1. Center for Drug Evaluation and Research Patterns of Prescription Weight-Loss Drug Use Endocrinologic and Metabolic Drugs Advisory Committee Meeting Rockville, Maryland September 8, 2004 Laura A. Governale, Pharm.D., MBA Drug Utilization Specialist Team Leader Division of Surveillance, Research and Communication Support Office of Drug Safety/CDER Endocrinologic and Metabolic Drugs Advisory Committee Meeting Rockville, Maryland September 8, 2004 Laura A. Governale, Pharm.D., MBA Drug Utilization Specialist Team Leader Division of Surveillance, Research and Communication Support Office of Drug Safety/CDER

2. Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004 Topics on Prescription Weight- Loss Drug Use Prescription Weight-Loss Drugs: –Dexfenfluramine –Sibutramine –Orlistat –Amphetamine Congeners Prescribing Trends Patient Demographics Not covered in this analysis: –Over-the-Counter Weight-Loss Drugs –Nutritional Supplements Prescription Weight-Loss Drugs: –Dexfenfluramine –Sibutramine –Orlistat –Amphetamine Congeners Prescribing Trends Patient Demographics Not covered in this analysis: –Over-the-Counter Weight-Loss Drugs –Nutritional Supplements

3. Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004 Topics on Prescription Weight- Loss Drug Use Prescription Weight-Loss Drugs: –Dexfenfluramine –Sibutramine –Orlistat –Amphetamine Congeners Prescribing Trends Patient Demographics Not covered in this analysis: –Over-the-Counter Weight-Loss Drugs –Nutritional Supplements Prescription Weight-Loss Drugs: –Dexfenfluramine –Sibutramine –Orlistat –Amphetamine Congeners Prescribing Trends Patient Demographics Not covered in this analysis: –Over-the-Counter Weight-Loss Drugs –Nutritional Supplements

4. Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004 Data Sources IMS Health, National Prescription Audit Plus™ (NPA Plus™) –Measures the “retail outflow” of prescriptions from pharmacies to consumers via prescriptions –Includes: chain, independent, mass merchandisers, food stores with pharmacies, mail-order, and long-term care pharmacies IMS Health, National Disease and Therapeutic Index (NDTI™) –Survey of roughly 3,000 office-based physician practice patterns in the continental U.S. –Data include profiles and trends of diagnoses, patients and treatment patterns IMS Health, National Prescription Audit Plus™ (NPA Plus™) –Measures the “retail outflow” of prescriptions from pharmacies to consumers via prescriptions –Includes: chain, independent, mass merchandisers, food stores with pharmacies, mail-order, and long-term care pharmacies IMS Health, National Disease and Therapeutic Index (NDTI™) –Survey of roughly 3,000 office-based physician practice patterns in the continental U.S. –Data include profiles and trends of diagnoses, patients and treatment patterns

5. Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004 Prescribing Trends for Prescription Weight-Loss Drugs Data Source: IMS Health, National Prescription Audit Plus™ (NPA Plus™) –Total Number of Prescriptions Dispensed, 1966 – 2003 –Method of Payment for Prescription Weight-Loss Drugs, 1999 – 2003 Data Source: IMS Health, National Prescription Audit Plus™ (NPA Plus™) –Total Number of Prescriptions Dispensed, 1966 – 2003 –Method of Payment for Prescription Weight-Loss Drugs, 1999 – 2003

6. Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004 IMS Health, National Prescription Audit Plus7™, Years 1997 – 2003, Extracted March 2004, NPA Plus™ Therapeutic Category Report, Years December 1966 -1996, Hard Copy Books

7. Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004 IMS Health, National Prescription Audit Plus7™, Years 1997 – 2003, Extracted March 2004, NPA Plus™ Therapeutic Category Report, Years December 1966 -1996, Hard Copy Books

8. Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004 IMS Health, National Prescription Audit Plus7™, Years 1997 – 2003, Extracted March 2004, NPA Plus™ Therapeutic Category Report, Years December 1966 -1996, Hard Copy Books

9. Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004 IMS Health, National Prescription Audit Plus7™, Years 1999 – 2003, Extracted August 2004

10. Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004 Patient Demographics IMS Health, National Disease and Therapeutic Index™ (NDTI™) –Principle Diagnoses Associated with Prescription Weight-Loss Drug* Use –Gender Distribution –Age Distribution –Race Distribution IMS Health, National Disease and Therapeutic Index™ (NDTI™) –Principle Diagnoses Associated with Prescription Weight-Loss Drug* Use –Gender Distribution –Age Distribution –Race Distribution *Prescription Weight-Loss Drugs: phentermine, orlistat, sibutramine, phendimetrazine, diethylpropion, benzphetamine, mazindol, fenfluramine, and dexfenfluramine

11. Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004 Diagnoses Associated with Prescription Weight-Loss Drug* Use as Reported by Office-Based Physician Practice Settings in Year 2003 Year 2003 No.(%) Total Projected Diagnosis Visits2,031,000(100.0) Obesity1,803,000(88.8) Abnormal Weight Gain133,000(6.5) Other Diagnoses95,000(4.7) IMS Health, National Disease and Therapeutic Index™, Years 1998-2003, Extracted July 2004 * Prescription Weight-Loss Drugs: phentermine, orlistat, sibutramine, phendimetrazine, diethylpropion, benzphetamine, mazindol, fenfluramine, and dexfenfluramine

12. Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004 IMS Health, National Disease and Therapeutic Index™, Years 1998-2003, Extracted September 2004

13. Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004 IMS Health, National Disease and Therapeutic Index™, Years 1998-2003, Extracted September 2004

14. Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004 IMS Health, National Disease and Therapeutic Index™, Years 1998-2003, Extracted September 2004

15. Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004 IMS Health, National Disease and Therapeutic Index™, Years 1998-2003, Extracted September 2004

16. Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004 LimitationsLimitations NPA Plus  provides only limited demographic information on prescription use NDTI  is based on a sample size of 2000 - 3000 office-based physicians. The small sample size can make these data projections unstable, particularly when use is not highly prevalent. –Data not be generalizable to all obese patients since only patients seen by physicians in office-based settings are represented –Due to the limitations in sampling in this database, any perceived trends must be interpreted with caution. NPA Plus  provides only limited demographic information on prescription use NDTI  is based on a sample size of 2000 - 3000 office-based physicians. The small sample size can make these data projections unstable, particularly when use is not highly prevalent. –Data not be generalizable to all obese patients since only patients seen by physicians in office-based settings are represented –Due to the limitations in sampling in this database, any perceived trends must be interpreted with caution.

17. Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004 ConclusionsConclusions Drug use for prescription weight-loss drugs has fluctuated over the last 38 years and has declined in recent years. Cash payment remains an important mechanism for payment for these drugs. The primary users of these products are Caucasian women between the ages of 18-44. Drug use for prescription weight-loss drugs has fluctuated over the last 38 years and has declined in recent years. Cash payment remains an important mechanism for payment for these drugs. The primary users of these products are Caucasian women between the ages of 18-44.

18. Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004 AcknowledgementsAcknowledgements Gerald DalPan, M.D., MHS, Division of Surveillance, Research and Communication Support Eric Colman, M.D., Division of Metabolic and Endocrine Drug Products Bruce Stadel, M.D., Division of Metabolic and Endocrine Drug Products Anne Trontell, M.D., MPH, Office of Drug Safety Gerald DalPan, M.D., MHS, Division of Surveillance, Research and Communication Support Eric Colman, M.D., Division of Metabolic and Endocrine Drug Products Bruce Stadel, M.D., Division of Metabolic and Endocrine Drug Products Anne Trontell, M.D., MPH, Office of Drug Safety