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R. William Soller, PhD
Professor, UCSF School of Pharmacy
Executive Director, Center for Self Care
Invited Lecturer:
International Society for Pharmacoeconomics and Outcomes Research
November 19, 2009
Via international conference call
UCSF


Context
Pharmacist Care Services
 Definition
 Asheville
 Center for Self Care

Challenges
2
2008 Total Medical Claims for
Selected Diseases/Conditions by Age Cohorts
$1,400,000
$1,200,000
ICD-9
250
401-405
410-414
428
430-438
440
490-496
Disease/Condition
Diabetes
Hypertension
Ischemic heart disease
Heart failure
Cerebrovascular disease
Atherosclerosis
Asthma/COPD
$1,000,000
$800,000
$600,000
$400,000
$200,000
$0
21-25
26-35
36-45
46-55
56-65
66-75
76-85
86-95
3
Seven of every 10
Americans who die
each year, or more
than 1.7 million
people, die of a
chronic disease.
http://www.cdc.gov/NCCdphp/overview.htm
4
 >133 MM (~50% Americans), > 1 chronic condition.
 Chronic diseases account for:
▪ 70% of all deaths in US
▪ >75% of $2 trillion medical care costs in US
▪ 33% of the years of potential life lost before age 65.
 The annual direct and indirect costs
▪
▪
▪
▪
▪
DM
Smoking
Heart disease and stroke
Obesity
Cancer
$174 billion
$193 billion
$448 billion
$117 billion
$ 89 billion
http://www.cdc.gov/NCCdphp/overview.htm
5
Age-Adjusted Percentage of Civilian,
Noninstitutionalized Population
with Diagnosed Diabetes, by Race
and Sex, United States, 1980–2006
10
Prevalence of Diabetes in California9
 18-44 yr olds
 45-64 yr olds
 65-79 yr olds

4.3%
11.8%
12.4%
For Californians with Diabetes *:
 82% are overweight or obese
 60% have high blood cholesterol
 63% have hypertension
8
7
Prevalence %

 40% had fewer than 2 HbA1c tests annually
 30% those over 65 did not receive a flu shot

88% saw a health professional for diabetes
 67% received a dilated eye exam w/in last year
 62% perform daily foot self-exam
*most recent data from CDC, 2006
6
5
4
3
2
1
0
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006
White Male
Black Male
Hispanic Male
White Female
Black Female
Hispanic Female
6

Diabetes:
 Retinopathy
 Kidney disease
 Microvascular disease – heart attack and stroke
 Amputation
 High health care costs
For diabetes…
• With better glucose control
…significant risk reductions
40%
Eye, kidney and nerve disease
• With better blood pressure control
33-50%
Heart disease & stroke
•7 With better control of blood lipids
20-50%
Cardiovascular complications

“Supported Self Care” for Chronic Disease Management
An on-going process that
•
•
•
•

Facilitates the knowledge, skill, and ability necessary for self-care;
Incorporates the needs, goals, and life experiences of the person;
Is guided by evidence-based standards.
Is distinguished from “self-determined self care” and “facilitated self care.”
The Role of the Pharmacist
 Serves as a coach through counseling and supervision of self care
 Supports problem-solving, informed decision-making, and behavioral changes by the
patient;
 Improves clinical outcomes, health status, and quality of life by making
recommendations for appropriate use of medications, nutrition, exercise, and wellness
activities;
 Facilitates connectivity/active collaboration among the health care team.
Implications for Industry
• Patients not meeting standards of care – HEDIS:
• Improve adherence, presumably if increase adherence, increase sales
• But, the issue is medication adjustments….Pharma not prepared for this
8
Bunting B et al. J Am Pharm Assoc. 2008;48:23–31.





Setting
 12 community and hospital pharmacy clinics in Asheville, N.C.
Time Period: 2000 through 2005.
Participants
 Patients in 2 self-insured health plans
 Educators at Mission Hospitals
 18 certificate-trained pharmacists.
Interventions
 CV risk reduction education (cardio- or cerebrovascular)
 Regular, long-term follow-up by pharmacists (reimbursed by health plans)
▪ Scheduled consultations
▪ Monitoring
▪ Recommendations to physicians.
Main Outcome Measures
 Clinical and economic parameters
9
Bunting B et al. J Am Pharm Assoc. 2008;48:23–31.
10
Bunting B et al. J Am Pharm Assoc. 2008;48:23–31.
11
Bunting B et al. J Am Pharm Assoc. 2008;48:23–31.
Outcomes (n=625/financial; n=565/clinical)
Pre
Post








