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Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Surveillance and Epidemiology
M. Dianne Murphy, MD Director, Office of Pediatric Therapeutics (OPT), OIASI Office of the Commissioner CDR Lisa L. Mathis, USPHS, MD Associate Director, Pediatric and Maternal Health Team (PMHS) Office of New Drugs Laura Governale, Pharm.D., MBA Drug Use Data Analyst Team Leader Division of Epidemiology Office of Surveillance and Epidemiology Hina Mehta, Pharm.D. Drug Use Data Analyst Division of Epidemiology Office of Surveillance and Epidemiology Subject: Abilify® (aripiprazole), Geodon® (ziprasidone), Seroquel® (quetiapine), Zyprexa® (olanzapine), Risperdal® (risperidone), Invega® (paliperidone) Drug Use Review Abilify® (aripiprazole), Geodon® (ziprasidone), Seroquel® (quetiapine), Zyprexa® (olanzapine), Risperdal® (risperidone), Invega® (paliperidone) **This document contains proprietary drug use data obtained by FDA under contract. The drug use data/information cannot be released to the public/non-FDA personnel without contractor approval obtained through the FDA/CDER Office of Surveillance and Epidemiology.** EXECUTIVE SUMMARY
This review examines drug utilization patterns for six atypical antipsychotics, Abilify® (aripiprazole), Geodon® (ziprasidone), Seroquel® (quetiapine), Zyprexa® (olanzapine), Risperdal® (risperidone), Invega® (paliperidone), in the pediatric population (age 0-2 years, 3-6 years, 7-12 years, 13-17 years, and 18+ years) from year 2004 through June 2009. Since approximately 56%-81% of the atypical antipsychotics were sold to U.S. outpatient retail settings during year 2008, this review focuses on the outpatient setting. • All of the antipsychotic agents studied except for olanzapine had an increase in the number of dispensed prescriptions over the past 5 years. • Dispensed prescriptions for aripiprazole increased the most by approximately 135% from year 2004 • Antipsychotic use among pediatric patients has increased by 22% over the 5 years. The greatest increase was seen for aripiprazole during this time period. • Risperidone had the most prescriptions dispensed (26%) to pediatric patients (0-17 years) and had a greater amount of use in younger children compared to the other antipsychotics. Aripiprazole had the second highest number of dispensed prescriptions (23%) in the pediatric population. • In year 2008, 2.3 million unique patients received a prescription for quetiapine followed by risperidone with 1.5 million and aripiprazole with 1.2 million. • For all of the agents studied, the majority of prescriptions dispensed to patients over the entire study period were prescribed by Psychiatrists. • In children aged 7-12 years old, concomitant use with stimulant medications were most common for those already on aripiprazole, risperidone and olanzapine. Mood stabilizing agents, other antipsychotics and antidepressants were the most common concomitant products for quetiapine and ziprasidone in this age group as well as for older age groups. INTRODUCTION
Using the currently available proprietary drug use databases licensed by the Agency, this review describes outpatient drug use patterns for Abilify® (aripiprazole), Geodon® (ziprasidone), Seroquel® (quetiapine), Zyprexa® (olanzapine), Risperdal® (risperidone), Invega® (paliperidone) in the pediatric population as well as in the adult population for years 2004 through 2008 and year-to-date June 2009. METHODS AND MATERIALS
2.1 DETERMINING SETTINGS OF CARE
IMS Health, IMS National Sales Perspectives™ data (see Appendix 2) were used to determine the setting
in which these six atypical antipsychotic products were sold. Sales of these products by number of bottles,
packets of pills (eaches) sold from the manufacturer into the various retail and non-retail channels of
distribution were analyzed for year 2008 (data not provided).1 During the review period, retail settings (chain
stores, independent pharmacies, and food stores) accounted for the majority of atypical antipsychotic product
sales (56% or greater). Distribution towards non-retail pharmacy settings ranged from 22% to 37% during
year 2008. The long term care setting within the non-retail channels received the majority of atypical
antipsychotic sales. Mail order distribution ranged from 4% to 8% for the six agents analyzed. Thus, we
examined outpatient utilization patterns. Mail order and long term care data are not included in this analysis.
1 IMS Health, IMS Nationals Sales PerspectivesTM, Years 2004-2008, Data extracted Aug 2009, Source file: 0908apsy.DVR 2.2 DATA SOURCES USED

Outpatient use and patient demographics (stratified by ages 0-2 years, 3-6 years, 7-12 years, 13-17 years, and
18+ years) were measured from SDI Vector One®: National (VONA) and Total Patient Tracker (TPT)
(Appendix 2). Indications for use were obtained from the SDI’s Physician’s Drug and Diagnosis Audit
(PDDA) (Appendix 2). From these data sources, estimates of the number of prescriptions dispensed, the
number of patients who received a prescription for Abilify® (aripiprazole), Geodon® (ziprasidone), Seroquel®
(quetiapine), Zyprexa® (olanzapine), Risperdal® (risperidone), Invega® (paliperidone), and the number of
drug mentions by office-based physicians, were obtained for years 2004-2008 and year-to-date June 2009.
