`RESEARCH
`
`
`
`APPLICATION NUMBER:
`
`020592Orig1s040s041
`
`
`OTHER REVIEW(S)
`
`
`
`Department of Health and Human Services
`Public Health Service
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Surveillance and Epidemiology
`
`
`
`October 1, 2009
`Thomas Laughren, MD, Director
`Division of Psychiatry Products (DPP)
`Claudia Karwoski, PharmD, Director
`Division of Risk Management (DRISK)
`
`LaShawn Griffiths, MSHS-PH, BSN, RN
`Patient Product Information Reviewer, Acting Team Leader
`Division of Risk Management
`Sharon R. Mills, BSN,RN, CCRP
`Senior Patient Product Information Reviewer, Acting Team
`Leader
`Division of Risk Management
`DRISK Review of Patient Labeling (Medication Guide),
`Zyprexa (olanzapine) Tablet and Zyprexa Zydis (olanzapine)
`Tablet, Orally Disintegrating
`NDA 20-592
`
`S-040 and S-041
`Eli Lilly and Company
`2009-1412
`
`Date:
`To:
`
`Through:
`
`From:
`
`Subject:
`Drug Name(s):
`
`Application
`Type/Number:
`Submission Number:
`Applicant/sponsor:
`OSE RCM #:
`
`
`
`
`1
`
`INTRODUCTION
`This review is written in response to a request by the Division of Psychiatry
`Products (DPP) for the Division of Risk Management (DRISK) to review the
`Applicant’s proposed Medication Guide (MG) for Zyprexa (olanzapine) Tablet and
`Zyprexa Zydis (olanzapine) Tablet, Orally Disintegrating. Please let us know if DPP
`would like a meeting to discuss this review or any of our changes prior to sending to
`the Applicant. The proposed REMS revision is being reviewed by DRISK and will be
`provided to DPP under separate cover.
`
` 2
`
` MATERIAL REVIEWED
`(cid:131) Draft Zyprexa (olanzapine) Tablet and Zyprexa Zydis (olanzapine) Tablet, Orally
`Disintegrating Prescribing Information (PI) submitted May 5, 2009 and revised by
`the Review Division throughout the current review cycle, most recent revision
`dated September 9, 2009.
`(cid:131) Draft Zyprexa (olanzapine) Tablet and Zyprexa Zydis (olanzapine) Tablet, Orally
`Disintegrating Medication Guide (MG) submitted on May 5, 2009 and revised by
`the review division throughout the review cycle, most recent version dated
`September 9, 2009.
`3 RESULTS OF REVIEW
`Since DRISK previously reviewed the Zyprexa MG in February 2009 and March
`2009, we have limited this review to the identified PI revisions, in particular relating
`to the addition of information about adolescents, and changes to the Indications for
`Use. In our review of the MG we have:
`simplified wording and clarified concepts where possible
`•
`• made minimal reformatting changes to enhance readability
`ensured that the MG is consistent with the PI
`•
`•
`ensured that the MG meets the Regulations as specified in 21 CFR 208.20
`•
`ensured that the MG meets the criteria as specified in FDA’s Guidance for
`Useful Written Consumer Medication Information (published July 2006)
`
`
`Our annotated MG is appended to this memo. Any additional revisions to the PI
`should be reflected in the MG.
`
`
`Please let us know if you have any questions.
`
`
`
`
`
`
`1
`
`9 Page(s) of Draft Labeling have been Withheld in Full as b4 (CCI/TS) immediately following
`this page
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`SHARON R MILLS
`10/01/2009
`
`CLAUDIA B KARWOSKI
`10/01/2009
`concur
`
`
`
`Department of Health and Human Services
`Public Health Service
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Surveillance and Epidemiology
`
`
`
`Date:
`To:
`
`Thru:
`
`From:
`
`September 3, 2009
`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
`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)
`Application Type/Number: Various
`Applicant/sponsor:
`Various
`OSE RCM #:
`2009-1004
`**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.**
`
`
`Subject:
`
`Drug Name(s):
`
`
`
`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
` 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
` had an increase in the number of
`dispensed prescriptions over the past 5 years.
