evidence based outcomes strategies

To Register, please visit www.worldcongress.com/pharmaevidence Phone: 800-767-9499 • Fax: 781-939-2543 • Email: [email protected]

Organized by:Educational Underwriter:

Media Partners: @wrldhealthcare

#wcoutcomes

S a v e $ 2 0 0 i f Y o u R e g i s t e r b e f o r e 1 0 / 1 7 / 2 0 1 4 !

ToP REaSonS To aTTEnd:

• Discusspayerneedsforevidenceandlearnhowitfactorsintoformularydecisionmaking

• Deliveraproductvaluepropositionthatpayers,ACOs,andIDNsfavor

• Aligntheclinicaldevelopmentplanwithcommercializationandmarketaccessstrategies

• Developpharmacoeconomicmodelsproventoincreasethepayer’sunderstandingofeconomicbenefitsandbudgetimpact

• Overcomepayerskepticismaboutpharmaceuticaldrivenevidencethroughamulti-stakeholdercollaborativeresearchframework

• GaininsightintoexpectedFDAguidanceonFDAMASection114anditsimplicationsforcommunicationsandclaims

Steven G. Avey RPh, MS, FAMCP Vice President, Specialty Pharmacy MedIMPACt

eirum Chaudhri, Md Executive Director, Global Director of Scientific Affairs for Hepatitis MeRCk And Co

Shailja dixit Md, MS, MPH Executive Director, Health Economics and Outcome Research FoReSt ReSeARCH InStItute, InC

Jacob drapkin Executive Director, Global Market Access and Pricing JoHnSon & JoHnSon dIAbeteS SolutIonS

Michael n. dubroff, do, FACoP Senior Director for Payer Support, Medical Affairs GenenteCH

eleonora Ford, Phd Director, Payer and Formulary Medical Information, AMGen

C. bernie Good, Md, MPH Professor of Medicine and Pharmacy unIveRSIty oF PIttSbuRGH Chair, Medical Advisory Panel for Pharmacy Benefits Management dePARtMent oF veteRAnS AFFAIRS

Craig Mattson RPh, MS, MbA Senior Director, Drug and Technology Assessment, PRIMe tHeRAPeutICS

F E a T u R E d F a c u l T Y :

D e c e m b e r 8 - 9 , 2 0 1 4 • P h i l a D e l P h i a , P a

T h e 2 n D a n n u a l w o r l D c o n g r e s s s u m m i T o n

Outcomes Strategies to Support Pricing, Reimbursement and Market Access

Translate Evidence into Favorable Coverage Decis ions

Who Should aTTEnd:

PharmaceuticalandMedicalDeviceIndustries

• HealthEconomicsOutcomesResearch(HEOR)

• MarketAccess

• PayerMarketing

• MedicalAffairs

• Pharmacoeconomics

• Epidemiology

Benefit from one-on-one meetings, corporate

branding and relationship building by participating as an active corporate supporter and sponsor.

To inquire about sponsorship and executive networking opportunities, contact:

David Capobianco, Vice President, Business Development, World Congress

781-939-2635 [email protected]

Dear Colleague,

The value of Health Economics and Outcomes Research (HEOR) is increasing as payers and providers face more pressure to reduce costs in a value-based payment world. To stay competitive and ensure market adoption, pharma needs market intelligence about how payers apply evidence in their value determinations about drugs, and then must apply that knowledge when planning research on products in early development, followed by HEOR initiatives and subsequent communications to demonstrate value.

The World Congress Summit on Outcomes Strategies to Support Pricing, Reimbursement, and Market Access offers attendees strategies to improve the ways to generate, package, and disseminate evidence about the value of their products which leads to favorable decisions on formulary placement and reimbursement. Specific topics on the agenda include:

• Payerevidenceneedsandhowtheyapplyevidenceinformulary decision-making

• SuccesseswithHTAsubmissions

• InsightsonexpectedguidancefromtheFDAonFDAMASection114

• Thevalueofamulti-stakeholderresearchcollaborativeframework to tackle payer skepticism

• Provenpharmacoeconomicmodelsthatgetresults

• Andmore!

Join us in Philadelphia on December 8-9 for this leading event that brings together stakeholders to discuss Evidence, plus a special discussion on contemporary issues in the Hep C market and the conclusions that can be drawn on changing value.