3.1 DISPENSED PRESCRIPTIONS
Figure 1 in Appendix 1 shows the total number of prescriptions dispensed in the outpatient retail setting (mail order excluded) for Abilify® (aripiprazole), Geodon® (ziprasidone), Seroquel® (quetiapine), Zyprexa® (olanzapine), Risperdal® (risperidone), Invega® (paliperidone). During year 2008, nearly 32 million prescriptions were dispensed for these products, an increase of 31% from approximately 24.4 million dispensed prescriptions in year 2004. Approximately 11.9 million prescriptions were dispensed for quetiapine (37% of market) followed by risperidone (25% of market) and aripiprazole (16% of market) with 7.9 million and 5.2 million prescriptions, respectively. All of the agents had an increase in the number of prescriptions dispensed in the past 5 years except for olanzapine which decreased by about a third during the same time period. Dispensed prescriptions for aripiprazole increased by 135% from year 2004 (2,217,625 prescriptions) to year 2008 (5,220,606 prescriptions) followed by ziprasidone with 71% increase and quetiapine with 66% increase. 3.2 DISPENSED PRESCRIPTION BY PEDIATRIC AGE GROUPS
Antipsychotic use in the pediatric population (0-17 years) has increased 22% in the past 5 years (Figure 2: Appendix 1). The greatest increase was seen for aripiprazole at 96%. In year 2008, of the six agents analyzed, risperidone had the most prescriptions dispensed to pediatric patients aged 0-17 years (26% of all risperidone dispensed to pediatric patients versus adults; 2.1 million risperidone prescriptions), followed by aripiprazole (23%; 1.2 million prescriptions), quetiapine (9%; 1.1 million prescriptions), ziprasidone (10%; 238,425 prescriptions), olanzapine (4%; 169,121 prescriptions), and paliperidone (11%; 74,559 prescriptions). Analysis of pediatric sub-age groups revealed that the majority of antipsychotic use during year 2008 was among those aged 13-17 years; aripiprazole (13%), quetiapine (6%), ziprasidone (7%), olanzapine (2%), and paliperidone (7%). Risperidone, on the other hand, was most commonly dispensed to pediatric patients aged 7-12 years, accounting for 14% of dispensed prescriptions. Prescriptions dispensed to pediatric patients aged 0-2 years and 3-6 years accounted for less than 1% of the combined total dispensed prescriptions for all six agents with the exception of risperidone in which 2% of prescriptions are dispensed to pediatrics aged 3-6 years (Table 1: Appendix 1). 3.3 PATIENT-LEVEL DATA
Trends for patient data were similar to that of prescription data. In year 2008, approximately 5.4 million patients received a prescription for these selected antipsychotic agents in the outpatient retail pharmacy setting, an increase of 21% from 4.5 million patients in year 2004. Approximately, 2.3 million unique patients received a prescription for quetiapine followed by risperidone and aripiprazole with 1.5 million and 1.2 million, respectively. As with dispensed prescription data, analysis of pediatric sub-age groups revealed similar trends in use with patient-level data (Table 2: Appendix 1). 3.4 DIAGNOSES ASSOCIATED WITH USE
We also examined the most common diagnosis associated with the use of Abilify® (aripiprazole), Geodon® (ziprasidone), Seroquel® (quetiapine), Zyprexa® (olanzapine), Risperdal® (risperidone), Invega® (paliperidone) as reported by office-based physician practices in the U.S. (Appendix 1: Tables 3a-3e). Diagnoses among the pediatric age groups 0-2 years and 3-6 years were below the acceptable count allowable to provide a reliable estimate. Among the pediatrics aged 7-12 years “Bipolar Affective NOS” ICD-9 296.7 was the most common diagnosis associated with a mention of aripiprazole with approximately 25% of all mentions for that age group from year 2004 through year to date June 2009 followed by “Attention Deficit Dis” ICD-9 314.0 with 17%. For risperidone, the most common diagnosis among pediatrics aged 7-12 years was “Attention Deficit Dis” ICD-9 314-0 with 18% followed by “Bipolar Affective NOS” ICD-9 296.7 and “Infantile Autism” ICD-9 299.0 with 15% and 11%, respectively. For adolescents aged 13-17 years the most common diagnosis associated with a mention for aripiprazole, quetiapine, olanzapine, and ziprasidone was “Bipolar Affective NOS” ICD-9 296.7. “Attention Deficit Dis” ICD-9 314-0 and “Infantile Autism” ICD-9 299.0 were the most common diagnosis for risperidone and paliperidone, respectively, for this age group. 3.5 PEDIATRIC DISPENSED PRESCRIPTION BY PRESCRIBING SPECIALTY
Table 4a-4f in Appendix 1 shows the total number of prescriptions dispensed for Abilify® (aripiprazole), Geodon® (ziprasidone), Seroquel® (quetiapine), Zyprexa® (olanzapine), Risperdal® (risperidone), Invega® (paliperidone) by patient age and physician specialty. The majority of prescriptions dispensed to patients were prescribed by Psychiatrists over the entire study period for the pediatric as well as adult age groups for all of the agents studied. During year 2008, Nurse Practitioners were the second most common prescriber for aripiprazole, ziprasidone and paliperidone for both adult and pediatric age groups. For risperidone, quetiapine, and olanzapine, GP/FM/DO2 were the second most common prescribers of these medications to both adult and pediatric age groups. 3.6 CONCOMITANT USE
Tables 5a-5e in Appendix 1 shows the total number of health care physician mentions where one of the select antipsychotics were used concomitantly with another class of products to treat the same diagnosis. Concomitancy for all of the agents among the pediatric age groups 0-2 years and 3-6 years were below the acceptable count allowable to provide a reliable estimate of use. In those aged 7-12 years old, concomitant use with stimulant medications were most common for aripiprazole, risperidone and olanzapine. For quetiapine and ziprasidone, mood stabilizing agents such as anticonvulsants, other antipsychotics, and antidepressants were commonly used together to treat the same diagnosis. In those aged 13-17 years, concomitant use with mood stabilizing agents, other antipsychotics and antidepressants were the most common concomitant class of products for all antipsychotic agents studied. LIMITATIONS
Findings from this consult should be interpreted in the context of the known limitations of the databases used. We estimated Abilify® (aripiprazole), Geodon® (ziprasidone), Seroquel® (quetiapine), Zyprexa® (olanzapine), Risperdal® (risperidone), Invega® (paliperidone) are distributed primarily in outpatient settings based on the IMS Health, IMS National Sales Perspectives™. These data do not provide a direct estimate of use but do provide a national estimate of units sold from the manufacturer into the various channels of distribution. The amount of product purchased by these retail and non-retail channels of distribution may be a possible surrogate for use, if we assume the facilities purchase drugs in quantities reflective of actual patient use. SDI’s Physician Drug & Diagnosis Audit (PDDA) data provide estimates of patient demographics and indications for use of medicinal products in the U.S. Due to the sampling and data collection methodologies, 2 GP/FM/DO – General Practice, Family Medicine, Doctor of Osteopathy the small sample size can make these data unstable, particularly if use is not common in the pediatric population. SDI recommends caution interpreting projected annual uses or mentions below 100,000 as the sample size is very small with correspondingly large confidence intervals. CONCLUSIONS
All of the antipsychotic agents studied except for olanzapine had an increase in the number of dispensed prescriptions over the past 5 years. Dispensed prescription for Abilify® (aripiprazole) increased the greatest amount (135%). Antipsychotic use among pediatric patients aged 0-17 years have increased 22% over the past 5 years. Use among pediatrics aged 0-2 years and 3-6 years accounted for less than 1% of the total for each of the antipsychotic agents studied. Risperidone was the most commonly dispensed atypical antipsychotic agent among pediatrics, especially those aged 7-12 years. Aripiprazole pediatric prescriptions are most commonly dispensed to adolescents aged 13-17 years. Trends for patient data were similar to that of prescription data. Psychiatrists prescribe the majority of antipsychotic prescriptions dispensed. In younger children (7-12 years old), concomitant use with stimulant medications were most common for aripiprazole, risperidone and olanzapine. Mood stabilizing agents, other antipsychotics and antidepressants were the most common concomitant class of products used with quetiapine and ziprasidone in this age group as well as for older age groups.
