Empowering Precise Actions with

Real World Evidence

Marcus Wilson, Pharm.D.

President

February 9, 2012

1

                    

Of All the Relationship in Healthcare, this One is the Most

Important

Everything we do must be done with the intent of strengthening the bond and improving

decision-making between these two individuals.

Slide 2

Evidence

       

Post Marketing Studies

Root of the Evidence Gap

Utilization

Little to No

Evidence

Little to No

Evidence

Evidence -Post-Marketing Studies

Clinical TrialsClinical Trials

Off-label indications

Unstudied co-morbid conditions

Differing concomitant medications

Varying levels of compliance – i.e. < 80%

Variances in population

characteristics from what

was studied

Conceptualization FDA Approval

Differing age groups – elderly, pediatrics

Race, ethnicity, gender variances

Varying severity of disease

Slide 3

We are at a very unique point in healthcare evolution

Slide 4

 

Shifting Landscape

To Innovate To Approve To Prescribe To Adhere

Industry FDA Physician Patient

Traditional Environment for Decision-Making

Evidence Demands C

linic

al

Efficacy

Safe

ty SAE & Overall Tolerability

Cost

Direct cost of product acquisition

Slide 5

 

Shifting Landscape (15-20 Years Ago)

The Demand then was for Better real world evidence (or CER)

So what was Driving the Change?

Disappointing outcomes

Increasing safety concerns

Escalating costs

Slide 6

 

Shifting Landscape

To Innovate To Approve To Pay for To Prescribe To Adhere

Industry FDA Physician Patient

Health Plan

IDNs

Government

Emergence of the Payor in the Decision-Chain

Evidence Used C

linic

al

Efficacy

Safe

ty SAE & Overall Tolerability

Evidence Demands C

linic

al

Effectiveness

Safe

ty Population Safety/Long­term Safety

Cost

Total Cost of Care Impact

Slide 7

Cost

Direct cost of product acquisition

 

Shifting Landscape

Why the Disconnect?

Limited means of seeing and assessing real world outcomes

(Valid) skepticism in results using claims data

Misaligned reimbursement model in healthcare

Slide 8

 

Shifting Landscape

Growing experience and improved methods in using claims data and use of

So What is now Enabling Change?

Data Environments vs data bases for research

Rising adoption of HIT and resulting electronic clinical data availability

Evolving payment models

Slide 9

 

Shifting Landscape

To Innovate To Approve To Pay for To Prescribe To Adhere

Industry FDA Physician Patient

Health Plan

IDNs

Government

Emergence of the Payor in the Decision-Chain

Evidence Demands C

lin

ical

Effectiveness

Safe

ty Population Safety/Long­term Safety

Co

st

Total Cost of Care Impact

Slide 10

APPENDIX

The Issue of Cycle Time

How do we reduce the time from bench to bedside?

Slide 11

         

Current Complaints

Patient History

Test Results

Barriers to Improved Quality & Affordability

Coverage Reimbursement Medical Policy

Socioeconomic Issues

New Study Findings

For Complex Patients the time

needed to make the most

informed set of decisions

1-2 Hours

Amount of time the physician

actually spends per patient

13 minutes Errors &

waste

Errors &

waste

D i s c o n n e c t

Translation of population-based evidence to the

individual in front of me

Slide 12

   

–

-

Expansion of Knowledge

0

100,000

200,000

300,000

400,000

500,000

600,000

700,000

800,000

Yearly Citation Count Totals from 2009 MEDLINE/PubMed Baseline:

17,764,826 Citations Found

(Publication Date Used for Categorization)

It is not sufficient to simply produce more research. We must facilitate its incorporation into day-to-day decisions

,Between 2,000 4,000 references are added each day, 5 days per week , 5,398 journals referenced in PubMed (as of July, 2009)

, Represents 20 25% of the Journals in circulation

Source: National Library of Medicine Slide

   A Necessary Connection

Research

&

Analytics

Policy

Aligned Payment

Model

Care

Management

Programs

Relevant Information

at POC

Slide 14

APPENDIX

Closing Thoughts

Slide 15