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Evidence-based Medicine and the Drug Effectiveness Review Project:

States Using Research in Quest for Improved Pharmaceutical Value

Attorneys General Pharmaceutical Meeting Columbia Law School

May 10, 2007

Mark Gibson, Deputy DirectorCenter for Evidence-based Policy

Oregon Health and Science University

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What is Evidence-based Medicine?

“…evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research.”

David Sackett

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Oregon Experience (DERP is born)

• 60% increase in Medicaid drug spend• Faltering state revenues• PDL legislation

– Effectiveness first– If effectiveness the same cost considered

• Collaboration with OHSU EPC• Idaho and Washington join• Broader base required

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Drug Effectiveness Review Project

• Self-governing collaboration of organizations that:

• Obtains and synthesizes global evidence on the relative effectiveness, safety and effect on subpopulations of drugs within classes of medications.

• Support policy makers in using the evidence to inform policy in local decision making

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Drug Effectiveness Review Project Organization

PRIVATE NON PROFITS AND STATES

CENTER FOR EVIDENCE-BASED POLICY

COORDINATING EVIDENCE BASED PRACTICE CENTER

OREGON EPC UNC EPC CALIF EPC

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Participating Organizations

Arkansas New YorkCADTH North CarolinaIdaho OregonKansas WashingtonMichigan WisconsinMissouri WyomingMinnesota Montana

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DERP Systematic Review Process

• Creation of Key Questions (public comment)• Inclusion/exclusion Criteria• Global Search for Evidence• Critical Assessment of Evidence• Synthesis of Evidence• Peer Review and Critique (public comment)• Final Draft (public domain)• Update

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Why are Systematic Reviews Helpful?

"The plural of anecdote is policy."

Dan Fox

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Why are Systematic Reviews Helpful?

• “Four out of five studies showed that…”– How big were the studies?– What was their quality?– How big were the results?

• “Carvedilol superior to metropolol in preventing death in heart failure patients.”

• “We have a meta-analysis that shows that…”

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Conclusions: During 6 weeks’ treatment, ziprasidone and olanzapine demonstrated comparable antipsychotic efficacy. Differences favoring ziprasidone were observed in metabolic parameters.

Simpson et al, 2004

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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?

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Drug Company Interaction

• One day informational conference• Dossier Submission

- Evidence relevant to key questions

- No economic data- Center is industry

contact• Full disclosure policy• Public comment periods

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1. Proton Pump Inhibitors - PPIs2. Long-acting Opioids3. Statins4. Non-steroidal Anti-Inflammatory Drugs - NSAIDS5. Estrogens6. Triptans7. Skeletal Muscle Relaxants - SMRS8. Oral Hypoglycemics - OHs9. Urinary Incontinence, Drugs to Treat - UI10. ACE Inhibitors – ACE-I11. Beta Blockers - BB12. Calcium Channel Blockers –CCBS13. Angiotensin II Receptor Antagonists - ARBs

14. 2nd Generation Antidepressants

15. Antiepileptic Drugs in Bipolar Mood Disorder and Neuropathic Pain

16. Atypical Anti-psychotics AAP17. 2nd Generation

Antihistamines18. Inhaled Corticosteroids - ICS19. ADHD & ADD, Drugs to

treat20. Alzheimers, Drugs to treat21. Anti-platelet Drugs22. Thiazolidinedione – TZDs23. 5HT3 Receptor Antagonists24. Sedative Hypnotics25. Targeted Immune

Modulators26. Beta Agonists27. Newer Anti-emetics28. Drugs for Multiple Sclerosis

Classes Reviewed

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DERP 2 (three more years)

• Runs through 2009

• 8-10 Original Reports

• Annual scan of evidence for classes already reviewed

• 20-25 Updates

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DERP 2 New Report Topics

• Neuropathic pain (Sept. 2007)

• Drugs for constipation (Sept. 2007, now one drug shorter with Zelnorm withdrawal)

• Combined products for diabetes and hyperlipidemia (Nov. 2007)

• Next topics selected in May 2007

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Results In General

1) Good evidence, no significant differences (PPIs)

2) No good comparative evidence (Opiod Analgesics)

3) Good evidence, marginal differences (Triptans)

4) Good evidence, significant clinical differences (Beta Blockers)

5) Even classes with good evidence often have significant gaps (subpopulations)

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Uses by Participating Organizations

• Primary source for clinical information used by P&T committee

• Supplement to other clinical information used by P&T committee

• Provide to other partners

• Education for prescribers

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Contact Information

Mark Gibson, Deputy Director

Center for Evidence-based Policy

2611 SW 3rd Avenue, MQ 280

Portland, Oregon 97201

gibsomar@ohsu.edu

503-494-2679