APPENDICES
APPENDIX 1: Figures and Tables
Figure 1: Total Number of Dispensed Prescriptions for 6 Atypical Antipsychotic Agents
Through U.S. Outpatient Retail Pharmacies, Years 2004-2008 and YTD Jun 2009
Source: SDI: Vector One®: National. Data Extracted 8-4-09. File: VONA 2009-1004 TRx 8-4-09.qry Figure 2: Total Number of Prescriptions Dispensed for 6 Atypical Antipsychotics Among
Pediatrics 0-17 Years Through U.S. Outpatient Retail Pharmacies, 2004-2008 and YTD Jun
x 3,000,000
Source: SDI: Vector One: National. Data Extracted 9-1-09. File: VONA 2009-1004 TRx by Ages 0-17 only 9-1- Table 1: Total Number of Prescriptions Dispensed for Atypical Antipsychotics Through U.S. Outpatient Retail Pharmacies, Years 2004-2008 and YTD 2009
YTD/JUN/2009
Share
Share
Share
Share
Share
Share
%
%
%
%
%
%
TOTAL MARKET
24,435,769
100.0%
25,290,095
100.0% 27,109,846
100.0%
29,707,935
100.0%
31,965,360
100.0% 16,343,519
100.0%
quetiapine fumarate
Age 13-17
Age UNSPEC.
risperidone
Age 13-17
aripiprazole
Age 13-17
Age UNSPEC.
olanzapine
Age 13-17
Age UNSPEC.
ziprasidone hcl
Age 13-17
Age UNSPEC.
paliperidone
Age 13-17
Age UNSPEC.
Source: SDI: Vector One®: National. Data Extracted 8-4-09. File: VONA 2009-1004 TRx by Age 8-4-09.qry Table 2. Total Number of Unique Patients Receiving a Prescription for Atypical Antipsychotics Through U.S. Outpatient Retail Pharmacies, 2004-2008 and YTD 2009
YTD/Jun/2009
%
%
%
%
%
%
Total Market
4,489,529
100.00%
4,444,417
100.00%
4,660,191
100.00%
4,969,311
100.00%
5,448,785
100.00%
3,979,597
100.00%
Seroquel (quetiapine)
1,542,314
34.35%
1,744,179
39.24%
1,943,537
41.71%
2,173,053
43.73%
2,328,813
42.74%
1,598,624
40.17%
Age 13 - 17
Age Unknown
Risperdal (risperidone)
Age 13 - 17
Age Unknown
Abilify (aripirazole)
Age 13 - 17
Age Unknown
Zyprexa (olanzapine)
Age 13 - 17
Age Unknown
Geodon (ziprasidone)
Age 13 - 17
Age Unknown
Invega (paliperidone)
Age 13 - 17
Age Unknown
Source: SDI: Total Patient Tracker. Data Extracted 8-5-09 and 8-6-09. Files: TPT 2009-1004 Abilify Patient Count by Age 8-5-09.xls, TPT 2009-1004 Abilify Patient Count by Age YTD 2009 8-5-09.xls, TPT 2009-1004 Geodon Patient Count by Age 8-5-09.xls, TPT 2009-1004 Geodon Patient Count by Age YTD 2009 8-5-09.xls, TPT 2009-1004 Invega Patient Count by Age 8-5-09.xls, TPT 2009-1004 Invega Patient Count by Age YTD 2009 8-5-09.xls, TPT 2009-1004 Risperdal Patient Count by Age 8-5-09.xls, TPT 2009-1004 Risperdal Patient Count by Age YTD 2009 8-5-09.xls, TPT 2009-1004 Seroquel Patient Count by Age 8--5-09.xls, TPT 2009-1004 Seroquel Patient Count by Age YTD 2009 8-5-09.xls, TPT 2009-1004 Total Patient Count 8-6-09.xls, TPT 2009-1004 Total Patient Count YTD 2009 8-6-09.xls, TPT 2009-1004 Zyprexa Patient Count by Age 8-5-09.xls, TPT 2009-1004 Zyprexa Patient Count by Age YTD 2009 8-5-09.xls Table 3a. Most Common Indications by Age Associated with the Use of Atypical Antipsychotics in Office-Based Practice Settings, 2004-2008 and YTD 2009
Uses (000)
Share (%)
TOTAL MARKET
100.0%
quetiapine fumarate
29.9%
2969 AFFECT PSYCHOSES NEC/NOS
2967 BIPOLAR AFFECTIVE NOS
3003 OBSESSIVE-COMPULSIVE DIS
3129 CONDUCT DISTURBANCE NOS
3123 IMPULSE CONTROL DIS NEC
3139 EMOTIONAL DIS CHILD NOS
2962 DEPR PSYCH, SINGL EPISOD
3110 DEPRESSIVE DISORDER NEC
3138 OTH EMOTIONAL DIS CHILD
2968 MANIC-DEPRESSIVE NEC/NOS
2998 EARLY CHLD PSYCHOSES NEC
3000 ANXIETY STATES
3129 CONDUCT DISTURBANCE NOS
2967 BIPOLAR AFFECTIVE NOS
3098 OTHER ADJUST REACTION
3003 OBSESSIVE-COMPULSIVE DIS
2969 AFFECT PSYCHOSES NEC/NOS
All Others
Age 13-17
2969 AFFECT PSYCHOSES NEC/NOS
2967 BIPOLAR AFFECTIVE NOS
3140 ATTENTION DEFICIT DIS
2968 MANIC-DEPRESSIVE NEC/NOS
3098 OTHER ADJUST REACTION
3123 IMPULSE CONTROL DIS NEC
3138 OTH EMOTIONAL DIS CHILD
3139 EMOTIONAL DIS CHILD NOS
3120 UNSOCIALIZED AGGRESSION
2959 SCHIZOPHRENIA NOS
All Others
2967 BIPOLAR AFFECTIVE NOS
2957 SCHIZOAFFECTIVE TYPE
2968 MANIC-DEPRESSIVE NEC/NOS
2953 PARANOID SCHIZOPHRENIA
3110 DEPRESSIVE DISORDER NEC
2959 SCHIZOPHRENIA NOS
2989 PSYCHOSIS NOS
3098 OTHER ADJUST REACTION
2962 DEPR PSYCH, SINGL EPISOD
2966 BIPOLAR AFFECTIVE, MIXED
All Others
Age UNSPEC.
