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Real World Data: Moving Beyond Clinical Trials:The WellPoint Outcomes-Based Formulary
T Jeffrey White, Pharm.D., M.S.Director – Clinical Analytic StrategiesWellPoint NextRx
2
Presentation Objectives
Provide an overview of WellPoint NextRxReview the WellPoint NextRx Outcomes-Based Formulary ProcessProvide examples of data and analyses used to support formulary decisions (emphasis on observational data)Provide highlights of the WellPoint Health Technology Assessment GuidelinesPresentation summary
3
MissionMissionWe deliver integrated pharmacy and health solutions
providing exceptional value to our customers
VisionVisionWellPoint NextRx will transform our industry and become the most trusted and valued Pharmacy Benefits Manager (PBM)
Differentiating StrategiesDifferentiating StrategiesLeader in affordable quality care
Most trusted choice for consumers
NextRx Strategy
4
The Value of Integration
MEDICALRx
The integration of pharmacy and medical data can provide information for the improvement of health, and better
management of total health care cost.
Pharmacy Perspective
Pharmacy and Medical
Perspective
GOAL = IMPROVE HEALTH, QUALITY OF SERVICE, AND
REDUCE TOTAL COSTS
5
Presentation Objectives
Provide an overview of WellPoint NextRxReview the WellPoint NextRx Outcomes-Based Formulary ProcessProvide examples of data and analyses used to support formulary decisionsProvide highlights of the WellPoint Health Technology Assessment GuidelinesPresentation summary
6
Outcomes-Based Formulary Management
General ApproachGeneral ApproachConsider the complete burden
of disease
Clinical Burden
Epidemiology
Natural History of Disease
Total Cost of Care
Productivity Impact
Quality of Life Impact
Leverage the formulary process to improve patient
outcomesImprove Quality of Care(clinical status, quality of life)
Reduce Total Cost(pharmacy, medical, ancillary, home
health, nursing home, etc.)
Optimize Care(cost effectiveness)
Improve Productivity
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P & T Process and Committee Overview
Pharmacy and Therapeutics
(P&T) Committee
Clinical appropriateness
FIRST
Financial considerations
SECOND
OUTCOMES ADVISORY COMMITTEEOutcomes / Pharmacoeconomic Review
Value Assessment Committee
(VAC)
Value Assessment Committee
(VAC)
Reviews the clinical, outcome, and financial data and makes final tier placement
decisions
Clinical Review
Committee (CRC)
Critical review of the literature,
Assigns a clinical designation based on the evidence.
Recommendations sent to the VAC
ACTUARIAL SUBCOMMITTEE TO VAC (ASVAC)
Analyzes Financial and PharmacoeconomicResults
Integrated Pharmacy and Medical AnalysisIntegrated Pharmacy and Medical Analysis
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A Critical Review of Clinical Trial Data
Each clinical trial and guideline is carefully critiqued before being included in the drug monograph
• Only high quality evidence material is included in the monograph
• Many studies fall short
The focus of decision-making is based on patient-oriented clinical outcomes
• Outcomes that are understood and desired by patients (e.g. decreased risk of heart attack/stroke/death)
• Many studies fall short here too
9
Common Pitfalls of Clinical Trial Data
• High-drop out rates or missing data, with no sensitivity analysis• Use of post-hoc analysis to draw cause and effect conclusions
• Subgroup analysis where subgroups were not determined in advance.
• Non-significant findings or power calculation is not clear• Non-ITT analysis (>5% of patients excluded from the primary
outcome analysis)• Inadequate dosages• Use of non-validated scoring methods • Disease oriented outcomes only (BP lowering vs. CV mortality)• Unclear quality assessment methods for meta-analysis studies• Study duration too short for endpoint (e.g. 6 weeks HbA1c)• Use of other medications that may influence or confound the effect of
the primary drug on outcomes
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Pharmacoeconomic and Outcomes Data
How well does the drug perform in the real world (effectiveness vs. efficacy)?
Are we achieving the outcomes we expect based on clinical trial data?
Is the drug being used properly (right patient, dose, duration, etc.)?
Are there quality of life or productivity benefits?
Are there medical cost offset benefits
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Efficacy vs. Effectiveness
Real-world clinical practiceControlled clinical trialSetting / Design
Medium to highLow to mediumExternal Validity (generalize to other populations)
LowHighInternal Validity
Example: Cardiovascular events, hospitalizations
Clinical endpoints (e.g. BP, HbA1c, LDL)Outcomes
Low to HighHighCompliance
Heterogeneous / any subjectsHomogenous/highly selective (stringent inclusion/exclusion criteria)Subjects
Active comparator/usual carePlaceboComparatorFlexible regimenFixed regimenIntervention or treatmentDrug performance in real-worldRegulatory approval (FDA)Purpose
Does it work under usualcircumstances
Does it work under idealcircumstancesObjective
Effectiveness (Real-World Data)
Efficacy (Clinical Trial Data)
12
Presentation Objectives
Provide an overview of WellPoint NextRxReview the WellPoint NextRx Outcomes-Based Formulary ProcessProvide examples of data and analyses used to support formulary decisionsProvide highlights of the WellPoint Health Technology Assessment GuidelinesPresentation summary
13
Alz. Dz.
