Managed Healthcare Executive - January 2009 - (Page 31)

Editorial Index The following is a list of the companies that appear in this issue. Although every effort is made to ensure accuracy, this publication assumes no liability for errors or omissions. I Institute of Medicine 23 America’s Health Insurance Plans 7, 15 American Hospital Assn. 7 American Well Inc. 29 APS Healthcare 26 Association for Community Af liated Plans 26 J Journal of Managed Care Pharmacy 19 K Kaiser Commission on Medicaid 26 Kaiser Family Foundation 29 Bayer 24 BlueCross BlueShield Assn 7, 15 BCBS of Florida 22 Brookings Institution 15 L Lewin Group 17, 26 LifeMasters 26 Linden Consulting Group 18 M Mathematica Policy Research 10 Medem Inc 24 Microsoft Corp 16, 29 Milliman 4, 7 MVP Health Care 28 Cejka Search 28 Center for Medicines in the Public Interest 24 Center for Studying Health System Change 7 CMS 10, 11, 29 Computer Sciences Corp. 27 CVS Caremark 22 N NCQA 17 P PCMA 22 Premera Blue Cross 7 PricewaterhouseCoopers 7, 8, 14, 30 Deloitte Center for Health Solutions 12 Department of Human Services 29 Disease Management Purchasing Consortium International Inc. 19 DMAA 17 R Regence Group 27 Robert Wood Johnson Foundation 25 S SummaCare 15 SureScripts-RxHub 22 e-Health Initiative 14, 22 Center for Drug Evaluation and Research 23 T The Commonwealth Fund 29 The Lancet Oncology 29 TNS Global 29 TriZetto 30 G George Mason University 26 H Hawaii Medical Service Assn. 29 Healthcare Information Management Systems Society 28 HHS 7, 14, 21 Horizon BCBSNJ 21 Hudson Health Plan 14 U Urban Institute 29 U.S. Census Bureau 29 U.S. Department of Labor and Statistics 27 United BioSource Corp. 24 USA Today 29 Ad Index The following is a list of the advertisers in this issue. Although every effort is made to ensure accuracy, this publication assumes no liability for errors or omissions. Abbott Laboratories CV2 Forest Labs Inc. 5,6,31,32,CV3,CV4 Jacobson Group 9 Trizetto Group Inc. 3 Rx Only Brief Summary: For complete details, please see full Prescribing Information for Lexapro. Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Lexapro or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Lexapro is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use) INDICATIONS AND USAGE Major Depressive Disorder Lexapro (escitalopram) is indicated for the treatment of major depressive disorder. The efficacy of Lexapro in the treatment of major depressive disorder was established in three, 8-week, placebo-controlled trials of outpatients whose diagnoses corresponded most closely to the DSM-IV category of major depressive disorder (see CLINICAL PHARMACOLOGY). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The efficacy of Lexapro in hospitalized patients with major depressive disorders has not been adequately studied. The efficacy of Lexapro in maintaining a response, in patients with major depressive disorder who responded during an 8-week, acute-treatment phase while taking Lexapro and were then observed for relapse during a period of up to 36 weeks, was demonstrated in a placebo-controlled trial (see Clinical Efficacy Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Lexapro for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Generalized Anxiety Disorder Lexapro is indicated for the treatment of Generalized Anxiety Disorder (GAD). The efficacy of Lexapro was established in three, 8-week, placebo-controlled trials in patients with GAD (see CLINICAL PHARMACOLOGY). Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance. The efficacy of Lexapro in the long-term treatment of GAD, that is, for more than 8 weeks, has not been systematically evaluated in controlled trials. The physician who elects to use Lexapro for extended periods should periodically re-evaluate the longterm usefulness of the drug for the individual patient. CONTRAINDICATIONS Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated (see WARNINGS). Concomitant use in patients taking pimozide is contraindicated (see Drug Interactions – Pimozide and Celexa). Lexapro is contraindicated in patients with a hypersensitivity to escitalopram or citalopram or any of the inactive ingredients in Lexapro. WARNINGS WARNINGS-Clinical Worsening and Suicide Risk Clinical Worsening and Suicide Risk Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older. The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 1. TABLE 1: Age Range and Drug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated: Increases Compared to Placebo; <18 (14 additional cases); 18-24 (5 additional cases); Decreases Compared to Placebo; 25-64 (1 fewer case); 65 (6 fewer cases). No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide. It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression. All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and

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Managed Healthcare Executive - January 2009 Contents Editorial Advisors For Your Benefit News Analysis Politics & Policy Letter of the Law Managed Care Outlook New Day 5 New Realities of Disease Management Pharmacy Best Practices Health Management Technology State Report: Hawaii MHE Resource Ad/Edit Index

Managed Healthcare Executive - January 2009

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