1. R. William Soller, PhD Professor, UCSF School of Pharmacy Executive Director, Center for Self Care UC SF Invited Lecturer: International Society for Pharmacoeconomics and Outcomes Research November 19, 2009 Via international conference call

2.  Context  Pharmacist Care Services  Definition  Asheville  Center for Self Care  Challenges 2

3. 3 ICD-9Disease/Condition 250Diabetes 401-405Hypertension 410-414Ischemic heart disease 428Heart failure 430-438Cerebrovascular disease 440Atherosclerosis 490-496Asthma/COPD

4. 4 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

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

6.  Prevalence of Diabetes in California  18-44 yr olds 4.3%  45-64 yr olds11.8%  65-79 yr olds12.4%  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 6

7.  Diabetes:  Retinopathy  Kidney disease  Microvascular disease – heart attack and stroke  Amputation  High health care costs 7 For diabetes……significant risk reductions With better glucose control40%Eye, kidney and nerve disease With better blood pressure control33-50%Heart disease & stroke With better control of blood lipids20-50%Cardiovascular complications

8. 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. 8 “Supported Self Care” for Chronic Disease Management “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.” 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

9.  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. 10 Bunting B et al. J Am Pharm Assoc. 2008;48:23–31.

11. 11 Bunting B et al. J Am Pharm Assoc. 2008;48:23–31.

12. Outcomes (n=625/financial; n=565/clinical) PrePost  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 12 Bunting B et al. J Am Pharm Assoc. 2008;48:23–31.

13.  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)

14.  Types of Services (All publications)  General pharmacother. monitoring services34.4% (32)  Target drug programs29.1% (27)  Disease state management services22.6% (21)  Settings (All publications)  Hospitals43.0% (40)  Ambulatory care clinics or physician’s offices21.5% (20)  Community pharmacies17.2% (16) 14 Perez A et al. Pharmacotherapy 2008:28(11);285e-323c)

15. 15 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.

16.  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

17. Community Pharmacists Design, Field Ops, Analysis UC SF Blue Shield CalPERS Corporate Pharmacy Services ’ Patients ’ PCP S Patients

18. Tele- Pharmacists UC SF Patients Nurse Educators Benefits Administrator Patients ’ PCP S Counseling Design Field Ops Analysis Scheduling

19.  The Northern California Pharmacist Care Collaborative (NCPCC) = = Patients + Payers (employers, insurers, unions) + Health Providers (physicians, pharmacists, nurses) + Pharma companies + Foundations + Researchers (universities) 19 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.

20. 20 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 ^ 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.

21. 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

22. 22 Would you recommend this program to a family member of friend? n=69 n=39 Early return achievable with low numbers

23.  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

24. 24 Tracking RPh Recommendations: Early Return & QA Tool for Expansion

25.  HbA1c  LDL  Systolic BP  Diastolic BP 25

26. 26 83%, lowered or maintained HbA1c <7% Mean reduction from 8.4% at baseline to 7.1% (p=.0046)

27. 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 ScaleAll/most of time Half/some of time None of timeNot apply 27 Lerner D et al. The Work Limitations Questionnaire. Medical Care 2001;39:72-85.

28. 28 Lerner D et al. The Work Limitations Questionnaire. Medical Care 2001;39:72-85. Workplace Outcomes Are Important to Employers.

29.  RALEY’s (n=25) /6 months  DM-related Medical Claims ▪Enrollees41 % decrease  DM-related Rx claims ▪Enrollees 14% increase  UA447 (n= 23) /6months  Total Medical Claims (DM and ASM) ▪Enrollees 28% decrease ▪Non-enrollees11% increase 29 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

30.  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

31.  Market Awareness of the Value of Pharmacist Services  C-Suite & Credible Underestimates 31

32.  The Northern California Pharmacist Care Collaborative (NCPCC) = = Patients + Payers (employers, insurers, unions) + Health Providers (physicians, pharmacists, nurses) + Pharma companies + Foundations + Researchers (universities) 32 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

33.  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

34.  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

35. Outcomes (n=625/financial; n=565/clinical) PrePost  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 35 Bunting B et al. J Am Pharm Assoc. 2008;48:23–31.

36.  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

37.  Accountability for Quality and Outcomes  Access to Data  Type of Data ▪Adherence vs. Optimal medication utilization 37

38.  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

39. Questions? 39