White Paper: The Treatment of Schizophrenia and Bipolar Disorder

Transcription

1 White Paper: The Treatment of Schizophrenia and Bipolar Disorder in Children: What is Medically Necessary? For Health Plans, Medical Management Organizations and TPAs Trends in the Diagnosis and Treatment of Pediatric Bipolar Disorder and Schizophrenia According to one study s estimates, the diagnosis of bipolar disorder in children grew by 40-fold between and Many of these children exhibited a pattern not consistent with a bipolar diagnosis. Speci cally, bipolar disorder involves episodes of mania, which can show up in children as irritability. However, many of the children diagnosed did not have clear-cut episodes of irritability; instead, they were constantly irritable. Some experts believe that many children are being misdiagnosed. Bipolar disorder has become a controversial diagnosis in children. Diagnosis in young children is di!cult, especially since many of the symptoms are similar to those of attention de cit hyperactivity disorder (ADHD) or conduct disorders. Overdiagnosis of bipolar disorder results in unnecessary use of medications, which are often associated with serious side e"ects. On the other hand, underdiagnosis can be harmful as well if children remain untreated. Early-onset schizophrenia (onset before adulthood) is a rare, severe, and chronic form of schizophrenia. When it is diagnosed in young children, it results in long-term use of antipsychotic medication as a mainstay of treatment, along with psychotherapeutic intervention. Increasingly, e"orts are being made toward early detection and management of prodromal symptoms, which may make it possible to implement early preventative and treatment strategies before the onset of the syndromal illness. The use of medication at the prodromal stage, however, presents clinical and ethical challenges. Clinical Characteristics of Bipolar Disorder and Schizophrenia Bipolar Disorder Diagnosis in young children is di cult, especially since many of the symptoms are similar to those of ADHD or conduct disorders. The exact symptoms of bipolar disorder vary from person to person. For some people, depression causes the most problems; for others, manic symptoms are the main concern. Symptoms of depression and mania may also occur together. The manic phase of bipolar disorder can include severe changes in mood. Individuals may either be unusually happy or silly, or be very irritable, angry, agitated, or aggressive. Patients may also have unrealistic highs in self-esteem. For example, a teenager may feel all-powerful or like a superhero with special powers. Some patients may experience a great increase in energy and the ability to go with little or no sleep for days without feeling tired. Other manic symptoms of bipolar disorder include an increase in talking (talking too much or too fast, changing topics too quickly, and cannot be interrupted), distractibility (attention moves constantly from one thing to the next), and repeated high-risk-taking behavior (abusing alcohol and drugs, reckless driving, or sexual promiscuity). Depressive symptoms of bipolar disorder include irritability, depressed mood, persistent sadness, frequent crying, thoughts of death or suicide, and loss of enjoyment in favorite activities. Patients may also have frequent complaints of physical illnesses (such as headaches or stomach aches), or even boredom. Other depressive symptoms may include low energy level, fatigue, poor concentration, and major changes in eating or sleeping patterns. The fth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for bipolar disorder do not distinguish adult-onset from childhood- or adolescent-onset symptoms of bipolar disorder. The diagnostic criteria for bipolar disorder are the same regardless of the patient s age at the onset of symptoms. Despite clinically important di"erences in the way mood disorders, particularly behavioral di"erences manifest in a child or an adolescent, no diagnostic accommodations have yet been made on the basis of age. The criteria require a distinct period of elevated, expansive, or irritable mood and abnormally and persistently increased goal-directed activity or energy that lasts at least one week AllMed Healthcare Management Inc. 1