Source: SDI: Physician Drug and Diagnosis Audit, Extracted 8-4-09. File: PDDA 2009-1004 Dx4 by Age 8-4-09.qry Table 3b. Most Common Indications by Age Associated with the Use of Atypical Antipsychotics in Office-Based Practice Settings, 2004-2008 and YTD 2009
Uses (000)
Share (%)
aripiprazole
17.2%
3140 ATTENTION DEFICIT DIS
V409 MENTAL/BEHAVIOR PROB NOS
2956 RESIDUAL SCHIZOPHRENIA
3072 TICS
2968 MANIC-DEPRESSIVE NEC/NOS
2967 BIPOLAR AFFECTIVE NOS
3140 ATTENTION DEFICIT DIS
3003 OBSESSIVE-COMPULSIVE DIS
3009 NEUROTIC DISORDER NOS
2999 EARLY CHLD PSYCHOSIS NOS
7834 LACK NORM PHYSIOL DEVEL
3138 OTH EMOTIONAL DIS CHILD
3129 CONDUCT DISTURBANCE NOS
All Others
2969 AFFECT PSYCHOSES NEC/NOS
3140 ATTENTION DEFICIT DIS
2967 BIPOLAR AFFECTIVE NOS
2990 INFANTILE AUTISM
3138 OTH EMOTIONAL DIS CHILD
2999 EARLY CHLD PSYCHOSIS NOS
3003 OBSESSIVE-COMPULSIVE DIS
3139 EMOTIONAL DIS CHILD NOS
2998 EARLY CHLD PSYCHOSES NEC
3129 CONDUCT DISTURBANCE NOS
All Others
Age 13-17
2969 AFFECT PSYCHOSES NEC/NOS
2967 BIPOLAR AFFECTIVE NOS
3110 DEPRESSIVE DISORDER NEC
3138 OTH EMOTIONAL DIS CHILD
3140 ATTENTION DEFICIT DIS
3129 CONDUCT DISTURBANCE NOS
2962 DEPR PSYCH, SINGL EPISOD
3000 ANXIETY STATES
2968 MANIC-DEPRESSIVE NEC/NOS
3098 OTHER ADJUST REACTION
All Others
2967 BIPOLAR AFFECTIVE NOS
2957 SCHIZOAFFECTIVE TYPE
2968 MANIC-DEPRESSIVE NEC/NOS
3110 DEPRESSIVE DISORDER NEC
2959 SCHIZOPHRENIA NOS
2962 DEPR PSYCH, SINGL EPISOD
2953 PARANOID SCHIZOPHRENIA
2989 PSYCHOSIS NOS
2963 DEPR PSYCH, RECUR EPISOD
2966 BIPOLAR AFFECTIVE, MIXED
All Others
Age UNSPEC.
Source: SDI: Physician Drug and Diagnosis Audit, Extracted 8-4-09. File: PDDA 2009-1004 Dx4 by Age 8-4-09.qry Table 3c. Most Common Indications by Age Associated with the Use of Atypical Antipsychotics in Office-Based Practice Settings, 2004-2008 and YTD 2009
Uses (000)
Share (%)
risperidone
23.1%
3129 CONDUCT DISTURBANCE NOS
V403 BEHAVIORAL PROBLEMS NEC
V409 MENTAL/BEHAVIOR PROB NOS
3138 OTH EMOTIONAL DIS CHILD
3129 CONDUCT DISTURBANCE NOS
3003 OBSESSIVE-COMPULSIVE DIS
2967 BIPOLAR AFFECTIVE NOS
3128 OTHER CONDUCT DISTURB
2969 AFFECT PSYCHOSES NEC/NOS
7803 CONVULSIONS
3013 EXPLOSIVE PERSONALITY
2990 INFANTILE AUTISM
V403 BEHAVIORAL PROBLEMS NEC
2989 PSYCHOSIS NOS
All Others
2990 INFANTILE AUTISM
3140 ATTENTION DEFICIT DIS
3138 OTH EMOTIONAL DIS CHILD
2967 BIPOLAR AFFECTIVE NOS
2969 AFFECT PSYCHOSES NEC/NOS
2966 BIPOLAR AFFECTIVE, MIXED
V403 BEHAVIORAL PROBLEMS NEC
7805 SLEEP DISTURBANCES
2989 PSYCHOSIS NOS
3129 CONDUCT DISTURBANCE NOS
All Others
Age 13-17
2969 AFFECT PSYCHOSES NEC/NOS
2967 BIPOLAR AFFECTIVE NOS
3072 TICS
3110 DEPRESSIVE DISORDER NEC
3140 ATTENTION DEFICIT DIS
3138 OTH EMOTIONAL DIS CHILD
2990 INFANTILE AUTISM
3003 OBSESSIVE-COMPULSIVE DIS
2953 PARANOID SCHIZOPHRENIA
3190 MENTAL RETARDATION NOS
All Others
2953 PARANOID SCHIZOPHRENIA
2957 SCHIZOAFFECTIVE TYPE
2959 SCHIZOPHRENIA NOS
2967 BIPOLAR AFFECTIVE NOS
2989 PSYCHOSIS NOS
2948 OTH PERSIS MED DISO NOS
3098 OTHER ADJUST REACTION
2962 DEPR PSYCH, SINGL EPISOD
3000 ANXIETY STATES
2963 DEPR PSYCH, RECUR EPISOD
All Others
Age UNSPEC.
