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Using Evidence to Make Prescription Drug Purchasing Decisions JOHN SANTA MD MPH Grant Administrator Attorney Generals Consumer and Prescriber Grants Program Center for Evidence-based Policy Oregon Health & Science University “More than any other time in history, mankind faces a crossroads. One path leads to despair and utter hopelessness. The other to total extinction. Let us pray we have the wisdom to choose correctly.” Woody Allen Wisdom to Choose • There are more than these two options • Act like a purchaser. Understand: • playing field/negotiating table • who you represent • who the “sellers” are. • DON’T BLINK Playing Field American Culture • Tension between individual freedom and equality • Individual freedom • Religion • Capitalism • Equality of opportunity • Land of opportunity, not economic security Playing Field Employer based, FFS • Unlimited access to the most sophisticated acute care in the world when desperately ill. • Multiple tiers of care unless need acute care, desperately ill. • Unlimited access to the most health care information in the world in every imaginable medium. Playing Field “Perfect Competition” • • • • Homogeneity of product Perfect information Freedom of entry and exit Numerous small firms and customers Microeconomics Principles and Policy, Baumol, W.J., and Binder A.S. Who you represent Systems are perfectly designed to get the results they achieve. Who you represent • • • • Working people Sick people—high % chronic diseases People 50-65 years old You are negotiating a substantial % of their income. Annual income of families at 100% of federal poverty level Who you represent • Almost 2 million adults (almost 1%) file for bankruptcy every year • 28% major factor = illness/injury • 27% leading factor = uncovered medical bills • 21% cite loss of income due to illness • 75% had health insurance • Average age in forties, over 90% middle class • HEALTH CARE COSTS NOW THE MAJOR CAUSE OF BANKRUPTCY Archives of General Psychiatry June 2006 • In 2002, antipsychotic drugs were prescribed to 1,438 children per 100,000, up from 275 children per 100,000 between 1993 and 1995 – five fold increase; • One-third of children who received antipsychotic drugs had behavior disorders, one-third had psychotic symptoms or developmental problems and one-third had mood disorders; • Overall, more than 40% of children who received an antipsychotic drug were taking at least one other antipsychotic medication; • Between 2000 and 2002, more than 90% of prescriptions analyzed were for newer atypical antipsychotic drugs which were introduced in the early and mid-1990s; • Caucasian boys are the most common recipients of antipsychotic medications. New York Times, June 2006 "We are using these medications and don't know how they work, if they work or at what cost," John March, a professor of child and adolescent psychiatry at Duke University, said. He added, "It amounts to a huge experiment with the lives of American kids, and what it tells us is that we've got to do something other than [what] we're doing now." Sellers Transparency/Conflict of Interest • 16 Billion on RX marketing---much more than spent on medical education or research • Academic medical centers especially conflicted • Gifts/relationships make a difference Sellers Conflict of Interest “The medical profession has sold its soul in exchange for what can only be described as bribes from manufacturers of drugs and medical devices” NY Times Jan 2006 Is there hope? “We can’t solve problems by using the same kind of thinking we used when we created them.” Albert Einstein VA • Government administered and provided health care system • Means tested • Provides a basic benefit for a fixed amount • Integrated system Who are VA Patients? Disadvantaged Populations • Older ~49% over age 65 • Sicker ~Compared to Age-Matched Americans -3 additional Medical Diagnoses -1 Additional Mental Health Diagnosis • Poorer ~70% with annual incomes < $26,000 ~40% with annual incomes < $16,000 • Homelessness ~1/3 of all homeless individuals are veterans approximately 200,000 More than 400,000 may experience homelessness in a given year • Changing Demographics ~4.5% female