Sys BP (mean)
Dias BP (mean)
% at BP goal
LDL (mean)
% at LDL goal
Total cholesterol, (mean)
Serum TG (mean)
HDL (mean)
137.3
82.6
40.2
127.2
49.9
211.4
192.8
48
126.3 mm Hg;
77.8 mm Hg;
67.4 %
108.3 mg/dL;
74.6 %
184.3 mg/dL
154.4 mg/dL
46.6 mg/dL
Risk of a CV event
- 53 % reduction
CV-related medical costs
- 38 % of total health care costs
mean cost/CV event
- 30% ($14,343 vs.$9,931)
 CV medication use
threefold increase
 Total medical costs
- 46 %
 Risk of CV-rel. ED/hosp visits - 50% reduction



12
Perez A et al. Pharmacotherapy 2008:28(11);285e-323c)

Contracted by American College of Clinical Pharmacy
(ACCP)

A systematic review of pharmacoeconomic studies
relating to pharmacist care services from 2001
through 2005
 45 studies with economic evaluations (48.4%)
 15 studies with sufficient data to perform a benefit-cost
ratio

Main Economic Finding:
 Pooled median value of PCS was 4.8:1
 For every dollar invested in CPS, $4.81 was achieved
in reduced costs or other economic benefits.
13
Perez A et al. Pharmacotherapy 2008:28(11);285e-323c)

Types of Services (All publications)
 General pharmacother. monitoring services
 Target drug programs
 Disease state management services

34.4% (32)
29.1% (27)
22.6% (21)
Settings (All publications)
 Hospitals
 Ambulatory care clinics or physician’s offices
 Community pharmacies
43.0% (40)
21.5% (20)
17.2% (16)
14
For every dollar invested in CPS,
$4.81 was achieved in reduced
costs or other economic benefits.
Perez, A. et al. Pharmacotherapy 2008:28(11);285e-323c)
15

Clinical Services
 St. Anthony’s Free Medical Clinic
 UA Local 447 Pipefitters, members/dependents
 Raley’s employees, members/dependents
 CalPERS members/dependents

Patients n=150, >500 visits
16
Community
Pharmacists
Corporate
Pharmacy
Services
Patients’
PCPS
Patients
Blue
Shield
CalPERS
UCSF
Design,
Field Ops,
Analysis
Benefits
Administrator
• Scheduling
Patients
UCSF
Nurse
Educators
TelePharmacists
Patients’
PCPS
• Counseling
• Design
• Field Ops
• Analysis
Our collaborative has included:

◦ Patients
 CalPERS (California Public Employee Retirement
System)
 Raley’s Employees and their dependents
The Northern California
 Union Local 447 (Pipe Trades) members and dependents
Pharmacist Care Collaborative
 St. Anthony’s Free Medical Clinic Patients
(NCPCC) =
◦ Patient Groups
◦ California Chronic Care Coalition
= Patients
◦ Health Care Providers
+ Payers (employers, insurers,
 Raley’s pharmacists
unions)
 UCSF pharmacists of the Center for Self Care, UCSF
Department of Clinical Pharmacy
+ Health Providers (physicians,
◦ Payers
pharmacists, nurses)
◦ Blue Shield of California
+ Pharma companies
◦ Raley’s Pharmacies
◦ Pharma Companies
+ Foundations
◦ Sanofi-Aventis
+ Researchers (universities)
12 years of mounting evidence
shows
◦ GlaxoSmithKline
pharmacist monitoring
of chronic care
◦ Foundations
patients is clinically and◦ cost
effective.
Nat’l Assoc.
Chain Drug Stores Foundation
◦ The Pharmacy Foundation of California
◦ McKesson Foundation
◦ Researchers
◦ University of California School of Pharmacy Center for
Self Care
Our Premise
19
Overview of Selected Key Outcomes for Pharmacist Care Chronic Disease
Management for Self-insured Employers and Taft Hartley Union Trust Fund
Administrators Using Diabetes as an Example
Selected National
Standards of Clinical Care
Measures ^
 Hemoglobin A1c (<7%)
 Low Density
Lipoprotein (<100)
 Blood Pressure
(<130/80 mm Hg)
 Body Weight Index
(<30)
 Aspirin therapy (unless
contraindicated)
 Annual rates of
physician check-ups
and lab values

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





Economic and Resource
Utilization Measures from
Claims Data
Total medical claims cost
Diabetes related medical
claims
Total pharmacy claims
Diabetes-related pharmacy
claims
Adherence (e.g., refill rates)
Diabetes supplies (e.g.,
syringes)
Diabetes-associated ED
visits
Diabetes-associated
hospitalizations
Humanistic Assessments
from Patient/Provider
Surveys
 Patient satisfaction
 Provider satisfaction
 Absenteeism
 Presenteeism
 Quality of Life selfassessments reflecting
better control of
diabetes
^ Depends on co-morbidities associated with diabetes. For example, if asthma is a co-morbidity with
diabetes, then national standards of care associated with asthma management also apply (e.g., with
respect to force expiratory volume). Values for shown for national standards of care are goals, and it
is important to show sustained progression to goal, as it is to show attainment.
20

