1. Department of Public Health and Preventive Medicine Systematic Reviews of Drugs Within Classes: Bringing Clinical Evidence to State Policy Makers NAMI 2005 Annual Convention June 20, 2005 Austin, Texas

2. Slide 2 Dept of PublicHealth andPreventiveMedicine Oregon Experience 60% Increase in drug spending Faltering state revenues PDL Legislation Consider effectiveness first Consider cost if effectiveness equal Mental Health drugs not included Collaboration with OHSU EPC Washington and Idaho join Approach requires broader base

3. Slide 3 Dept of PublicHealth andPreventiveMedicine Drug Effectiveness Review Project Self-governing collaboration of organizations that: Obtain and synthesize global evidence on the relative effectiveness of drugs. Support policy makers in using the evidence to inform policy in local decision making.

4. Slide 4 Dept of PublicHealth andPreventiveMedicine Overview of Project STATES & PRIVATE NON PROFITS CENTER FOR EVIDENCE-BASED POLICY COORDINATING EVIDENCE BASED PRACTICE CENTER OREGON EPCUNC EPCEPC RAND

5. Slide 5 Dept of PublicHealth andPreventiveMedicine Currently Announced Participating Organizations Alaska Arkansas California Oregon Washington Idaho Wyoming Kansas Michigan Missouri Minnesota North Carolina Wisconsin CHCF/CALPERS CCOHTA

6. Slide 6 Dept of PublicHealth andPreventiveMedicine Systematic Reviews Comparing Effectiveness of Drugs Within Classes Key questions Inclusion/exclusion criteria Global data search Evaluation of data quality Synthesis of good quality data Draft report and peer/public review Final report Presentation to participants PowerPoint Executive Summary Full text report

7. Slide 7 Dept of PublicHealth andPreventiveMedicine Template Key Questions 1. What is the comparative efficacy of different (name drug class) in improving (name the outcome desired) for (name type of patients by symptoms, disease etc.)? 2. What are the comparative incidence and nature of complications (serious or life threatening, or those that may adversely affect compliance of different (name the drug class)) for patients being treated for (name the type of patients by symptoms, disease, etc.)? 3. Are there subgroups of patients based on demographics (age, racial/ethnic groups, gender), other medications or co-morbidities (obesity for example) for which one or more medications or preparations are more effective or associated with fewer adverse effects?

8. Slide 8 Dept of PublicHealth andPreventiveMedicine Drug Company Interaction One day informational conference Dossier Submission Evidence relevant to key questions No economic data Center is industry contact Public Comment Period Full disclosure policy

9. Slide 9 Dept of PublicHealth andPreventiveMedicine Interaction with the Public, Advocates, and Medical Community Drafts of key questions Directly to the Center Evidence-based Policy Through local processes of participants Draft report public comments Draft report peer review comments (AHRQ model) Local decision-making processes

10. Slide 10 Dept of PublicHealth andPreventiveMedicine Four Major Types of Results 1.Good evidence, no difference (PPI’s) 2.Good evidence marginal difference (Triptans) 3.Good evidence significant difference (Beta Blockers) 4.No good evidence (Opiod analgesics)

11. Slide 11 Dept of PublicHealth andPreventiveMedicine Classes Reviewed 1.Proton Pump Inhibitors - PPIs 2.Long-acting Opioids 3.Statins 4.Non-steroidal Anti-Inflammatory Drugs - NSAIDs 5.Estrogens 6.Triptans 7.Skeletal Muscle Relaxants - SMRs 8.Oral Hypoglycemics - OHs 9.Urinary Incontinence, Drugs to treat - UI 10.ACE Inhibitors – ACE-I 11.Beta Blockers - BB 12.Calcium Channel Blockers - CCBs 13.Angiotensin II Receptor Antagonists - ARBs 14.2 nd Generation Antidepressants 15.Antiepileptic Drugs in Bipolar Mood Disorder and Neuropathic Pain 16.2 nd Generation Antihistamines 17.Atypical Antipsychotics - AAP 18.Inhaled Corticosteroids - ICS 19.ADHD and ADD, Drugs to treat 20.Alzheimers, Drugs to treat 21.Anti-platelet Drugs 22.Thiazolidinedione - TZDs 23.5HT3 Receptor Antagonists 24.Sedative Hypnotics 25.Targeted Immune Modulators

12. Slide 12 Dept of PublicHealth andPreventiveMedicine Use by Participants Provider/prescriber/consumer education (NC, CHCF) Augment P&T Committee Information with thorough and transparent reports (AK, MI, WI, MN, MO) Primary P&T Committee Information base (WA, WY, OR, ID, KS) States all have public disclosure and hearings Support to other levels of government (CCOHTA)

13. Slide 13 Dept of PublicHealth andPreventiveMedicine Participant Use of Mental Health Reports 2 nd Generation Antidepressants Multiple available Grandfathering of stable patients Atypical Antipsychotics No use in PDLs Scope expanded due to peer review and public feedback Observational studies Inpatient studies Anti-epileptic Drugs in Bipolar disorder Alzheimers Treatments ADHD/ADD Treatments (final report due 9/05) Newer Sedative Hypnotics (final report due 11/05)

14. Slide 14 Dept of PublicHealth andPreventiveMedicine Contact Information John Kitzhaber, MD, Director 503-494-2182   Chair, Governance Process   Represents Center to policy-makers and interest groups   Communication Mark Gibson, Deputy Director 503-494-2679 gibsomar@ohsu.edu   Project Director  Project Representative to Participating Organizations  Communication John Santa, MD, Assistant Director for Health Projects 503-494-2691 santaj@ohsu.edu   Project Medical Director   Contact to pharmaceutical companies   Project Representative to Participating Organizations Pam Curtis, MS, Assistant Director for Planning 503-494-3094 curtispa@ohsu.edu   Project Planning Director   Facilitator for Governance Process   Process and facilitation issues   Project administration Susan Daniels, Office Manager 503-494-2182 danielss@ohsu.edu  Executive Assistant  Web Manager  Logistics and operations  Project support www.ohsu.edu/policycenter