Outpatient use of Atypical Antipsychotic Agents in the Pediatric Population Years

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Outpatient use of Atypical Antipsychotic Agents in the Pediatric Population Years 2004-2008 Laura Governale, Pharm.D., MBA Team Leader, Drug Utilization Data Analyst Hina Mehta, Pharm.D. Drug Utilization Data Analyst Division of Epidemiology Office of Surveillance and Epidemiology December 8, 2009 1

Outline Objective Describe the outpatient use of atypical antipsychotics in the pediatric population for years 2004 2008 Methods and data sources used SDI, Vector One : National SDI, Physician Drug and Diagnosis Audit Results Overall trends in prescriptions and patients Prescribing specialty Diagnoses associated with use Concomitant use Limitations Summary and Conclusion 2

Products Included Aripiprazole Olanzapine Paliperidone Quetiapine Risperidone Ziprasidone 3

National dispensed prescription data SDI, Vector One : National (VONA) National-level projected prescription and patient-centric tracking service. Receives over 2.0 billion prescription claims per year, representing over 160 million unique patients The number of dispensed prescriptions is obtained from a sample of approximately 59,000 pharmacies throughout the U.S., accounting for nearly all retail pharmacies and representing nearly half of retail prescriptions dispensed nationwide Retail pharmacies include: national retail chains, mass merchandisers, pharmacy benefits managers and their data systems, and provider groups 4

Total Number of Prescriptions Dispensed for Atypical Antipsychotic Agents in the Pediatric Population (Ages 0-17 Years) from U.S. Outpatient Retail Pharmacies, Years 2004-2008 Source: SDI: Vector One: National. Data Extracted 9-1-09. 6.00 TRx (millions) 5.00 4.00 3.00 2.00 3.94 M TOTAL MARKET 4.15 M 4.21 M 4.56 M 4.80 M Antipsychotic use in the pediatric population (0-17 years) has increased 22% in the past 5 years 1.00 0.00 2004 2005 2006 2007 2008 Year 5

Total Number of Prescriptions Dispensed for Atypical Antipsychotic Agents in the Pediatric Population (Ages 0-17 Years) from U.S. Outpatient Retail Pharmacies, Years 2004-2008 Source: SDI: Vector One: National. Data Extracted 9-1-09. 2.50 TRx (millions) 2.00 1.50 1.00 0.50 risperidone aripiprazole quetiapine ziprasidone olanzapine paliperidone The greatest increase for aripiprazole at 96%. 0.00 2004 2005 2006 2007 2008 Year 6

Proportion of adult and pediatric use of atypical antipsychotic agents in the from U.S. outpatient retail pharmacies, Year 2008 Source: SDI: Vector One: National. Data Extracted 9-28-09. Risperidone - 2.1 million pediatric TRx (26% of total) Aripiprazole - 1.2 million pediatric TRx (23% of total) Quetiapine - 1.1 million pediatric TRx (9% of total) Ziprasidone - 238,425 pediatric TRx (10% of total) Olanzapine - 169,121 pediatric TRx (4% of total) Paliperidone - 74,559 pediatric TRx (11% of total) 7

Atypical antipsychotic prescription use among pediatric patients aged 0-2 years old, Years 2004 2008 Source: SDI: Vector One : National. Data Extracted 8-4-09 TRx 9,000 8,000 7,000 6,000 5,000 4,000 3,000 2,000 1,000 0 Age 0-2 risperidone quetiapine aripiprazole olanzapine ziprasidone paliperidone 2004 2005 2006 2007 2008 Years Age 0-2 years: 51% decrease in TRx between Y2004-Y2008 Risperidone 44.6% decrease Aripiprazole 1.1% increase Olanzapine 86.5% decrease Ziprasidone 63.2% decrease Paliperidone 327.3% increase (Y2007 Y2008) 8

Atypical antipsychotic prescription use among pediatric patients aged 3-6 years old, Years 2004 2008 Source: SDI: Vector One : National. Data Extracted 8-4-09 300,000 TRx 250,000 200,000 150,000 100,000 50,000 0 2004 2005 2006 2007 2008 Years Age 3-6 risperidone aripiprazole quetiapine olanzapine ziprasidone paliperidone Age 3-6 years: 3% increase in TRx between Y2004- Y2008 Quetiapine 31.9% decrease Risperidone 11.3% increase Aripiprazole 70.6% increase Olanzapine 72.7% decrease Ziprasidone 37.2% decrease Paliperidone 111.4% increase (Y2007-Y2008) 9

Atypical antipsychotic prescription use among pediatric patients aged 7-12 years old, Years 2004 2008 Source: SDI: Vector One : National. Data Extracted 8-4-09 2,500,000 TRx 2,000,000 1,500,000 1,000,000 500,000 0 2004 2005 2006 2007 2008 Years Age 7-12 risperidone aripiprazole quetiapine ziprasidone olanzapine paliperidone Age 7-12 years: 21% increase in TRx between Y2004-Y2008 Quetiapine 9.2% increase Risperidone 17.1% increase Aripiprazole 85.6% increase Olanzapine 56.5% decrease Ziprasidone 24.5% increase Paliperidone 149.2% increase (Y2007-Y2008) 10