Sincerely,

Nancy FelsheimNancy Felsheim Chairperson, World Congress Summit on Outcomes Strategies to Support Pricing, ReimbursementandMarketAccess



Outcomes Strategies to Support Pricing, Reimbursement and Market Access Translate Evidence into Favorable Coverage Decis ions

W H Y Y O U S H O U L D S P O N S O R

POSITION your company as a leading

solutions and service provider

MEET your market

SHOWCASE new technology

innovations

INCREASE brand awareness

GENERATE leads and new

business

DEVELOP new and

current client relationships


daY onE — MondaY, dEcEMBER 8, 20147:30 am – 8:30 am Workshop Registration and Morning Coffee

In-conFEREncE WoRkShoP / ExTEndEd WoRkIng gRouP8:30 am – 11:45 am

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10:

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Strategic Application of Indirect (ITC) and Mixed Treatment Comparisons (MTC) to Address HTA Evidentiary RequirementsWhen head-to-head RCT data is lacking, indirect and mixed treatment comparisons can provide useful evidence for decision making about treatment interventions. Since indirect comparisons are observational, results need to be interpreted with caution. Learn best practices on the interpretation of clinical evidence from these models and how to provide analyses to payers and other health care decision makers in a manner they will find useful.

• Evolvingmethodology• Integrationindrugdevelopment• Acceptedguidelinesandrecommendations• ReportingITCdatatopolicymakersformarketaccessdecisionmaking• Technologyenablers• Aneffectivevisualdemonstrationoftheresultsfromamixedtreatmentcomparison• Casestudyanalysis

Workshop Facilitator TBA

11:45 am – 1:00 pm Lunch on your own / Main Summit Registration

MaIn SuMMIT1:00 pm – 1:15 pm Chairperson’s Welcome and Opening Remarks

1:15 pm – 2:15 pm MulTI-STAkEHOldER PAnEl dISCuSSIOn

Tipping Point — The Hep C Market Example and Implications for Future Value Propositions• Discussevolvingpayermanagementstrategiesforanewgenerationoflargepopulation,specialtydrugsthatcouldbeclinically

superior to existing therapies, but at a higher cost• Determinetheevidencepayersneedtomakedecisionsaboutfirst-in-classdrugsandwhenbenefitsoutweighcost• Evaluatethebesttimingtobegindiscussionsonpricingwithpayers• LearnwhatconclusionscanbedrawnfromtheHepCmarketexperienceanditsimplicationsforthevaluationofspecialtydrugs• Audienceparticipationquestion—IsSocietyreadyforacureforachronicdiseasestate?

Moderator TBA Panelists:

C. Bernie Good, MD, MPH Professor of Medicine and Pharmacy, UNivERSiTy OF PiTTSBURGH Chair, Medical Advisory Panel for Pharmacy Benefits Management DEPARTMENT OF vETERANS AFFAiRS

Eirum Chaudhri, MD Executive Director, Global Director of Scientific Affairs for Hepatitis MERCk AND CO

F. Michael White, PharmD, CSP Director, Clinical Pharmacy Services BlUECROSS BlUESHiElD OF TENNESSEE


daY onE — MondaY, dEcEMBER 8, 2014 (conTInuEd)2:15 pm – 3:00 pm PAnEl dISCuSSIOn

Payer Evidence needs and its Application to Value determinations• Improveon-goingcommunicationbetweenthepharmaceuticalcompanyandpayerthroughouttheassessmentprocesstomanage

expectations and maximize the quality of available evidence• Hearexamplesofevidencerequirementsforspecialtydrugsandcompaniondiagnostics• Illustratehowpayersdetermineifsufficientevidenceisavailabletoassessefficacy,safety/tolerability,value,

and subpopulation identification• Evaluatetheroleoftheproposeddruginsignificantlyimprovingpatientoutcomes

Craig Mattson, RPh, MS, MBA Senior Director, Drug and Technology Assessment PRiME THERAPEUTiCS

Jessica Daw, PharmD, MBA Director, Clinical Pharmacy UPMC HEAlTH PlAN

3:00 pm – 3:30 pm Networking and Refreshment Break

3:30 pm – 4:15 pm The AMCP Format for Formulary Submissions —

Changes and Impact to Promote Better Evidence and decisions• Hearamanufacturer’spoint-of-viewondossierpreparation• UnderstandahealthplanorPBMperspectiveontheapplicationofevidencetoformularydecision-making• Analyzeresultsfromanauditandreviewareasidentifiedforimprovement

