delivering evidence to the marketto the market 6 christopher marron… · number of...

Delivering Evidence to the Marketto the Market

Chris Marrone, PharmDOutcomes LiaisonEli Lilly and Company

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2www.diahome.orgDrug Information Association

Why Communication Matters

• Even the very best evidence is useless if no one knows about, understands it, or acts on it.

• Poor communication can have a negative impact• Poor communication can have a negative impactConsider the recent example of breast cancer screening recommendations– Evidence was strong– Communication was confusing, unclear, and uncoordinated– Consumer and other stakeholder reaction was negative and practiceConsumer and other stakeholder reaction was negative and practice

patterns have not changed

Drug Information Association www.diahome.org 3

Communication Opportunities

• Medical practice has been slow to absorbMedical practice has been slow to absorb evidence-based findings

• Comparative Effectiveness Research is becoming increasingly important:– Reimbursement approval– Significant investment increase


Medical practice has been slow to absorb evidence-based findings

A l ti f th h lth A i i i t

Institute of Medicine Panel Findings:

• A large proportion of the health care Americans receive is not based on rigorously tested empirical evidence.

• A large proportion of the rigorous evidence produced byA large proportion of the rigorous evidence produced by researchers is not easily or well used by clinicians and patients.

• A small proportion of evidence with practical value is transmitted to clinicians and patients as practical advice that is “valid, relevant, timely, feasible and actionable.”

• A small proportion of important, well-grounded research findings make their way into practice.


Importance of Health Outcomes Information

Health Outcomes evidence is often a 4th hurdle in reimbursement approval

• Traditional requirements• Traditional requirements– Quality– Safety– Efficacy

• Emerging requirements… Efficac

Valueg g q

– Clinical effectiveness– Patient outcomes (QoL)

Cost EffectivenessSafety

Efficacy

– Cost Effectiveness– Budget Impact Quality


Taylor RS, et al. BMJ. Oct 23 2004;329(7472):972-975.

What does CER look like?

• Systematic reviews of the literature

– summarizes a body of evidence

– identifies information gaps

– generates new ideas for research questions

• Large database studies

• Prospective registries and cohort studies

• Real-world clinical trials


Publications

Number of Pharmacoeconomic and Health Outcomes Papers Indexed Annually in Embase

1987 20111987 – 2011

2012% i2012% increasefrom 1987 to 2011


ARRA has Heightened the Interest in CER

• Groups have been doing CER, but Federal funding was relatively b f th A i R d R i t t A t fmeager before the American Recovery and Reinvestment Act of

2009 (ARRA).

• Recent Efforts Due to Realization of Need for Longer-term,Recent Efforts Due to Realization of Need for Longer term, System-wide Investment– CER being thought of beyond limited settings to which is was

l t d i irelegated in previous years

– Investment not limited to single area, agency, or mission

Conceptual buy-in by both public and private payers– Conceptual buy-in by both public and private payers

– Push to distinguish bench research from “real world” research


Affordable Care Act

Five elements that are especially significant for CER dissemination policydissemination policy

• The creation of PCORI

• The preservation of AHRQ’s role

• The focus on clinical effectiveness

• The prohibition of linkages to payment policy

• Support for broadly scoped CER studiesSupport for broadly scoped CER studies


CER Matters Across Audiences

• Government/Regulators• Population-based health care decision makers• Clinicians and prescribersClinicians and prescribers• Patients


Who is Conducting CER?

• Federal government• Academic centers• Large commercial payersLarge commercial payers• Third party organizations• Pharmaceutical companies• Pharmaceutical companies


The Role of Commercial Payers

• Several large US Payers have amassed huge data sets and have strategically improved their research expertise

• These 3rd party payers with R&D arms are a competitive• These 3rd party payers with R&D arms are a competitive force that will play a more important role in CER moving forward


Commercial Payers are Becoming A Stronger Voice in CERg

• Wellpoint conducted an internal study comparing Boniva to other osteoporosis treatments and used the results to inform formularyosteoporosis treatments and used the results to inform formulary decision-making.

