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.qryFigure 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 Share 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 Share 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. --------------------------------------------------------------------------------------------------------- /s/ ----------------------------------------------------
LAURA A GOVERNALE09/10/2009Cleared by data vendors for PAC background package.
Opportunities for generic savings in 2013 and 2014 During 2013 and 2014, 37 brand-name prescription drugs, used by more than 334,000 people in upstate New York, are scheduled to become available in their generic form. With more than $558 million spent annually on these drugs in 39 upstate New York counties, the introduction of these generics promises to provide substantial savings of more
The Human-Centred Organization There is growing international recognition that corporate (and indeed national) success should be measured in terms which go beyond profit and productivity. Organisations are being assessed not just on their return on the investment of their owners but also on much broader issues, such as how well they fulfil their responsibility to society, and the impact th
Department of Health and Human Services