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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 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 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