1. Ann L. Woloson, Executive Director Prescription Policy Choices Show Me the Evidence Ensuring Access to Safe, Effective and Affordable Prescription Drugs 2011 International Symposium on Safe Medicine October 4, Portland, Maine (image from http://www.deskpicture.com/DPs/Nature/Autumn/FallScene_1.html)http://www.deskpicture.com/DPs/Nature/Autumn/FallScene_1.html

2. Prescription Policy Choices (PPC) Nonprofit, nonpartisan 501(c ) (3) educational & public policy organization providing objective research, information and expertise on prescription drug policy to ensure access to safe, effective and affordable prescription drugs in Maine and the US Foundation & Consumer Advocacy Group Funding: Nathan Cummings Foundation, Endowment for Health, Maine Health Access Foundation, Bingham Program, Consumers Union, Community Catalyst-Pew Prescription Project, Sadie and Harry Davis Foundation, Maine Community Foundations

3. Evidence-based prescribing: Most effective, safe and cost-effective drugs Uses unbiased, objective information (the science) about the relative effectiveness, safety and cost-effectiveness of Rx drugs Improves health care quality Helps maintain access to health care services by investing resources wisely Reduces prescription drug (and health care) costs “Preferred” does not always mean “evidenced-based ” or best value

4. Rising Expenditures for Rx Drugs 2008 US spending for Rx drugs was nearly 6 times that spent in 1990 ($234.1 billion in 2008, $40.3 billion in 1990) One of the fastest growing health care cost components, until early 2000s, growing at double-digit rates Rx drugs contributed 13% of the total growth in national health expenditures from 1990 to 2008. $58 billion estimated by the New England Healthcare Institute to be wasted on misuse, overuse & underuse of prescription drugs in 2008

5. Government share of prescription drug spending increasing (Kaiser: Rx Drug Trends, 5/10)

6. PPACA and Medicare affecting Rx coverage/spending ACA: – Medicaid expansion for uninsured adults – Rx drugs are “essential health benefits” (included in the exchanges and “benchmark-equivalent” for new eligibles under Medicaid) – Changes in rebates (Feds to retain increases in rebates to certain amount) Medicare: – 50% discount for brand name drugs for beneficiaries in the doughnut hole/gap starting in 2011 – 7% discount for generics annual phase in – Coinsurance phase-in over time for both brand and generics

7. Evidenced-based Drugs: Three Points for Impact 1. Prescribers – Academic detailing/prescriber education (counters drug reps in prescriber’s offices) 2. Consumers – Consumer Reports Health Best Buy Drugs™ / Consumer component to academic detailing (counters direct-to- consumer advertising) 3. Payers – Drug Effectiveness Review Project (DERP), AHRQ Effective Healthcare, Consumer Reports Health Best Buy Drugs™

8. Pharmaceutical Industry Marketing Industry marketing in 2009 – $10.9 billion $6.6 billion direct to physicians; $4.3 billion direct to consumers (Kaiser Family Foundation) In Maine: – $68 million in 2007 – $90.6 million in 2008

9. Maine Independent Clinical Information Service (MICIS) Maine’s academic detailing program – Educational outreach to prescribers at practice site – Balanced data about medications based on evidenced-based, non-commercial sources – Current clinical modules: Adult Type 2 Diabetes, Antiplatelet Therapy, Hypertension, Atrial Fibrillation, Chronic Pain Management – Upcoming: Anti-psychotics – Administered by the Maine Medical Association www.mainemed.com

10. Maine Independent Clinical Information Service (MICIS) Impact: – Over 1100 modules detailed to over 750 unique prescribers – 76% reported that they plan to change their prescribing habits based on information from a MICIS educational module

11. Consumer engagement 80 drug ads every hour, every day on TV (Nielsen Co.) 30% of people have spoken to their doctors about a drug ad; 44% got the prescription they asked about (Kaiser Family Foundation) PPC is working with Consumer Reports Health Best Buy Drugs™ to promote evidence-based used of drugs Vision: independent scientific evidence - not branding and marketing - should drive consumers

