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Atypical Antipsychotics Policy Number: C5016-A

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Prior Authorization Criteria Atypical Antipsychotics Policy Number: C5016-A CRITERIA EFFECTIVE DATES: ORIGINAL EFFECTIVE DATE LAST REVIEWED DATE NEXT REVIEW DATE 4/2014 07/31/2019 07/31/2020 J CODE TYPE OF CRITERIA LAST P&T APPROVAL/VERSION J1942/C9035 Injection, aripiprazole lauroxil Q1 2019 (aristada initio), 1 mg 20190828C5016-A J0401 Injection, aripiprazole, RxPA extended release, 1 mg J3490 (NOC)- Unclassified drugs, Saphris PRODUCTS AFFECTED: ABILIFY (aripiprazole), FANAPT (iloperidone), INVEGA (paliperidone), LATUDA (lurasidone), REXULTI (brexpiprazole), SAPHRIS (asenapine), SEROQUEL XR (quetiapine), VRAYLAR (cariprazine) DRUG CLASS: Atypical Antipsychotic ROUTE OF ADMINISTRATION: Oral, Injection PLACE OF SERVICE: Retail Pharmacy, Specialty Pharmacy, Buy and Bill The recommendation is that medications in this policy will be for pharmacy benefit coverage and patient self-administered or shipped to provider setting for administration AVAILABLE DOSAGE FORMS: Abilify tablets 2MG, Abilify tablets 5MG, Abilify tablets 10MG, Abilify tablets 15MG, Abilify tablets 20MG, Abilify tablets 30MG, Aripiprazole Tab 2MG, Aripiprazole Tab 5MG, Aripiprazole Tab 10MG, Aripiprazole Tab 15MG, Aripiprazole Tab 20MG, Aripiprazole Tab 30MG, Abilify Maintena 300MG, Abilify Maintena 400MG, Fanapt tablets 1MG, Fanapt tablets 2MG, Fanapt tablets 4MG, Fanapt tablets 6MG, Fanapt tablets 8MG, Fanapt tablets 10MG, Fanapt tablets 12MG, Fanapt Titration Pack tablets 1 & 2 & 4 & 6MG, Invega tablets 1.5MG, Invega tablets 3MG, Invega tablets 6MG, Invega tablets 9MG, Paliperidone tablets ER 24HR 1.5MG, Paliperidone tablets ER 24HR 3MG, Paliperidone tablets ER 24HR 6MG, Paliperidone tablets ER 24HR 9MG, Latuda tablets 20MG, Latuda tablets 40MG, Latuda tablets 60MG, Latuda tablets 80MG, Latuda tablets 120MG, Saphris SUBL 2.5MG, Saphris SUBL 5MG, Saphris SUBL 10MG, SEROquel XR tablet 50MG, SEROquel XR tablet 150MG, SEROquel XR tablet 200MG, SEROquel XR tablet 300MG, SEROquel XR tablet 400MG, Quetiapine Fumarate Tab ER 24HR 50MG, Quetiapine Fumarate Tab ER 24HR 150MG, Quetiapine Fumarate Tab ER 24HR 200MG, Quetiapine Fumarate Tab ER 24HR 300MG, Quetiapine Fumarate Tab ER 24HR 400MG, Vraylar capsules 1.5MG, Vraylar capsules 3MG, Vraylar capsules 4.5MG, Vraylar capsule 6MG FDA-APPROVED USES: Page 1 of 8 Molina Healthcare, Inc. confidential and proprietary © 2018 This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed or printed without written permission from Molina Healthcare. This page contains prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliated with Molina Healthcare. Prior Authorization Criteria � Abilify Oral Tablets and Oral Solution are indicated for the treatment of: Schizophrenia, Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder, Adjunctive Treatment of Major Depressive Disorder, Irritability Associated with Autistic Disorder, Treatment of Tourette’s Disorder Fanapt tablets are indicated for the treatment of adults with schizophrenia. Invega (paliperidone) Extended-Release Tablets are indicated for the treatment of schizophrenia, treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressant therapy. Latuda is indicated for the treatment of patients with schizophrenia, depressive episodes associated with bipolar I disorder monotherapy, adjunctive therapy with lithium or valproate Rexulti is indicated for: Adjunctive treatment of major depressive disorder (MDD), Treatment of schizophrenia Saphris is indicated for: Schizophrenia, Acute treatment of manic or mixed episodes associated with Bipolar I disorder as monotherapy or adjunctive treatment to lithium or valproate. Seroquel XR is indicated for the treatment of schizophrenia, acute treatment of manic or mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex, acute treatment of depressive episodes associated with bipolar disorder, maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex, adjunctive therapy to antidepressants for the treatment of MDD. Vraylar is indicated for the treatment of schizophrenia, acute treatment of bipolar mania COMPENDIAL APPROVED OFF-LABELED USES: Invega Delusional infestation (also called delusional parasitosis), psychosis/agitation associated with dimensia Latuda Major depressive disorder with mixed features; psychosis/agitation associated with dimensia Rexulti Psychosis/agitation associated with dementia Saphris psychosis/agitation associated with dementia Seroquel XR Agitation and/or delirium, delusional