1. Anesthetic and Life Support Drugs, and Drug Safety and Risk Management Advisory Committees, November 13, 2008 Outpatient Drug Utilization Trends for Oxycodone Products Laura Governale, Pharm.D., MBA Drug Utilization Analyst Team Leader Division of Epidemiology Office of Surveillance and Epidemiology November 13, 2008 Laura Governale, Pharm.D., MBA Drug Utilization Analyst Team Leader Division of Epidemiology Office of Surveillance and Epidemiology November 13, 2008

2. Anesthetic and Life Support Drugs, and Drug Safety and Risk Management Advisory Committees, November 13, 2008 2OutlineOutline Sales distribution analysis: IMS Health, IMS National Sales Perspectives™ Retail and Non-Retail Dispensed prescription analysis: SDI Vector One ® : National (VONA) –Opioid market –Oxycodone ER products –Dispensing and prescribing characteristics –Prescriber specialty Patient-level analysis: SDI Vector One ® : National (VONA) and SDI Total Patient Tracker (TPT) –Age distribution Summary Sales distribution analysis: IMS Health, IMS National Sales Perspectives™ Retail and Non-Retail Dispensed prescription analysis: SDI Vector One ® : National (VONA) –Opioid market –Oxycodone ER products –Dispensing and prescribing characteristics –Prescriber specialty Patient-level analysis: SDI Vector One ® : National (VONA) and SDI Total Patient Tracker (TPT) –Age distribution Summary

3. Anesthetic and Life Support Drugs, and Drug Safety and Risk Management Advisory Committees, November 13, 2008 3 Oxycodone products included Modified release/Extended-Release (ER) oxycodone products: Oxycodone HCL ER, OxyContin, Oxycodone ER Immediate-release (IR) oxycodone products: Oxycodone w/APAP, Oxycodone, Endocet, Roxicet, Percocet-5, Percocet-10, Oxycodone w/ASA, Oxydose, Roxicodone, Percocet-7, Roxilox, Percocet-2, Endodan, Tylox, OxyIR, Magnacet, Perloxx, Narvox, Roxicodone Intensol, OxyFast, Oxycodone/Ibuprofen, Percolone, Oxycodone HCl Bulk, Roxiprin, Endocodone, SK-Oxycodone w/APAP, SK-Oxycodone w/ASA Modified release/Extended-Release (ER) oxycodone products: Oxycodone HCL ER, OxyContin, Oxycodone ER Immediate-release (IR) oxycodone products: Oxycodone w/APAP, Oxycodone, Endocet, Roxicet, Percocet-5, Percocet-10, Oxycodone w/ASA, Oxydose, Roxicodone, Percocet-7, Roxilox, Percocet-2, Endodan, Tylox, OxyIR, Magnacet, Perloxx, Narvox, Roxicodone Intensol, OxyFast, Oxycodone/Ibuprofen, Percolone, Oxycodone HCl Bulk, Roxiprin, Endocodone, SK-Oxycodone w/APAP, SK-Oxycodone w/ASA

4. Anesthetic and Life Support Drugs, and Drug Safety and Risk Management Advisory Committees, November 13, 2008 Sales distribution data Year 2007 IMS Health, IMS National Sales Perspectives™ Retail and Non-Retail

5. Anesthetic and Life Support Drugs, and Drug Safety and Risk Management Advisory Committees, November 13, 2008 5 IMS Health, IMS National Sales Perspectives™ Measures the volume of products, in units and dollars, moving from manufacturers to retail and non-retail channels of distribution –Extended Units are the number of tablets, capsules, milliliters, ounces, etc. of a product shipped in each unit Retail Channels - chain, independent, mass merchandisers, food stores with pharmacies, and mail- order pharmacies Non-Retail Channels - federal facilities, non-federal hospitals, clinics, long-term care facilities, home health care (began 1998), HMOs, miscellaneous channels (began 1999; prisons, universities, other) Measures the volume of products, in units and dollars, moving from manufacturers to retail and non-retail channels of distribution –Extended Units are the number of tablets, capsules, milliliters, ounces, etc. of a product shipped in each unit Retail Channels - chain, independent, mass merchandisers, food stores with pharmacies, and mail- order pharmacies Non-Retail Channels - federal facilities, non-federal hospitals, clinics, long-term care facilities, home health care (began 1998), HMOs, miscellaneous channels (began 1999; prisons, universities, other)

6. Anesthetic and Life Support Drugs, and Drug Safety and Risk Management Advisory Committees, November 13, 2008 6 Projected number of ER oxycodone tablets (in thousands) sold from the manufacturer to retail and non-retail pharmacies in the U.S., Year 2007 Projected number of ER oxycodone tablets (in thousands) sold from the manufacturer to retail and non-retail pharmacies in the U.S., Year 2007 IMS HEALTH, IMS National Sales PerspectiveTM, Extracted 3/2008 Retail pharmacy distribution, 87% Non-retail pharmacy distribution, 13%

