R. William Soller, PhDProfessor, UCSF School of PharmacyExecutive Director, Center for Self Care

UCSF

Invited Lecturer:International Society for Pharmacoeconomics and Outcomes ResearchNovember 19, 2009Via international conference call

Context Pharmacist Care Services

Definition Asheville Center for Self Care

Challenges

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ICD-9 Disease/Condition250 Diabetes401-405 Hypertension410-414 Ischemic heart disease428 Heart failure430-438 Cerebrovascular disease440 Atherosclerosis490-496 Asthma/COPD

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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

>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 $174 billion▪ Smoking $193 billion▪ Heart disease and stroke $448 billion▪ Obesity $117 billion▪ Cancer $ 89 billion

5http://www.cdc.gov/NCCdphp/overview.htm

Prevalence of Diabetes in California 18-44 yr olds 4.3% 45-64 yr olds 11.8% 65-79 yr olds 12.4%

For Californians with Diabetes *: 82% are overweight or obese 60% have high blood cholesterol 63% have hypertension

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

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Diabetes: Retinopathy Kidney disease Microvascular disease – heart attack and stroke Amputation High health care costs

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For diabetes……significant risk

reductions• With better glucose

control40%

Eye, kidney and nerve disease

• With better blood pressure control

33-50%

Heart disease & stroke

• With better control of blood lipids

20-50%

Cardiovascular complications

The Role of the Pharmacist 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.

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““Supported Self Care” for Chronic Disease ManagementSupported 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.”

Implications for IndustryImplications 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

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

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Bunting B et al. J Am Pharm Assoc. 2008;48:23–31.

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Bunting B et al. J Am Pharm Assoc. 2008;48:23–31.

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Bunting B et al. J Am Pharm Assoc. 2008;48:23–31.

Outcomes (n=625/financial; n=565/clinical)Pre Post

Sys BP (mean) 137.3 126.3 mm Hg; Dias BP (mean) 82.6 77.8 mm Hg; % at BP goal 40.2 67.4 % LDL (mean) 127.2 108.3 mg/dL; % at LDL goal 49.9 74.6 % Total cholesterol, (mean) 211.4 184.3 mg/dL Serum TG (mean) 192.8 154.4 mg/dL HDL (mean) 48 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

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Bunting B et al. J Am Pharm Assoc. 2008;48:23–31.

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.

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Perez A et al. Pharmacotherapy 2008:28(11);285e-323c)

Types of Services (All publications) General pharmacother. monitoring services 34.4% (32) Target drug programs 29.1% (27) Disease state management services 22.6% (21)

Settings (All publications) Hospitals 43.0%

(40) Ambulatory care clinics or physician’s offices 21.5% (20) Community pharmacies 17.2% (16)

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Perez A et al. Pharmacotherapy 2008:28(11);285e-323c)

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Perez, A. et al. Pharmacotherapy 2008:28(11);285e-323c)

For every dollar invested in CPS, $4.81 was achieved in reduced costs or other economic benefits.

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

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CommunityPharmacists

Design, Design, Field Ops, Field Ops, AnalysisAnalysis

UCUCSFSFBlue Blue ShieldShield

CalPERSCalPERS

Corporate Corporate Pharmacy Pharmacy ServicesServices

Patients’’

PCPS

Patients

Tele-Pharmacists

UCUCSFSF

PatientsPatients

Nurse Educators

BenefitsAdministrator

Patients’

PCPS

• Counseling• Design• Field Ops• Analysis

• Scheduling

The Northern California Pharmacist Care Collaborative (NCPCC) = = Patients + Payers (employers, insurers,

unions) + Health Providers (physicians,

pharmacists, nurses) + Pharma companies + Foundations+ Researchers (universities)

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Our collaborative has included:

◦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

Our Premise 12 years of mounting evidence shows pharmacist monitoring of chronic care patients is clinically and cost effective.

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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 ExampleSelected National

Standards of Clinical Care Measures ^

Economic and Resource Utilization Measures from

Claims Data

Humanistic Assessments from Patient/Provider

Surveys 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

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

Patient satisfaction Provider satisfaction Absenteeism Presenteeism Quality of Life self-

assessments 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.

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

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Would you recommend this program to a family member of friend?

n=69 n=39

Early return achievablewith low numbers

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

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Tracking RPh Recommendations:Early Return & QA Tool for

Expansion

HbA1c LDL Systolic BP Diastolic BP

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83%, lowered or maintained HbA1c <7%Mean reduction from 8.4% at baseline to 7.1% (p=.0046)

Presenteeism – QuestionsHow 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

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Lerner D et al. The Work Limitations Questionnaire. Medical Care 2001;39:72-85.

Lerner D et al. The Work Limitations Questionnaire. Medical Care 2001;39:72-85.

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Lerner D et al. The Work Limitations Questionnaire. Medical Care 2001;39:72-85.

Lerner D et al. The Work Limitations Questionnaire. Medical Care 2001;39:72-85.

Workplace Outcomes Are Important to Employers.

RALEY’s (n=25) /6 months DM-related Medical Claims

▪ Enrollees 41 % decrease DM-related Rx claims

▪ Enrollees 14% increase

UA447 (n= 23) /6months Total Medical Claims (DM and ASM)

▪ Enrollees 28% decrease

▪ Non-enrollees 11% increase

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A Rigorous Program with Defined Protocols and Excellent Field Management Can Demonstrate

Positive Clinical Outcomes in 4-6 Months in Relatively Low Numbers of Patients

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.”

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Market Awareness of the Value of Pharmacist Services C-Suite & Credible Underestimates

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Total Pilot Model with Productivity Gains: Raley's plus CalPERS (N=300)

$2,964,917$2,746,621$2,544,399

$0

$500,000

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PCS

Total Prescription Claims

Insurance Claims

Projected w/o Raley's Program

33% increased Productivity

The Northern California Pharmacist Care Collaborative (NCPCC) = = Patients + Payers (employers, insurers,

unions) + Health Providers (physicians,

pharmacists, nurses) + Pharma companies + Foundations+ Researchers (universities)

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Our collaborative has included:

◦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

Stakeholder Alignment

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

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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

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Outcomes (n=625/financial; n=565/clinical)Pre Post

Sys BP (mean) 137.3 126.3 mm Hg; Dias BP (mean) 82.6 77.8 mm Hg; % at BP goal 40.2 67.4 % LDL (mean) 127.2 108.3 mg/dL; % at LDL goal 49.9 74.6 % Total cholesterol, (mean) 211.4 184.3 mg/dL Serum TG (mean) 192.8 154.4 mg/dL HDL (mean) 48 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

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Bunting B et al. J Am Pharm Assoc. 2008;48:23–31.

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

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Accountability for Quality and Outcomes Access to Data Type of Data

▪ Adherence vs. Optimal medication utilization

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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.

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Questions?Questions?

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