overall Improved Efficiency: Enrollees, Patients & Resources/Patient 1996-2004 $12.0 7 Enrollees $10.0 6 $8.0 5 4 Resources/Patient in Nominal Dollars $6.0 3 $4.0 Veteran Patients 2 $2.0 1 0 $0.0 1996 1997 1998 1999 2000 Fiscal Year 2001 2002 2003 2004 Resources Per Patient (in Thousands) Enrollees and Patients (in Millions) 8 Economies of Scale: VA’s PBM (Pharmacy Benefits Management Program) 1996 - 2004 • $4.72 Billion in savings: • • • In drug acquisition costs from standardization contracting ($1.92B) In labor/mail costs through CMOP prescription processing (>$2.3B) In negative distribution fees (rebates) the Pharmaceutical Prime Vendor contract (~$503M)* • * Savings achieved in collaboration with VA’s National Acquisition Center • Quality Improvements resulting in unmeasured cost savings: • • • • CMOP error rate reduction (approaching six sigma) Two-thirds reduction in reported medication errors through BCMA Evidence-based prescribing guidance Outcomes assessment to monitor/maintain safe prescribing Portland VA Medical Center 2005 HEDIS Commercial 2004 HEDIS Medicare 2004 HEDIS Medicaid 2004 Breast cancer screening 72% 73% 74% 54% Cervical cancer screening 89% 81% Not Reported 65% Colorectal cancer screening 71% 49% 53% Not Reported LDL Cholesterol < 100 after AMI, 59% 51% 54% 29% Diabetes: Poor control HbA1c > 9.0% PTCA, CABG (lower is better) 15% 31% 23% 49% Diabetes: Cholesterol (LDL-C) controlled (<100) 61% 40% 48% 31% Diabetes: Cholesterol (LDL-C) controlled (<130) 76% 65% 70% 41% Diabetes: Eye Exam 79% 51% 67% 45% Hypertension: BP <= 140/90 most recent visit 70% 67% 65% 61% Follow-up after Hospitalization for Mental Illness (30 days) 77% 76% 61% 55% Immunizations: influenza, (note patients age groups) 73% 38.9% (50-64) 74.8% (65 and older) 70% (65 and older) Immunizations: Pneumococcal, patients 65 and older 98% Not Reported Not Reported 65% CLINICAL PERFORMANCE INDICATOR Balancing Access & Resources Waiting for Medically Non-Urgent Care Numbers waiting over 30 days for elective care by region. VA Patient Satisfaction: • VA Inpatient – 83% • Private Sector Inpatient -*73% • VA Outpatient – 80% • Private Sector Outpatient - *75 • *American Customer Satisfaction Index Are there problems? • FDA---recent IOM report---”sweeping” changes needed • CMS---prohibited from using evidence funded by the Medicare Modernization Act that compares drugs • Academic centers/pharma companies--growing concerns about corruption--www.hcrenewal.blogspot.com “We are drowning in information but starved for knowledge.” John Naisbitt Megatrends, 1982 Do you believe that the health care services you receive should be based on the best and most recent research available? Yes No Don’t know 95% 4% 1% Source: National survey, 2005, Charlton Research Company for Research!America The Ethics of Pharmaceutical Benefit Management Burton S.L. et al, Health Affairs, 20, #5, Sept/Oct 2001 • • • • • • Accept resource constraints Help the sick Protect the worst off Respect autonomy Sustain trust Promote inclusive decision making Major issues • Effectiveness---especially comparative effectiveness. How does Drug A compare to Drug B?? • Safety---especially longer term safety • Off label uses---uses not approved of by the FDA Lets just focus on comparative effectiveness $$ Market Share Over 24 Months — Single Rx Class $500,000 $450,000 $400,000 $350,000 $$/Month $300,000 $250,000 $200,000 $150,000 $100,000 $50,000 $0 Months – 1/00 to 6/02 The Prescription Drug Purchasing Process • • • • • Information Price Credibility/Transparency/Trust Implementation Evaluation The Drug Effectiveness Review Project • Systematic drug class reviews focusing on comparative effectiveness and safety • Focus on the most important 25 drug classes • Update every 12-24 months (sooner if needed) • Each participant uses local decision makers to draw conclusions from the evidence for their use Drug Classes 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. Proton Pump Inhibitors Long-acting Opioids Statins Non-steroidal Anti-Inflammatory Drugs Estrogens Triptans Skeletal Muscle Relaxants Oral Hypoglycemics Over Active Bladder, Drugs to treat ACE Inhibitors Beta Blockers Calcium Channel Blockers Angiotensin II Receptor