45%
Compliance Varies Significantly by Therapeutic Category
100
0
10
20
30
40
50
60
70
80
90
61%
ARB
SOURCE: Internal Claims Database Analyses – WellPoint NextRx 2008
46%
Anti-Depressants
50%
DM ACEI
57%
49%
HMGs
69%
PlavixPsych
34%
14
0
0.1
0.2
0.3
0.4
0.5
0.6
All 0.5 0.44 0.45 0.42 0.41 0.38 0.36Depression 0.52 0.47 0.47 0.44 0.42 0.4 0.48Anxiety 0.49 0.46 0.46 0.42 0.37 0.39 0.39
Drug A Drug B Drug C Drug D Drug E Drug F Drug G
Pro
porti
on o
f Day
s C
over
ed
Source: Data on file – WellPoint NextRx, 2008
Antidepressant Compliance(Proportion of Days Covered Over a 1-Year Period)
15
$0
$2,000
$4,000
$6,000
$8,000
$10,000
$12,000
Rx Cost $2,249 $1,774 $1,684 $1,153 $3,597 $1,510 $1,763Medical Cost $4,486 $3,534 $3,668 $3,169 $6,546 $3,079 $3,024Total Cost $6,682 $5,290 $5,340 $4,406 $10,065 $4,581 $4,771
Drug A Drug B Drug C Drug D Drug E Drug F Drug G
1-Ye
ar C
ost
Source: Data on file – WellPoint NextRx, 2008
Antidepressant Total Cost(Pharmacy and Medical Cost Over a 1-Year Period)
16
A Small Percentage of Patients Newly Started on Bisphosphonate Therapy are > 80% Compliant
<10% 10-20% 20-30% 30-40% 40-50% 50-60% 60-70% 70-80% 80-90% 90-100% >100%0
5
10
15
20
25
Per
cent
of P
atie
nts
Percent of Days Covered
Percent of Patients Compliant on Bisphosphonate Medication
Source: Data on file – WellPoint NextRx, 2008
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REAL StudyIncidence of Hip Fractures 1-Year Post Index
Cumulative Incidence of Hip Fractures
43% difference
0.21% absolute difference Fosamax
0.37
Actonel
Silverman SL, Watts NB, Delmas PD, Lange JL, Lindsay R. Osteoporos Int (2007) 18:25–34
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WellPoint Data:Incidence of Hip Fractures 1-Year Post Index
Fosamax
Boniva
Actonel
Source: Data on file, WellPoint NextRx 2008
N= 26,086
Kaplan-Meier cumulative incidence of hip fractures (1 year post-index)
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WellPoint Data:Incidence of All Fractures 1-Year Post Index
Fosamax
BonivaActonel
Source: Data on file, WellPoint NextRx 2008
N= 26,086
Kaplan-Meier cumulative incidence of all fractures (1 year post-index)
20
Proportion of Patients at HbA1c Goal (<7)and Cost per Patient at HbA1c Goal
$0.00
$1,000
$2,000
$3,000
$4,000
$5,000
$6,000
$7,000
$8,000Or
al/Inj
(1)Or
al/Inj
(2)Or
al/Inj
(3+)
Ins (1
)Ins
(2)
Ins (3
+)Ins
(1) +
Oral
/Inj (1
)Ins
(1) +
Oral
/Inj (2
+)Ins
(2) +
Oral
/Inj (1
)Ins
(2) +
Oral
/Inj (2
+)Ins
(3+)
+ Oral
/Inj (1
)Ins
(3+)
+ Oral
/Inj (2
+)
Cost
per
Pt a
t Goa
l
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
Perc
ent a
t Goa
l
Cost per GoalPercent at Goal
Source: Data on file – WellPoint NextRx, 2008
21
Observed Percent Change in LDL-C by Different Statin Doses
4774,5896,0501,377
8416213
2,015121528
3,07211,518
21,495
Sample Size
(Obs. Data)
-46-39-35-28----55-52-46----51
-48-43
-37
Mean % LDL-C Reduction in
STELLAR Clinical Trial
-47-41-38-30-26-63-55-52-45-60
-50-43
-39
Package Insert
-30-34-32-28-21-43-37-39-30-38
-40-38
-35
Mean % LDL-C Reduction
(Observational Data)Drug and Dose
Simvastatin 80
Simvastatin 40
Simvastatin 20
Simvastatin 10
Simvastatin 5
Rosuvastatin 40
Rosuvastatin 20
Rosuvastatin 10
Rosuvastatin 5
Atorvastatin 80
Atorvastatin 40
Atorvastatin 20
Atorvastatin 10
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Simvastatin is Associated With a Lower Cost Per Percentage LDL Reduction
$0.00
$20.00
$40.00
$60.00
$80.00
$100.00
$120.00
$140.00
0% 10% 20% 30% 40% 50% 60% 70%
% LDL Reduction
Ingr
edie
nt C
ost (
30 D
ay S
uppl
y)
LOV 20
SIM 5
ZOC 5
SIM 10
ZOC 10
LOV 40
SIM 20
ZOC 20
LIP 10
SIM 40
ZOC 40
LIP 20
CRE 5VYT 10-10
SIM 80
ZOC 80
LIP 40
CRE 10VYT 10-20
CRE 20
VYT 10-40VYT 10-80
LIP 80
CRE 40
LOV 10
More favorable
Less favorable
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COPD Health Care Utilization (1)
7.4(9.5)8.7(10.3)8(10)Mean# of outpatient visits
9392100≥ 1 outpatient visit %
Outpatient visits
0.4(0.9)0.6(1)0.4(0.9)Mean# of hospital stay
313626≥ 1 inpatient stay %
Inpatient hospitalization
0.1(0.5)0.2(0.6)0.1(0.6)Mean# of ER visits
