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Utah Medicaid Dur Report December 2020 Newer Oral UTAH MEDICAID DUR REPORT DECEMBER 2020 NEWER ORAL ANTIPSYCHOTICS Brexpiprazole (Rexulti) Cariprazine (Vraylar) Lumateperone (Caplyta) Report finalized: November 2020 Report presented: December 2020 Drug Regimen Review Center Lauren Heath, Pharm.D., MS, BCACP, Assistant Professor (Clinical) Valerie Gonzales, Pharm.D., Clinical Pharmacist Vicki Frydrych, B.Pharm., Pharm.D., Clinical Pharmacist Joanne LaFleur, Pharm.D., MSPH, Associate Professor University of Utah ColleGe of Pharmacy, DruG ReGimen Review Center Copyright © 2020 by University of Utah ColleGe of Pharmacy Salt Lake City, Utah. All riGhts reserved Contents Background on Antipsychotic Medications ................................................................................................. 3 Table 1. Overview of Oral and Short-acting Injectable Antipsychotics Indications ............................. 6 Methods ..................................................................................................................................................... 13 Guideline Recommendations for Schizophrenia, Bipolar Disorder and Autism Spectrum Disorder ......... 14 A. Schizophrenia ................................................................................................................................ 14 Table 2. Summary of Select Recent Clinical Practice Guidelines for Schizophrenia in Adults ........... 18 B. Bipolar Disorder ............................................................................................................................ 25 Table 3. Summary of Select Recent Clinical Practice Guidelines for Bipolar Disorder ...................... 30 C. Autism Spectrum Disorder ............................................................................................................ 39 Table 4. Select Recent Autism Spectrum Disorder Related Treatment Guidelines ........................... 40 Metabolic Side Effects (MSE) of Antipsychotics ........................................................................................ 43 Table 5. Antipsychotic Approximate Relative Side Effects with Oral Formulations .......................... 46 Recommendations related to MSE among selected schizophrenia and bipolar disorder guidelines ... 47 Table 6. Selected Information about Relative Metabolic Side Effects in Schizophrenia and Bipolar Treatment Guidelines ........................................................................................................................ 49 Efficacy and Safety of Newer Antipsychotics (brexpiprazole, cariprazine, lumateperone) ....................... 54 Efficacy for schizophrenia and/or bipolar disorder ............................................................................... 54 Expert opinion about potential differences .......................................................................................... 56 Safety ..................................................................................................................................................... 57 Summary of Warnings and Precautions ..................................................................................................... 59 Table 9. Warnings and precautions for select FGAs and all SGAs ..................................................... 61 Considerations for Prior Authorization Criteria ......................................................................................... 64 Summary .................................................................................................................................................... 68 References ................................................................................................................................................. 70 Appendix A: Proposed Mechanism of Action and Receptor Binding Profile ............................................. 77 Appendix B: Literature Search Strategy ..................................................................................................... 79 Appendix C: Overview of Other Common Medications for Bipolar Disorder ............................................ 81 Appendix D: Summary of a Meta-analysis for Efficacy Measures with Cariprazine and Brexpiprazole for Schizophrenia ............................................................................................................................................. 