1. 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

2. “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

3. 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

4. Playing Field American Culture Tension between individual freedom and equality Individual freedom Religion Capitalism Equality of opportunity Land of opportunity, not economic security

5. 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.

6. 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.

7. Who you represent Systems are perfectly designed to get the results they achieve.

8. 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

9. 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

10. 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.

11. 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."

12. 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

13. 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

14. Is there hope? “We can’t solve problems by using the same kind of thinking we used when we created them.” Albert Einstein

15. VA Government administered and provided health care system Means tested Provides a basic benefit for a fixed amount Integrated system

16. 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

17. Improved Efficiency: Enrollees, Patients & Resources/Patient 1996-2004

18. 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

19. CLINICAL PERFORMANCE INDICATOR Portland VA Medical Center 2005 HEDIS Commercial 2004 HEDIS Medicare 2004 HEDIS Medicaid 2004 Breast cancer screening72%73%74%54% Cervical cancer screening89%81%Not Reported65% Colorectal cancer screening71%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 Exam79%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 65%

20. Balancing Access & Resources Waiting for Medically Non-Urgent Care Numbers waiting over 30 days for elective care by region.

21. VA Patient Satisfaction: VA Inpatient – 83% Private Sector Inpatient -*73% VA Outpatient – 80% Private Sector Outpatient - *75 *American Customer Satisfaction Index

22. 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

23. “We are drowning in information but starved for knowledge.” John Naisbitt Megatrends, 1982

24. Do you believe that the health care services you receive should be based on the best and most recent research available? Yes 95% No 4% Don’t know 1% Source: National survey, 2005, Charlton Research Company for Research!America

25. 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

26. 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

27. $0 $50,000 $100,000 $150,000 $200,000 $250,000 $300,000 $350,000 $400,000 $450,000 $500,000 Months – 1/00 to 6/02 $$/Month $$ Market Share Over 24 Months — Single Rx Class Jan-00 Feb-00 Mar-00 Apr-00 May-00 Jun-00 Jul-00 Aug-00 Sep-00 Oct-00 Nov-00 Dec-00 Jan-01 Feb-01 Mar-01 Apr-01 May-01 Jun-01 Jul-01 Aug-01 Sep-01 Oct-01 Nov-01 Dec-01 Jan-02 Feb-02 Mar-02 Apr-02 May-02 Jun-02

28. The Prescription Drug Purchasing Process Information Price Credibility/Transparency/Trust Implementation Evaluation

29. 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 The Drug Effectiveness Review Project

30. Drug Classes 1.Proton Pump Inhibitors 2.Long-acting Opioids 3.Statins 4.Non-steroidal Anti-Inflammatory Drugs 5.Estrogens 6.Triptans 7.Skeletal Muscle Relaxants 8.Oral Hypoglycemics 9.Over Active Bladder, Drugs to treat 10.ACE Inhibitors 11.Beta Blockers 12.Calcium Channel Blockers 13.Angiotensin II Receptor Antagonists 14.2nd Generation Antidepressants 15.Antiepileptic Drugs in Bipolar Mood Disorder and Neuropathic Pain 16.2nd Generation Antihistamines 17.Atypical Antipsychotics 18.Inhaled Corticosteroids 19.ADHD and ADD, Drugs to treat 20.Alzheimers, Drugs to treat 21.Anti-platelet Drugs 22.Thiazolidinedione 23.Newer Antemetics 24.Sedative Hypnotics 25.Targeted Immune Modulators 26.Inhaled Beta Agonists

31. Overview of Project PRIVATE NON PROFITS AND STATES CENTER FOR EVIDENCE-BASED POLICY COORDINATING EVIDENCE BASED PRACTICE CENTER OHSU EPCUNC EPCCALIF RAND EPC

32. 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

33. Currently Announced Participating Organizations Alaska Arkansas California Oregon Washington Idaho Wyoming Kansas New York Michigan Missouri Minnesota North Carolina Wisconsin CHCF CCOHTA Montana

34. 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

35. 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.

36. 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

37. 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

38. Systematic Review Process Problem formulation/key questions Find evidence Select evidence Synthesize and present Peer review and revision Maintain and update

39. 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

40. Key Questions Drugs to be included in class Indications Outcomes of interest Types of studies

41. Possible Results No good quality comparative studies done. Good studies done. No differences. Good studies done. Small differences. Good studies done. Significant differences.

42. 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

43. 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?

44. 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

45. 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

46. More Information Project website at www.ohsu.edu/drugeffectiveness. www.ohsu.edu/drugeffectiveness Email comments/questions regarding the Center to santaj@ohsu.edu.santaj@ohsu.edu Call John Santa at 503-494-2691 if questions regarding the Center or Project.