Pete Penna, PharmD Principal, Co-Founder FORMUlARy RESOURCES, llC Committee Chair, AMCP FORMAT FORMUlARy SUBMiSSiONS

Steven G. Avey, RPh, MS, FAMCP Vice President, Specialty Pharmacy MEDiMPACT

Eleonora Ford, PhD Director, Payer and Formulary Medical Information AMGEN

4:15 pm – 5:00 pm Global Perspective — Incorporate Health Technology Assessment (HTA) discussions

Early in Planning for Relevant data Generation• Improvedialoguebetweenindustryandpayersonexpectationsabouttherapeuticbenefitsandonbenefitsworthpayingfor• Keepyourevidencestoryflexibleallowingforadjustmentspost-marketwhencostandclinicaleffectivenessdatafromthereal-life

clinical use of the drug become available • Understandthespecificmarketanditsnuances(e.g.size,payer,politicalclimateandothermarketforces)toincreaseefficiency

in the preparation of global value dossiers • Acquirecompetitiveintelligence,assessandadjustyourevidencestrategyasrequired

Brooke Harrow, PhD Head, Health Economics and Outcomes Research, Medical Affairs MEDA PHARMACEUTiCAlS, iNC.

5:00 pm – 5:45 pm Expected FdA Guidance —

FdAMA Section 114 and its Implications for Evidence-Based Marketing Strategies• DescriberecenteventsregardingFDAMASection114suchastheexpectedFDAdraftguidancecontent• DiscusstherelevanceofFDAMASection114incommunicatingessentialCERfindings• AnalyzeimplicationsoftheexpectedFDAdraftguidanceonFDAMASection114onindustrycommunicationsandclaims• ArticulatewhatpharmaceuticalsindustrypersonnelneedtoknowaboutFDAMASection114

Eleanor Perfetto, PhD Professor, Pharmaceutical Health Services Research, School of Pharmacy UNivERSiTy OF MARylAND

Daniel kracov Partner ARNOlD & PORTER, llP

5:45 pm – 6:45 pm Cocktail and Networking Reception


daY TWo — TuESdaY, dEcEMBER 9, 20147:30 am – 8:30 am Morning Coffee

8:30 am – 8:45 am Chairperson’s Welcome and Review of day One

8:45 am – 9:15 am The Impact of HEOR on Payer decision Making

• UnderstandhowU.S.payersviewHEORstudies• ReviewfeedbackfrompayersonhowtheyuseHEORtomakeaccessdecisionsinthetoptherapeuticcategories• IdentifyopportunitiesforengagingandcollaboratingwithpayersthataredevelopingtheirownHEORstudies• Forecasthowpayers’useofHEORstudiesisevolving

Nicole Hengst Director, Payer Services, HEAlTH STRATEGiES GROUP

9:15 am - 10:00 am Overcome Payer Skepticism about Pharmaceutical driven Evidence through

a Multi-Stakeholder Collaborative Research Framework• Learnaboutamulti-yearcollaborationtoconductrealworldresearchtogenerateinsightsintowhatworksforrespiratorypatients• Addressthetransparencyissuebycollaboratingonstudydesignandanalysisfromthebeginning• Leverage a large repository of EHR data to support future CER programs, new product planning activities, HEOR, and observational insights• Appreciatehownextgenerationanalyticstoolsandaplatformwillbringstakeholderstogether

Shailja Dixit, MD, MS, MPH Executive Director, Health Economics and Outcome Research FOREST RESEARCH iNSTiTUTE, iNC.