Source: SDI: Physician Drug and Diagnosis Audit, Extracted 8-4-09. File: PDDA 2009-1004 Dx4 by Age 8-4-09.qry Table 3d. Most Common Indications by Age Associated with the Use of Atypical Antipsychotics in Office-Based Practice Settings, 2004-2008 and YTD 2009
Uses (000)
Share (%)
olanzapine
17.1%
2967 BIPOLAR AFFECTIVE NOS
2962 DEPR PSYCH, SINGL EPISOD
3110 DEPRESSIVE DISORDER NEC
3098 OTHER ADJUST REACTION
3140 ATTENTION DEFICIT DIS
2960 MANIC DIS, SINGL EPISODE
3140 ATTENTION DEFICIT DIS
2990 INFANTILE AUTISM
3000 ANXIETY STATES
2969 AFFECT PSYCHOSES NEC/NOS
2966 BIPOLAR AFFECTIVE, MIXED
2959 SCHIZOPHRENIA NOS
2998 EARLY CHLD PSYCHOSES NEC
3098 OTHER ADJUST REACTION
V202 ROUTIN CHILD HEALTH EXAM
2960 MANIC DIS, SINGL EPISODE
Age 13-17
2967 BIPOLAR AFFECTIVE NOS
3098 OTHER ADJUST REACTION
2998 EARLY CHLD PSYCHOSES NEC
2964 BIPOLAR AFFECTIVE, MANIC
2989 PSYCHOSIS NOS
3071 ANOREXIA NERVOSA
2954 AC SCHIZOPHRENIC EPISODE
3003 OBSESSIVE-COMPULSIVE DIS
2953 PARANOID SCHIZOPHRENIA
3110 DEPRESSIVE DISORDER NEC
All Others
2959 SCHIZOPHRENIA NOS
2957 SCHIZOAFFECTIVE TYPE
2967 BIPOLAR AFFECTIVE NOS
2953 PARANOID SCHIZOPHRENIA
2989 PSYCHOSIS NOS
3110 DEPRESSIVE DISORDER NEC
2962 DEPR PSYCH, SINGL EPISOD
2968 MANIC-DEPRESSIVE NEC/NOS
2948 OTH PERSIS MED DISO NOS
3098 OTHER ADJUST REACTION
All Others
Age UNSPEC.
Source: SDI: Physician Drug and Diagnosis Audit, Extracted 8-4-09. File: PDDA 2009-1004 Dx4 by Age 8-4-09.qry Table 3e. Most Common Indications by Age Associated with the Use of Atypical Antipsychotics in Office-Based Practice Settings, 2004-2008 and YTD 2009
Uses (000)
Share (%)
ziprasidone hcl
11.1%
2956 RESIDUAL SCHIZOPHRENIA
2957 SCHIZOAFFECTIVE TYPE
2969 AFFECT PSYCHOSES NEC/NOS
2967 BIPOLAR AFFECTIVE NOS
3138 OTH EMOTIONAL DIS CHILD
3003 OBSESSIVE-COMPULSIVE DIS
4939 ASTHMA NOS
3140 ATTENTION DEFICIT DIS
2999 EARLY CHLD PSYCHOSIS NOS
3000 ANXIETY STATES
2966 BIPOLAR AFFECTIVE, MIXED
3098 OTHER ADJUST REACTION
All Others
Age 13-17
2967 BIPOLAR AFFECTIVE NOS
3110 DEPRESSIVE DISORDER NEC
7805 SLEEP DISTURBANCES
2969 AFFECT PSYCHOSES NEC/NOS
3138 OTH EMOTIONAL DIS CHILD
2957 SCHIZOAFFECTIVE TYPE
2948 OTH PERSIS MED DISO NOS
V681 ISSUE REPEAT PRESCRIPT
3123 IMPULSE CONTROL DIS NEC
2989 PSYCHOSIS NOS
All Others
2967 BIPOLAR AFFECTIVE NOS
2953 PARANOID SCHIZOPHRENIA
2957 SCHIZOAFFECTIVE TYPE
2959 SCHIZOPHRENIA NOS
2966 BIPOLAR AFFECTIVE, MIXED
2968 MANIC-DEPRESSIVE NEC/NOS
2989 PSYCHOSIS NOS
2962 DEPR PSYCH, SINGL EPISOD
2963 DEPR PSYCH, RECUR EPISOD
3110 DEPRESSIVE DISORDER NEC
All Others
Age UNSPEC.
paliperidone
1.5%
3129 CONDUCT DISTURBANCE NOS
Age 13-17
2957 SCHIZOAFFECTIVE TYPE
3129 CONDUCT DISTURBANCE NOS
V403 BEHAVIORAL PROBLEMS NEC
2990 INFANTILE AUTISM
2989 PSYCHOSIS NOS
2953 PARANOID SCHIZOPHRENIA
2957 SCHIZOAFFECTIVE TYPE
2959 SCHIZOPHRENIA NOS
2967 BIPOLAR AFFECTIVE NOS
2966 BIPOLAR AFFECTIVE, MIXED
2962 DEPR PSYCH, SINGL EPISOD
2968 MANIC-DEPRESSIVE NEC/NOS
2964 BIPOLAR AFFECTIVE, MANIC
2963 DEPR PSYCH, RECUR EPISOD
2956 RESIDUAL SCHIZOPHRENIA
All Others
Age UNSPEC.