Atypical antipsychotic prescription use among pediatric patients aged 13-17 years old, Years 2004 2008 Source: SDI: Vector One : National. Data Extracted 8-4-09 3,000,000 2,500,000 2,000,000 Age 13-17 risperidone Age 13-17 years: 25% increase in TRx between Y2004-Y2008 TRx 1,500,000 1,000,000 aripiprazole quetiapine ziprasidone olanzapine paliperidone Quetiapine 26.7% increase Risperidone 2.5% increase Aripiprazole 106.0% increase Olanzapine -53.9% decrease 500,000 0 Ziprasidone 42.6% increase Paliperidone 116.9% increase (Y2007-Y2008) 2004 2005 2006 2007 2008 Years 11

Analysis by sub-age groups Majority of antipsychotic use during year 2008 was among those aged 13-17 years 13% of aripiprazole TRx to patients aged 13-17 years 10% of risperidone highest proportion of TRx to pediatric patients aged 7-12 years (14%) 7% of ziprasidone 7% of paliperidone 6% of quetiapine 2% of olanzapine In general, use in pediatric patients aged 0-2 years and 3-6 years accounted for less than 1% Except for risperidone in which 2% of prescriptions are dispensed to patients aged 3-6 years 12

Prescribing specialties 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/DO were the second most common prescribers of these medications to both adult and pediatric age groups. 13

Office-based physician survey data SDI, Physician Drug and Diagnosis Audit Monthly survey composed of approximately 3,100 officebased physicians that monitors disease states and the physician intended prescribing habits on a national-level Designed to provide descriptive information on the patterns and treatment of diseases encountered in officebased physician practices in the U.S. Represents 29 specialties across the United States Link drug use with diagnosis by ICD-9 code Concomitant use with other class of drug products to treat the same condition 14

Diagnoses associated with the use of atypical antipsychotic agents in the pediatric population, Cumulative 1/2004 12/2008 SDI, Physician Drug and Diagnosis Audit, Extracted 11/09 Uses in thousands (V%) 3-digit ICD-9 Diagnoses Age 0-2 Age 3-6 Age 7-12 Age 13-17 295 Schizophrenic disorders 15 (35%) 14 (3%) 39 (2%) 234 (7%) V40 Mental and behavioral problems 17 (40%) 314 Hyperkinetic syndrome of childhood 7 (15%) 82 (15%) 315 (16%) 289 (9%) 313 Emotional disturbance of child/adol 4 (10%) 60 (11%) 184 (9%) 298 (9%) 296 Episodic mood disorders 168 (31%) 662 (34%) 1,078 (34%) 312 Conduct Disturbance NEC 79 (15%) 132 (7%) 228 (7%) 299 Pervasive developmental disorders 49 (9%) 230 (12%) 208 (7%) 15

Diagnoses associated with the use of atypical antipsychotic agents in the pediatric population, Cumulative 1/2004 12/2008 SDI, Physician Drug and Diagnosis Audit, Extracted 11/09 Uses in thousands (V%) 4-digit ICD-9 Diagnoses Age 0-2 Age 3-6 Age 7-12 Age 13-17 295.6 Residual Schizophrenia 15 (35%) V40.9 Mental/behavioral prob NOS 12 (28%) 314.0 Attention deficit disorder 7 (15%) 82 (15%) 309 (16%) 289 (9%) V40.3 Behavioral problems NEC 5 (12%) 313.8 Other/mixed emotional disturb of childh/adol 4 (10%) 48 (9%) 174 (9%) 293 (9%) 296.7 Bipolar affective NOS 69 (13%) 402 (20%) 506 (16%) 296.9 Other/unspecified episodic mood disorder 51 (10%) 170 (9%) 263 (8%) 312.9 Unspecified disturbance of conduct 48 (9%) 102 (5%) 98 (3%) 299.0 Infantile autism 32 (6%) 129 (7%) 113 (4%) 16

Concomitant use with another class of products to treat the same diagnosis In those aged 7-12 years old, concomitant use with stimulant medications were most common for aripiprazole and risperidone. For quetiapine, olanzapine 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 mood stabilizing agents, other antipsychotics and antidepressants were the most commonly used with antipsychotic agents, except risperidone which had highest use with stimulant medications. 17

Limitations Only describing outpatient prescription use Use in outpatient clinics, *long term care facilities*, and hospitals not captured/ analyzed 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. 18

Summary Antipsychotic use among pediatric patients has increased by 22% over the 5 years. The greatest increase was seen for aripiprazole during this time period. 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 had the most prescriptions dispensed (26%) to pediatric patients 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. 19

Summary For all of the agents studied, the majority of prescriptions prescribed by Psychiatrists. Most common diagnoses in the overall pediatric population Bipolar Affective NOS, Attention Deficit Disorder, Other Emotional Disability Child, Affective Psychoses NEC/NOS, Infantile Autism In children aged 7-12 years old, concomitant use with stimulant medications were most common with aripiprazole and risperidone. Mood stabilizing agents, other antipsychotics and antidepressants were the most common concomitant products for quetiapine, olanzapine and ziprasidone in this age group as well as for older age groups. 20