Brett Davis General Manager CONvERGEHEAlTH

10:00 am – 10:30 am Networking and Refreshment Break

10:30 am – 11:15 am InduSTRy PAnEl dISCuSSIOn

develop Reimbursable Files and data Packages — Secondary Endpoints, Pivotal Studies, and Post-Market Studies• DiscussthehurdlesforgettingaproductapprovedbytheFDAversusfavorablypositionedwithapayeronaformulary• Outlineindustryapproachestostudydesignandcreatingclinicalprograms•Weightheprosandconsofincludingsecondaryendpointsinpivotaltrials,orconductingspecificstudiesthatfocussolelyonthose

endpoints from an economic, regulatory, and clinical standpoint

Stephen B. Camper, MS, PhD Additional Panelists TBA Sr. Director, Medical Affairs, Strategic Lead, Health Economics and Outcomes Research ENDO PHARMACEUTiCAlS iNC. (tentative)

11:15 am – 12:00 pm InduSTRy PAnEl dISCuSSIOn

Effectively Working within the Firewall to Align Clinical Affairs with Commercialization Strategies • Sharebestpracticesoninterpretingandapplyingregulatoryguidelines• Utilizebrandmessagingbasedonscienceandeffectivelypartnerwithclinicalaffairs• Developacommunicationsplantoinvolveclinicalaffairsearlyinstrategydevelopment,operationalplanning,andlifecycle

management of a product

Panelists:

Jacob Drapkin Executive Director, Global Market Access and Pricing, JOHNSON & JOHNSON DiABETES SOlUTiONS

Michael N. Dubroff, DO, FACOP Senior Director for Payer Support, Medical Affairs GENENTECH

Additional Panelists TBA


daY TWo — TuESdaY, dEcEMBER 9, 2014 (conTInuEd)12:00 pm – 1:00 pm Luncheon

1:00 pm – 1:45 pm Pharmacoeconomic Models Proven to Increase the Payer’s understanding of Economic

Benefits and Budget Impact• Examinebestpracticemodelsforquantifyingtherisk-benefittradeoffofaproductanditseconomicvalue• Estimatedrugcosts,healthcarecostoffsets,adverseeventcosts,andexpectedutilization• Integratethespecificrequirementsthatindividualpayershavefordatainamodel• Effectivelyformatandcommunicatetheevidencegeneratedbythemodeltopayers

Jamie Partridge, PhD, MBA Health Economics and Outcomes Research ABBOTT NUTRiTiON RESEARCH & DEvElOPMENT

1:45 pm – 2:30 pm Integrate the Patient Voice into Research Studies — A Focus on Patient-Reported Outcomes

• StrategiestoqualifyPROinstrumentsfordatacollectioninclinicaltrials• IncreasingtheuseofPROsinEHRsandrealworldapplication• Howtoimprovemessagingaboutevidencewithconsumersandphysicians

Eric S. Meadows, PhD Senior Director of Scientific Development MEDMiNiNG (GEiSiNGER HEAlTH PlAN) tentative

James Wu Senior Manager, Global Health Economics, AMGEN (and one of 13 inaugural members of the PCORI Rare Disease Advisory Panel)

2:30 pm – 3:15 pm Advances in Technology to digitize, Analyze and Access Strategic HEOR data from

Around the Globe• Anagileandtargetedapproachtosystematicliteraturereviewsandevidencesynthesis—

Role of structured enterprise data warehouse and cloud technologies • LeveragingHEORsourcesandtechniquestomapPatientjourney—

Secondary databases, social media synthesis, patient interviews, evidence synthesis

Thought Leader TBA

3:15 pm Close of Summit


Benefit from one-on-one meetings, corporate branding and relationship building by participating as an active corporate supporter and sponsor.

To inquire about sponsorship and executive networking opportunities, contact: david capobianco, Vice President, Business development, World congress

781-939-2635 | [email protected]

W H Y Y O U S H O U L D S P O N S O R

POSITION your company as a leading

solutions and service provider

MEET your market

SHOWCASE new technology

innovations

INCREASE brand awareness

GENERATE leads and new

business

DEVELOP new and

current client relationships

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Outcomes Strategies to Support Pricing, Reimbursement and Market Access

Translate Evidence into Favorable Coverage Decis ions

S a v e $ 2 0 0 i f Y o u R e g i s t e r b e f o r e 1 0 / 1 7 / 2 0 1 4 !

M E E T a n d h E a R F R o M T h E S E E x P E R T S :

eleanor Perfetto, Phd Professor, Pharmaceutical Health Services Research,

School of Pharmacy unIveRSIty oF MARylAnd

Pete Penna, Pharmd Principal, Co-Founder

FoRMulARy ReSouRCeS, llC

daniel kracov Partner

ARnold & PoRteR, llP