Source: SDI: Physician Drug and Diagnosis Audit, Extracted 8-4-09. File: PDDA 2009-1004 Dx4 by Age 8-4-09.qry Table 4a. Estimated Number of Prescriptions Dispensed for Atypical Antipsychotics by Patient Age and Top 5 Physician Specialty, Years 2004 -2008 and YTD/Jun/2009
YTD/JUN/2009
Share
Share
Share
Share
Share
Share
%
%
%
%
%
%
TOTAL MARKET
24,071,730 100.00% 24,941,679 100.00%
26,764,745 100.00%
29,265,565
100.00%
28,149,646 100.00%
12,269,230
100.00%
Abilify (aripiprazole)
Age 13-17
Age 13-17
Age 13-17
GP/FM/DO
Age 13-17
Age 13-17
Age 13-17
All Others
Source: SDI: Vector One®: National. Custom Run. File: Copy of VONA Custom_Spec by Age_HMehta081309.xls Table 4b. Estimated Number of Prescriptions Dispensed for Atypical Antipsychotics by Patient Age and Top 5 Physician Specialty, Years 2004 -2008 and YTD/Jun/2009
YTD/JUN/2009
Share
Share
Share
Share
Share
Share
%
%
%
%
%
%
Geodon (ziprasidone)
Age 13-17
Age 13-17
GP/FM/DO
Age 13-17
Age 13-17
Age 13-17
Age 13-17
All Others
Source: SDI: Vector One®: National. Custom Run. File: Copy of VONA Custom_Spec by Age_HMehta081309.xls Table 4c. Estimated Number of Prescriptions Dispensed for Atypical Antipsychotics by Patient Age and Top 5 Physician Specialty, Years 2004 -2008 and YTD/Jun/2009
YTD/JUN/2009
Share
Share
Share
Share
Share
Share
%
%
%
%
%
%
Invega (paliperidone)
Age 13-17
Age 13-17
Age 13-17
GP/FM/DO
Age 13-17
Age 13-17
Age 13-17
All Others
Source: SDI: Vector One®: National. Custom Run. File: Copy of VONA Custom_Spec by Age_HMehta081309.xls Table 4d. Estimated Number of Prescriptions Dispensed for Atypical Antipsychotics by Patient Age and Top 5 Physician Specialty, Years 2004 -2008 and YTD/Jun/2009
YTD/JUN/2009
Share
Share
Share
Share
Share
Share
%
%
%
%
%
%
Risperdal (risperidone)
Age 13-17
GP/FM/DO
Age 13-17
Age 13-17
Age 13-17
Age 13-17
Age 13-17
All Others
Source: SDI: Vector One®: National. Custom Run. File: Copy of VONA Custom_Spec by Age_HMehta081309.xls and VONA Custom_Spec by Age_HMehta081709_v2.xls Table 4e. Estimated Number of Prescriptions Dispensed for Atypical Antipsychotics by Patient Age and Top 5 Physician Specialty, Years 2004 -2008 and YTD/Jun/2009
YTD/JUN/2009
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Share
Share
Share
Share
Share
%
%
%
%
%
%
Seroquel (quetiapine)
Age 13-17
GP/FM/DO
Age 13-17
Age 13-17
Age 13-17
Age 13-17
Age 13-17
All Others
Source: SDI: Vector One®: National. Custom Run. File: Copy of VONA Custom_Spec by Age_HMehta081309.xls Table 4f. Estimated Number of Prescriptions Dispensed for Atypical Antipsychotics by Patient Age and Top 5 Physician Specialty, Years 2004 -2008 and YTD/Jun/2009
YTD/JUN/2009
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Share
Share
Share
Share
Share
%
%
%
%
%
%
Zyprexa (olanzapine)
Age 13-17
GP/FM/DO
Age 13-17
Age 13-17
Age 13-17
Age 13-17
Age 13-17
All Others
Source: SDI: Vector One®: National. Custom Run: File: Copy of VONA Custom_Spec by Age_HMehta081309.xls Table 5a. Total Number of Mentions for Atypical Antipsychotics used Concomitantly
with Another Class of Products to Treat the Same Diagnosis Through U.S. Outpatient
Retail Pharmacies, Jan 2004 - June 2009
Share
%
TOTAL MARKET
100.0%
quetiapine fumarate
Used Alone
20200 SEIZURE DISORDERS
64190 ANTIPSYCHOTICS OTH
64340 ANTI-DEPRESSANTS SSRIS
64500 ANALEPTICS
Used Alone
20200 SEIZURE DISORDERS
64500 ANALEPTICS
64330 NEW GENERTN ANTIDEPR
64190 ANTIPSYCHOTICS OTH
64340 ANTI-DEPRESSANTS SSRIS
31450 CENTRAL ACT ALONE/COMB
64310 ANTIDEP TRI/TETRA
64400 ANTI-MANIA
Age 13-17
Used Alone
20200 SEIZURE DISORDERS
64340 ANTI-DEPRESSANTS SSRIS
64190 ANTIPSYCHOTICS OTH
64400 ANTI-MANIA
31450 CENTRAL ACT ALONE/COMB
64500 ANALEPTICS
64330 NEW GENERTN ANTIDEPR
64700 NEW GENRTN PSYCH OTR
78800 MISC ETHICALS OTHER
17210 ANTNAUS ANTIDOPA PHENO
All Others
Used Alone
20200 SEIZURE DISORDERS
64340 ANTI-DEPRESSANTS SSRIS
64190 ANTIPSYCHOTICS OTH
64330 NEW GENERTN ANTIDEPR
64350 ANTI-DEPRESSANTS SNRIS
64400 ANTI-MANIA
64610 BENZODIAZEPINES
64310 ANTIDEP TRI/TETRA
20400 ALZHEIMER'S DISEASE TH
67290 NON-BARBITUATE, OTHER
64690 ANTIANXIETY OTHER
64110 PHENOTHIAZINE DERIV
20119 ANTIPRKNSON OTHER
All Others
Age UNSPEC.