• Express Scripts published an analysis comparing first line SSRI/SNRI to branded therapy use

• Medco Research Institute and leading French researchers conducted study comparing Effient and double dose of Plavix in heart patients y p g preceiving Prevacid

• Medco Research Institute is conducting a head-to-head study of Plavix(clopidogrel) and Effient (prasugrel) that measures how the(clopidogrel) and Effient (prasugrel) that measures how the effectiveness of these drugs is impacted by their genetic make-up


Commercial Payers are Becoming A Stronger Voice in CERg

• Wellpoint/HealthCore and AstraZeneca“To generate "real world" data on the most effective and economic ways to treat disease, with a focus on chronic ailments such as diabetes, cardiovascular disease and dyslipidemia but also addressing areas such as oncology ”and dyslipidemia, but also addressing areas such as oncology.

• Medco/UBC and Sanofi“Medco and UBC will contribute their perspective and comparative data to the product development strategy, allowing Sanofi ‘to define the relative value for products early in p gy, g p ydevelopment, by more precisely identifying patient populations in which drugs are most effective.’”

• Humana/Competitive Health Analytics and Pfizer“St d t i th lit t d t f h lth f i“Study ways to improve the quality, outcomes and costs of health care for senior citizens”

• Medco and Pfizer“To identify and evaluate patient subgroups in which experimental and currentlyTo identify and evaluate patient subgroups in which experimental and currently marketed drugs are shown to be most effective.”

• WellPoint/HealthCore and IBM “Develop and launch Watson-based solutions to help improve patient care through the


delivery of up-to-date, evidence-based health care for millions of Americans.” Goal is to improve provider decision making and improve patient outcomes in oncology.

Other players

• Oregon DERPg• BCBS (TEC)• Academic institutes• Academic institutes• Think tanks • Pharmaceutical/Medical Device

Manufacturers


Industry CER Dissemination

• Public Disclosures: abstracts, posters, ppresentations, publications

• FDAMA 114 piecesFDAMA 114 pieces• Medical Letters

D i (AMCP W ll i t)• Dossiers (AMCP, Wellpoint)• Budget Impact Models and Heath

Outcomes Tools• Company Medical Personnely


FDAMA 114

• Congress added Section 114 to the 1997 Food and Drug Administration Modernization Act (FDAMA)g ( )

• Set a new, less stringent standard applicable to promotional dissemination of health care economic information to MCO formulary committees– “directly relates to an indication approved”

– “Based on competent and reliable scientific evidence”

• Covers health economic data only; Health-related yquality of life claims are considered under the established "adequate and well-controlled trials" standardstandard


Field Outcomes Personnel

Does your company have separate Medical Liaisons (ML)and Outcomes Liaisons (OL)?( )

14%

Di ti tOL R l

86%

Distinct OL RoleNo Distinct OL Role

Drug Information Association www.diahome.org 19DIA Outcomes Liaison Survey. To be presented, DIA Annual Meeting 2012.

Field Outcomes Job Responsibilities

80%85%

FR…

Which of the following job responsibilities do the Outcomes Liaisons in your organization currently perform?Responding to Med Info/HO requests

70%75%75%75%

80%

A…D…H…I…F…Formulary Presentations

Decision-maker relationshipsHEOR Research Generation

Internal company scientific projectsTool development

55%60%

65%70%70%

H…S…D…T…D…Developing payer collaborations

Advisory board coordination/participationDisease state Presentations

Scientific intelligenceDossier dissemination

35%45%

50%50%

55%

DC…P…M…D…HEOR Research Generation

Promotional HEOR PresentationsMedicaid Testimony Presentations

Company Pipeline PresentationsDossier creation

5%5%

15%25%25%

35%

PO…C…D…S…D…Dossier creation

Disease State TrainingSales force trainingCME Presentations

Promotional speaker trainingOther please specify 5%

0% 20% 40% 60% 80% 100%

P…


Other, please specify

DIA Outcomes Liaison Survey. To be presented, DIA Annual Meeting 2012.

Field Outcomes Disseminations

70%Hard-copies of publications/articles/abstracts

What materials are OLs able to provide to external customers upon request?

60%

70%

Hard copies of publications/articles/abstracts

PDFs of publications/articles via email (i.e. electronic copies)

Tools (Claims Analyzers, Budget Impact M d l t )

50%

60%Models, etc.)