83 2 Background on Antipsychotic Medications Antipsychotics encompass a broad class of medications named for the ability to treat psychotic or related symptoms. Early antipsychotics (often referred to as first generation or “typical” antipsychotics [FGAs]), starting with chlorpromazine, were pioneered in the 1950s.1 Since then, many more antipsychotics have been developed; the next “phase” of antipsychotics emerged in the 1980s, with the approval of clozapine.2 This next generation of antipsychotics is often referred to as second generation or “atypical” antipsychotics [SGAs]. More recently, newer antipsychotics with unique pharmacodynamic properties have emerged (starting in 2002 with aripiprazole) that are sometimes referred to as third generation antipsychotics (TGA).3,4 For this report, we will use the terminology of FGAs and SGAs (with “TGA” included among SGAs). SGAs were initially lauded as having a better side effect profile (primarily fewer extrapyramidal side effects such as dystonia, parkinsonism, and a lower propensity for tardive dyskinesia [TD]) with possibly greater efficacy for certain symptoms of schizophrenia incompletely treated with FGAs. However, now some of these distinctions are questioned, and most SGAs are known to have negative metabolic side effects. Although the FGAs and SGAs terminology are still commonly used, the medications are heterogeneous with some varying potential benefits and side effect profiles.1 In general, compared to FGAs, most SGAs are associated with fewer EPS and more metabolic side effects such as weight gain, hyperglycemia, and dyslipidemia.1,5 Most FGAs and SGAs seem similarly effective for psychotic and manic symptoms, but SGAs may have additional benefits for mood disorders.1 For the maintenance treatment of schizophrenia, SGAs are often a treatment of choice compared to FGA, perhaps due to concerns for the long-term risk of TD.1 However, both short-acting injectable FGAs and SGAs may be used for the acute treatment of agitation associated with schizophrenia or bipolar disorder.6,7 For bipolar disorder, SGAs are mainstay treatment options as first-line therapy for the treatment of acute symptoms and option for maintenance therapy. The 2018 Canadian Network for Mood and Anxiety Treatments (CANMAT) guideline specifies FGAs as third-line options for certain situations, but other guidelines by the British Association for Psychopharmacology (BAP) and National Institute for Health Care Excellence (NICE) include haloperidol as a first-line option along with SGAs for the treatment of mania.8-10 There are approximately 27 unique chemical entities available in the US (12 FGAs, 15 SGAs) with common pharmacologic properties (eg, dopamine receptor antagonism and/or partial agonism) that can be referred to as “antipsychotics”; however, not all of these products are approved to treat psychotic symptoms. Table 1 lists antipsychotics available in the US, along with their approved indication and possible off-label uses (except for long-acting injectables, which will be discussed in a future report). Note that in some cases FDA-approval varies by formulation. Most antipsychotics are indicated to treat schizophrenia/psychotic disorders or agitation/aggression associated with schizophrenia or bipolar I disorder. Among those indicated for schizophrenia, clozapine is uniquely indicated for treatment- resistant schizophrenia and for reducing the risk of suicide associated with schizophrenia/schizoaffective disorders; and paliperidone is indicated for schizoaffective disorder.2,11 Two dopamine antagonists are not FDA-approved for any psychiatric condition (ie, droperidol and amisulpride which are approved for postoperative nausea and vomiting). Some additional indications (may vary by formulation; see Table 1) include Tourette’s syndrome (pimozide, haloperidol, aripiprazole); anxiety (prochlorperazine, trifluoperazine); irritability associated with autism spectrum disorders (aripiprazole, risperidone); 3 adjunctive treatment of major depressive disorder (aripiprazole, brexpiprazole, quetiapine extended- release) or treatment-resistant depression (olanzapine/fluoxetine); and Parkinson’s disease associated psychosis (pimavanserin).3,12-20 Antipsychotic approval for treatment of bipolar I disorder varies based on the primary symptoms (ie, mania vs. depression), duration (ie, acute mania or depression vs. maintenance treatment), and as monotherapy or adjunctive use. The only FGA indicated for bipolar disorder [BD] (other than for agitation) is chlorpromazine, for bipolar mania.21 SGAs oral formulations indicated in adults for the treatment of bipolar disorder are as follows: • BD I depression (acute) as monotherapy: cariprazine, lurasidone, olanzapine/fluoxetine15,22,23 • BD I depression (acute) as adjunct to lithium or valproate: lurasidone22 • BD I/II depression (acute) as monotherapy: quetiapine13 • BD I mania/mixed (acute) as monotherapy: aripiprazole, asenapine, cariprazine, olanzapine, quetiapine (immediate-release is only labeled for mania), risperidone, ziprasidone3,23,24 12,25-27 • BD I mania/mixed (acute) as adjunct to lithium or valproate: aripiprazole, asenapine, olanzapine,
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