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Using Real World Data (RWD) to
Assess the Value of
New Technology for Patients
April 12, 2012
Diana Brixner, RPh, PhD
Professor and Chair, College of Pharmacy
Director, Pharmacotherapy Outcomes Research Center
[email protected]
Key Points
• Definition of Value
• The pros and cons of Real World Data
• Development of Patient-Centered
Retrospective Research Registries
(PCR3s) within our system
• Application to value assessment of new
technology
UHC Technology Reimbursement
Considerations under HCR
• Improving health care efficiency
• Improving health care quality
• Allocation of scare healthcare resources
Cost
VALUE
═
Outcome
Information is Needed Beyond RCTs . . .
Efficacy and safety in a
small population with a
restricted study protocol
GAP
Real world information to make
health care decisions for large
populations within defined
budgets
RCT
Randomized
Clinical Trials
Patient
Population
Real World Data
Garrison LP Jr, Neumann PJ, Erickson P, Marshall D, Mullins CD. Using real-world data for
coverage and payment decisions: the ISPOR Real- World Data Task Force report. Value
Health. 2007;10(5):326-35.
Efficacy vs. Effectiveness
• Efficacy
– RCT
– High internal validity
– Limited generalizability
• Effectiveness
– Observational studies
– High external validity
– Lack of Controls
Holtorf AP, Watkins JB, Mullins CD, Brixner D. Incorporating obser- vational data into the formulary
decision-making process-summary of a roundtable discussion. J Manag Care Pharm. 2008;14(3):302-08.
UU Patient Centered
Retrospective Research Registries
• Collaboration with University of Utah:
–
–
–
–
Information Technology and Bioinformatics
Utah Population Database
HCI/UHOSP investigators and clinicians
Enterprise Data Warehouse (EDW)
• Contain longitudinal data on patient cohorts from
1995 to current including clinical, survival and
charge data.
• Used to develop models to predict cost-effective
outcomes of new pharmaceuticals and diagnostic
tests
4 Cancer Cohorts in Development
Ovarian Patient Flow
ICD-9
LINKED TO CANCER REGISTRY
n
2295
1150
RESTRICTED BY ICD0
455
RESTRICTED BY VISIT COUNTS
371
NSCLC Patient Flow
ICD-9
4521
LINKED TO CANCER REGISTRY
3201
RESTRICTED BY ICD0
1879
RESTRICTED BY VISIT COUNTS
1228
Brain Mets Patient Flow
Melanoma Patient Flow
n
n
n
ICD-9
2612
ICD-9
5863
LINKED TO CANCER REGISTRY
2210
LINKED TO CANCER REGISTRY
3773
RESTRICTED BY VISIT COUNTS
1602
RESTRICTED BY ICD0
3062
Restricted to Exclude ICD0 of brain primary site
1464
RESTRICTED BY VISIT COUNTS
2547
• Cohort for HCC, Breast Cancer and CML already completed
• Prostate cancer cohort is next planned cohort for development
• Developing one for Atrial Fibrillation in collaboration with CARMA
Population Based Research to Inform Individual Care
We can determine survival by stage…
1.00
Kaplan-Meier survival estimates
0.75
Stage I
Stage II
0.25
0.50
Stage III
0.00
Stage IV
0
1
2
3
4
5
6
7
8
9 10 11
Follow up time (years)
stage = 1
stage = 3
12
stage = 2
stage = 4
13
14
15
16
We can determine charges by stage…
Annualized Charges by Stages and Types of Charges
* $80,000
$70,000
$60,000
$50,000
$40,000
$30,000
$20,000
$10,000
$0
Stage 1 (N=739)
non-cancer inpatient
Stage 2 (N=666)
non-cancer outpatient
Stage 3 (N=285)
cancer-outpatient
Stage 4 (N=93)
cancer-inpatient
* Inpatient and outpatient charges for one year post staging across the Huntsman
Cancer Institute and the University Healthcare system
The Promise of Personalized Medicine
• Pharmacogenomic tests can fine tune
treatment pathways for patients with breast
cancer after surgery
– Stratify patients as to whether they should receive
treatment based on risk
– Stratify patients by which treatment would provide
the best response
• However these tests come at a cost that need
to be weighed against the benefit they can
bring to patients
The Value of Personalized Medicine
75 Chemo
Not Tested
$10,000
$0
25 No Chemo
90% 5 year survival
$750/patient
$0
100 women after
breast cancer
surgery
40 Chemo
Tested
$10,000
90% 5 year survival
$4100
60 No Chemo
$8100/patient
$0
• Assist researchers in development
• Assist payers in reimbursement decisions
• Assist patients in treatment decisions
Summary
• Development of Patient-Centered
Retrospective Research Registries
(PCR3s) are in process within our system
• These PCR3s can be applied to value
assessment of new technology for Health
Care Reform