`• Dispensed prescriptions for
` increased the most by approximately % from year 2004
`to year 2008.
`• Antipsychotic use among pediatric patients has increased by % over the 5 years. The greatest
`increase was seen for
` during this time period.
` had the most prescriptions dispensed %) to pediatric patients (0-17 years) and had a
`greater amount of use in younger children compared to the other antipsychotics.
` had
`the second highest number of dispensed prescriptions %) in the pediatric population.
`In year 2008,
` unique patients received a prescription for
` followed by
` with
` and
` with
`.
`• 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
` Mood stabilizing agents, other
`antipsychotics and antidepressants were the most common concomitant products for
` in this age group as well as for older age groups.
`
`
`
` 1
`
`
`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.
`
`2 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 % or greater). Distribution towards non-retail pharmacy settings ranged from
`% 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
`% 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
`
`•
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`•
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`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 RESULTS
`
`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
`
`prescriptions were dispensed for these products, an increase of % from approximately
`dispensed prescriptions in year 2004. Approximately
` prescriptions were dispensed for
`% of market) followed by
`% of market) and
`% of market) with
` prescriptions, respectively. All of the agents had an increase in the number of
`prescriptions dispensed in the past 5 years except for
`which decreased by abou
` during the
`same time period. Dispensed prescriptions for
`increased by % from year 2004
`
`prescriptions) to year 2008 (
` prescriptions) followed by
` with % increase and
` with % increase.
`
`
`
`3.2 DISPENSED PRESCRIPTION BY PEDIATRIC AGE GROUPS
`Antipsychotic use in the pediatric population (0-17 years) has increased % in the past 5 years (Figure 2:
`Appendix 1). The greatest increase was seen for
`%. In year 2008, of the six agents
`analyzed,
` had the most prescriptions dispensed to pediatric patients aged 0-17 years % of all
` dispensed to pediatric patients versus adults
` risperidone prescriptions), followed by
`%;
` prescriptions),
` prescriptions),
`
`
` prescriptions), and
` prescriptions),
`prescriptions). Analysis of pediatric sub-age groups revealed that the majority of antipsychotic use during
`year 2008 was among those aged
`years;
`
`.
`, on the other hand, was most commonly dispensed to
`pediatric patients aged 7-12 years, accounting for % of dispensed prescriptions. Prescriptions dispensed to
`pediatric patients aged 0-2 years and 3-6 years accounted for less than
` of the combined total dispensed
`prescriptions for all six agents with the exception of
` in which
` 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
`patients received a prescription for these selected antipsychotic agents in the outpatient retail pharmacy
`setting, an increase of % from
` patients in year 2004. Approximately,
` unique
`
`patients received a prescription for
` 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
`
`
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`2
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`(b) (4)
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`(b) (4)
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`
`
`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 “
` was the most common diagnosis associated with a mention of aripiprazole with approximately
`% of all mentions for that age group from year 2004 through year to date June 2009 followed by
` with %. For risperidone, the most common diagnosis among
` with % followed by “
`
`pediatrics aged 7-12 years was “
` with
`%, respectively. For
` and
`adolescents aged 13-17 years the most common diagnosis associated with a mention for aripiprazole,
`quetiapine, olanzapine, and ziprasidone was “
`
`
`
`paliperidone, respectively, for this age group.
`
` were the most common diagnosis for risperidone and
`
`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
`. For
` 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.
`
`4 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
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`3
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`
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`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.
`
`5 CONCLUSIONS
` had an increase in the number of dispensed
`All of the antipsychotic agents studied except for
`prescriptions over the past 5 years. Dispensed prescription for
`) increased the greatest
`amount
`%). Antipsychotic use among pediatric patients aged 0-17 years have increased % over the
`past 5 years. Use among pediatrics aged 0-2 years and 3-6 years accounted for less than
` of the total for
`each of the antipsychotic agents studied.
` was the most commonly dispensed atypical
`antipsychotic agent among pediatrics, especially those aged 7-12 years.
