Dialogue on Pharmaceutical Pricing and Safety in the USA Washington, DC September 25, 2007 John Rother Director of Policy & Strategy, AARP Who takes Rx drugs? 100% 93% 77% 80% 60% 81% “Any Medication” includes: 50% 40% 20% Rx % of U.S. Adults Using Medications in Previous Week Any Meds 0% • Prescription drugs (Rx) • Over-the-counter meds (OTCs) • Vitamins & Minerals • Dietary Supplements • Natural & Herbal Remedies • Contraceptive Drugs & Devices All Elderly All Elderly Rx Rx Any Any Meds Meds Meds Meds Source: JAMA, Vol 287, No. 3, Jan 16, 2002, based on adult population survey in 1998-99. U.S. Total Drug Expenditures as Percent of National Healthcare Expenses: 1988 to 2010 % of NHE (Projected) 23.8% 25% 22.1% 19.2% 20% 16.6% Will have tripled share 15% 10.7% 10% Doubled share in 10 years 8.1% Today 5% Source: Compiled by the PRIME Institute, University of Minnesota from data found in Pharmaceutical Benefits Under Medical Assistance Programs, National Pharmaceutical Council, 1975 to 2002 and in HCFA Form 64. 2010 2009 2008 2007 2006 2005 2004 2003 2002 2001 2000 1999 1998 1997 1996 1995 1994 1993 1992 1991 1990 1989 1988 0% Lack of Compliance with Medications a Serious Problem with Chronically Ill • 89% of seniors reported taking Rx drugs in last year • Nearly half take five or more • More than half have more than one M.D. • About a third use more than one pharmacy • Among seniors with at least 3 chronic conditions, nearly 3 out of 4 take five or more meds regularly • More than half of the chronically ill admit they do not take all their drugs as prescribed Source: Kaiser Family Foundation/Commonwealth Fund joint study, 2005. Good Chronic Care Management Key to a Large Segment of Cost SOURCE: Conwell & Cohen, Agency for Healthcare Research and Quality, Statistical Brief #73, March 2005 80 60 40 20 0% % Health Care Dollars Spent 100% 22% of costs for 1% of people 3% of costs for 50% of people 20% 40% 60% Percent of Population 80% 100% Checking with the 50+ population Before Medicare Modernization Act (MMA) Polling Results Major Problem 35% 71% Not a Problem 28% Minor Problem 36% Great majority saw “paying for Rx drugs” a problem Typical MMA Rx Drug Personal Impact With NO other coverage $12,000 TOTAL Rx SPENDING $10,000 What Medicare pays Individual's Co-pay $8,000 Individual's Premiums $6,155 $6,000 $1,500 $4,000 $1,500 $2,000 $1,313 $188 $563 $0 $500 $1,000 $2,000 $3,000 $5,000 PRESCRIPTION COST $10,000 Use of Generic Drugs Checking with the 50+ population Polling Results 70% • About 7 in 10 respondents– with monthly out-of-pocket Rx drug expenses over $200– say they “routinely ask for generic drugs” Generic Substitution Rates in USA, 1984-2005 60% Percent of Rx Filled 50% 40% 30% 20% 10% 20 06 20 04 20 02 20 00 19 98 19 96 19 94 19 92 19 90 19 88 19 86 19 84 0% •More than half of Rx drugs dispensed in USA are GENERIC •Yet they account for only 13% of total Rx costs Special Research Effort – Since 2003 Tracking Rx Drug Prices through the AARP Rx Watchdog Program How were prices measured? •Manufacturers’ prices measured by “Wholesale Acquisition Cost” (WAC) • Invoice price of manufacturer to wholesaler • Manufacturers’ prices account for most of a retail drug’s cost • Typically, a change in a manufacturer’s price is passed on to final purchaser •Tracked the 197 brand-name drugs most widely used by Americans age 50+ The “Black Box” of U.S. Pharmaceutical Pricing U.S. Pharmaceutical Supply & Payment Drug Manufacturer Pharmacy Consumer U.S. Pharmaceutical Supply & Payment Pharmacy Benefit Manager (PBM) Drug Manufacturer Employer/ Plan Sponsor or Health Insurer Pharmacy Consumer Wholesale Distributor Source: AARP---Based on work of The Health Strategies Consultancy (now Avalere Health) for the Kaiser Family Foundation U.S. Pharmaceutical Supply & Payment Employer/ Plan Sponsor or Health Insurer Pharmacy Benefit Manager (PBM) M.D. Drug Manufacturer Pharmacy Consumer RxRxRx Advertising Wholesale Distributor Payment for Marketing and Advertising Source: AARP---Based on work of The Health Strategies Consultancy (now Avalere Health) for the Kaiser Family Foundation 2% Proctor & Gamble Eisai Zocor 20 Mg McNeil Merck Levaquin 500 mg B-Myers Squibb AstraZeneca Lilly Toprol Xl 50 mg Evista 60 mg Pravachol 20, 40 mg Sanofi Pharm Merck Ambien 10 mg Vioxx 25mg Aricept 10 mg Xalatan Sol 0.005% Pfizer Actonel 35mg Abbott AstraZeneca Flomax 0.4 mg Nexium 40 mg Pfizer Wyeth Pfizer 8% Norvasc 5, 10 mg Protonix 40 mg Celebrex 200 mg TAP Pfizer Prevacid 30 mg Dr Lipitor 20, 40mg B-Myers Squibb 90, 30 Pfizer Merck 4% Plavix 75 mg Lipitor 10 mg Fosamax 70 mg 10% Prices Increases Vary Substantially by Drug Example: 1st-3rd Quarter 2004 25 Most-Used Drugs Price increases in 9-month period 6% 60% Average % Change 50% 40% 30% 53.6% 20% 10% Inflation 20.3% 0% Cumulative Rise 2000 thru 2006 Years refer to change from previous year. Source: AARP Public Policy Institute Years refer to change from previous year. Source: AARP Public Policy Institute April, 2007 Rx Manufacturers’ Price Increases FAR Outpacing Inflation Distribution of Gross Revenues for U.S. Drug Companies by Expense Type $100 $80 $60 $40 $20 $31 $6 Marketing, Advertising, & Administrative Costs Taxes & Other Costs $20 Net Profit $13 Research & Development $30 Cost of Production $0 Out $100 Every $100 Outofofevery Source: Compiled by the PRIME Institute, University of Minnesota from data found in DHHS, CMS, Jan 2003, and from