2 and presents most of the day, nearly every day in which three or more of the following are present (four if mood is only irritable): In#ated self-esteem or grandiosity Deacresed need for sleep More talkative, pressured speech Flight of ideas or racing thoughts Increased distractibility Increased goal-directed activity (psychomotor agitation) Involvement with pleasurable behaviors with the potential for painful consequences Schizophrenia The earliest indications of childhood schizophrenia may include developmental problems, such as language delays, late or unusual crawling, late walking, and other abnormal motor behaviors (such as rocking or arm #apping). Some of these signs and symptoms are also common in children with pervasive developmental disorders, such as autism. Ruling out these developmental disorders is one of the rst steps in diagnosing childhood schizophrenia. As children with schizophrenia age, more typical signs and symptoms of the disorder begin to appear, including: Seeing things and hearing voices that are not real (hallucinations) Odd and ecentric behavior and/or speech Unusual or bizarre thoughts and ideas Confusing television and dreams for reality Confused thinking Extreme moodiness Ideas that people are out to get them or talking about them (paranoia) Severe anxiety and fearfulness Di!culty relating to peers, and keeping friends Withdrawn and increased isolation Worsening personal grooming The DSM-V criteria for schizophrenia require two (or more) of the following, each present for a signi cant portion of time during a one-month period, or less if successfully treated (at least one of these should include 1-3): 1. Delusions 2. Hallucinations 3. Disorganized Speech 4. Grossly disorganized or catatonic behavior 5. Negative symptoms (i.e., diminished emotional expression or avolition) Pharmacologic Treatment Options Bipolar Disorder Medications Mood stabilizers, such as lithium carbonate, sodium divalproex, and carbamazepine, have traditionally been the mainstays of treatment of patients with bipolar disorder. They are indicated for control of manic episodes occurring in bipolar disorder. Lithium is considered a rst-line agent for long-term prophylaxis in bipolar illness. 2

3 Anticonvulsants have been e"ective in preventing mood swings associated with bipolar disorder. Valproic acid has proven e"ectiveness in treating and preventing mania. It is classi ed as a mood stabilizer and can be used alone or in combination with lithium. It is useful in treating rapid-cycling bipolar disorders and has been used to treat aggressive or behavioral disorders. Carbamazepine is e"ective in cases that do not respond to lithium therapy. It has been e"ective in treating rapid-cycling bipolar disorder. Atypical antipsychotics are increasingly used in bipolar disorder, with or without psychotic symptoms. This class of medications includes risperidone, quetiapine, olanzapine, aripiprazole, ziprasidone, and clozapine. In addition, benzodiazepines may be used to improve sleep and to modulate agitation during hospitalization. Schizophrenia Medications Atypical antipsychotics, such as aripiprazole, risperidone, quetiapine, olanzapine, and ziprasidone, are generally chosen as rst-line antipsychotic therapy for patients with schizophrenia. Occasionally, the agitated child with new-onset schizophrenia may need a benzodiazepine (such as lorazepam) to calm and alleviate the anxiety accompanying the experience of psychosis. Benzodiazepines have been used in combination with antipsychotic agents early in the treatment of acute psychosis when sedation is needed. Neuroleptic malignant syndrome (NMS) is an adverse e"ect of antipsychotic drugs and is characterized by fever, muscle rigidity, and autonomic dysfunction. The syndrome has been treated with dopamine agonists, such as bromocriptine and amantadine. Other drugs used include dantrolene sodium, benztropine, and diphenhydramine. Anticholinergic drugs have been used to prevent and treat acute dystonia, parkinsonism, and NMS, as well as tardive dyskinesia. Benztropine can be started concurrently with antipsychotic drugs to prevent or control extrapyramidal reactions that occur as adverse e"ects of neuroleptic agents. In addition, beta-adrenergic blockers have been used to treat akathisia, tremor, anxiety, and aggression. Propranolol may be helpful in treating akathisia. Potential Side E"ects of Atypical Antipsychotics The use of atypical antipsychotics has been associated with metabolic changes, such as weight gain, hyperglycemia, and hyperlipidemia. Other potential side e"ects include sedation, restlessness, and extrapyramidal side e"ects such as movement disorders (e.g., tardive dyskinesia). Recommendations for monitoring adults on atypical antipsychotics include checking the following: Weight at baseline, 4, 8, and 12 weeks, and then quarterly Waist circumference at baseline and annually Blood pressure at baseline, 12 weeks, and annually Fasting plasma glucose level at baseline, 12 weeks, and annually Fasting lipid pro le at baseline, 12 weeks, and every 5 years Similar recommendations regarding atypical antipsychotics are not yet available for children and adolescents, but careful monitoring of weight, waist circumference, blood pressure, and glucose and lipids levels may be warranted. Nonpharmacologic Treatment Approaches Therapeutic interventions that appear to be helpful in bipolar disorder include family-focused therapy, interpersonal and social rhythm therapy, and cognitive-behavioral therapy. The goals of these therapies are shown in Table 1. 3