` 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
`. Mood stabilizing agents, other antipsychotics and antidepressants
`were the most common concomitant class of products used with
` in this age group
`as well as for older age groups.
`
`
`
`4
`
`
`(b) (4)
`
`(b) (4)
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`(b)
`(4)
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`(4)
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`(b
`)
`(4
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`
`
`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
`
` quetiapine fumarate
` risperidone
` aripiprazole
` olanzapine
` ziprasidone hcl
` paliperidone
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`YTD/JUN/2009
`
`Year
`Source: SDI: Vector One®: National. Data Extracted 8-4-09. File: VONA 2009-1004 TRx 8-4-09.qry
`
`
`
`14,000,000
`
`12,000,000
`
`10,000,000
`
`8,000,000
`
`6,000,000
`
`TRx
`
`4,000,000
`
`2,000,000
`
`0
`
`
`
`5
`
`
`(b) (4)
`
`
`
`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
`2009
`
`TOTAL MARKET
` risperidone
` aripiprazole
` quetiapine fumarate
` ziprasidone hcl
` olanzapine
` paliperidone
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`YTD/JUN/2009
`
`Year
`Source: SDI: Vector One: National. Data Extracted 9-1-09. File: VONA 2009-1004 TRx by Ages 0-17 only 9-1-
`09.qry
`
`
`
`6,000,000
`
`5,000,000
`
`4,000,000
`
`3,000,000
`
`TRx
`
`2,000,000
`
`1,000,000
`
`0
`
`
`
`6
`
`
`(b) (4)
`
`
`
`Table 1: Total Number of Prescriptions Dispensed for Atypical Antipsychotics Through U.S. Outpatient Retail Pharmacies, Years 2004-2008 and YTD 2009
`2004
`2005
`2006
`2007
`2008
`
`TRxs
`N
`
`Share
`%
`
`TRxs
`N
`
`Share
`%
`
`TRxs
`N
`
`Share
`%
`
`TRxs
`N
`
`Share
`%
`
`TRxs
`N
`
`Share
`%
`
`TOTAL MARKET
`
`YTD/JUN/2009
`Share
`TRxs
`%
`N
`
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` Age UNSPEC.
`
`Source: SDI: Vector One®: National. Data Extracted 8-4-09. File: VONA 2009-1004 TRx by Age 8-4-09.qry
`
`
`
`
`
`
`
`
`
`
`7
`
`
`
`
`(b) (4)
`
`(b) (4)
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`
`
`Table 2. Total Number of Unique Patients Receiving a Prescription for Atypical Antipsychotics Through U.S. Outpatient Retail Pharmacies, 2004-2008 and YTD 2009
`2004
`2005
`2006
`2007
`2008
`YTD/Jun/2009
`%
`N
`
`
`Total Market
`
`N
`
`%
`
`N
`
`%
`
`N
`
`%
`
`N
`
`%
`
`N
`
`%
`
`Age 0 - 2
`Age 3 - 6
`Age 7 - 12
`Age 13 - 17
`Age 18+
`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
`
`
`
`
`
`
`
`
`
`8
`
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`(b) (4)
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`(b) (4)
`
`
`
`Table 3a. Most Common Indications by Age Associated with the Use of Atypical Antipsychotics in Office-Based Practice Settings, 2004-2008 and YTD 2009
`Share (%)
`Uses (000)
`
`TOTAL MARKET
` quetiapine fumarate
`
`
`
`Source: SDI: Physician Drug and Diagnosis Audit, Extracted 8-4-09. File: PDDA 2009-1004 Dx4 by Age 8-4-09.qry
`
`
`
`
`
`
`9
`
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`(b) (4)
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`
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`
`
`
`
`
`
`
`
`
`
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`(b) (4)
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`
`
`Table 3b. Most Common Indications by Age Associated with the Use of Atypical Antipsychotics in Office-Based Practice Settings, 2004-2008 and YTD 2009
`Share (%)
`Uses (000)
`
` aripiprazole
`