Antagonists 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 2nd Generation Antidepressants Antiepileptic Drugs in Bipolar Mood Disorder and Neuropathic Pain 2nd Generation Antihistamines Atypical Antipsychotics Inhaled Corticosteroids ADHD and ADD, Drugs to treat Alzheimers, Drugs to treat Anti-platelet Drugs Thiazolidinedione Newer Antemetics Sedative Hypnotics Targeted Immune Modulators Inhaled Beta Agonists Overview of Project PRIVATE NON PROFITS AND STATES CENTER FOR EVIDENCE-BASED POLICY COORDINATING EVIDENCE BASED PRACTICE CENTER OHSU EPC UNC EPC CALIF RAND EPC Governance Group • 17 Organizations • State Medicaid organizations • State employee plans • Private organizations • Decisions to be made • • • • Key policy decisions Drug classes to be reviewed Key questions Timelines Currently Announced Participating Organizations • • • • • • • • • Alaska Arkansas California Oregon Washington Idaho Wyoming Kansas New York • • • • • • • • Michigan Missouri Minnesota North Carolina Wisconsin CHCF CCOHTA Montana Center for Evidence-based Policy • MISSION: To address policy challenges by applying the best available evidence through self-governing communities of interest. • Department of Public Health and Preventive Medicine, Oregon Health & Science University • Supports collaboration, facilitates communication OHSU Evidence-based Practice Center • Designated an EPC by AHRQ • Department of Medical Informatics and Clinical Epidemiology, OHSU • Agreement with Center for drug class reviews. • Credible, experienced (10 years) source of comprehensive information. Evidence-based Practice Center • Emphasize getting questions right • State of art methods for conducting systematic reviews • Multiple reviewers • Accustomed to timelines, deliverables • Extensive, external peer review • Many EPC products available for the world to evaluate Expert Strategy • Experts may underplay controversy or select only supportive evidence • Without systematic approach bias may be introduced • Experts may ask good research questions but the wrong questions for patients and providers • Experts may not be aware of all evidence • Experts may or may not disclose conflicts Systematic Review Process • • • • • • Problem formulation/key questions Find evidence Select evidence Synthesize and present Peer review and revision Maintain and update Key Questions • EPC drafts initial KQ using standard comparative review approach • Three questions • Comparative effectiveness • Comparative safety profile • Subpopulations • Multiple discussions • Multiple inputs • Consensus process Key Questions • • • • Drugs to be included in class Indications Outcomes of interest Types of studies Possible Results • No good quality comparative studies done. • Good studies done. No differences. • Good studies done. Small differences. • Good studies done. Significant differences. Some examples • COX 2s/NSAIDs—never more effective, risks were suppressed • Heartburn medicines---No differences in effectiveness for vast majority of patients • Long acting narcotics---little comparative evidence • Antidepressants---all effective at similar levels, different side effect profiles Subpopulations • All reports include evidence focused on subpopulations • Gender, race, ethnicity, age, income • Evidence frequently not found • General population evidence vs no evidence • Strive for studies that meet rigorous standards for all populations. • If we don’t make decisions based on evidence can we ever hope to get it? Update Reports • Every 12-24 months — some continuously updated every 7 months • Start with key questions from previous final report • Integrate input from local discussions • New drugs, new studies, additional issues added • Chance to improve reports Final Comments • • • • Credible, transparent, explicit, trustworthy Good information, reasonably current Consumers/patients have access to info Insist practitioners disclose financial relationships to purchasers and patients • Don’t blink • Shift market share More Information • Project website at www.ohsu.edu/drugeffectiveness. • Email comments/questions regarding the Center to [email protected]. • Call John Santa at 503-494-2691 if questions regarding the Center or Project.