Bloomberg, analysts models, & corporate annual reports. Presented by AARP Rx Watchdog Forum February 2005 Drug Safety is also an Issue in the USA A seemingly effective pain medication for arthritis . . . Was heavily advertised, thus widely demanded Total Advertising Dollars per Year $200 Millions of Dollars $175 $150 $125 $100 $75 $50 $25 $0 Nike Pepsi Source: Thomas Rice, UCLA, National Academy of Social Insurance Annual Mtg February, 2007 Vioxx VIOXX PROVIDES POWERFUL 24-HOUR RELIEF OF ARTHRITIS. VIOXX VIOXX VIOXX VIOXX VIOXX VIOXX VIOXX VIOXX VIOXX VIOXX ONCE DAILY VIOXX © AARP’s Efforts on Drug Safety and Effectiveness Rx Drug Home Page Access by Specific Drug Access by Medical Condition Summary of Effectiveness and Safety Information Relative COST of Similar Drugs Safety with Drug Importation Checking with the 50+ population Polling Results Have imported 8% Have not imported 91% Fewer than 1 in 10 have actually imported Rx drugs Insuring Safety when Importing Rx Drugs Check that the Canadian pharmacy: 1. Provides on its website its license number and name of Canadian regulatory agency that granted license (to check authenticity) 2. Displays seals of CIPA or IMPAC, organizations that set standards for safety and service, and accredit Canadian mail-order pharmacies that sell to Americans and meet standards 3. Requires prescription from your doctor. Reputable pharmacies will either confirm a faxed prescription in a phone call to doctor’s office or await receipt of original in the mail before filling Rx 4. Requires patient to submit details of medical history and clearly states pharmacy’s policies for ensuring medical and personal privacy 5. Requires patient to have taken drug for at least one month before order by mail, so that patient and doctor know medication suits 6. Provides a full mailing address and a toll-free phone number on its website so patient can call to ask questions of a pharmacist (Continued) Source: AARP Website http://www.aarp.org/bulletin/prescription/a2004-08-02-rxcanada.html Insuring Safety when Importing Rx Drugs Check that the Canadian pharmacy: 7. Explains differences between American and Canadian drug names and labeling and why pharmacy does not sell some drugs 8. Normally sends drugs in the manufacturer’s original container with seals intact. In some cases, though, drugs may arrive in ordinary pharmacy bottles if the quantity of pills in the manufacturer’s own container exceeds 90-day supply 9. Sends drugs with labeling that includes strength, dosing directions, expiration date, appropriate warnings and a Drug Identification Number (DIN) [Shows drug is approved by Canadian health authorities 10. Displays -on its website- full information about shipping fees, payment policies and refunds. Reputable pharmacies offer secure (encrypted) online payment for credit cards, alternative options for payment (such as electronic fund transfers and regular checks) and do not charge any separate fees, except shipping fees 11. Charges cost of drugs to your credit card only when the drugs are shipped to customer, not when order is first placed 12. Refunds money or re-ships drugs immediately if order does not arrive Source: AARP Website http://www.aarp.org/bulletin/prescription/a2004-08-02-rxcanada.html Sites on Getting Rx Drugs Safely From Canada • Canadian International Pharmacy Association (CIPA) • Internet and Mail-Order Pharmacy Accreditation Commission (IMPAC) • PharmacyChecker.com Summary of Problems • Due to lack of transparency, U.S. Rx drug pricing is a “black box” • Industry profits are extraordinary; scrambel for profits leads to lack of manufacturing care, in some cases • Price increases have averaged 2 to 3 times the CPI (Consumer Price Index) • Price negotiations are based on volume changes, formularies • Rx drugs continue to be a growing percent of overall healthcare costs, especially in the care of the chronically ill, where they are often crucial Summary of Problems • USA lacks comparative-effectiveness studies which could reduce cost, improve safety, and increase the quality of care • Consumer cost-sharing as a means of cutting costs, especially for the elderly, can be counter-productive, leading to more serious complications • The raising public resentment at high prices, lack of fairness in pricing and coverage, compared to other countries, is driving politics Characteristics of Quality, Affordable, Patient-Centered Health Care • Integrated team knows person’s entire situation • Care is coordinated, all doctors know all a patient’s meds, and tests are not repeated needlessly • Patient given decision tools, other supports, appropriate to his/her level of understanding • Patient controls and has access to own health information, is an active partner in own care • Patient has coaching or counseling support • Patient has access to information on cost and quality of procedures and understands treatment options ahead of time How do We Offer a Quality, Affordable Health System? 3. 4. 5. 6. 1. Medical home 2. Electronic prescribing/medical records/decision support Chronic care management Benefits based on “comparative effectiveness” studies for procedures and pharmaceuticals Low or no cost-sharing for services with high medical or preventive value --e.g. flu shots, blood pressure medication, insulin, etc. Coaching patients to understand and to act on prevention, price and quality information Dialogue on Pharmaceutical Pricing and Safety in the USA