`Source: SDI: Physician Drug and Diagnosis Audit, Extracted 8-4-09 File: PDDA 2009-1004 Dx4 by Age 8-4-09 qry
`
`
`
`
`
`
`10
`
`
`(b) (4)
`
`(b) (4)
`
`
`
`Table 3c. Most Common Indications by Age Associated with the Use of Atypical Antipsychotics in Office-Based Practice Settings, 2004-2008 and YTD 2009
`Share (%)
`Uses (000)
`
` risperidone
`
`Source: SDI: Physician Drug and Diagnosis Audit, Extracted 8-4-09 File: PDDA 2009-1004 Dx4 by Age 8-4-09 qry
`
`
`
`
`
`
`11
`
`
`(b) (4)
`
`(b) (4)
`
`
`
`Table 3d. Most Common Indications by Age Associated with the Use of Atypical Antipsychotics in Office-Based Practice Settings, 2004-2008 and YTD 2009
`Share (%)
`Uses (000)
`
` olanzapine
`
`Source: SDI: Physician Drug and Diagnosis Audit, Extracted 8-4-09. File: PDDA 2009-1004 Dx4 by Age 8-4-09.qry
`
`
`
`
`
`
`12
`
`
`(b) (4)
`
`(b) (4)
`
`
`
`Table 3e. Most Common Indications by Age Associated with the Use of Atypical Antipsychotics in Office-Based Practice Settings, 2004-2008 and YTD 2009
`Share (%)
`Uses (000)
`
` ziprasidone hcl
`
`Source: SDI: Physician Drug and Diagnosis Audit, Extracted 8-4-09 File: PDDA 2009-1004 Dx4 by Age 8-4-09 qry
`
`
`
`
`
`
`
`13
`
`
`(b) (4)
`
`(b) (4)
`
`
`
`TRxs
`N
`
`Share
`%
`
`TRxs
`N
`
`Share
`%
`
`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
`2004
`2005
`2006
`2007
`2008
`YTD/JUN/2009
`TRxs
`Share
`N
`%
`
`TRxs
`N
`
`Share
`%
`
`TRxs
`N
`
`Share
`%
`
`TRxs
`N
`
`Share
`%
`
`TOTAL MARKET
`Abilify (aripiprazole)
` PSYCH
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` NP
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` UNSPEC
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` GP/FM/DO
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` IM
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` PED
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
`All Others
`
`
`
`Source: SDI: Vector One®: National. Custom Run. File: Copy of VONA Custom_Spec by Age_HMehta081309.xls
`
`
`
`
`
`
`
`
`
`
`
`
`
`14
`
`
`(b) (4)
`
`
`
`TRxs
`N
`
`Share
`%
`
`TRxs
`N
`
`Share
`%
`
`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
`2004
`2005
`2006
`2007
`2008
`YTD/JUN/2009
`TRxs
`Share
`N
`%
`
`TRxs
`N
`
`Share
`%
`
`TRxs
`N
`
`Share
`%
`
`TRxs
`N
`
`Share
`%
`
`Geodon (ziprasidone)
` PSYCH
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` NP
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` GP/FM/DO
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` UNSPEC
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` IM
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` PA
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
`All Others
`
`Source: SDI: Vector One®: National. Custom Run. File: Copy of VONA Custom_Spec by Age_HMehta081309.xls
`
`
`
`
`
`
`15
`
`
`(b) (4)
`
`
`
`TRxs
`N
`
`Share
`%
`
`TRxs
`N
`
`Share
`%
`
`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
`2004
`2005
`2006
`2007
`2008
`YTD/JUN/2009
`TRxs
`Share
`N
`%
`
`TRxs
`N
`
`Share
`%
`
`TRxs
`N
`
`Share
`%
`
`TRxs
`N
`
`Share
`%
`
`Invega (paliperidone)
` PSYCH
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` NP
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` UNSPEC
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` GP/FM/DO
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` PA
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` IM
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
`All Others
`
`Source: SDI: Vector One®: National. Custom Run. File: Copy of VONA Custom_Spec by Age_HMehta081309.xls
`
`
`
`
`
`
`16
`
`
`(b) (4)
`
`
`
`TRxs
`N
`
`Share
`%
`
`TRxs
`N
`
