y n a mic s
Member
Reimbursement
Enrollment
F-Tags
AdjudicatePrior Authorization
PA
MTMServices
Lidoderm Rx
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MedicationReconciliation
Prescriber
BedRetention
LTCFacility
LTCPharmacy
ConsultantPharmacist
Reimbursement
Medicare PlanSponsor
Quality Rating Stars
CMS
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IT ALL BEGINS IN THE FIELD WITH A CLIENT MEETING
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ESTABLISH A DIALOGUE
Identify the Right payers
Individuals
Employers
Government
Health Care Delivery
OrganizationsInstitutions Medical
Providers Pharmacy Providers
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ESTABLISH A DIALOGUE
Identify the Right payers
Create a Safe Environment Allow for Time
Ask Meaningful Questions
LISTENDon’t Preach
Follow Up and Confirm
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DEVELOP ORGANIZATIONAL CAPABILITIES
Objective: Achieve cross-functional excellence with
Managed Markets Field Sales Government Affairs Business Development Pricing and Reimbursement Medical Affairs and Clinical Development
Strategy: Establish cross functional partnerships and joint business plans
specific to each region Protocols for roles in developing timely Outcomes studies.Measurement: Supportive policies and processes within HOPE identified,
developed and adopted
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Objective : Leverage HOPE core competencies to strengthen company position
with managed care customers to obtain superior growth from key products
Strategy: Utilize pharmacoeconomic and analytic resources developed by
HOPE team to communicate the value of company products to managed care decision-makers
Collaborate with payers to provide them analytic tools and data customized to their subscriber populations
Measurement: Successful execution of HOPE projects involving payers, regional
outcomes centers, State and Federal government agencies
HOPE FIELD TEAM EXECUTION
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HEALTH OUTCOMES STRATEGY TEAMS
HEOR Strategic
LeadProject
Management
Brand Marketing
Compliance
LegalRegulatory
Managed Markets Accounts
Managed Markets
Marketing
Medical Director
Care pathway
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©2010 Endo Pharmaceuticals Inc.
HEALTH OUTCOMES STRATEGY TEAMS
Cross-functional Project Teams (HOST) Aligned along Care Pathway’s Vetting Proposed Projects CASE Format
Concept Analysis Solution Execution
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WHAT WE DO…DEMONSTRATE VALUE
Concept
Analysis
SolutionExecution
CASE
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grow. collaborate. innovate. thrive.
©2010 Endo Pharmaceuticals Inc.
THE PLATFORM
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CHADDS FORD, PENNSYLVANIA 19317
Responsible Opioid Prescribingand UtilizationTodd Berner MD
Health Outcomes and PharmacoeconomicsResearch and Development
Endo Pharmaceuticals
June 13th 2011
22Endo Pharmaceuticals Responsible Opioid Prescribing and Utilization Series. © 2010 Endo Pharmaceuticals. OP-0453/May 2010.
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CHADDS FORD, PENNSYLVANIA 19317
The Challenges for Managed Care Organizations
Assure access to effective therapies for patients who need pain relief
Control or reduce costs associated with inappropriate opioid use
23Endo Pharmaceuticals Responsible Opioid Prescribing and Utilization Series. © 2010 Endo Pharmaceuticals. OP-0453/May 2010.
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The Foundation
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OPANA® ER Users Consumed Fewer Pills per DayCompared to OxyContin® Users
DACON analysis demonstrates opioid choice can affect use patterns
Considerations for overall use patterns, in addition to direct pill costs, have important economic implications for MCOs
Overall, OPANA ER users took 2.2 tablets, while OxyContin userstook 2.6 tablets per day for LBP and OA.
Endo Pharmaceuticals Responsible Opioid Prescribing and Utilization Series. © 2010 Endo Pharmaceuticals. OP-0453/May 2010.
Berner T, et al P&T Journal Mar 2011
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CHADDS FORD, PENNSYLVANIA 19317 Endo Pharmaceuticals Responsible Opioid Prescribing and Utilization Series. © 2010 Endo Pharmaceuticals.
Prevalence and Economic Impact of CYP450 Pharmacokinetic Drug-Drug
Exposures (DDEs) among Patients Taking Opioids
Health Outcomes and PharmacoeconomicsResearch and Development
Endo Pharmaceuticals
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Drug-Drug Exposure: A New Surrogate
Marker for DDIConcomitant use of opioids and other drugs that are metabolized by the CYP450 enzyme system possibly result in DDIs, which may alter the metabolism and/or elimination of 1 or more ofthe drugs1,2
The effect of CYP450 opioid DDEs can lead to dangerous DDIs caused by1,2:
Increases in plasma concentrations that can be toxic
Decreases in plasma concentrations that can lead to decreased efficacy and the need to increase dosages
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1. Goodman LS, Limbird LE, Milinoff PB, et al, eds. Goodman and Gilman's: The Pharmacological Basis of Therapeutics. 9th ed. New York, NY: McGraw Hill; 1996.2. Hartshorn EA, Tatro DS. Principles of drug interactions. In: Tatro DS, ed. Drug Interaction Facts. 5th ed. St Louis: Facts and Comparisons; 1996:xix. 3. Holmquist GL. Pain Medicine. 2009;10(1):S20-S29.
