Center for Drug Evaluation and Research Patterns of Prescription Weight-Loss Drug Use Endocrinologic and Metabolic Drugs Advisory Committee Meeting Rockville,

Center for Drug Evaluation and ResearchCenter for Drug Evaluation and Research

Patterns of Prescription Weight-Patterns of Prescription Weight-Loss Drug UseLoss Drug Use Patterns of Prescription Weight-Patterns of Prescription Weight-Loss Drug UseLoss Drug Use

Endocrinologic and Metabolic Drugs Advisory Committee Endocrinologic and Metabolic Drugs Advisory Committee MeetingMeetingRockville, MarylandRockville, MarylandSeptember 8, 2004September 8, 2004

Laura A. Governale, Pharm.D., MBADrug Utilization Specialist Team LeaderDivision of Surveillance, Research and Communication SupportOffice of Drug Safety/CDER

Endocrinologic and Metabolic Drugs Advisory Committee Endocrinologic and Metabolic Drugs Advisory Committee MeetingMeetingRockville, MarylandRockville, MarylandSeptember 8, 2004September 8, 2004

Laura A. Governale, Pharm.D., MBADrug Utilization Specialist Team LeaderDivision of Surveillance, Research and Communication SupportOffice of Drug Safety/CDER

Endocrinologic and Metabolic Drugs Advisory Committee Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004September 8, 2004

Topics on Prescription Weight-Topics on Prescription Weight-Loss Drug UseLoss 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














Data SourcesData SourcesData SourcesData 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


Prescribing Trends for Prescribing Trends for Prescription Weight-Loss DrugsPrescription Weight-Loss Drugs

Prescribing Trends for Prescribing Trends for Prescription Weight-Loss DrugsPrescription 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


Total Number of Prescription Weight-Loss Drugs Dispensed from 1966 - 2003 in Retail Pharmacies

0

5

10

15

20

25

Years

To

tal

Pre

scri

pti

on

s

(mil

lio

ns)

Total Market

PHENTERMINE

FENFLURAMINE

DEXFENFLURAMINE

ORLISTAT

SIBUTRAMINE

MAZINDOL

BENZPHETAMINE

DIETHYLPROPION

PHENDIMETRAZINE

IMS Health, National Prescription Audit Plus7™, Years 1997 – 2003, Extracted March 2004,NPA Plus™ Therapeutic Category Report, Years December 1966 -1996, Hard Copy Books



0

5

10

15

20

25

Years

To

tal

Pre

scri

pti

on

s

(mil

lio

ns)

Total Market

PHENTERMINE

FENFLURAMINE

DEXFENFLURAMINE

ORLISTAT

SIBUTRAMINE

MAZINDOL

BENZPHETAMINE

DIETHYLPROPION

PHENDIMETRAZINE




Total Market (21 million)

Phentermine (11 million)

Fenfluramine(7 million)

Dexfenfluramine (2.3-2.7 million) Orlistat

Sibutramine0

5

10

15

20

25

Years

To

tal P

resc

rip

tion

s(m

illio

ns)

Total Market

Phentermine

Fenfluramine

Dexfenfluramine

Orlistat

Sibutramine

Mazindol

Benzphetamine

Diethylpropion

Phendimetrazine



IMS Health, National Prescription Audit Plus7™, Years 1999 – 2003, Extracted August 2004

79.1%

20.4%

74.5%

24.4%

69.2%

29.3%

68.3%

30.2%

68.5%

29.8%

0

1

2

3

4

5

6

7

New

Rx

(mill

ions

)

1999 2000 2001 2002 2003

Year

Number of New Prescriptions Dispensed by Method of Payment for Prescription Weight-Loss Drugs, 1999 - 2003

Third Party

Medicaid

Cash


Patient DemographicsPatient DemographicsPatient DemographicsPatient 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


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 Visits 2,031,000 (100.0)

Obesity 1,803,000 (88.8)

Abnormal Weight Gain 133,000 (6.5)

Other Diagnoses 95,000 (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


IMS Health, National Disease and Therapeutic Index™, Years 1998-2003, Extracted September 2004

0

1

2

3

4

To

tal D

rug

Ap

pea

ran

ces

(mill

ion

s)

1998 1999 2000 2001 2002 2003

Years

Gender Distribution for Patients with Prescription Weight-Loss Drug Use Mentions in Office-Based

Physician Practice Settings, 1998 - 2003

Male

Female



0

1

2

3

4

To

tal D

rug

Ap

pea

ran

ces

(mill

ion

s)

1998 1999 2000 2001 2002 2003

Years

Gender Distribution for Patients with Prescription Weight-Loss Drug Use Mentions in Office-Based

Physician Practice Settings, 1998 - 2003

Male

Female



0

200

400

600

800

1,000

1,200

To

tal D

rug

Ap

pea

ran

ces

(th

ou

san

ds)

0-17 18-44 45-64 65+

Age

Age Distribution for Male and Female Patients with Prescription Weight-Loss Drug Use Mentions in Office-

Based Physician Practice Settings in Year 2003

Female

Male



0

1

2

3

4

Tota

l Dru

g A

ppea

ranc

es

(mill

ions

)

1998 1999 2000 2001 2002 2003Year

Race Distribution for Patients with Prescription Weight-Loss Drug Use Mentions in Office-Based Physician

Practice Settings, 1998 - 2003

Other Patients

Asian Patients

Hispanic Patients

Black Patients

White Patients

0

1

2

3

4

Tota

l Dru

g A

ppea

ranc

es

(mill

ions

)

1998 1999 2000 2001 2002 2003Year

Race Distribution for Patients with Prescription Weight-Loss Drug Use Mentions in Office-Based Physician

Practice Settings, 1998 - 2003

Other Patients

Asian Patients

Hispanic Patients

Black Patients

White Patients


LimitationsLimitationsLimitationsLimitations

• 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.


ConclusionsConclusionsConclusionsConclusions

• 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.


AcknowledgementsAcknowledgementsAcknowledgementsAcknowledgements

• 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

Documents

Center for Drug Evaluation and Research Patterns of Prescription Weight-Loss Drug Use Endocrinologic and Metabolic Drugs Advisory Committee Meeting Rockville,