11129≥ 1 ER visit %
ER Visits
COPD-Related utilization
CombiventN=4,206
AtroventN=1,463
SpirivaN=3,030
12 months post-index date
24
COPD Health Care Utilization (2)
27.5(21.8)28.6(23)28.1(22.6)Mean# of outpatient visits
10099100≥ 1 outpatient visit %
Outpatient visits
0.7 (1.2)0.9(1.5)0.6(1.2)Mean# of hospital stay
404433≥ 1 inpatient stay %
Inpatient hospitalization
0.4 (1)0.5(1.6)0.4(1.3)Mean# of ER visits
272823≥ 1 ER visit %
ER Visits
All-Cause Utilization
CombiventN=4,206
AtroventN=1,463
SpirivaN=3,030
12 months post-index date
25
COPD Health Care Utilization (3)12 months post-index date
$5,224$7,226§$5,172*Total (Medical + Pharmacy)
$171¶$310§$324Pharmacy
$4,782¶$6,612§$4,317*Medical
COPD-related adjusted cost
$13,116$16,093§$13,007*Total (Medical + Pharmacy)
$1,952¶$1,927$2,584*Pharmacy
$11,182$14,316§$10,378*Medical
All-Cause unadjusted cost
CombiventN=4,206
AtroventN=1,463
SpirivaN=3,030
Adjusters are prior year cost, age, gender, health plan Charlson Comorbidity index, hypertension, depression, asthma, and stroke* p<0.05 pairvise comparison between spiriva and atrovent§ p<0.05 pairvise comparison between atrovent and combivent¶ p<0.05 pairvise comparison between spiriva and combivent
26
Quality of Life Summary
Some diseases are associated with significant QoLburdenSome treatments can result in significant improvement in QoL• QoL consistent with disease in remission• QoL approaches that of the US population norm
QoL is an important endpoint from a patient perspective
27
Presentation Objectives
Provide an overview of WellPoint NextRxReview the WellPoint NextRx Outcomes-Based Formulary ProcessProvide examples of data and analyses used to support formulary decisionsProvide highlights of the WellPoint Health Technology Assessment GuidelinesPresentation summary
28
Revised WellPoint Guidelines for Formulary Submissions: 2008
Standards and Recommendations
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WellPoint Outcomes Based Formulary
Supports WellPoint’s leadership position in the provision of a high-quality pharmacy benefit that is evidence-based
Formulary decisions are based on high quality evidence focused on patient outcomes
Studies should be representative of WellPoint patient populations
Product choice and continuing formulary support should be supported by clinical evidence and product value (e.g. cost-effectiveness)
Patient focused claims are judged by their impact in a naturalistic environment and should be monitored on an ongoing basis, validated and reported on by manufacturers
30
Presentation Objectives
Provide an overview of WellPoint NextRxReview the WellPoint NextRx Outcomes-Based Formulary ProcessProvide examples of data and analyses used to support formulary decisionsProvide highlights of the WellPoint Health Technology Assessment GuidelinesPresentation Summary
31
Presentation Summary (1)
WellPoint NextRx strategy• Transform our industry. . .• Deliver integrated pharmacy and health solutions. . .• Leader in affordable quality care. . .
Outcomes-based formulary• Understand the complete burden of disease• Leverage the formulary process to improve patient outcomes
– Improving quality of care (clinical status, quality of life)– Reducing total cost of care (pharmacy, medical, total)– Optimize care (cost effectiveness)– Leverage both clinical trial data and observational data
Compliance challenges• Generally poor (~50%)• Leverage tier placement and other tools to drive utilization towards drugs
associated with better outcomes (quality and total cost)
32
Presentation Summary (2)
Efficacy and effectiveness data to be used to make formulary decisions
There are differences in performance of drugs within the same therapeutic category• Goal is to identify the “best” performing drugs
Health Technology Assessment Guidelines• Inform manufacturers regarding information most useful to WellPoint
Expected Outcomes• A pharmacy benefit that is high quality and cost effective• Better quality of care• Improved cost-effectiveness of care
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