Company-provided educational materials

Company-approved medical slide sets

30%

45%Company-approved medical slide sets

Company-approved promotional slide sets

Oth

10%

15%Other

OL-created slide sets


0% 20% 40% 60% 80%DIA Outcomes Liaison Survey. To be presented, DIA Annual Meeting 2012.

Improving Communication of CER


ISPOR VISION 2020 TASK FORCE COMMUNICATIONS WORKING GROUP

• Improve understanding of outcomes research findings and applications among decision makersfindings and applications among decision makers and targeted audiences.

• Improve understanding of outcomes researchImprove understanding of outcomes research findings and applications among decision makers and targeted audiences.

• Achieve greater exposure and dissemination of outcomes research findings within and outside the field.


ISPOR Advisory Panel ReportPanel 7: Communication and Reporting Health Economic Information

Keys to more effective communication:• Relevance: Is it needed?• Usefulness: Will the intended audience be able to

make use of it?• Credibility: Is it believable?



Relevance:• the varied information needs of end-users and their

magnitude of importance;• the changing environment or time constraints in

which decisions are being made;• the predominant influence(s) over those making

them, for example, political, social, budgetary, clinical or logisticalclinical, or logistical.


Relevance: Understand the End User

ce

+t D

iffer

enc

-C

os

Efficacy Difference +


- Efficacy Difference +

Relevance

• Understand the end userN d• Needs

• Decision Process

K l d L l• Knowledge Level

• Areas of importance

I fl• Influences

• Develop Data and Communication Materials that meet the end users’ needsmeet the end users needs



Usefulness:• reporting standards• communication formats• content


Usefulness• reporting standards

– allow for greater clarity and understanding of the content– create a sense of familiarity with terminology and format

that allows faster integration of new informationt bilit t di– promote comparability across studies

• communication formatsAb t t• Abstracts

• Posters• Public presentations• Public presentations• Reports and articles• Health economic communicationsHealth economic communications


Usefulness• Content -- One size does not fit all

– variety of backgrounds and expertise y g

– needs of the audience

– Managed care organizations vs physicians vs consumers

– The key is knowing the needs and abilities of an audience



Credibility:• accepted standards of practice• the concept of disclosure• validation of the information


Strong Communications

• Identify Users and Their NeedsIdentify Users and Their Needs• Create Standard Communication Formats

D l R ti G id (RG )• Develop Reporting Guidances (RGs)• Ensure Public Accessibility


What I hear in the field

• What is provided is more important than how it is provided:is provided:– Head-to-Head Superiority Trials– Pertinent Controls– Pertinent Controls– Real World Data

Actionable Health Outcomes Data– Actionable Health Outcomes Data

• Users want communications that are:F i B l d– Fair Balanced

– Transparent– Credible


Conclusions

• Comparative Effectiveness Research is being completed and communicated by a variety ofcompleted and communicated by a variety of entities

• Not all receivers and users of CER are the• Not all receivers and users of CER are the same

• Data must be generated and communications• Data must be generated and communications must be created with the intended audience in mindmind.

• Users are looking for relevant, credible, and fair balanced communications of datafair balanced communications of data.


Delivering Evidence to the Marketto the Market

Chris Marrone Outcomes Liaison Consultant Eli Lilly and Company

Chris Marrone graduated with a BS in Pharmacy from Rutgers University, and a PharmD from the University of Texas at Austin. He completed a Pharmacy Practice Residency at Fletcher Allen Health Care in Burlington, VT, and a Drug Information Specialty Residency with Eli Lilly and Company and Purdue University. Chris spent two years at Lilly working as a Global Medical Information Administrator, before moving into various field-medical roles interacting with and providing medical information to external customers. Chris spent over 6 years at Lilly as a Medical Liaison; the first five years in Critical Care and the remaining year and a half in Oncology. Chris has spent the past four years in a Managed Care Outcomes Liaison role at Lilly where he currently focuses on National Accounts. Chris has been active within the Drug Information Association, conducting and publishing various Field Medical surveys and serving as track co-chair for the CER/HTA track of the DIA Annual Meeting.

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