Source: SDI: Physician Drug and Diagnosis Audit. File: PDDA 2009-1004 Concomitant Class 8-28-09.qry Table 5b. Total Number of Mentions for Atypical Antipsychotics used Concomitantly
with Another Class of Products to Treat the Same Diagnosis Through U.S. Outpatient
Retail Pharmacies, Jan 2004 - June 2009
Share
%
risperidone
Used Alone
Used Alone
64500 ANALEPTICS
31450 CENTRAL ACT ALONE/COMB
64340 ANTI-DEPRESSANTS SSRIS
20200 SEIZURE DISORDERS
All Others
Used Alone
64500 ANALEPTICS
31450 CENTRAL ACT ALONE/COMB
20200 SEIZURE DISORDERS
64340 ANTI-DEPRESSANTS SSRIS
64700 NEW GENRTN PSYCH OTR
64190 ANTIPSYCHOTICS OTH
64330 NEW GENERTN ANTIDEPR
All Others
Age 13-17
Used Alone
64500 ANALEPTICS
64340 ANTI-DEPRESSANTS SSRIS
20200 SEIZURE DISORDERS
64330 NEW GENERTN ANTIDEPR
31450 CENTRAL ACT ALONE/COMB
64400 ANTI-MANIA
64700 NEW GENRTN PSYCH OTR
64190 ANTIPSYCHOTICS OTH
64690 ANTIANXIETY OTHER
64610 BENZODIAZEPINES
All Others
Used Alone
64340 ANTI-DEPRESSANTS SSRIS
20200 SEIZURE DISORDERS
64190 ANTIPSYCHOTICS OTH
64330 NEW GENERTN ANTIDEPR
64350 ANTI-DEPRESSANTS SNRIS
64400 ANTI-MANIA
20119 ANTIPRKNSON OTHER
20400 ALZHEIMER'S DISEASE TH
64610 BENZODIAZEPINES
64310 ANTIDEP TRI/TETRA
67290 NON-BARBITUATE, OTHER
64690 ANTIANXIETY OTHER
14110 ANTIHISTAMINE CAP-TAB
All Others
Age UNSPEC.
Source: SDI: Physician Drug and Diagnosis Audit. File: PDDA 2009-1004 Concomitant Class 8-28-09.qry Table 5c. Total Number of Mentions for Atypical Antipsychotics used Concomitantly
with Another Class of Products to Treat the Same Diagnosis Through U.S. Outpatient
Retail Pharmacies, Jan 2004 - June 2009
Share
%
aripiprazole
Used Alone
64190 ANTIPSYCHOTICS OTH
Used Alone
64500 ANALEPTICS
64190 ANTIPSYCHOTICS OTH
64340 ANTI-DEPRESSANTS SSRIS
Used Alone
64500 ANALEPTICS
64190 ANTIPSYCHOTICS OTH
31450 CENTRAL ACT ALONE/COMB
20200 SEIZURE DISORDERS
64340 ANTI-DEPRESSANTS SSRIS
64700 NEW GENRTN PSYCH OTR
64400 ANTI-MANIA
64330 NEW GENERTN ANTIDEPR
64310 ANTIDEP TRI/TETRA
20119 ANTIPRKNSON OTHER
All Others
Age 13-17
Used Alone
64340 ANTI-DEPRESSANTS SSRIS
64500 ANALEPTICS
20200 SEIZURE DISORDERS
64190 ANTIPSYCHOTICS OTH
64330 NEW GENERTN ANTIDEPR
64400 ANTI-MANIA
64690 ANTIANXIETY OTHER
64700 NEW GENRTN PSYCH OTR
20119 ANTIPRKNSON OTHER
31450 CENTRAL ACT ALONE/COMB
All Others
Used Alone
20200 SEIZURE DISORDERS
64340 ANTI-DEPRESSANTS SSRIS
64190 ANTIPSYCHOTICS OTH
64330 NEW GENERTN ANTIDEPR
64350 ANTI-DEPRESSANTS SNRIS
64400 ANTI-MANIA
64610 BENZODIAZEPINES
64310 ANTIDEP TRI/TETRA
67290 NON-BARBITUATE, OTHER
64110 PHENOTHIAZINE DERIV
76140 MULTIVIT GEN
20119 ANTIPRKNSON OTHER
64500 ANALEPTICS
64690 ANTIANXIETY OTHER
All Others
Age UNSPEC.
Source: SDI: Physician Drug and Diagnosis Audit. File: PDDA 2009-1004 Concomitant Class 8-28-09.qry Table 5d. Total Number of Mentions for Atypical Antipsychotics used Concomitantly
with Another Class of Products to Treat the Same Diagnosis Through U.S. Outpatient
Retail Pharmacies, Jan 2004 - June 2009
Share
%
olanzapine
Used Alone
20200 SEIZURE DISORDERS
64340 ANTI-DEPRESSANTS SSRIS
64400 ANTI-MANIA
64500 ANALEPTICS
31450 CENTRAL ACT ALONE/COMB
Used Alone
31450 CENTRAL ACT ALONE/COMB
64500 ANALEPTICS
20200 SEIZURE DISORDERS
64190 ANTIPSYCHOTICS OTH
64340 ANTI-DEPRESSANTS SSRIS
64330 NEW GENERTN ANTIDEPR
Age 13-17
Used Alone
64340 ANTI-DEPRESSANTS SSRIS
20200 SEIZURE DISORDERS
64190 ANTIPSYCHOTICS OTH
64400 ANTI-MANIA
20119 ANTIPRKNSON OTHER
64350 ANTI-DEPRESSANTS SNRIS
64610 BENZODIAZEPINES
67290 NON-BARBITUATE, OTHER
64330 NEW GENERTN ANTIDEPR
64310 ANTIDEP TRI/TETRA
Used Alone
64340 ANTI-DEPRESSANTS SSRIS
20200 SEIZURE DISORDERS
64190 ANTIPSYCHOTICS OTH
64330 NEW GENERTN ANTIDEPR
64350 ANTI-DEPRESSANTS SNRIS
64400 ANTI-MANIA
64310 ANTIDEP TRI/TETRA
64610 BENZODIAZEPINES
64690 ANTIANXIETY OTHER
20400 ALZHEIMER'S DISEASE TH
64110 PHENOTHIAZINE DERIV
67290 NON-BARBITUATE, OTHER
20119 ANTIPRKNSON OTHER
All Others
Age UNSPEC.
