Post on 26-Dec-2015
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
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
• 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
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
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
• 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
Endocrinologic and Metabolic Drugs Advisory Committee Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004September 8, 2004
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
Endocrinologic and Metabolic Drugs Advisory Committee Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004September 8, 2004
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
Endocrinologic and Metabolic Drugs Advisory Committee Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004September 8, 2004
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
Endocrinologic and Metabolic Drugs Advisory Committee Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004September 8, 2004
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
Endocrinologic and Metabolic Drugs Advisory Committee Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004September 8, 2004
Total Number of Prescription Weight-Loss Drugs Dispensed from 1990 - 2003 in Retail Pharmacies
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 1997 – 2003, Extracted March 2004,NPA Plus™ Therapeutic Category Report, Years December 1966 -1996, Hard Copy Books
Endocrinologic and Metabolic Drugs Advisory Committee Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004September 8, 2004
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
Endocrinologic and Metabolic Drugs Advisory Committee Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004September 8, 2004
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
Endocrinologic and Metabolic Drugs Advisory Committee Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004September 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 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
Endocrinologic and Metabolic Drugs Advisory Committee Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004September 8, 2004
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
Endocrinologic and Metabolic Drugs Advisory Committee Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004September 8, 2004
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
Endocrinologic and Metabolic Drugs Advisory Committee Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004September 8, 2004
IMS Health, National Disease and Therapeutic Index™, Years 1998-2003, Extracted September 2004
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
Endocrinologic and Metabolic Drugs Advisory Committee Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004September 8, 2004
IMS Health, National Disease and Therapeutic Index™, Years 1998-2003, Extracted September 2004
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
Endocrinologic and Metabolic Drugs Advisory Committee Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004September 8, 2004
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.
Endocrinologic and Metabolic Drugs Advisory Committee Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004September 8, 2004
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.
Endocrinologic and Metabolic Drugs Advisory Committee Endocrinologic and Metabolic Drugs Advisory Committee September 8, 2004September 8, 2004
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