`Share
`%
`
`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
`2004
`2005
`2006
`2007
`2008
`YTD/JUN/2009
`TRxs
`Share
`N
`%
`
`TRxs
`N
`
`Share
`%
`
`TRxs
`N
`
`Share
`%
`
`TRxs
`N
`
`Share
`%
`
`Risperdal (risperidone)
` PSYCH
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` GP/FM/DO
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` UNSPEC
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` IM
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` NP
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` PED
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
`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
`
`
`
`
`
`
`17
`
`
`(b) (4)
`
`
`
`TRxs
`N
`
`Share
`%
`
`TRxs
`N
`
`Share
`%
`
`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
`2004
`2005
`2006
`2007
`2008
`YTD/JUN/2009
`TRxs
`Share
`N
`%
`
`TRxs
`N
`
`Share
`%
`
`TRxs
`N
`
`Share
`%
`
`TRxs
`N
`
`Share
`%
`
`Seroquel (quetiapine)
` PSYCH
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` GP/FM/DO
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` IM
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` NP
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` UNSPEC
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` NEURO
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
`All Others
`
`Source: SDI: Vector One®: National. Custom Run. File: Copy of VONA Custom_Spec by Age_HMehta081309.xls
`
`
`
`
`
`
`18
`
`
`(b) (4)
`
`
`
`TRxs
`N
`
`Share
`%
`
`TRxs
`N
`
`Share
`%
`
`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
`2004
`2005
`2006
`2007
`2008
`YTD/JUN/2009
`TRxs
`Share
`N
`%
`
`TRxs
`N
`
`Share
`%
`
`TRxs
`N
`
`Share
`%
`
`TRxs
`N
`
`Share
`%
`
`Zyprexa (olanzapine)
` PSYCH
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` GP/FM/DO
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` IM
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` NP
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` UNSPEC
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
` HOSP
` Age 0-2
` Age 3-6
` Age 7-12
` Age 13-17
` Age 18+
`All Others
`
`Source: SDI: Vector One®: National. Custom Run: File: Copy of VONA Custom_Spec by Age_HMehta081309.xls
`
`
`
`
`
`19
`
`
`(b) (4)
`
`
`
`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
`
`TOTAL MARKET
` quetiapine fumarate
`
`Occur
`(000)
`
`Share
`%
`
`Source: SDI: Physician Drug and Diagnosis Audit. File: PDDA 2009-1004 Concomitant Class 8-28-09.qry
`
`
`
`
`
`20
`
`
`(b) (4)
`
`(b) (4)
`
`
`
`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
`
` risperidone
`
`Occur
`(000)
`
`Share
`%
`
`Source: SDI: Physician Drug and Diagnosis Audit. File: PDDA 2009-1004 Concomitant Class 8-28-09.qry
`
`
`
`
`
`21
`
`
`(b) (4)
`
`(b) (4)
`
`
`
`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
`
` aripiprazole
`
`Occur
`(000)
`
`Share
`%
`
`Source: SDI: Physician Drug and Diagnosis Audit. File: PDDA 2009-1004 Concomitant Class 8-28-09.qry
`
`
`
`
`
`22
`
`
`(b) (4)
`
`(b) (4)
`
`
`
`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
`
` olanzapine
`
`Occur
`(000)
`
`Share
`%
`
`Source: SDI: Physician Drug and Diagnosis Audit. File: PDDA 2009-1004 Concomitant Class 8-28-09.qry
`
`
`
`
`
`23
`
`
`(b) (4)
`
`(b) (4)
`
`
`
`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
`
` ziprasidone hcl
`
`Occur
`(000)
`
`Share
`%
`
`Source: SDI: Physician Drug and Diagnosis Audit. File: PDDA 2009-1004 Concomitant Class 8-28-09.qry
`
`
`
`
`
`24
`
`
`(b) (4)
`
`(b) (4)
`
`
`
`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 ret