Source: SDI: Physician Drug and Diagnosis Audit. File: PDDA 2009-1004 Concomitant Class 8-28-09.qry Table 5e. Total Number of Mentions for Atypical Antipsychotics used Concomitantly
with Another Class of Products to Treat the Same Diagnosis Through U.S. Outpatient
Retail Pharmacies, Jan 2004 - June 2009
Share
%
ziprasidone hcl
64190 ANTIPSYCHOTICS OTH
Used Alone
Used Alone
20200 SEIZURE DISORDERS
64340 ANTI-DEPRESSANTS SSRIS
64190 ANTIPSYCHOTICS OTH
64400 ANTI-MANIA
64330 NEW GENERTN ANTIDEPR
20119 ANTIPRKNSON OTHER
Age 13-17
Used Alone
64340 ANTI-DEPRESSANTS SSRIS
64310 ANTIDEP TRI/TETRA
64500 ANALEPTICS
64190 ANTIPSYCHOTICS OTH
31450 CENTRAL ACT ALONE/COMB
20200 SEIZURE DISORDERS
67210 SED NON-BARB CHLOR
64610 BENZODIAZEPINES
64690 ANTIANXIETY OTHER
20119 ANTIPRKNSON OTHER
Used Alone
20200 SEIZURE DISORDERS
64340 ANTI-DEPRESSANTS SSRIS
64190 ANTIPSYCHOTICS OTH
64330 NEW GENERTN ANTIDEPR
64400 ANTI-MANIA
64350 ANTI-DEPRESSANTS SNRIS
64610 BENZODIAZEPINES
67290 NON-BARBITUATE, OTHER
64310 ANTIDEP TRI/TETRA
64110 PHENOTHIAZINE DERIV
76140 MULTIVIT GEN
20119 ANTIPRKNSON OTHER
64690 ANTIANXIETY OTHER
20400 ALZHEIMER'S DISEASE TH
All Others
Age UNSPEC.
paliperidone
Used Alone
Age 13-17
Used Alone
64190 ANTIPSYCHOTICS OTH
20200 SEIZURE DISORDERS
64330 NEW GENERTN ANTIDEPR
64690 ANTIANXIETY OTHER
Used Alone
20200 SEIZURE DISORDERS
64340 ANTI-DEPRESSANTS SSRIS
64190 ANTIPSYCHOTICS OTH
64350 ANTI-DEPRESSANTS SNRIS
64400 ANTI-MANIA
64330 NEW GENERTN ANTIDEPR
64610 BENZODIAZEPINES
67290 NON-BARBITUATE, OTHER
20119 ANTIPRKNSON OTHER
76140 MULTIVIT GEN
64500 ANALEPTICS
64110 PHENOTHIAZINE DERIV
All Others
Age UNSPEC.
Source: SDI: Physician Drug and Diagnosis Audit. File: PDDA 2009-1004 Concomitant Class 8-28-09.qry Appendix 2: Database Descriptions
SDI Vector One®: National (VONA)
SDI’s VONA measures retail dispensing of prescriptions or the frequency with which drugs move out of retail pharmacies into the hands of consumers via formal prescriptions. Information on the physician specialty, the patient’s age and gender, and estimates for the numbers of patients that are continuing or new to therapy are available. The Vector One® database integrates prescription activity from a variety of sources including national retail chains, mass merchandisers, mail order pharmacies, pharmacy benefits managers and their data systems, and provider groups. Vector One® receives over 2.0 billion prescription claims per year, representing over 160 million unique patients. Since 2002 Vector One® has captured information on over 8 billion prescriptions representing 200 million unique patients. Prescriptions are captured from a sample of approximately 59,000 pharmacies throughout the US. The pharmacies in the data base account for nearly all retail pharmacies and represent nearly half of retail prescriptions dispensed nationwide. SDI receives all prescriptions from approximately one-third of the stores and a significant sample of prescriptions from the remaining stores. SDI Vector One®: Total Patient Tracker (TPT)
SDI’s Total Patient Tracker is a national-level projected audit designed to estimate the total number of unique patients across all drugs and therapeutic classes in the retail outpatient setting. TPT derives its data from the Vector One® database which integrates prescription activity from a variety of sources including national retail chains, mail order pharmacies, mass merchandisers, pharmacy benefits managers and their data systems. Vector One® receives over 2 billion prescription claims per year, which represents over 160 million patients tracked across time. IMS Health, IMS National Sales Perspectives™: Retail and Non-Retail
The IMS Health, IMS National Sales Perspectives™ measures the volume of drug products, both prescription and over-the-counter, and selected diagnostic products moving from manufacturers into various outlets within the retail and non-retail markets. Volume is expressed in terms of sales dollars, eaches, extended units, and share of market. These data are based on national projections. Outlets within the retail market include the following pharmacy settings: chain drug stores, independent drug stores, mass merchandisers, food stores, and mail service. Outlets within the non-retail market include clinics, non-federal hospitals, federal facilities, HMOs, long-term care facilities, home health care, and other miscellaneous settings. SDI Physician Drug & Diagnosis Audit (PDDA)
SDI's Physician Drug & Diagnosis Audit (PDDA) is a monthly survey designed to provide descriptive information on the patterns and treatment of diseases encountered in office-based physician practices in the U.S. The survey consists of data collected from approximately 3,100 office-based physicians representing 29 specialties across the United States that report on all patient activity during one typical workday per month. These data may include profiles and trends of diagnoses, patients, drug products mentioned during the office visit and treatment patterns. The data are then projected nationally by physician specialty and region to reflect national prescribing patterns. SDI uses the term "drug uses" to refer to mentions of a drug in association with a diagnosis during an office-based patient visit. This term may be duplicated by the number of diagnosis for which the drug is mentioned. It is important to note that a "drug use" does not necessarily result in prescription being generated. Rather, the term indicates that a given drug was mentioned during an office visit. SDI uses the term "drug occurrences" to refer to the number of times a product has been reported on a patient information form during an office-based patient visit for that period. It is important to note that a "drug occurrence" does not necessarily result in a prescription being generated. A “drug occurrence” can result from a prescription written, a sample given, a recommendation for OTC products, recommendation with sample, a product dispensed or administered in the office, a hospital order, a nursing home order or a combination of these. ---------------------------------------------------------------------------------------------------------
This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
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/s/
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LAURA A GOVERNALE09/10/2009Cleared by data vendors for PAC background package.

Source: http://www.namingandtreating.com/wp-content/uploads/2010/09/6-Product-including-Abilify-1.pdf