RENO
Program Reach

CalPERS-Raley’s-Blue Shield
 ~30,000 square miles

Based on zip codes (pt &
store)

48 Raley’s pharmacies

360 CalPers members

UA Local 447 Sacramento
 150 patients
 Multiple chronic diseases
 DM
 ASM/COPD
 HTN
 CVD
 CHF
 Depression

St Anthony Free Medical Clinic
 60 patients with DM
 Includes insulin titration
Hollister
21
Would you recommend this program
to a family member of friend?
Early return achievable
with low numbers
n=69
n=39
22

UA447 Pharmacist Consult Service
 Chart review of 96 past visits within 6 week period
 December 2008 – February 15, 2009
 2 clinical pharmacists
 Study n = 44
▪ n = 23 w/DM
▪ n = 21 other chronic conditions and/or polypharmacy (>5 medications)
 Parameter
▪ Top three recommendations to patient and/or provider
▪ In some cases < 3 recommendations were made
23
Main Categories of Pharmacist-Initiated
Recommendations to Patient's PCP:
DM TP Participants: All Visits
(n=51 rec's over 57 visits for 23 patients, as of Jan 27,
2008)
Main Categories of Telepharmacist-Initiated
Recommendations to DM Patients
(n=171 rec's over 57 visits for 23 patients as of Jan 27, 2009)
SIDE EFFECTS
SCREENING
REFER TO PCP
SCREENING
PROPER ADMINISTRATION
MEDWATCH DRUG SAFETY…
MEDWATCH DRUG SAFETY
REPORTING
MEDICATION ADJUSTMENT
MED OR DOSAGE CHANGE
LIFESTYLE
MEDICATION ADJUSTMENT
LABS
IMMUNIZATION
LABS
GLYCEMIC CONTROL
DRUG INTERACTION
IMMUNIZATION
DISEASE EDUCATION
Tracking RPh Recommendations:
Early Return & QA Tool for Expansion
DIAGNOSTIC DEVICE USE
0
5
10
15
20
25
30
Number of Pharamcist-initiated Recommendations
0
10
20
30
40
50
24
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


HbA1c
LDL
Systolic BP
Diastolic BP
25
HbA1C
10
83%, lowered or maintained HbA1c <7%
Mean reduction from 8.4% at baseline to 7.1% (p=.0046)
> or < 7% goal of therapy
8
6
4
BL><7%
Fup><7%
2
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
-2
-4
Pairs of HbA1c Values for Each Patient with Baseline and Follow-up at 4-6 months
26
Lerner D et al. The Work Limitations Questionnaire. Medical Care 2001;39:72-85.
Presenteeism – Questions
How difficult is it for you to:
1. Get going at beginning of the day
2. Start job as soon as arrive at work
3. Sit, stand, stay in 1 position w/o difficulty
4. Repeat motions over & over w/o difficulty
5. Concentrate on work
6. Speak in person, meetings, on phone
7. Handle the workload
8. Finish work on time
Likert Scale
All/most of time
Half/some of
time
None of time
Not apply
Lerner D et al. The Work Limitations Questionnaire. Medical Care 2001;39:72-85.
27
Lerner D et al. The Work Limitations Questionnaire. Medical Care 2001;39:72-85.
60.0%
50.0%
40.0%
30.0%
20.0%
Workplace Outcomes Are
Important to Employers.
10.0%
0.0%
Initial
6 month
Difficulty finishing work on time
All/most of time
Half/some of time
None of time
Not apply
Lerner D et al. The Work Limitations Questionnaire. Medical Care 2001;39:72-85.
28


RALEY’s (n=25) /6 months
 DM-related Medical Claims
▪ Enrollees
41 % decrease
A Rigorous
with Defined Protocols and
DM-related RxProgram
claims
Excellent
Demonstrate
▪ EnrolleesField Management
14%Can
increase
Positive Clinical Outcomes in 4-6 Months in
UA447 (n= 23) /6months
LowandNumbers
of Patients
 Total Relatively
Medical Claims (DM
ASM)
▪ Enrollees
28% decrease
▪ Non-enrollees
11% increase
29