Endo Pharmaceuticals Responsible Opioid Prescribing and Utilization Series. © 2010 Endo Pharmaceuticals.
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CHADDS FORD, PENNSYLVANIA 19317
Simple Budget Impact Calculator
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LegendTotal Plan Membership 14,288,181 Default, User Input
Total # of patients, oxy & oxm 87,956 OxyContin® 3.1 Calculation
Total # of Chronic Users*, oxc & oxm(LA) 7,363 OPANA® ER 2.5Average Number of Months on Therapy 12
Absolute Count Percent Mix
OxyContin® 6,567 89.2%
OPANA® ER 796 10.8%TOTAL 7,363 100%
Tier Status Average Co - PayAverage
Coinsurance
OxyContin® Tier 3 $50.00 38%
OPANA® ER Tier 2 $25.00 25%
Patient Cost Sharing MixCo-pay 86%Coinsurance 14%
TOTAL 100%
OxyContin® OPANA® ERAverage WAC per Tablet $5.97 $6.64Rebate (%) 0% 0%
Cost To Plan: OxyContin® OPANA® ERCost per Tablet $5.97 $6.64Cost per Day / Patient $18.50 $16.59Cost per Month / Patient $555 $498
Cost per Year / Patient $6,662 $5,974
Plan Cost per Patient Per Year $5,786 $5,503
(Net Rebates & Cost Share)
Current Low Conversion Expected Conversion High Conversion% Oxycontin patients 89% 0% 0% 0%% OPANA ER patients 11% 0% 0% 0%Est. Budget Impact ($) $42,375,916 $0 $0 $0
Reimbursement
Chronic Utilization Detail
Budget Impact Calculations
Patient Cost Sharing
Daily Average Supply (DASUP)Daily Average Consumption (DACON)
OPANA ® ER Budget Impact Calculator June 6, 2011
Utilization
$0
$10,000,000
$20,000,000
$30,000,000
$40,000,000
$50,000,000
Current Low Conversion Expected Conversion High Conversion
Default
Default
Default
Default
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CHADDS FORD, PENNSYLVANIA 19317
Full Economic Model
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Figure 1: Hypothetical Cost Savings of Migration from OxyContin® to OPANA® ER In the hypothetical example, there are 1,000 patients prescribed OxyContin®, with a monthly per patient cost of $1,000 (medical and drug), and 200 patients prescribed OPANA® ER, with a monthly per patient cost of $950. If 20 percent of the OxyContin® patients (i.e., 0.2 x 1,000 = 200) are migrated to OPANA® ER, then the realized cost savings are 200 x $50 = $10,000, where $50 is the per patient monthly cost difference between patients prescribed OxyContin® and patients prescribed OPANA® ER.
OxyContin® n = 1,000 patients Cost per patient-month = $1,000
OPANA® ER n = 200 patients Cost per patient-month = $950
20% of OxyContin® patients migrated = 200
Potential savings from migration per patient - month = $1,000 - $950 = $50
Total monthly plan savings = 200 x $50 = $10,000
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CHADDS FORD, PENNSYLVANIA 19317
A Dynamically Changing Landscape
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Daily Average Consumption (DACON) of Oxycodone CR and Oxymorphone ER Before and After the Introduction of
Reformulated Oxycodone CR
R. Amy Puenpatom, PhD,1 Kent Summers, PhD,1 Robert Garvin, MA,1 Larry Ma, PhD,1
Sheryl L. Szeinbach, PhD,2 Rami Ben-Joseph, PhD1
CR=controlled release; ER= extended release.1Department of Health Outcomes and Pharmacoeconomics, Endo Pharmaceuticals Inc., Chadds Ford, PA; 2Ohio State University, College of Pharmacy, Columbus, OH
This research was supported by Endo Pharmaceuticals, Inc., Chadds Ford, PA.
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grow. collaborate. innovate. thrive.
©2010 Endo Pharmaceuticals Inc.
PUTTING IT ALL TOGETHER:OUTCOMES BASED CONTRACTING
Reference Pricing v. Reward/Incentives Reguires:
Decision Tool Highlights Transparent Pricing Quality Outcomes Considerations of Plan Sponsor
Standardize and Calibrate Benefits
Center for Health Value Innovation Outcomes Based Contracting Frameworkhttp://www.vbhealth.org/wp-content/uploads/CHVI-OBCtm-MIP1.pdf
Accessed 12.7.2010