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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 d [email protected]. Key Points. Definition of Value - PowerPoint PPT Presentation
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Using Real World Data (RWD) to Assess the Value of
New Technology for Patients
April 12, 2012
Diana Brixner, RPh, PhDProfessor and Chair, College of Pharmacy
Director, Pharmacotherapy Outcomes Research [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
═VALUE
Cost
Outcome
Information is Needed Beyond RCTs . . .
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.
RCT Randomized Clinical Trials
Efficacy and safety in a small population with a restricted study protocol
Real world information to make health care decisions for large populations within defined budgets
Patient Population
GAP
Real World Data
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
NSCLC Patient Flow n
ICD-9 4521
LINKED TO CANCER REGISTRY 3201
RESTRICTED BY ICD0 1879
RESTRICTED BY VISIT COUNTS 1228
Ovarian Patient Flow n
ICD-9 2295
LINKED TO CANCER REGISTRY 1150
RESTRICTED BY ICD0 455
RESTRICTED BY VISIT COUNTS 371
Melanoma Patient Flow n
ICD-9 5863
LINKED TO CANCER REGISTRY 3773
RESTRICTED BY ICD0 3062
RESTRICTED BY VISIT COUNTS 2547
4 Cancer Cohorts in Development
Brain Mets Patient Flow n
ICD-9 2612
LINKED TO CANCER REGISTRY 2210
RESTRICTED BY VISIT COUNTS 1602
Restricted to Exclude ICD0 of brain primary site 1464
• 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
0.00
0.25
0.50
0.75
1.00
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16Follow up time (years)
stage = 1 stage = 2stage = 3 stage = 4
Kaplan-Meier survival estimates
We can determine survival by stage…
Stage I
Stage II
Stage III
Stage IV
We can determine charges by stage…
*
* Inpatient and outpatient charges for one year post staging across the Huntsman Cancer Institute and the University Healthcare system
Stage 1 (N=739) Stage 2 (N=666) Stage 3 (N=285) Stage 4 (N=93)$0
$10,000
$20,000
$30,000
$40,000
$50,000
$60,000
$70,000
$80,000
Annualized Charges by Stages and Types of Charges
non-cancer inpatient non-cancer outpatient cancer-outpatient cancer-inpatient
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
100 women after breast cancer
surgery
Not Tested
Tested
$0
$4100
75 Chemo
$10,000
25 No Chemo
40 Chemo
60 No Chemo
$0
$10,000
$0
90% 5 year survival
$750/patient
90% 5 year survival
$8100/patient
• 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