7. Anesthetic and Life Support Drugs, and Drug Safety and Risk Management Advisory Committees, November 13, 2008 Prescription and Patient-level Data SDI Vector One ® : National (VONA) SDI Vector One ® : Total Patient Tracker (TPT) SDI Vector One ® : National (VONA) SDI Vector One ® : Total Patient Tracker (TPT)

8. Anesthetic and Life Support Drugs, and Drug Safety and Risk Management Advisory Committees, November 13, 2008 8 Surveillance Data, Inc. Vector One ® : National (VONA) SDI’s Vector One ® : National (VONA) is a national-level projected prescription and patient-centric tracking service. –Receives over 2.0 billion prescription claims per year, representing over 160 million unique patients. The number of dispensed prescriptions is obtained from a sample of approximately 59,000 pharmacies throughout the U.S., accounting for nearly all retail pharmacies and represent nearly half of retail prescriptions dispensed nationwide. Retail pharmacies include: –national retail chains –mass merchandisers –pharmacy benefits managers and their data systems –provider groups Data on prescribing specialty and patient age/gender are available SDI’s Vector One ® : National (VONA) is a national-level projected prescription and patient-centric tracking service. –Receives over 2.0 billion prescription claims per year, representing over 160 million unique patients. The number of dispensed prescriptions is obtained from a sample of approximately 59,000 pharmacies throughout the U.S., accounting for nearly all retail pharmacies and represent nearly half of retail prescriptions dispensed nationwide. Retail pharmacies include: –national retail chains –mass merchandisers –pharmacy benefits managers and their data systems –provider groups Data on prescribing specialty and patient age/gender are available

9. Anesthetic and Life Support Drugs, and Drug Safety and Risk Management Advisory Committees, November 13, 2008 9 Total number of prescriptions dispensed for selected opioids from U.S. outpatient retail pharmacies, Years 1998-2007 SDI Vector One ® : National (VONA). Extracted 10/2008 Hydrocodone products #1 dispensed of entire prescription drug market for the past 10 years Oxycodone products, ER and IR, over 42 million dispensed prescriptions during year 2007, account for over 24% of market Hydrocodone products #1 dispensed of entire prescription drug market for the past 10 years Oxycodone products, ER and IR, over 42 million dispensed prescriptions during year 2007, account for over 24% of market

10. Anesthetic and Life Support Drugs, and Drug Safety and Risk Management Advisory Committees, November 13, 2008 10 Total number of prescriptions dispensed for selected opioids (WITHOUT hydrocodone and IR oxycodone products) from U.S. outpatient retail pharmacies, Years 1998-2007 SDI Vector One ® : National (VONA). Extracted 10/2008 Extended-release oxycodone products: ~7.5 million retail Rx in Y2007 Fentanyl & morphine tied at ~5.5 million retail Rx in Y2007 Extended-release oxycodone products: ~7.5 million retail Rx in Y2007 Fentanyl & morphine tied at ~5.5 million retail Rx in Y2007

11. Anesthetic and Life Support Drugs, and Drug Safety and Risk Management Advisory Committees, November 13, 2008 11 Total number of prescriptions dispensed for oxycodone products (IR and ER) from U.S. outpatient retail pharmacies, Years 1998 – 2007 SDI Vector One ® : National (VONA). Extracted 10/2008 Majority (~82% Y2007) of oxycodone market is immediate-release products Extended-release market relatively constant at 6-7 million dispensed Rx for last 7 years, account for 18% of entire oxycodone market in Y2007 Majority (~82% Y2007) of oxycodone market is immediate-release products Extended-release market relatively constant at 6-7 million dispensed Rx for last 7 years, account for 18% of entire oxycodone market in Y2007

12. Anesthetic and Life Support Drugs, and Drug Safety and Risk Management Advisory Committees, November 13, 2008 12 Total number of prescriptions dispensed for brand and generic extended-release oxycodone products from U.S. outpatient retail pharmacies, Years 1998-2007 SDI Vector One ® : National (VONA). Extracted 11/2008 Rx volume for Brand dropped by 2/3 between Y2004 (6.1 million Rx) and Y2007 (2.0 million Rx) Generics account for nearly 5.5 million Rx or 75% of the ER oxycodone market in Y2007 Rx volume for Brand dropped by 2/3 between Y2004 (6.1 million Rx) and Y2007 (2.0 million Rx) Generics account for nearly 5.5 million Rx or 75% of the ER oxycodone market in Y2007

13. Anesthetic and Life Support Drugs, and Drug Safety and Risk Management Advisory Committees, November 13, 2008 13 Total number of prescriptions dispensed for all extended- release oxycodone products by strength from U.S. outpatient retail pharmacies, Years 1998-2007 SDI Vector One ® : National (VONA). Extracted 10/2008 20mg leading strength since 1998: 2.4 million Rx in Y2007 (32%) 40mg second since Y2002: 2.3 million Rx in Y2007 (31%) 10mg and 80 mg: 1.4 million Rx each in Y2007 (19% each) 20mg leading strength since 1998: 2.4 million Rx in Y2007 (32%) 40mg second since Y2002: 2.3 million Rx in Y2007 (31%) 10mg and 80 mg: 1.4 million Rx each in Y2007 (19% each)