infestation, generalized anxiety disorder, MDD monotherapy, obsessive compulsive disorder, posttramatic stress disorder, psychosis/agitation associated with dementia, psychosis in Parkinson disease Vraylar Major depressive disorder, unipolar, augmentation of antidepressant; Psychosis/agitation associated with dementia COVERAGE CRITERIA: INITIAL AUTHORIZATION DIAGNOSIS: see FDA approved uses and compendial approved off-labeled uses REQUIRED MEDICAL INFORMATION: A. FOR ALL INDICATIONS: 1. Member is using the requested drug for an FDA-Approved indication OR an indication supported in the compendia of current literature (examples: AHFS, Micromedex, current accepted guidelines) AND Page 2 of 8 Molina Healthcare, Inc. confidential and proprietary © 2018 This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed or printed without written permission from Molina Healthcare. This page contains prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliated with Molina Healthcare. Prior Authorization Criteria � 2. (a) The member’s medication history includes use of all preferred generic formulary atypical antipsychotic agents with matching indication OR documented intolerance, FDA labeled contraindication, or hypersensitivity to all preferred generic formulary atypical antipsychotic agents with matching indication OR (b) Documentation that the patient is using the requested agent AND is at risk if therapy is changed OR has recently (within 48 hours) been discharged AND 3. The member is requesting Abilify OR Abilify Discmelt for Tourette’s Disorder AND ONE of the following: the member’s medication history includes the use of haloperidol OR pimozide in the past 90 days OR has a documented intolerance, FDA labeled contraindication, or hypersensitivity to generic haloperidol and pimozide DURATION OF APPROVAL: Initial authorization: 12 months, Continuation of therapy: 12 months QUANTITY: No requirement PRESCRIBER REQUIREMENTS: None AGE RESTRICTIONS: ABILIFY (aripiprazole): 6 years of age and older LATUDA (lurasidone), SAPHRIS (asenapine), SEROQUEL XR (quetiapine): 10 years of age and older INVEGA (paliperidone): 12 years of age and older FANAPT (iloperidone), REXULTI (brexpiprazole), VRAYLAR (cariprazine): 18 years of age and older GENDER: Male and female CONTINUATION OF THERAPY: A. FOR ALL INDICATIONS: 1. Documentation in target symptom improvement AND 2. Treatment plan that contains either plan for discontinuation or rationale for continued use (with monitoring for tardive dyskinesia) CONTRAINDICATIONS/EXCLUSIONS/DISCONTINUATION: All other uses of atypical antipsychotics are considered experimental/investigational and therefore, will follow Molina’s Off- Label policy. Antipsychotics are NOT covered for members with use of more than one antipsychotic, unless cross titration is needed for up to 60 days, unless prescriber can provide documentation that that the first agent is titrated to highest possible dose, before adding on another agent for unsolved symptoms. OTHER SPECIAL CONSIDERATIONS: None Page 3 of 8 Molina Healthcare, Inc. confidential and proprietary © 2018 This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed or printed without written permission from Molina Healthcare. This page contains prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliated with Molina Healthcare. Prior Authorization Criteria � BACKGROUND: Schizophrenia The initial choice of antipsychotic medication or the decision to switch to a new antipsychotic should be made on an individual basis, considering prior treatment response, side effect experience; adherence history; relevant medical history, risk factors; individual medication side effect profile; and long-term treatment planning. Clozapine can be effective for psychotic symptoms in patients not responding to other drugs, and appears to be more effective vs other antipsychotics in decreasing the risk of suicide. Although clozapine is the most effective antipsychotic drug, it is reserved for refractory disease due to its potential hematologic toxicity and strict monitoring requirements. Olanzapine may have some slight advantages over other drugs in efficacy, but its adverse effects on weight and metabolism may be unacceptable for long term use. Some patients who do not respond to one antipsychotic may respond to another. Long-acting injectable antipsychotics may be useful when adherence is a problem. Bipolar Disorder For acute manic episodes, patients not already taking long-term treatment for bipolar disorder should consider oral administration of a dopamine antagonist when
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