Soller RW and Vogt E. Defining barriers to Expanded
Pharmacist Care Services. International Journal of
Pharmacy Practice 17;December 2009. Accepted 11/09
“Yet, significant challenges remain on both the market
and the profession sides of the equation. These
challenges are interlinked and relate to: market
awareness of the value of pharmacist services;
stakeholder alignment; model sustainability and
scalability; data access; program design; and
accountability for quality and outcomes.”
30
Market Awareness of the Value of Pharmacist Services
 C-Suite & Credible Underestimates
Total Pilot Model with Productivity Gains: Raley's plus
CalPERS (N=300)
$2,746,621
$2,964,917
$60,000
$2,544,399
$2,500,000
$50,000
$2,000,000
$40,000
$1,500,000
$30,000
$1,000,000
$20,000
$500,000
$10,000
$0
ar
2n
d
ye
ea
ty
1s
Ba
r
$0
Productivity (Dollar
gains/Baseline)
$3,000,000
se
lin
e
Mean Cost For All Members
(Dollars)

PCS
Total Prescription Claims
Insurance Claims
Projected w/o Raley's Program
33% increased Productivity
31
Our collaborative has included:

Stakeholder Alignment

The Northern California
Pharmacist Care Collaborative
(NCPCC) =
= Patients
+ Payers (employers, insurers,
unions)
+ Health Providers (physicians,
pharmacists, nurses)
+ Pharma companies
+ Foundations
+ Researchers (universities)
◦ Patients
 CalPERS (California Public Employee Retirement
System)
 Raley’s Employees and their dependents
 Union Local 447 (Pipe Trades) members and dependents
 St. Anthony’s Free Medical Clinic Patients
◦ Patient Groups
◦ California Chronic Care Coalition
◦ Health Care Providers
 Raley’s pharmacists
 UCSF pharmacists of the Center for Self Care, UCSF
Department of Clinical Pharmacy
◦ Payers
◦ Blue Shield of California
◦ Raley’s Pharmacies
◦ Pharma Companies
◦ Sanofi-Aventis
◦ GlaxoSmithKline
◦ Foundations
◦ Nat’l Assoc. Chain Drug Stores Foundation
◦ The Pharmacy Foundation of California
◦ McKesson Foundation
◦ Researchers
◦ University of California School of Pharmacy Center for
Self Care
32

Model Sustainability and Scalability
 Stereotypic role of pharmacist as dispenser of medicines
 Pharmacist Care Services for MTM and Chronic Disease
Management:
▪ Multi-visit: 40 min, 20 min
▪ Reimbursement: $2.00/minute (?); $150/visit (?)
 Key Questions
▪
▪
▪
▪
Who gets paid – the plan or the pharmacist?
Who does the services – PharmD, RN, tech help?
What is the optimal model?
What model is scalable?
▪ Clinic to Municipality to State to Nation
33

Data Access -- Evidence is the engine that runs health policy.
 Disadvantages of Large Payer Systems
▪ Contractual Arrangements – limit data to aggregate form
▪ Competing Programs
▪ True control a question
▪ Comparator group in context of a Phase IV open label study design
 Cost, an issue and related to power calculations if “active vs. active” type
comparison

Program Design
 Training in research design, an issue in payer/benefits
management
 E.g.: risk stratification, rolling enrollment, protocol development
34
Bunting B et al. J Am Pharm Assoc. 2008;48:23–31.
Outcomes (n=625/financial; n=565/clinical)
Pre
Post








Sys BP (mean)
Dias BP (mean)
% at BP goal
LDL (mean)
% at LDL goal
Total cholesterol, (mean)
Serum TG (mean)
HDL (mean)
137.3
82.6
40.2
127.2
49.9
211.4
192.8
48
126.3 mm Hg;
77.8 mm Hg;
67.4 %
108.3 mg/dL;
74.6 %
184.3 mg/dL
154.4 mg/dL
46.6 mg/dL
Risk of a CV event
- 53 % reduction
CV-related medical costs
- 38 % of total health care costs
mean cost/CV event
- 30% ($14,343 vs.$9,931)
 CV medication use
threefold increase
 Total medical costs
- 46 %
 Risk of CV-rel. ED/hosp visits - 50% reduction



35

Regression to the mean
 The chance that patients would have improved without
program interventions because on average a bad year
would be followed by a good year

Steps taken to reduce potential for this type of bias
 Historical data
▪ Historical data went back 3 years pre-enrollment, to be sure they
didn’t enroll just because they had a bad year
▪ Highest CV event rate was 3 years before enrollment
▪ Lowest CV event rate was the year before enrollment
 Follow-up data
▪ 6-years
36

Accountability for Quality and Outcomes
 Access to Data
 Type of Data
▪ Adherence vs. Optimal medication utilization
37

Growing body of evidence support the
value of pharmacist care services (PCS),
with substantial return on investment.

Issues and challenges remain.

Future is bright, given the nature of how
pharmacist care services have evolved in
past 20 years.
38
Questions?
39