14. Anesthetic and Life Support Drugs, and Drug Safety and Risk Management Advisory Committees, November 13, 2008 14 Dispensing and prescribing characteristics for ER oxycodone products from U.S. outpatient retail pharmacies, Year 2007 † SDI Vector One ® : National (VONA). Extracted 10/2008 ‡ SDI Physician Drug and Diagnosis Audit (PDDA), Extracted 11/2008 Average days of therapy per new prescription † –10mg: 26 days –20mg, 40mg, 80mg: 28 days –160mg: 20 days Most common total daily dose ‡ : 40mg per day (15%), 20mg per day (14%), 80mg per day (10%), 120mg per day (8%) Average days of therapy per new prescription † –10mg: 26 days –20mg, 40mg, 80mg: 28 days –160mg: 20 days Most common total daily dose ‡ : 40mg per day (15%), 20mg per day (14%), 80mg per day (10%), 120mg per day (8%)

15. Anesthetic and Life Support Drugs, and Drug Safety and Risk Management Advisory Committees, November 13, 2008 15 Prescription type for ER oxycodone products by new, continuing, and add-switch parameters, Year 2007 SDI Vector One ® : National (VONA). Extracted 11/2008 ~81% of new Rx dispensed to those had previous Rx for ER oxycodone product within past 3 months ~6% of new Rx had no previous Rx ~14% of new Rx switched or added-on from another pain therapy product *3 month look-back period

16. Anesthetic and Life Support Drugs, and Drug Safety and Risk Management Advisory Committees, November 13, 2008 16 Total number of prescriptions dispensed for all extended- release oxycodone products by top 10 prescribing specialties from U.S. outpatient retail pharmacies, Years 1998-2007 SDI Vector One ® : National (VONA), Extracted 10/2008 Leading prescribers in Y2007: General Practice* 2.1 million Rx (28%), Internal Medicine 1.3 million Rx (18%), Anesthesiology 843,000 Rx (11%) *Family Medicine, Osteopathic Medicine, General Practice † All Others includes Unspecified specialties

17. Anesthetic and Life Support Drugs, and Drug Safety and Risk Management Advisory Committees, November 13, 2008 17 Total number of unique patients and prescriptions dispensed for all extended-release oxycodone products from U.S. outpatient retail pharmacies, Year 2007 SDI Vector One ® : National (VONA), Data Extracted 11/08 SDI Total Patient Tracker, Extracted 11/08 ER oxycodone products (brand and generic combined): ~1.5 million patients Majority of prescriptions dispensed to 40-59 year age group Younger patients (0-19 years) account for ~1% On average, 5 prescriptions dispensed per patient per year ER oxycodone products (brand and generic combined): ~1.5 million patients Majority of prescriptions dispensed to 40-59 year age group Younger patients (0-19 years) account for ~1% On average, 5 prescriptions dispensed per patient per year

18. Anesthetic and Life Support Drugs, and Drug Safety and Risk Management Advisory Committees, November 13, 2008 18 Summary of Use for Extended-Release Oxycodone Products, Year 2007… Hydrocodone products #1 dispensed prescription product –~119 million Rx Oxycodone products (ER & IR combined) 2 nd among opioids –ER & IR combined: 42.2 million Rx and 14.7 million patients –All ER oxycodone (brand and generic): 7.5 million Rx and ~1.5 million patients Leading prescribers: General Practitioners (28%), Internal Medicine (18%), Anesthesiologists (11%) Hydrocodone products #1 dispensed prescription product –~119 million Rx Oxycodone products (ER & IR combined) 2 nd among opioids –ER & IR combined: 42.2 million Rx and 14.7 million patients –All ER oxycodone (brand and generic): 7.5 million Rx and ~1.5 million patients Leading prescribers: General Practitioners (28%), Internal Medicine (18%), Anesthesiologists (11%)

19. Anesthetic and Life Support Drugs, and Drug Safety and Risk Management Advisory Committees, November 13, 2008 19 … Summary of Use for Extended-Release Oxycodone Products, Year 2007 Top dispensed strength –20mg (32%), 40mg (31%), 10mg (19%), 80mg (19%) Average days of therapy per new prescription –10mg: 26 days –20mg, 40mg, 80mg: 28 days –160mg: 20 days Most common total daily dose: 40mg per day (15%), 20mg per day (14%), 80mg per day (10%), 120mg per day (8%) ~81% of new Rx dispensed to those had previous Rx for ER oxycodone product within past 3 months ER oxycodone Rxs most commonly dispensed to patients aged 40-59 years On average, 5 prescriptions dispensed per patient per year Top dispensed strength –20mg (32%), 40mg (31%), 10mg (19%), 80mg (19%) Average days of therapy per new prescription –10mg: 26 days –20mg, 40mg, 80mg: 28 days –160mg: 20 days Most common total daily dose: 40mg per day (15%), 20mg per day (14%), 80mg per day (10%), 120mg per day (8%) ~81% of new Rx dispensed to those had previous Rx for ER oxycodone product within past 3 months ER oxycodone Rxs most commonly dispensed to patients aged 40-59 years On average, 5 prescriptions dispensed per patient per year