4 Table 1. Goals of Psychosocial Treatment of Pediatric Bipolar Disorder Family-focused therapy Interpersonal and social rhythm therapy Cognitive-behavioral therapy > Increased communication > Educate patient about prodromes and develop a plan to intervene > Examine beliefs about medication and adherence > Stabilize daily routines and sleep-wake cycle > Improve personal relationships and insight into moods > Track sleep, activities, and mood > Restructure dysfunctional beliefs > Monitor moods and prodromes > Intervene constructively to alter moods Psychosocial treatment of pediatric schizophrenia should include psychoeducation for the patient and the patient s family. For the patient, this involves education about the illness and treatment options, relapse prevention, basic life skills training, social skills training, and problem-solving skills training. Families must also be educated on the illness and treatment options, as well as the patient s prognosis and strategies to cope with the patient. Children with bipolar disorder or schizophrenia require multimodal care. Additional psychosocial treatments that may be indicated include special education, vocational programs, and community support with social acceptance (such as school programs). Health Plan Coverage Requirements Based on American Academy of Child and Adolescent Psychiatry (AACAP) Practice Parameters Most health plans cover treatment of pediatric bipolar disorder and schizophrenia based on practice parameters developed by the AACAP. The latest recommendations for the assessment and treatment of children and adolescents with bipolar disorder can be summarized as follows: Psysciatric assessments for children and adolescents should include screening questions for bipolar disorder Youths with suspected bipolar disorder must also be carefully evaluated for other associated problems, including suicidality, comorbid disorders (including substance abuse), psychosocial stressors, and medical problems The diagnostic validity of bipolar disorder in young children has yet to be established. Caution must be taken before applying this diagnosis in preschool children Psyschopharmacological interventions require baseline and follow-up symptom, side e"ect (including patient s weight), and laboratory monitoring as indicated Psyschotherapeutic interventions are an important component of a comprehensive treatment plan for early-onset bipolar disorder For children and adolescents with schizophrenia, the AACAP recommends the following: Psychiatric assessments for children and adolescents should include screening questions for psychosis The diagnosis of schizophrenia in children and adolescents should follow DSM-V criteria, using the same criteria as for adults Youth with suspected schizophrenia should be carefully evaluated for other pertinent clinical conditions and/or associated problems, including suicidality, comorbid disorders, substance abuse, developmental disabilities, psychosocial stressors, and medical problems Antipsychotic medication is a primary treatment for schizophrenia spectrum disorders in children and adolescents. Ongoing medication therapy should be provided to most youths with schizophrenia to improve functioning and prevent relapse Some youths with schizophrenia spectrum disorders may bene t from adjunctive medication treatments to address side e"ects of the antipsychotic agent or to alleviate associated symptomatology (such as agitation, mood instability, depression, explosive outbursts) A trial of clozapine should be considered for youths with treatment resistant schizophrenia spectrum disorders. Baseline and follow-up monitoring of symptoms, side e"ects, and laboratory tests should be performed as indicated. Psychotherapeutic interventions should be provided in combination with medication therapies 4

