disseminate clinical data early to support payer coverage decisions

grow. collaborate. innovate. thrive.

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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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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



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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



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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


grow. collaborate. innovate. thrive.grow. collaborate. innovate. thrive.

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


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


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


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

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

Buy SmartDraw!- purchased copies print this document without a watermark .

Visit www.smartdraw.com or call 1-800-768-3729.

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


ESTABLISH A DIALOGUE

Identify the Right payers

Individuals

Employers

Government

Health Care Delivery

OrganizationsInstitutions Medical

Providers Pharmacy Providers


ESTABLISH A DIALOGUE

Identify the Right payers

Create a Safe Environment Allow for Time

Ask Meaningful Questions

LISTENDon’t Preach

Follow Up and Confirm


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


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


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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HEALTH OUTCOMES STRATEGY TEAMS

Cross-functional Project Teams (HOST) Aligned along Care Pathway’s Vetting Proposed Projects CASE Format

Concept Analysis Solution Execution


WHAT WE DO…DEMONSTRATE VALUE

Concept

Analysis

SolutionExecution

CASE


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THE PLATFORM

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.


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.


The Foundation

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CHADDS FORD, PENNSYLVANIA 19317 25

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

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.


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


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


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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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

http://www.vbhealth.org/wp-content/uploads/CHVI-OBCtm-MIP1.pdf

disseminate clinical data early to support payer coverage decisions

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