12. Consumer Reports Health Best Buy Drugs ™ What works best, is safest and most cost- effective (tried and true)

13. www.CRBestBuyDrugs.orgReports Drugs to treat high cholesterol: The Statins / Drugs to treat hepatitis C Drugs to treat rheumatoid arthritis/ Migraine Headache Drugs – the Triptans Drugs to Treat Enlarged Prostate / Osteoarthritis, Pain – the NSAIDsDrugs to treat hepatitis C Drugs to treat rheumatoid arthritisi Drugs to Treat Enlarged ProstateOsteoarthritis, Pain – the NSAIDs Drugs to Treat Muscle Spasms and Spasticity: Muscle Relaxants Drugs to Treat Nausea and Vomiting: The Oral 5-HT3 Antagonists Drugs for Heartburn, Acid Reflux Disease - the PPIs Drugs to Treat Schizophrenia and Bipolar DisorderDrugs to Treat Schizophrenia and Bipolar Disorder /AntidepressantsAntidepressants Attention Deficit Hyperactivity Disorder Drugs Angina, High Blood Pressure – Calcium Channel Blockers High Blood Pressure, Heart Failure – the ACE Inhibitors Heart Disease and High Blood Pressure – Beta-Blockers Treating Type 2 Diabetes – the Oral Diabetes Drugs Constipation DrugsAttention Deficit Hyperactivity Disorder Drugs Angina, High Blood Pressure – Calcium Channel Blockers High Blood Pressure, Heart Failure – the ACE Inhibitors Heart Disease and High Blood Pressure – Beta-Blockers Treating Type 2 Diabetes – the Oral Diabetes Drugs Constipation Drugs / Menopause – Hormones/ Sleeping Pills for Insomnia Treating Chronic Pain – the Opioids Treating Bipolar Disorder, Nerve Pain and Fibromalagia – the Anticonvulsants Treating Heart Disease, Heart Attack, and Stroke – Antiplatelets Overactive Bladder / Asthma and Lung Disease – Inhaled Steroids Alzheimer’s Disease Drugs/ Allergies, Hay Fever, and Hives – Antihistaminesenopause – HormonesSleeping Pills for Insomnia Treating Chronic Pain – the Opioids Treating Bipolar Disorder, Nerve Pain and Fibromalagia – the Anticonvulsants Treating Heart Disease, Heart Attack, and Stroke – Antiplatelets Overactive BladderAsthma and Lung Disease – Inhaled Steroids Alzheimer’s Disease DrugsAllergies, Hay Fever, and Hives – Antihistamines

14. Payers: Lewin Group Study (12/2010) Identified $30 billion in state savings over the next decade beyond rebates – Savings associated with improved pharmacy benefit management from Medicaid managed care organizations Generic utilization (68% in Medicaid FFS vs. 80% in Medicaid MCO) Dispensing fees & ingredient costs (higher for FFS than MCO) Drug Utilization (evidence-based) Estimated 14.8% reduction → Lewin estimates these approaches could yield14.8% savings for pharmacy spending ($14 mil for ME)

15. Payers: Minnesota Study* Increasing the utilization of evidenced-based recommended drugs can yield cost-savings of more than 50% (for drug categories studied) Achieved through formulary/ PDL changes that incentivize value-based utilization of prescription drugs * Kjos, AL, et al. A comparison of drug formularies and the potential for cost-savings. American Health & Drug Benefits, vol 3, No. 5 (September/October 2010): 321-330.

16. Payers: Avandia Example ME: Avandia was listed as preferred in 2009 Avandia sales peaked at about $3 billion in 2006 - world’s best- selling diabetes Type II med. Sales dropped sharply after a 2007 NE Journal of Medicine report linking it to increased heart attach and cardiovascular death risks Metformin, a generic drug, is recommended drug alternative (supported by DERP/CRHBBD ™ ) Estimated potential savings for replacing Avandia with metformin in 2009: $150,000 (does not include potential savings related to improved quality)

17. Evidence-based Resources for Medicaid DERP Collaboration of public entities (the Center for Evidence-based Policy and the Oregon Evidence-based Practice Center) that produces systematic, evidence-based reviews of the comparative effectiveness and safety of drugs in many widely used drug classes in order to inform public policy and related activities in local settingsOregon Evidence-based Practice Center Medicaid Evidenced-based Decisions Project Provides participating states with high quality evidence and analysis to support benefit design and coverage decisions made by state programs (Alabama, Alaska, Arkansas, Minnesota, Missouri, New York, Oklahoma, Oregon, Washington Wisconsin, West Virginia)

18. Payers Are States working to make sure public health programs are incentivizing the use of the best, most effective and safest drugs? Are states using evidence-based information? How are States integrating evidenced-based information into Rx drug coverage decision-making processes?

19. Payers “Generic medications will continue to offer greater value than brand-name medications for most patients…Encouraging cost-effective medication use, regardless of levels of subsidies applied, will reduce seniors’ overall out-of-pocket costs as well as federal outlays for prescription medications, allowing health care resources to be used more efficiently.” (Shrank, W. & Choudhry, N. NEJM p 1011625, Jan. 19, 2011)

20. Resources Consumer Reports Health Best Buy Drugs ™ www.CRBestBuyDrugs.org Drug Effectiveness Review Project (DERP) http://www.ohsu.edu/xd/research/centers- institutes/evidence-based-policy- center/derp/index.cfm AHRQ Effective Healthcare Program http://www.effectivehealthcare.ahrq.gov/

21. For more information Please visit www.policychoices.orgwww.policychoices.org Contact information: Ann Woloson awoloson@policychoices.org Jennifer Reck jreck@policychoices.org 207-512-2138