5 Electroconvulsive therapy may be used with severely impaired adolescents if medications either are not helpful or cannot be tolerated. Due to the speci c risks associated with the use of atypical antipsychotic agents (AAAs), the AACAP states that factors to address, prior to the initiation of treatment with the AAAs, include obtaining and documenting: target symptoms, pretreatment abnormal movements, suspected side e"ects, and the monitoring for known side e"ects; a personal and family history of diabetes and hyperlipidemia, seizures and cardiac abnormalities, as well as any family history of previous response or adverse events associated with AAAs; any required baseline and follow-up laboratory monitoring (parameters indicative of the onset of metabolic syndrome such as fasting blood sugar or hemoglobin A1C, lipid pro le, weight, and BMI); and treatment response. T The AACAP practice parameters for the use of AAAs in children and adolescents also recommend: Dosing of the AAAs should follow the start low and go slow approach and seek to nd the lowest e"ective dose, recognizing that dosing may di"er based on the targeted symptoms and patient diagnosis If side e"ects such as movement disorders or sedation do occur, a trial at a lower dose should be considered; however, certain side e"ects (e.g., NMS) may preclude further treatment with the speci c AAA The use of multiple psychotropic medications in refractory patients may, at times, be necessary but has not been studied rigorously. Clinicians should proceed with caution The acute and long-term safety of these medications in children and adolescents has not been fully evaluated; therefore careful and frequent monitoring of side e"ects should be performed A BMI measurement should be obtained at baseline and monitored at regular intervals throughout treatment with an AAA Careful attention should be given to the increased risk of developing diabetes with the use of AAA, and blood glucose levels and other parameters (clinical signs and symptoms of diabetes and hemoglobin A1C) should be obtained at baseline and monitored at regular intervals In those patients with signi cant weight changes and/or a family history indicating high risk, lipid pro les should be obtained at baseline and monitored at regular intervals Measurements of movement disorders utilizing structured measures, such as the Abnormal Involuntary Movement Scale, should be done at baseline and at regular intervals during treatment and during tapering of the AAA Due to limited data surrounding the impact of AAAs on the cardiovascular system, regular monitoring of heart rate, blood pressure and EKG changes should be performed Although there is a relationship between AAA use and elevations of prolactin, the current state of evidence does not support the need for routine monitoring of prolactin levels in asymptomatic youths Due to drug-speci c risks, additional monitoring should be considered for speci c AAAs o Clozapine may be associated with agranulocytosis and neutropenia, may lower the seizure threshold, and may cause substantial weight gain o Hematological monitoring, pre-treatment EEG and a comparison EEG when optimal drug levels have been achieved, and monitoring of liver enzymes should be conducted. o Quetiapine may increase risk of cataract formation. Baseline ophthalmologic examination with periodic o re-assessment should be conducted. Ziprasidone may increase risk of QTc changes An EKG at baseline and once a stable dose is achieved should be conducted. The limited long-term safety and e!cacy data warrants careful consideration, before the initiation of medication, of the planned duration of the medication trial Abrupt discontinuation of a medication is not recommended 5

6 The Role of External Independent Medical Review in Determining Medical Necessity for Treatment of Pediatric Bipolar Disorder and Schizophrenia Safe and e"ective treatment of pediatric patients with bipolar disorder and schizophrenia has become increasingly complex due to more common use of atypical antipsychotic agents in children and adolescents. An independent medical review, which is normally used by healthcare payers, looks at whether or not a speci c therapy or procedure was medically necessary. Healthcare plans may lack board-certi ed specialists internally. Independent review organizations (IROs) allow ready access to a range of board-certi ed physician specialists. The specialists who review cases for IROs keep up-to-date with the latest medical research literature and with the latest standard of care, staying on top of continually evolving therapies as they are studied more extensively and potentially accepted into clinical guidelines. Conclusion Accurate diagnoses of bipolar disorder and schizophrenia in children, which pose many challenges, are critical not only due to the importance of timely treatment, but also because of the risks associated with over-diagnosing and stigmatizing children. While studies have shown that medications are e"ective for the treatment of young patients with these disorders, a comprehensive treatment approach ideally consists of both pharmacologic and non-pharmacologic options in order to allow for optimal care while meeting the unique needs of individual patients. Bibliography American Academy of Child and Adolescent Psychiatry. Practice parameter for the use of atypical antipsychotic medications in children and adolescents. Available at: Atypical_Antipsychotic_Medications_Web.pdf. Accessed December 1, American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Arlington, Va: American Psychiatric Publishing; May McClellan J, Kowatch R, Findling RL; Work Group on Quality Issues. Practice parameter for the assessment and treatment of children and adolescents with bipolar disorder. J Am Acad Child Adolesc Psychiatry. 2007;46: McClellan J, Stock S; American Academy of Child and Adolescent Psychiatry (AACAP) Committee on Quality Issues (CQI). Practice parameter for the assessment and treatment of children and adolescents with schizophrenia. J Am Acad Child Adolesc Psychiatry. 2013;52: Moreno C, Laje G, Blanco C, Jiang H, Schmidt AB, Olfson M. National trends in the outpatient diagnosis and treatment of bipolar disorder in youth. Arch Gen Psychiatry. 2007;64: About AllMed AllMed Healthcare Management provides physician review outsourcing solutions to leading health plans, medical management organizations, TPAs and integrated health systems, nationwide. AllMed o"ers MedReview (SM), MedCert (SM), and Medical Director sta!ng services that cover initial pre-authorizations and both internal and external appeals, drawing on a panel of over 400 board-certi ed specialists in all areas of medicine. Services are deployed through PeerPoint, AllMed s state-of-the-art medical review portal. For more information on how AllMed can help your organization improve the quality and integrity of healthcare, contact us today at info@allmedmd.com or visit us at 621 SW Alder St., Suite 740 Portland, OR